As the COVID-19 pandemic continues to unfold, we're tracking the biopharma industry's response here.

Please read below for the latest updates. Daily COVID-19 tracker entries from Nov. 30 to Dec. 22 can be found here. April 29 to Nov. 29 can be found here. Daily entries from Nov. 2, 2020, to April 28 can be found here.

UPDATED: Wednesday, April 13 at 10:56 a.m. ET

By the fall, Pfizer could have an updated COVID-19 vaccine that would protect against omicron and previous variants, CEO Albert Bourla said during a press conference held by the International Federation of Pharmaceutical Manufacturers & Associations. “It’s easy to do something only against omicron,” said Bourla, who added that it is much more difficult to create a shot to defend against all variants.

Serum Institute of India CEO Adar Poonawalla said that COVID-19 vaccines made in India offer superior protection than mRNA vaccines from Pfizer and Moderna. “It’s good that vaccines like Pfizer and Moderna are not introduced in India, because in countries like U.S., people have taken second and third booster doses and still many are getting infected,” Poonawalla told Asia News International.

Shionogi’s COVID-19 oral antiviral, which is still awaiting approval, has been linked to birth defects and is not recommended for use by pregnant women, the Tokyo-based company said. Fetal abnormalities were discovered in testing on animals, a previous report had found.

UPDATED: Tuesday, April 12 at 10:46 a.m. ET

Thousands more patients in the U.K. will be able to access Pfizer’s oral antiviral Paxlovid after it was added to the national Panoramic study, which aims to assess how to best use the drug among Britain’s highly vaccinated population. It’s the second antiviral to join the trial behind Merck & Co. and Ridgeback Biotherapeuticsmolnupiravir, the U.K.’s Department of Health and Social Care noted in a release. The study has recruited more than 20,000 people to generate data on Merck and Ridgeback’s drug, and 17,500 more will be able to join to access Paxlovid, the U.K. said. Story

Meanwhile, Pfizer’s pandemic sales haul from vaccine Comirnaty and antiviral pill Paxlovid may disappoint in the first quarter, analysts at Cantor Fitzgerald warned in a note to clients Monday. Based on publicly available info from governments about antiviral orders delivered, the team figures “consensus [sales] estimates … are too high.” Despite dialing back its estimate for the first three months of the year, the Cantor Fitzgerald team noted it was keeping its full year projections for Pfizer intact. Story

Fierce Pharma has published its report on the top 20 pharma companies by 2021 revenue, and many pandemic stalwarts have made the cut. Pfizer clinched silver with $81.29 billion in annual sales, eclipsed only by Johnson & Johnson, which took home a whopping $93.77 billion in 2021 revenue. mRNA compatriot Moderna, for its part, landed the no. 18 spot with $18.47 billion in sales, buoyed by its massively successful vaccine Spikevax. Other COVID players like AstraZeneca and Eli Lilly also made the rankings. Story

The U.S. FDA slapped Ocugen with a clinical hold on the phase 2/3 study for its Bharat Biotech-partnered vaccine Covaxin, the company said Tuesday. Covaxin has been approved outside the U.S., but it recently ran into trouble with the World Health Organization over manufacturing shortfalls at Bharat’s facilities. The clinical hold stems directly from Ocugen’s move to “voluntarily implement a temporary pause in dosing participants of OCU-002 while it evaluates statements made by the World Health Organization following their inspection of Bharat Biotech International Limited’s (BBIL) manufacturing facility,” the company said in a statement. It added thatat it will work with the FDA to address any questions. Story

UPDATED: Monday, April 11 at 9:28 a.m. ET

After inking a deal to buy up to 120 million AstraZeneca COVID-19 doses, Japan is canceling a third of its order, Reuters reports. Local drugmaker Daiichi Sankyo has been responsible for producing most of the order. 

Oncology-focused biotech Veru reported that its oral drug sabizabulin bested placebo at reducing deaths among hospitalized patients. With the phase 3 results, the company plans to meet with the FDA to seek an emergency use authorization.

Pfizer has offered $100 million for Brisbane, Australia-based ResApp, which has developed smartphone tech that the company says can diagnose COVID-19 from the sound of a cough, The Sydney Morning Herald reports. It's reportedly part of a push at Pfizer to dive deeper into digital health. 

UPDATED: Friday, April 8 at 3:00 p.m. ET

Thailand has granted emergency use authorization to Novavax and the Serum Institute of India for their COVID-19 vaccine, Covovax. The shot also is authorized for use by adults in India, Indonesia, the Philippines and Bangladesh. In India, it is approved for those 12 and older.

The University of Illinois Chicago has scored a $22 million grant from the NIH to study long COVID. The goal of the nationwide Recover study is to determine why some who contract the virus suffer long-term effects while others shake it off quickly.

Since the last week of March, COVID-19 cases are on the rise by 60% in New York City and have doubled in Washington, D.C. The BA.2 variant of omicron has been key to the surges in the northeast part of the U.S., while cases in the country have generally plateaued after steadily falling over the previous few months.

The Tennessee legislature voted in favor of making the controversial horse parasite medicine Ivermectin available to COVID-19 patients over the counter. The bill would also excuse doctors who prescribe Ivermectin from liability. The state Senate voted 23-6 to approve the measure, and the state House came in with a 66-20 margin. Gov. Bill Lee will have the final say on passage.

COVID-19 has changed biotech in ways no one could have imagined. Companies had to think on their feet when presented with new, unforeseen challenges. Fierce Biotech examines 10 ways that the pandemic has altered the industry landscape. Story

UPDATED: Friday, April 8 at 10:50 a.m. ET

BioNTech will manufacture and supply mRNA vaccines in emergency situations for Germany as the company said it is among those who have been selected for pandemic preparedness. The contract runs through 2027 and specifies that BioNTech will provide 80 million doses to the country per year. Last month, a story by Reuters said that BioNTech and CureVac were among the companies Germany tapped to lock up emergency mRNA vaccine capacity.

In an interview with Employee Benefit News, Moderna’s senior director of global benefits Erin Sarin provides insight into the company’s hyper growth as it went from 800 employees to 3,000, becoming an industry force. As an example of what Moderna faces: Ten months ago, the company was in three countries. Now that number is 13. By July, it will be 22.

UPDATED: Thursday, April 7 at 11:00 a.m. ET

It takes more than a full approval to convince Americans to take a COVID-19 vaccine, according to study in the JAMA Network. The report showed that promoting the Pfizer vaccine from an emergency authorization to a full approval in September of last year did little to spur uptake of the shot among the unvaccinated.

How available are COVID-19 antiviral pills? Very available, at least in New York, where the state’s 55 Stop & Shop outlets are carrying both the Paxlovid oral treatment from Pfizer and Lagevrio from Merck. The drugs are free to those who have a valid prescription from a healthcare provider, the company said.

A phase 3 trial of Kintor Pharmaceutical’s proxalutamide shows it is 100% effective in outpatients with mild-to-moderate COVID-19 according to the China-based company. The drug showed effectiveness against both the delta and omicron variants.

Don't count on COVID-19 booster shots being provided seasonally. In Europe, regulators concluded that it is too early to consider allowing a fourth dose of the Pfizer or Moderna vaccine. Meanwhile in the U.S., a panel of experts has directed the FDA to devise a plan for annual boosting against COVID-19. This comes just a week after the FDA signed off on allowing people 50 and older to receive a fourth vaccine dose. Story

UPDATED: Wednesday, April 6 at 9:12 a.m. ET

As lawmakers work through a potential $10 billion COVID-19 aid package, the U.S. still owes $5 billion for Paxlovid pills it purchased from Pfizer, Bloomberg reports. That means about half of the new aid money could go toward paying the Pfizer contract, according to the news service.

New data from Israel show that a fourth Pfizer vaccine dose provided only a short duration of protection against infection for people 60 and older, CNN reports. Protection against severe infection seemed to last at least six weeks, but the study didn't run long enough to determine exactly how long the benefits lasted.

Shanghai's citywide testing program has detected a wave of cases, so the lockdown there is being extended, CNN reports. China on Tuesday reported more than 20,000 cases, its most at any point in the pandemic.

UPDATED: Tuesday, April 5 at 10:48 a.m. ET

COVAX and the African Union declined options to purchase more Moderna vaccine doses in a sign that demand may be waning for the mRNA shots, Bloomberg reports. The groups had options to purchase hundreds of millions of doses but opted not to.

The FDA is hosting an expert panel to discuss coronavirus vaccination strategy moving forward. The group will meet on Wednesday and discuss follow-up boosters, potential new COVID-19 vaccines and more. 

The pandemic has resulted in some major financial gains for companies on the front lines of the vaccination effort. For his part, BioNTech CEO Ugur Sahin collected 11.58 million euros ($12.67 million) in total compensation last year, according to an SEC filing.

UPDATED: Monday, April 4, at 10:52 a.m. ET

The FDA put Roche's application for full approval of Actemra as a COVID treatment under priority review, with a target decision date in the second half of the year. The repurposed rheumatoid arthritis drug currently bears an ermgency use authorization for hospitalized patients with serious COVID thanks to its mechanism to contain dangerous inflammatory reactions.

After the FDA cleared another round of vaccine boosters, experts are questioning whether boosting is an appropriate long-term strategy. “I don’t think we can simply boost our way out of the pandemic,” Weill Cornell Medicine professor of microbiology and immunology John P. Moore told Forbes. Dan Barouch of Harvard Medical School said that boosting every three to six months is not “practical” for wealthy countries and is “simply not possible” for poorer countries.

The Senate will discuss whether to trim a broader emergency coronavirus response package to $10 billion from $15.6 billion. The funding, part of a global vaccination effort, is key to President Joe Biden’s strategy of reducing vaccine inequality and limiting the impact of the next coronavirus variant, The New York Times reports.

Amid a lockdown, a robotic dog with a loudspeaker strapped to its back was seen as a messenger dispensing COVID-related safety advice in Shanghai, South China Morning Post reports.

UPDATED: Friday, April 1, at 10:55 a.m. ET

Merck and Ridgeback Therapeutics said new data analyses show their oral antiviral Lagevrio, also known as molnupiravir, was associated with faster elimination of infectious virus than placebo in a phase 3 trial. The companies are presenting the findings at the European Congress of Clinical Microbiology & Infectious Diseases.

Amid Congressional gridlock on new COVID-19 funding, a group of Democratic and Republican senators have reached an agreement to cut a proposed aid package to $10 billion from $15.6 billion, The New York Times reports. The Biden administration has been pushing for new funding to help pay for vaccines, therapeutics and tests.

A new study finds that vaccinated pregnant women and people who have had organ transplants are at higher risk of breakthrough infections. On the contrary, people with cancer didn't have a higher risk of being infected while fully vaccinated.

UPDATED: Thursday, March 31, at 11:05 a.m. ET

The NIH has kicked off a trial of a second booster dose in adults using a variety of vaccines and formulations in an attempt to discover which can best broaden immune responses. “We are looking beyond the omicron variant to determine the best strategy to protect against future variants,” said NIAID director Anthony S. Fauci, M.D. “This trial will help us understand if we can use prototype and variant vaccines alone or together to shift immune responses to cover existing and emerging COVID-19 variants.”

The FDA has added more than 20 states and territories to its list of those where distribution of GlaxoSmithKline and Vir Biotechnology’s COVID-19 antibody treatment will be halted because it is not effective against the omicron variant’s subvariant BA.2. Earlier in the week, the FDA halted its distribution in areas including New England, New York and New Jersey, where BA.2 accounted for at least half of new cases. Among the new states added to the list are Illinois, Michigan, Ohio, Wisconsin, Arizona, Nevada and California.

Quantum Leap Healthcare Collaborative and NRx Pharmaceuticals have halted their trial of a nebulized form of Zyesmi in severely ill COVID-19 patients. The drug was selected for testing because of its potential to reduce inflammation and stabilize the air sacs of those hospitalized because of acute distress syndrome (ARDS), which is the major cause of death in critically ill COVID patients.

UPDATED: Wednesday, March 30, at 9:50 a.m. ET

For people in the U.S. who received two doses of Johnson & Johnson's COVID-19 vaccine, the Centers for Disease Control and Prevention recommends a booster dose with an mRNA vaccine from either Moderna or Pfizer. The mRNA booster could strengthen the immune response and reduce the risks of rare but severe side effects, Forbes reports.

After CureVac's setback with its first-generation mRNA vaccine, the German company is moving ahead with a second-gen shot in partnership with GlaxoSmithKline. The team has dosed the first participant in a phase 1 trial. 

In pivotal trials, Adagio's adintrevimab reduced the risk of hospitalization or death in patients with mild to moderate COVID-19, Endpoints News reports. But there's evidence the drug doesn't work against omicron's BA.2 subvariant. Despite those concerns, Adagio is taking its drug to the FDA. 

The Biden administration is launching the website to inform the public about the government's new strategy of living with the virus, The Wall Street Journal reports. The website will also convey information about any potential future waves of infection.

UPDATED: Tuesday, March 29 at 11:40 a.m. ET

In President Joe Biden's new budget plan, nearly $82 billion is proposed for the HHS over five years “to prevent, detect and respond to emerging biological catastrophes.” Within that, $1.63 billion is set aside for pandemic preparedness as a mandatory budget request for the FDA in 2023. Story

The FDA has granted emergency use authorizations for COVID-19 vaccines from Pfizer-BioNTech and Moderna as second boosters. Both nods cover adults over 50 who have received a prior booster plus certain people with a wider age range who are immunocompromised. Story

Although boosters will likely keep the demand for COVID vaccines alive, the desperate shortages that existed during the shots' early launch days have waned. The excessive supply is creating new problems for local manufacturers from India to Indonesia that have aggressivly built capacity, Bloomberg reports.

U.K.'s large RECOVERY trial for COVID medicines will test Pfizer's Paxlovid in hospitalized patients to see whether the combo therapy could reduce the risk of death, Reuters reports. The Pfizer antiviral has been approved to treat nonhospitalized patients with mild to moderate COVID. 

Amid a surge in COVID cases caused by omicron, Shanghai has implemented a two-stage lockdown, a U-turn from the city government's previous stance against such stringent measures, The Wall Street Journal reports. The lockdown will be sequentially applied to two sides of Shanghai as divided by the Huangpu River.

UPDATED: Monday, March 28 at 10:18 a.m. ET

After reviewing the cost and efficacy of treatments from GlaxoSmithKline, Merck and Pfizer, the Institute for Clinical and Economic Review concluded that the meds "have prices reasonably aligned with patient benefits." In a statement, ICER president Steven Pearson said data show the medicines are "able to reduce hospitalizations among patients with mild-to moderate COVID-19 who are at high risk of progression to severe disease."

Europe is adding another tool to its pandemic toolbox. On Monday, regulators authorized AstraZeneca's antibody drug Evusheld to prevent COVID in a broad set of patients 12 and older, the company said.

As omicron's subvariant BA.2 circulates in the northeast United States, the FDA is halting the use of GlaxoSmithKline and Vir's Xevudy in the region. Eight states are affected by the pause. Story

After the World Health Organization said it would reject Medicago's plant-based COVID vaccine because of the company's ties to the tobacco industry, Medicago and Canadian officials are in talks with Philip Morris about a potential disinvestment, The Globe and Mail reports.

UPDATED: Friday, March 25 at 10:14 a.m. ET

Drugmakers have produced vaccines to prevent COVID and treatments for acute illness, but few options are available to patients with long-term COVID disease. Companies are now turning their focus to the condition and are asking researchers about how to proceed, Reuters reports. GlaxoSmithKline, Vir Biotechnology and Humanigen confirmed their interest in testing their existing medicines in long COVID patients, Reuters reports. Pfizer and Roche said they are interested but didn't offer details, according to the news service.

South Korea hasn't been able to buy in a supply of Pfizer's Paxlovid, so the country is looking for antiviral alternatives, Korea Herald reports. Starting this weekend, Merck's Lagebrio will be distributed in the country. The shortfall of treatment options comes after Celltrion’s Regkirona was removed from the market because data showed it didn't work against omicron.

The U.S. Congress hasn't approved new funding for COVID-19 treatments or vaccines, prompting Moderna to eye a potential shift to the private market. Private-market shots would carry a higher price tag than the public market vaccines. Pfizer previously telegraphed private-market plans after the pandemic shifts to an endemic phase. Story

UPDATED: Thursday, March 24 at 11:05 a.m. ET

AstraZeneca’s antibody treatment to prevent COVID-19 infection is set to be cleared in Europe, Reuters said. The injected drug already has been sanctioned in the United States and U.K. Evusheld is for those with compromised immune systems who can’t handle or don’t respond to vaccines. Infections are on the rise in Europe as the vaccination rate hovers at 83%. 

Fosun Pharma of China is gearing up to produce generic versions of COVID-19 medicines including Pfizer’s Paxlovid and Merck’s molnupiravir, said Fosun International CEO Chen Qiyu. The company is scouting out manufacturing sites for production. Fosun also is the lone company in China with rights to the Pfizer-BioNTech vaccine, but has not gained approval to supply shots on the mainlaind. Fosun has supplied 22 million doses of the shot to Hong Kong, Taiwan and Macau.

With the omicron subvariant surging in the U.K. following the relaxing of safety mandates, officials in the United States are closely monitoring the spread. While the seven-day average in the U.S. is at its lowest rate since last July, there is concern it will change. Roughly a third of the new cases in the U.S. are of the BA.2 subvariant of omicron.

UPDATED: Wednesday, March 23 at 11:10 a.m. ET

Boston-based startup Aerium Therapeutics released lab data showing that its two experimental monoclonal antibody treatments neutralized coronavirus variants, including omicron and its subvariant BA.2. The company is developing the drugs to prevent infection in those who immunocompromised. The company is led by former Takeda vaccine chief Rajeev Venkayya, who departed the Tokyo-based company last month.

Aspirin may improve survival in the months after a COVID-19 infection, according to researchers at the University of Bristol and Imperial College London. The study of 1,557 critically-ill patients from several countries showed that blood-thinning antiplatelet drugs can help over a period of three months to prevent blood clots that can lead to fatal organ damage.

At an undisclosed not-for-profit rate, Pfizer will supply up to four million courses of its COVID-19 antiviral pill Paxlovid to the United Nations Children’s Fund. The initiative will help supply 95 low- and middle-income countries including Afghanistan, Pakistan and Zimbabwe. Pfizer also is participating in the Medicines Patent Pool effort to supply these countries with Paxlovid by sharing the technology for its manufacture. The UNICEF deal will help supply Paxlovid as the scale up for the MPP deal is underway.  

Moderna has new data backing the use of its COVID-19 vaccine Spikevax at a low dose in the youngest children under the age of 6, and it’s moving forward with global regulatory submissions, as well as a delayed FDA filing in children ages 6 to 11. Story

In an effort to win back trust in Japan in its COVID-19 vaccine after contamination recalls last year, Moderna is linking itself to sumo wrestling as it tries to attract customers to a fourth booster dose. In ads, Moderna is employing sumo flags and the company name in heavy sumo-style script. Story

Initial uptake of Novavax’s newly launched COVID vaccine Nuvaxovid in Europe has been weak, but the company is still adamant the shot can reach the so-called vaccine hesitant across the continent—and hit its $4 billion sales projection. Story

UPDATED: Tuesday, March 22 at 11:15 a.m. ET

HDT Bio of Seattle has sued Emcure for $950 million, claiming that the India-based company stole its technology related to the development of a COVID-19 vaccine and planned to file patents on the shot. “Emcure’s Cinderella story is a fairy tale spun to lure investors to a generics maker whose prior attempt to go public failed for lack of interest,” HDT said in its complaint filed on Monday. Story

Malaysia has approved (PDF) the COVID-19 adenovirus vaccine produced by CanSino Biologics as a booster, regardless of original vaccine type. The CanSino shot joins mRNA vaccines by Pfizer and Moderna for booster use in the country. CanSino’s vaccine was first approved for use in September of last year.

In anticipation of a coming lawsuit, Pfizer’s COVID-19 vaccine development partner Acuitas has sued Arbutus and Genevant, asking that their patents covering mRNA delivery technology be invalidated. Earlier this month, Arbutus and Genevant sued Moderna claiming the mRNA vaccine producer infringed its patents in developing the shot. Last week, Alnylam made similar claims against Pfizer and Moderna, saying in separate lawsuits filed the same day that both companies infringed on their mRNA delivery technology. Story

UPDATED: Monday, March 21 at 10:17 a.m. ET

The FDA has scheduled a virtual meeting of its Vaccines and Related Biological Products Advisory Committee on April 6 to discuss the prospect of future boosters and the process for updating existing vaccines. The agency notes that "no vote is planned at this meeting and there will not be any discussion of any product-specific applications." Officials from the CDC and NIH will participate in the discussion as well.

As countries around the world face a renewed surge in cases, new mouse data show that the antibodies from AstraZeneca and GlaxoSmithKline retain activity against the worrisome omicron BA.2 variant, Bloomberg reports. The medicines lost some potency but helped reduce viral burden and lung inflammation, according to the news service. The results have not yet been peer-reviewed.

And on the vaccine front, the Pfizer and Moderna mRNA vaccines are effective at preventing hospitalization and death from omicron, but they weren't as effective at preventing mild infections, The Week reports. The data came from a Friday CDC report. 

UPDATED: Friday, March 18 at 10:15 a.m. ET

After the U.S., European Union, South Africa and India reached an agreement to suspend patent protections for COVID-19 vaccines, the issue will go to the World Trade Organization's 164 members for potential approval, The Wall Street Journal reports. The agency's rules require all countries to sign off for the program to go through.

In a trial in Brazil, ivermectin did not outperform placebo at helping COVID-19 patients at high risk of severe disease stay out of the hospital, The Wall Street Journal reports. All patients in the trial were recently diagnosed with COVID. Half were given ivermectin and half were given placebo.

Nearly three dozen generic drugmakers around the world have entered into deals to produce Pfizer's oral antiviral Paxlovid for 95 low- and middle-income countries. The list of generic manufacturers includes Teva, Viatris, Amneal and many others. Story.

A week after Pfizer asked the FDA to approve a second booster of its COVID-19 vaccine, Moderna has done the same. In one key difference, Moderna is asking the agency to authorize its second booster for people 18 and older, while Pfizer's request applies to people 65 and older, The Wall Street Journal reports.

UPDATED: Thursday, March 17 at 10:30 a.m. ET

President Joe Biden has tapped Ashish Jha, Brown University’s public health school dean, to lead the White House’s COVID-19 response. Jha will replace Jeff Zients, who’s served as the White House’s COVID-19 coordinator for the past 14 months. To fill his new role, Jha is taking a “short-term leave” from Brown’s School of Public Health, the university said Thursday. Jha’s new position takes effect on April 5. 

Moderna helmsman Stephane Bancel has sold about 2.8 million shares since the start of the pandemic, for a total value of roughly $408 million, CNBC reports, citing an analysis of the biotech’s filings. Bancel has cashed out using what are known as 10b5-1 stock plans, which were adopted before the pandemic in 2018, CNBC notes. These plans let executives sell a predetermined number of shares, executed by a broker, at regular intervals to avoid insider trading, the publication explains.

Sanofi employees in Swiftwater, Pennsylvania have until April 15 to get vaccinated against COVID-19, lest they lose their jobs, ABC-affiliated WNEP reports. Staffers were made aware of the plan back in November, the news outlet writes. Sanofi told WNEP it doesn’t disclose site-specific vaccination rates, so it’s unclear how many jobs could be affected by the mandate. 

The U.K. has approved AstraZeneca’s long-acting antibody therapy Evusheld to prevent COVID-19 infections in adults with poor immune response. Trials showed AZ’s drug cut the risk of development of symptomatic COVID-19 by 77%, with protection lasting for at least six months after a single dose, Britain’s Medicines and Healthcare products Regulatory Agency said Thursday. 

GSK vaccine partner Medicago’s links to Marlboro manufacturer Philip Morris International may lead to a rejection of the company’s plant-based COVID shot, Covifenz, by the World Health Organization, Bloomberg reports. Medicago’s request for pre-qualification was rejected, according to a WHO guidance document from early March, which suggests the organization is unlikely to approve Covifenz for emergency use. “The WHO and the UN have a very strict policy regarding engagement with the tobacco and arms industry, so it’s very likely it won’t be accepted for emergency use listing,” Mariangela Simao, WHO’s assistant director-general for drug access, vaccines and pharmaceuticals, told the media on Wednesday, as quoted by Bloomberg. Medicago is partially owned by Philip Morris, Simao added.

UPDATED: Wednesday, March 16 at 3:10 p.m. ET

Shionogi’s NIH-backed COVID-19 treatment is advancing to late-stage testing after the FDA finalized the drug’s study design. The trial is part of the National Institutes of Health’s ACTIV-2 study, which has been exploring multiple potential COVID outpatient therapies since late 2020. So far, data on Shionogi’s treatment has been mixed: Interim phase 2a results found that the therapy, dubbed S-217622, significantly reduced viral load, but phase 2b data found no major change in clinical symptoms, chalking up a failure on the primary endpoint. Story

A yeast-produced COVID-19 vaccine, paired with adjuvants, performed comparably to other approved shots, including Johnson & Johnson’s one-and-done vaccine, researchers at MIT and Beth Israel Deaconess Medical Center said Wednesday. The researchers’ vaccine has been designed for easy production, with both the particle and protein component produced by yeast, which can be grown in a bioreactor. Together with the Serum Institute of India, the universities say large quantities of the vaccine are already being produced, with plans to launch a clinical trial in Africa. Story

Germany will spend upward of €2.86 billion ($3.14 billion) to secure vaccine production capacity through 2029, Reuters reports, citing the country’s economy ministry. Wednesday, Germany OK’d plans to sign contracts with mRNA player BioNTech and the partnership between CureVac and GlaxoSmithKline, plus contract manufacturers Wacker, CordenPharma, Celonic and IDT. Story

China’s pandemic guidelines now cover the use of Pfizer’s antiviral pill Paxlovid, The New York Times reports. The drug won an emergency nod in China last month and the government this week announced the move to include Paxlovid in its treatment protocols, the publication said. China has tallied more than 15,000 COVID cases since the beginning of the month, which is the biggest surge for the country since the coronavirus first surfaced in Wuhan more than two years ago.

As COVID cases mount worldwide, countries need to maintain testing efforts and remain vigilant against the virus, the World Health Organization said Wednesday, as reported by Reuters. Omicron and its BA.2 subvariant are partially to blame for the recent case spike, alongside lifting of public health and social measures, the WHO said. "These [increases] are occurring despite reductions in testing in some countries, which means the cases we're seeing are just the tip of the iceberg," WHO director-general Tedros Adhanom Ghebreyesus said, as quoted by Reuters.

UPDATED: Wednesday, March 16 at 10:55 a.m. ET

Pfizer and BioNTech have asked the FDA for emergency use authorization for a second booster shot for adults ages 65 and older. The submission leverages data from Israel that shows older adults with three doses had double the infection rate of those with four and four times as many cases of severe illness. The submission also included data about the efficacy of a fourth dose for anyone older than 18, which showed a significant increase in antibody titers.

After much concern that Johnson & Johnson's single dose vaccine didn’t offer enough protection, new data are starting to show that may have been an unnecessary concern. The jury is still out, but new numbers suggest the J&J shot is now doing just as well as Moderna and Pfizer at stopping infections, hospitalizations and deaths. The reason for this uptick is still unclear; it's possible that J&J antibodies perform better against new variants, like Omicron, but it's also possible that the higher breakthrough infection rate early on means more people with J&J shots have already had COVID, with prior infection contributing to their current protection. 

As the discussion on a fourth vaccine dose gets louder, Japan is planning to buy 145 million doses of Moderna's and Pfizer's vaccines to supply a second round of boosters. According to local reports, a fourth dose rollout could start at the beginning of this summer.  

The European Medicines Agency said Tuesday that it's reviewing AstraZeneca’s application for Evusheld, an antibody-based COVID treatment. There’s still no timeline for when the EMA will reach a decision, but the treatment has already been authorized in the U.S. for those with weak immune systems or who can’t safely get vaccinated.

UPDATED: Tuesday, March 15 at 10:13 a.m. ET

AbbVie has been quieter than some of its Big Pharma peers during the pandemic fight, but now the Illinois drugmaker is teaming up with Scripps Research to develop novel antivirals for COVID-19. The team aims to bring "differentiated, next generation oral antiviral treatments" to the field and to promote global access, AbbVie chief scientific officer Tom Hudson said in a statement.

Execs for Pfizer and Moderna are split on whether Americans will need a fourth mRNA vaccine dose. Pfizer CEO Albert Bourla sees them as necessary, while Moderna president Stephen Hoge says the need should be determined on a case by case basis. Story

Two years into the global pandemic, White House chief medical advisor Dr. Anthony Fauci told CNBC "we are going in the right direction," but that uncertainties remain. He hoped people would learn lessons from the pandemic and remember the importance of outbreak preparedness. 

UPDATED: Monday, March 14 at 2:08 p.m. ET

Even as officials in Western countries ease COVID-19 mandates, China is turning back to lockdowns. Tens of millions of the country's residents now face stay-at-home orders as China battles a wave of omicron cases, The New York Times reports.

The world has faced one COVID-19 variant after another, but Pfizer CEO Albert Bourla figures the virus can keep mutating. Speaking with Yahoo Finance, Bourla said it's a "likely scenario" the world will see another variant.

Despite Novavax's marketing efforts to pitch its shot as an alternative option to the dominant mRNA vaccines, the Nuvaxovid rollout is off to a slow start in Europe, Reuters reports. So far, just 38,000 doses have been administered in Germany, and about 16,000 have been administered in Italy, the news service reports. 

UPDATED: Monday, March 14 at 9:35 a.m. ET

A fourth COVID-19 vaccine dose may be needed to prevent infection in the future, Pfizer CEO Albert Bourla said Sunday in an interview with CBS News’ Face the Nation. The CEO added that Pfizer is working on a shot that could tackle all known virus variants, including omicron, which would offer protection for at least a year. “We need to understand that the Covid will not go away in the years to come,” Bourla said. “We will have to live, to learn how to live with it, and we can, as we are living with many ― so many other viruses.”

Prescriptions for Pfizer and Merck’s competing COVID-19 antivirals have been about equal so far, despite expectations that Pfizer’s pill, Paxlovid, would reign supreme, The Wall Street Journal reports. Higher-than-expected demand for Merck and Ridgeback Biotherapeutics’ molnupiravir comes as calls for easy-to-use, at-home coronavirus therapies have spiked, WSJ said. More than 74,700 molnupiravir prescriptions were filled through Feb. 25, WSJ said, citing data from IQVIA. Over that same stretch, more than 79,150 Paxlovid scripts were filled. Many doctors say they’ve turned to molnupiravir because Paxlovid supplies have been limited, WSJ added. 

2020 COVID-19 restrictions prevented dengue virus infections in hundreds of thousands of people across Latin America and Southeast Asia, The New York Times reports, citing a new study published in The Lancet. Specifically, the study estimates there were 720,000 fewer dengue cases worldwide in 2020 because of restrictions on movement, NYT said. The findings could be relevant to other similar mosquito-borne viruses like Zika and chikungunya, the study argues. 

The Biden administration aims to expand a Trump administration-era COVID-19 tracking system that explores how respiratory and other infectious diseases are impacting patients and hospital resources, Reuters reports, citing a draft of proposed rules reviewed by the publication. Management of the hospital data collection system was transferred last month to the Centers for Disease Control and Prevention (CDC). Authorization for the current program is set to expire once the government lifts the national state of pandemic emergency, Reuters notes. The new plan would keep the program in place and add new requirements for the nearly 6,200 participating hospitals, including providing data on the number of patients with flu-like illnesses and other diseases that have pandemic potential.

UPDATED: Friday, March 11 at 3:10 p.m. ET

To prepare for future challenges, vaccines and COVID-19 medicines should be tested specifically against the BA.2 subvariant of omicron, urges GlobalData in a report that notes the unique mutations it contains that may allow it to circumvent existing countermeasures. “New variants evolve in ways that evade mAb therapies,” GlobalData says, noting that early studies show that GlaxoSmithKline’s sotrovimab may face a 27-fold drop in efficacy against BA.2 compared to its omicron predecessor.    

The Pfizer-BioNTech vaccine is only moderately effective against the omicron variant when tested in children ages 5 to 15. In a study conducted by the CDC and Abt Associates, the shot showed 59% efficacy in those ages 12 to 15 and 31% in those ages 5 to 11. The study also found that vaccinated children shook off the virus quicker than unvaccinated kids. The study included 1,364 children in Arizona, Florida, Texas and Utah.

A clinical trial conducted at RCSI University in Ireland shows that the anti-inflammatory protein alpha-1 antitryspin can help critically ill patients who have progressed to acute respiratory distress syndrome (ARDS). Treatment options for those with ARDS are particularly limited. Patients showed decreased inflammation after one week with no safety issues.

Pfizer is on the verge of submitting data to the FDA on a fourth dose of its COVID-19 vaccine, CEO Albert Bourla said during a CNBC interview on Friday. “Clearly there is a need in an environment of omicron to boost the immune response,” Bourla said. Bourla said researchers have found protection from an initial booster wanes after three to four months.

A month after China approved Pfizer’s COVID-19 oral antiviral Paxlovid, Meheco Corp said it has scored a licensing deal to supply the drug. Meheco becomes the exclusive rights holder for the treatment in China, the first of its kind to treat COVID-19 in the country.

Themis Medicare of India has gained approval in its country for its COVID-19 oral antiviral drug Viralex for patients with mild-to-moderate cases. In a trial of 499 participants, Viralex showed 52% efficacy with no serious side effects.

As a reward for guiding Moderna’s effort to develop and produce a COVID-19 vaccine, CEO Stéphane Bancel's golden parachute now clocks in at $926 million, the company revealed in its proxy report earlier this week. The news comes after a transformational year for the company as its revenues went from $803 million in 2020 to $18.5 billion last year. Story

Pfizer’s COVID vaccine ads have been light on branding and strong on “human spirit,” and that subtle marketing approach continues—though with a small difference—in its first commercial for COVID-fighting pills. Story

Pfizer, Moderna and Johnson & Johnson were quickest off the mark in getting COVID vaccines into American arms, but Novavax is hoping to add another pandemic vaccine to the U.S. mix soon—and it's pushing new campaigns to get the word out. Story

Immunome’s antibody cocktail COVID-19 treatment is free from an FDA hold, two months after the pause was first placed. In January, the FDA requested more information on the preparation and administration of IMM-BCP-01 at clinical sites. Immunome can now move forward with human trials after providing the agency with a “comprehensive report.” Story

Capricor Therapeutics development of a COVID-19 vaccine is coming to a halt. The company ended its work on the exosome-based jab due to “current availability” of vaccines for COVID-19. Story

A COVID-19 treatment development program between Histogen and Amerimmune has soured. Believing Amerimmune has failed to meet its R&D responsibilities, Histogen is seeking to terminate the partnership and retake control of the program. Story

UPDATED: Friday, March 11 at 10:35 a.m. ET

Fujifilm will end enrollment for its phase 3 trial of COVID treatment Avigan to avoid having the data skewed by patients infected with the omicron variant, which has fewer and milder symptoms. Avigan is being tested for its ability to stop COVID symptoms from becoming more severe, which is hard to measure with this milder but more infectious strain. The trial has been enrolling patients since last April, so the trial data will be based on what’s been collected so far.

The European Medical Agency has posed another set of questions for Valneva on its vaccine candidate VLA2001. Valneva expects answer the questions in the next few days. With a timetable from the EMA, Valneva expects to have conditional approval for its shot for those aged 18 to 55 on April, with doses arriving in Europe by the second quarter of this year. The company has already signed deals with the European Commission and the Kingdom of Bahrain to deliver shots.

Parents of young children have been struggling to decide on COVID procedures for their children as the BioNTech vaccine approved for the 5 to 11 age group remain less effective and, contrary to CDC guidance, the Florida surgeon general, Joseph A. Ladapo, M.D., recommended against COVID vaccinations for healthy children. New data expected soon from Pfizer and Moderna could simplify things if positive, but the problem lies less with the vaccinations themselves and more with the decreased dosage used for children, which may not be a problem in the non mRNA vaccines developed by Novavax and Sanofi. Despite the diminished efficacy, COVID vaccines are still recommended for children 5 or older, who can still develop severe cases or require hospitalization if unvaccinated.

UPDATED: Thursday, March 10 at 11:05 p.m. ET

Africa’s top health agency has an agreement in place with Pfizer to bring its COVID-19 oral antiviral Paxlovid to the continent for the first time. John Nkengasong, who heads up Africa’s Centers for Disease Control, added that he is in talks with Merck to receive its COVID-19 pill molnupiravir. The disclosure comes after the World Health Organization backed the use of molnupiravir for high-risk patients

The second arm of Moderna’s omicron booster trial has gotten underway with a first patient dosed in the phase 2 study testing a variant-specific vaccine against COVID-19. The company’s mRNA platform allows it to pivot “with speed and flexibility” to target new variants, CEO Stephane Bancel said in a release. He added that the shot could be ready by the fall booster season. Story

A COVID-19 vaccine developed by City of Hope and licensed to GeoVax Labs has been shown in a phase 1 study to produce robust neutralizing antibody and T cell response against the virus, with no significant side effects, according to a study published in The Lancet Microbe. COH04S1 targets both the spike and nucleocapsid proteins as opposed to FDA-approved shots that target only the spike protein.

Moderna’s business took flight in 2021 thanks to authorizations for its COVID-19 vaccine, and so did its CEO’s pay as Stephane Bancel was compensated to the tune of $18.2 million. Moderna’s chief could be up for bigger paychecks in the future as Moderna has changed its compensation peer group with additions of several Big Pharma companies. Story

UPDATED: Wednesday, March 9 at 3:15 p.m. ET

The National Institutes of Health has kicked off a trial to help better understand rare but potentially serious systemic allergic reactions to mRNA-based COVID shots, such as hives, swelling, trouble breathing and light-headedness. The study will enroll up to 100 people between the ages of 16 and 69 who’ve had an allergic reaction to their first mRNA vaccine dose. Patients will be given a second dose as inpatients “under carefully controlled conditions” at NIH’s Clinical Center in Bethesda, MD. 

Many children born during the pandemic are behind on vaccinations for diseases like measles, whooping cough and polio, The Hill reports. Before the pandemic, vaccination rates for these diseases were high, with most hovering around 80%, The Hill said. The publication cited a study that found vaccination rates for the measles, mumps and rubella vaccine slipped from 72% between March 2017 and March 2020 to as low as 62% between June and August of 2020. 

Americans who’ve already received free coronavirus tests through the U.S. Postal Service can now place an order for four more tests per household. With COVID cases on the decline, however, White House Officials and public health experts say it will be tricky to sustain interest in testing, as well as to ensure manufacturers keep producing diagnostics, The New York Times reports. 

As of March 5, omicron’s BA.2 subvariant was estimated to account for 11.6% of the coronavirus variants circulating in the U.S., The Centers for Disease Control and Prevent said Tuesday, as reported by Reuters. Other Omicron subvariants—dubbed BA.1.1 and B.1.1.529—now make up some 73.7% and 14.7% of circulating variants, respectively, Reuters said. 

UPDATED: Wednesday, March 9 at 11:13 a.m. ET

Pfizer has initiated a phase 2/3 study of its oral antiviral Paxlovid in non-hospitalized adolescents ages 6 to 17 who have symptomatic COVID-19 and are at risk for progressing to a more severe form of the virus. More than 11 million children under age 18, representing 18% of total cases, have been infected in the U.S., leading to more than 100,000 hospital admissions, Pfizer said. The treatment is already authorized in the U.S. for high-risk patients 12 and older.

All 12 of the emergency use authorizations issued last year by the FDA were for COVID-19-related indications, according to a report from GlobalData. Most of these were monoclonal antibodies and five of the EUAs were reissues for treatments that were originally blessed in 2020. Two were for oral antivirals developed by Pfizer and Merck.

Aspen Pharmacare of South Africa will supply its COVID-19 vaccine to other countries in Africa by June of this year. The news comes following a deal with Johnson & Johnson to package, market and distribute the vaccine, which will go by the name of Aspenovax.

UPDATED: Tuesday, March 8 at 11:15 a.m. ET

At the Global Pandemic Preparedness Summit, Monday and Tuesday, the Coalition for Epidemic Preparedness Innovations (CEPI) is rallying (PDF) efforts to foster development of new vaccines within 100 days of a future pandemic and ensure fair and equitable distribution around the world. Among the organization’s top goals are to invest in R&D to target pathogens with pandemic potential and develop promising vaccine and treatment candidates, reduce complexities and develop new methods of manufacturing to quickly expand capacity and also strengthen global clinical trial infrastructure to produce evidence of the efficacy and safety of products.

Merck donated 100,000 courses of its COVID-19 oral treatment, molnupiravir, to Direct Relief, which is providing emergency medical assistance to Ukraine, the company said. Merck also supplied 135,000 courses of the antiviral through a purchasing agreement with Ukraine. The company pledged $1 million in support for aid organizations, including $300,000 to the American Red Cross. “We will continue to monitor this tragedy and update our response as this crisis unfolds,” Merck added.

Takeda’s Icatibant, which is used to treat the blood vessel condition angioedema, has shown promise as a remedy for COVID-19 in the lab. The discovery came as researchers analyzed nasal cells of new COVID-19 patients, finding elevated levels of a protein that the virus uses as a gateway for infection. Use of Icatibant, which blocks this protein, reduced viral load by 90%, said researchers at the Technical University of Munich. The drug didn’t so much prevent infection as it lessened its effects.

Omicron patients remain contagious for the same duration as patients infected by the delta variant, says a small study from Massachusetts General Hospital in Boston. Mildly ill patients with either variant who were not hospitalized shed their virus within six days on average after symptoms began. The results were consistent regardless of vaccination or booster status.

Among patients hospitalized for COVID-19, those with heart defects are more likely to become critically ill or die, according to a recent study. The death rate among 421 patients with heart defects was twice that of more than 235,000 with normal hearts.

UPDATED: Monday, March 7 at 3:45 p.m. ET

The official world death toll from COVID-19 has exceeded 6 million, according to figures compiled by Johns Hopkins University. Of those deaths, the U.S. accounts for 959,287. The count for COVID-19 cases worldwide is now at 447 million. The actual worldwide death toll is much higher, according to The Economist, which estimates that 23.6 million have died from COVID-19, including many in low-income countries who were never tested for the virus.

A study from Oxford shows there can be significant impact on the brain from COVID-19 infections, with even some mild cases producing subtle tissue damage, a small loss in the brain’s overall volume and a deficit in cognitive function. It is the first study of the disease’s impact on the brain, comparing brain scans before and after infection.

Despite the lifting of COVID-19 restrictions throughout the U.S., many are still finding reason to protest. This weekend, truckers and those in other vehicles descended upon Washington, D.C., and on Sunday formed a slow-moving convoy around the 64-mile Capital Beltway, which encircles the city. The convoy disrupted traffic but caused no major snarls. The protesters returned to a staging area in Maryland with hopes of attracting more participants.

UPDATED: Monday, March 7 at 11:45 a.m. ET

Kenya will play host to Moderna’s $500 million bid to establish mRNA vaccine manufacturing in Africa, the company said Monday. The drugmaker has inked a memorandum of understanding with Kenyan officials to stand up a state-of-the-art mRNA plant, which was first unveiled in October 2021. The site will aim to produce up to 500 million doses a year for the continent, Moderna said. The facility could eventually be expanded to include fill-finish and packaging services, too. Story

Former Operation Warp Speed chief Moncef Slaoui is handing $3.86 million back to GlaxoSmithKline after he was fired last year over a sexual harassment claim. Slaoui was chairman of the board at GSK’s Galvani Bioelectronics when he was dismissed in March. In May 2020, Slaoui was tapped to manage the U.S.’ COVID-19 vaccine development effort, Operation Warp Speed. He ran the program until Jan. 2021, when President Joe Biden asked for his resignation. The following month, a female employee at GSK complained of Slaoui’s harassment. Story

The FDA is doubling the authorized dose of AstraZeneca’s long-acting COVID-19 antibody therapy, Evusheld, to 600 mg after the regulator found the currently authorized 300 mg dose was “suboptimal” against omicron subvariants. A single 600 mg Evusheld dose could provide three months protection against Omicron subvariant BA.1 and 1 to 3 months protection against subvariant BA.1.1, the FDA said. 

Novavax’s COVID-19 shot is inching closer to a U.S. authorization, thanks to the resolution of manufacturing issues that previously stalled the company’s application, The Wall Street Journal reports. To win an FDA emergency nod, Novavax needed to show that its vaccine’s spike protein and adjuvant were the same in every manufacturing batch–a process that took longer than expected, Novavax’s chief medical officer, Filip Dubovsky, told WSJ. 

UPDATED: Friday, March 3 at 11:15 a.m. ET

The FDA has rejected Ocugen’s COVID-19 vaccine Covaxin for emergency use in people between 2 years and 18 years, the company reported. The shot was developed by Ocugen’s partner Bharat Biotech of India. Ocugen said it will continue to work with the FDA to gain approval for the shot, which is the second-most used jab in India and is sanctioned by the World Health Organization. With the news, Ocugen’s shares tumbled 20% by late morning.

Japan has pledged $300 million and the U.K. will contribute £160 million ($211.3 million) to the Coalition for Epidemic Preparedness Innovations initiative to help end COVID-19 and prepare for future pandemics. The donations are to CEPI’s 100 Days Mission plan which aims to raise $3.5 billion by the end of its summit later this month.

Shionogi’s COVID-19 vaccine candidate has held its own against Pfizer’s Comirnaty in a study of the effect of booster shots on antibody levels, offering the company encouragement as it barrels toward a filing for approval of the shot in Japan. The clinical trial randomized 206 adults to receive S-268019 or Comirnaty six months or more after they completed a primary two-dose series with the Pfizer-BioNTech vaccine. Story

A trial in the U.K. conducted by Oxford showed that Eli Lilly’s rheumatoid arthritis drug Olumiant reduced the risk of death in patients with a severe case of COVID-19 by 13%. The reduction, which was measured over 28 days, was consistent over any of the other drugs that were tested, including tocilizumab, corticosteroids or remdesivir.

UPDATED: Thursday, March 3 at 10:00 a.m. ET

Merck & Co’s COVID-19 pill, molnupiravir, has now received WHO recommendation for use in high-risk patients with non-severe COVID to avoid hospitalization. The WHO has not recommended the pill for patients with more severe cases of COVID, citing a lack of trial data, or for young, healthy patients and pregnant or breastfeeding mothers due to safety concerns. Merck’s pill has been generally underused since its authorization in December, in part thanks to its 30% efficacy rate, but the WHO stated it is also planning to make a recommendation for Pfizer’s COVID-19 pill, Paxlovid, which boasts 89% efficacy against hospitalization and death.

Regeneron is facing a patent lawsuit from Allele Biotechnology and Pharmaceuticals Inc for using Allele’s patented mNeonGreen protein to test its COVID-19 treatment. Regeneron attempted to have the case dismissed early, arguing that federal law allows the use of patented materials to test drugs during FDA applications, but the request was denied. Allele previously settled a lawsuit against Pfizer and BioNTech for using the same protein to test their COVID vaccine. This case will hinge on whether Regeneron used Allele’s protein in testing for anything other than the FDA-approval process.

The FDA has been releasing hundreds of thousands of documents from its safety review of Pfizer’s COVID-19 vaccine, Comirnaty, after losing a court case against nonprofit the Public Health and Medical Professionals for Transparency. The FDA handed these documents over to PHMPT, which quickly posted the documents to its website with no additional explanation or commentary. Given the amount of data about the vaccine that’s already been published, it's unclear what this document release will accomplish in terms of providing relevant safety information.

UPDATED: Wednesday, March 2 at 2:55 p.m. ET

The Johnson & Johnson COVID-19 vaccine is five times less effective at keeping people out of the hospital than the mRNA shot from Pfizer-BioNTech, according to a study published in JAMA Network Open. The report urges those who have received the J&J vaccine to get boosted with an mRNA shot. The study was conducted in France and included 1.4 million participants 55 and older. Half were dosed with J&J vaccine and the other half with the Pfizer jab. The J&J vaccine provided 59% efficacy against hospitalization as opposed to 92% for Pfizer.

A new plan to help transition the United States from the pandemic has been unveiled by the White House. The National COVID-19 Preparedness Plan will require funding from Congress for COVID treatments and readiness for emerging variants. The plan calls for schools and business to remain open. In addition, Americans who received free COVID test kits will be eligible for a second round of kits.  

The United States will make available 1 million courses of Pfizer’s COVID-19 antiviral Paxlovid this month and double that supply in April according to the White House’s COVID preparedness director Jeff Zients. The announcement comes after President Joe Biden introduced the “Test To Treat” initiative where pharmacies will provide free doses of the Paxlovid to those who test positive and are deemed to be at high risk.

Drawing on a technology transfer agreement with AstraZeneca, Brazil is making the first COVID-19 vaccines produced entirely in the country. The Oswaldo Cruz Foundation and the Immunobiological Technology Institute are collaborating on the effort, which is expected to turn out 120 million vaccine doses by the end of the second quarter. Brazil has a high vaccination rate but booster coverage is low. Brazil is a regional leader in vaccine production. Bio-Manguinhos is producing mRNA shots via a technology transfer from the World Health Organization.

UPDATED: Wednesday, March 2 at 10:50 a.m. ET

China has conditionally approved another COVID-19 vaccine. The shot was developed by Anhui Zhifei Longcom Biopharmaceutical and is among six vaccines approved in the country, all domestically produced. The jab is the same recombinant protein subunit type as the shot developed by Novovax in the United States.

Those who test positive for COVID-19 at U.S. pharmacies and are at risk of developing a severe form of the virus will be supplied free doses of Pfizer’s antiviral Paxlovid. The "Test To Treat” initiative was introduced by President Joe Biden, during his State of the Union address on Tuesday.

UPDATED: Tuesday, March 1 at 4:00 p.m. ET

Roughly 140 million Americans had been infected by the coronavirus through the end of January, according to a report by the CDC. The estimate comes from testing samples of 72,000 people in all 50 states from December and January to assess the proportion of people with COVID-19 antibodies, known as seroprevalence. It found that 43.3% had antibodies, which is much higher than infection rates. While 58% of children showed seroprevalence, only 23% of those 65 and older did.

The Navy will not be able to discipline a group of special warfare personnel that cited religious reasons for not getting vaccinated. A federal appeals court in New Orleans made the ruling, dealing another blow to the Pentagon’s vaccine mandate for military personnel. The decision upholds a previous ruling by a Texas federal judge who barred the Navy from taking action against 35 sailors.

The International Air Transport Association does not expect overall traveler numbers to rebound to prepandemic levels until 2024. The projection remains unchanged from November, before the rise of the omicron variant. In 2021, traveler numbers were 47% of 2019 levels. This is expected to improve to 83% this year and 94% in 2023. International traveler numbers were 27% of 2019 levels, with improvements to 69% this year and 82% in 2023.

RedHill Biopharma’s second crack at developing a pandemic drug is working out better than its first attempt. In a phase 2 trial, RedHill’s COVID-19 pill has kept all 41 patients out of the hospital compared to three of 20 patients in the placebo arm. Upamostat was also safe and tolerable. RedHill’s previous try was with an SK2 inhibitor opaganib, but the treatment failed to help severely ill or hospitalized COVID patients. Story

UPDATED: Tuesday, March 1 at 10:55 a.m. ET

According to data collected by New York State health officials, the Pfizer vaccine is significantly less effective for children aged 5 to 11 than it is for older children and adults. The vaccine still protects against severe illness and hospitalization, but had little impact on lowering infection rates. Notably, children in this age group received a third of the dose given to older children and adults, which could explain the severe drop in efficacy for 11-year-olds compared to 12-year-olds, the latter of which were approved for a full dosage. This is the only COVID-19 vaccine that has been authorized for children in the 5 to 11 age group so far.

Novavax has shared the phase 3 clinical data from the UK for its COVID vaccine. The results show that this new shot is 82.5% effective after six months against infection for symptomatic and asymptomatic cases. While lower than the original efficacy rates from previous vaccines, like Pfizer and Moderna, this trial data was collected while several variants were already widely circulating, although it was prior to the omicron variant. The vaccine was 100% effective against severe disease.

CureVac has founded a new company, CureVac RNA Printer GmbH, to develop The RNA Printer, a new platform for manufacturing mRNA vaccines and treatments. Once completed, the tech is meant to expand access to mRNA technology and treatment use, particularly vaccine development and oncology. CureVac RNA is led by Markus Bergmann, Ph.D., as its general manager. Story

Novavax’s revenue hit $1.1 billion last year and the company expects to bring that to $4 billion to $5 billion this year now that it has launched its new COVID-19 vaccine. This year’s revenue is already twice that of last year's, and Novavax has attributed that spike to the vaccine as well. Even with a boost from the vaccine, Novavax still reported a net loss of $1.7 billion in 2021.

UPDATED: Monday, Feb. 28 at 11:15 a.m. ET

Heavy enrollment in Adamis’ phase 2/3 study of Tempol for the treatment of COVID-19 accelerated a meeting of the Data Safety Monitoring Board to review interim data. The DSMB has determined the study can continue as no safety or clinical concerns were identified, the company announced. Tempol has shown promise as a possible COVID treatment during in-vitro testing as it has shown strong anti-cytokine activity.

Hospitals in Hong Kong have been overrun with COVID-19 patients as the omicron variant sweeps across the area. The city reported 400 COVID deaths last week and on Sunday 26,000 new cases were reported. In some cases, patients are on gurneys outside of hospitals waiting for admission.

Last last year, Moderna lost a legal bid to invalidate two Arbutus Biopharma patents tied to the delivery of its COVID-19 vaccine. At the time, it wasn’t so much a question of whether Arbutus would sue the mRNA vaccine giant for infringement, but when. Now, the other shoe has dropped as Arbutus and Genevant have sued the big biotech for infringing on their patent on a lipid nanoparticle platform that they say was crucial to the delivery of Moderna’s shot. Story

Six weeks after telling investors what to expect in 2022 revenue, Emergent BioSolutions has adjusted its forecast. Instead of projecting revenues of $1.4 to $1.5 billion in 2022, Emergent has dropped the figure to $1.3 to $1.4 billion. The company said it is undergoing maintenance and upgrades as it readies for post-pandemic work. The company has been under scrutiny since manufacturing problems forced it to discard millions of doses of the Johnson & Johnson and AstraZeneca COVID-19 vaccines. Story

UPDATED: Thursday, Feb. 24 at 3:45 p.m. ET

The European Medicines Agency has recommended approval of the Moderna COVID-19 vaccine for those ages 6 to 11 and is sanctioning use of the Pfizer-BioNTech vaccine as a booster in those ages 12 to 17. The EU cleared teens for the Pfizer shot last May. The Moderna vaccine will be a half dose of what adults receive, with two shots spaced four weeks apart. In the last few months, as omicron swept Europe, cases among children soared.

As case numbers fall in the United States and mandates are being lifted, an average of more than 2,000 COVID-19 deaths have been reported in the country each day in the past month, the most since the pandemic began.

As Sanofi and GlaxoSmithKline's COVID-19 vaccine finally heads to regulators, another shot using GSK’s pandemic adjuvant has taken home its first global approval. The shot uses a plant-based virus-like particles technology to mimic the coronavirus’ spike protein and is combined with GSK’s pandemic adjuvant. Story

UPDATED: Thursday, Feb. 24 at 10:20 a.m. ET

Moderna on Thursday forecasted nearly $22 billion in sales of its COVID-19 vaccine Spikevax this year. The company has already locked up advanced purchase agreements worth $19 billion, with signed options valued at about $3 billion. In 2021, Moderna sold 807 million doses of its COVID-19 shot for full-year product sales of $17.7 billion. Moderna’s revenue for the year totaled $18.5 billion. Story

The Centers for Disease Control and Prevention has suggested certain people older than 12—especially boys and men between 12 to 39 years old—wait eight weeks between their first and second doses of Pfizer-BioNTech or Moderna’s mRNA-based COVID-19 vaccines. The change hinges on research that suggests a longer interval between doses can boost vaccine effectiveness and reduce the risk of a serious but rare side effect called myocarditis, or heart inflammation.

In a bid to expand COVID-19 vaccine production around the world, the World Health Organization is offering mRNA technology to five more countries: Bangladesh, Indonesia, Pakistan, Serbia and Vietnam. They join Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia, who are set to receive mRNA shot tech from the WHO’s hub in Cape Town, South Africa. The first African countries—Egypt, Kenya, Nigeria, Senegal, South Africa, and Tunisia—were named to get the technology last week, joining Argentina and Brazil, which were announced in September 2021. Story

The FDA on Wednesday said GlaxoSmithKline and Vir Biotech’s COVID-19 antibody therapy sotrovimab shouldn’t be used in places where the variants in circulation aren’t susceptible to the drug. Vir has said sotrovimab continues to work against the emerging BA.2 form of the omicron variant, though other research suggests the variant demonstrated resistance to nearly all monoclonal antibodies tested, including GSK and Vir’s drug, Reuters points out. Story

AstraZeneca sold Canada 100,000 doses of its long-acting antibody therapy Evusheld, Reuters reports. The drug is under review by Canada’s drug regulator as a preventative treatment against COVID-19 in immunocompromised people. First deliveries are expected to arrive within a month of authorization, the Canadian government said.

UPDATED: Wednesday, Feb. 23 at 4:01 p.m. ET

After a series of delays, Novavax has finally begun distributing its COVID vaccine, Nuvaxovid, to Austria, France and Germany, with shipments for more European countries to follow. The vaccine is protein-based, unlike the less traditional mRNA shots Pfizer and Moderna, which could make it more appealing to vaccine holdouts. It also requires less extreme temperatures to remain stable, making it a better candidate for distribution in middle- and low-income countries.

After a push from Oxfam, Johnson & Johnson and Moderna will face shareholder votes on pandemic vaccine access issues. J&J investors will vote on whether the company should release its COVID-19 vaccine pricing strategy, while Moderna shareholders will vote on whether to explore the feasibility of sharing technology.

Moderna has inked a 15-year a new manufacturing pact with a frequent partner, Thermo Fisher Scientific, to produce mRNA products, including its COVID vaccine. In addition to manufacturing, Thermo Fisher will also be involved in the inspection, labelling, and final packaging process.

UPDATED: Wednesday, Feb. 23 at 10:56 a.m. ET

The Africa CDC has asked COVAX and other international COVID vaccine distribution networks to stop donating vaccines to the continent until the third or fourth quarter of this year. According to Director John Nkengasong, the primary concern now is not getting vaccine doses, but getting those doses into patients. As vaccine hesitancy and logistical complications make the process of delivering doses slower, the organization is worried that vaccines will begin to expire before they can be administered, prompting the call to stop sending them.

After last year’s setbacks, Sanofi and GlaxoSmithKline are almost ready to start the approval process for their new COVID vaccine in the US and Europe. According to their most recent trial data, the vaccine is 58% effective against the omicron variant, which sounds quite a bit lower than the efficacy rates of earlier vaccines, like Pfizer and Moderna’s, but this trial was conducted against all the new variants that have come out recently, which previous shots have struggled to fight off. While the market in the US and Europe is already flooded, this particular dose might be more appealing to parts of the world where vaccine transportation and storage is an issue, as these doses would be stable at standard refrigerator temperature.

After a large study into the link between the AstraZeneca COVID vaccine and blood clots, UK researchers have found the risk to be very low, with only one to three cases per million patients, and only after one dose. This number only applied to those under 70 years of age, with no risk of clotting for those 70 or older. The researchers involved in the study predict that the minor risk of clotting will likely be outweighed by the much higher risk of hospitalization or death associated with COVID.

WHO Chief Scientist Soumya Swaminathan says that while the pandemic could be over by the start of next year, there won’t be a return to normal. Even when the pandemic ends, Swaminathan cautioned that COVID will still be around, which will mean wearing masks even with just the flu and constant vigilance around new and potentially more dangerous variants. This will also mean a better global surveillance system, which Swaminathan thinks could be a positive byproduct of the past two years.

UPDATED: Tuesday, Feb. 22 at 3:55 p.m. ET

The FDA has sent a warning letter to CytoDyn for the company’s posting of a video interview with then-CEO Nader Pourhassan that included promotional statement’s about the company’s investigational COVID-19 treatment, leronlimab. Earlier this month, Pourhassan was dumped by the company’s board of directors, which replaced him with Antonio Migliarese on an interim basis. Last May, the FDA publicly challenged CytoDyn’s take on a subgroup analysis of a trial investigating its COVID drug.

The FDA has cleared four batches of AstraZeneca’s COVID-19 vaccine that were produced at Emergent’s Baltimore plant. This appears to the be the last batch in question after many were put into storage a year ago after evidence of cross-contamination between the vaccines and others produced for Johnson & Johnson. The FDA divulged the new information in a Friday afternoon news roundup, saying it “does not anticipate making anymore determinations” on AZ vaccines.

It wasn’t a smooth ride last year for AstraZeneca as it responded to the COVID-19 pandemic, but it was a good year for the company’s bottom line. And as a result, CEO Pascal Soriot was well compensated, according to AZ’s annual report. Soriot’s pay in the year came to £13.86 million ($18.76 million), including £1.32 million in base pay, a £3.15 million bonus and £9 million in long-term incentives. Soriot made $21.52 million in 2020, when he was rewarded for guiding the company to quickly develop a COVID-19 vaccine. Story

Amid Adagio’s development of a COVID-19 antibody treatment—expected to be ready for the market this year—the Massachusetts company has abruptly had a change in leadership. CEO Tillman Gerngross is gone without explanation, replaced by David Hering, a former Pfizer executive who was instrumental in helping lead that company’s successful COVID-19 vaccine launch as president of its North America sector. Recent data showed its antibody was not effective against the omicron variant, the company said in an update on its progress. Story

UPDATED: Tuesday, Feb. 22 at 10:33 a.m. ET

Researchers in India have found in a new study that Merck’s molnupiravir can reduce the risk of hospitalization by 65%. This is a big jump from Merck’s own study last year, which found that the pill only reduced hospitalizations by 30%. Even with the new data, there are still concerns about the pill’s safety, and some scientists wonder whether antiviral COVID pills could cause mutations in the virus that lead to a new variant, The New York Times reports.

Malaysian researchers found ivermectin to be ineffective in preventing COVID-19 patients from developing severe illness. Among the 490 COVID patients the study monitored, half were given ivermectin in addition to standard treatment, and researchers found no statistically significant difference in health outcomes between the two groups. Both patients and doctors were aware of which treatment group each patient was in, which could have introduced bias that made ivermectin appear more effective, Reuters reports.

All 7.4 million residents of Hong Kong will be required to get tested three times in March as the city faces a rising surge of cases. Chief Executive Carrie Lam stated the city would not be entering a lockdown, but that schools would close early for summer break, and previous travel bans would stay in place. Researchers predict that the city could see 180,000 new cases a day in March.

CanSino Biologics’ new COVID booster Convidecia has been approved by China to be used with any completed vaccination schedule that allows mixing doses. This is the first adenovirus-vectored vaccine to be approved for use in this way by the Chinese government. According to a recent study, those who used Convidecia after two doses of an inactivated vaccine had significantly higher antibody levels than those who used recombinant protein boosters.

UPDATED: Friday, Feb. 18 at 3:55 p.m. ET

Concerns about a potential lack of efficacy against the omicron variant is why the FDA delayed its review of Pfizer and BioNTech’s COVID-19 vaccine in children aged 6 months to 4 years, reports the Wall Street Journal citing people familiar with the decision. Early results of testing the shot on children showed it to be effective against the delta variant when that was the dominant strain, but some vaccinated children contracted the virus after omicron emerged. Regulators want to see more data before making a decision.

The U.S. will provide financial, technical, and diplomatic support to 11 African nations in their efforts to combat the coronavirus. The Global Vax initiative will be run by the U.S. Agency for International Development. The countries set to benefit were selected based on the burden of COVID-19 to their populations and their ability to deploy the U.S. investments. The countries include Angola, Eswatini, Ghana, Ivory Coast, Lesotho, Nigeria, Senegal, South Africa, Tanzania, Uganda and Zambia.

Six African nations will receive access to the technology to produce COVID-19 mRNA vaccines, through a technology transfer project, according to the World Health Organization. Last year the WHO selected a consortium of South African companies to lead the effort, including Afrigen Biologics, which has used Moderna’s open-sourced vaccine sequence to develop its own shot, which could be approved by 2024. The six countries to receive the know-how will be Egypt, Kenya, Nigeria, Senegal, South Africa and Tunisia.

Vanderbilt University and Duke Clinical Research Institute are expanding their testing of ivermectin on COVID-19 patients, providing a higher dose and over a longer period. This is part of an effort to research three repurposed drugs for mild-to-moderate cases. The new dosage is 600 mg daily for six days as opposed to the previous 400 mg over three days. Touted by some despite a lack of scientific evidence, ivermectin has been steeped in controversy throughout the pandemic.

Billionaire philanthropist Bill Gates is warning that another pandemic is on its way. Speaking Friday at the Munich Security Conference, Gates said the new pandemic would stem from another pathogen, aside from the coronavirus, but advances made during the current pandemic would help the world react quickly to create countermeasures.

Some states—including Maine, Ohio and Wisconsin—have recently reported odd daily case counts for COVID-19 that sounded alarming. But these can be credited to catching up on backlogs of unreviewed positive tests that accumulated as the omicron variant surged. In Maine, for example, the backlog reached 58,000 at one point. But now the state is using artificial intelligence to quickly process the tests.

UPDATED: Friday, Feb. 18 at 10:09 a.m. ET

Despite Pfizer's licensing agreement with the Medicines Patent Pool on its COVID-19 drug Paxlovid, Public Citizen is raising concerns that the company is building a "patent wall" around the highly effective oral antiviral. The group's research found that Pfizer has filed or plans to file patent applications in 61 countries, plus four regional applications covering many more nations. Public Citizen argues Pfizer "left out much of the world" in its MPP licensing deal.

Merck, like Pfizer, also inked a licensing deal with MPP for its oral antiviral. Despite that effort, it appears molnupiravir may not make it to South Africa, as a cost-effectiveness group found it's not worth the expense, Reuters reports.

Appearing on CNBC recently, Moderna CEO Stéphane Bancel said it's "reasonable" to believe that the pandemic could be nearing an end. As the virus evolves, it's likely "we are going to see less and less virulent viruses," Bancel said, as quoted by CNBC.

Speaking of Moderna, the company's move to apply for patents in South Africa has some charities worried it could be planning to block local vaccine production, Reuters reports. A spokesperson for the company told the news service that's not the plan.

UPDATED: Thursday, Feb. 17 at 11:10 a.m. ET

With demand decreasing and supply increasing for Pfizer’s Paxlovid antiviral, the scramble to obtain the COVID-19 pills has subsided in the United States, Bloomberg reports. At Mount Sinai South Nassau hospital in New York, for example, there are only eight patients with COVID-19 as opposed to 122 during the peak of the omicron surge. The U.S. has ordered 20 million courses of the drug and three million of Merck’s less-effective molnupiravir oral treatment.

BioNTech CEO Uğur Şahin said that a slowdown in gathering data has delayed delivery of the Pfizer-BioNTech omicron-tweaked vaccine. Once it is ready, the companies will assess if there’s still a need for the reconfigured shot, Şahin told German news outlet Bild. BioNTech originally said it would be ready by the end of March.

Moderna will have an omicron-specific booster ready by August, said CEO Stéphane Bancel, but the company isn’t sure it will be needed. A study of the tweaked shot in monkeys showed that Moderna’s existing shot may offer better protection. In the interview conducted by Reuters, Bancel also said that the company was bolstering its commercial presence in Europe and Asia.

Despite some risks that remain from COVID-19, it’s time for the United States to return to a state of normalcy, the country’s top infectious disease expert Dr. Anthony Fauci said.The comments came after U.S. officials said they were preparing new guidance. Many states such as New York, California and New Jersey have announced plans to lift mask mandates over the next few weeks. Cases are down by 40% over the last seven days in the U.S. from the previous week, while the death toll remains high, averaging 2,200 per day, mostly among those who are unvaccinated. 

With a relatively short shelf life, AstraZeneca’s vaccine is posing distribution problems in poorer countries, according to Reuters, citing documents from the World Health Organization. The issue has become more pronounced as richer countries have donated their unused and older stock of shots to poorer nations. In some cases, the countries have discarded or turned down the donations.  

UPDATED: Wednesday, Feb. 16 at 3:30 p.m. ET

After the U.K.’s Joint Committee on Vaccination and Immunisation issued new guidance on the Pfizer-BioNTech COVID-19 vaccine, Scotland and Wales decided to offer the shot to kids 5-11. Now England and North Ireland are following suit. The shot was approved in the U.K. in December but until the new JCVI guidelines had only been offered to at-risk children and those who lived with immunocompromised people.

The CDC is gearing up to possibly update its recommendations for indoor masking, President Joe Biden told reporters on Wednesday. While several states have lifted mask mandates, the CDC has held firm to its guidelines. “We’re moving towards a time when COVID isn’t a crisis, but something we can protect against and treat,” White House COVID-19 Response Coordinator Jeff Zients said at the briefing.

While China in general has had an effective response to the coronavirus and has headed off the spread of the omicron variant, just offshore, Hong Kong is buckling under a brutal surge of the virus. Researchers have warned that 1,000 may die by the summer, which is four times the number that have died of the virus there over the last two years. The government of the semiautonomous city, which has many of the freedoms lacking on the mainland, is struggling with how to best deal with the spread of omicron.

The director of the Vaccine Research Center at the NIAID, John Mascola, will retire at the end of March after an eight-year run. Mascola and the VRC gained acclaim through their efforts to help Moderna quickly develop its COVID-19 vaccine. They also drew attention when Moderna tried to patent the vaccine without crediting the VRC. The company later dropped its claim. In Macola’s stead, deputy director Richard Koup will step in on an interim basis. Story

UPDATED: Wednesday, Feb. 16 at 8:28 a.m. ET

Merck is struggling to win European authorization to distribute its COVID-19 antiviral molnupiravir, The Financial Times reports. The European Medicines Agency isn't likely to approve the drug this month as reviewers work through "problematic" data, the newspaper says, citing people familiar with the process. One of the newspaper's sources said it's "possible" the medicine won't be approved at all in Europe.

After Spain's Rovi jumped into the pandemic vaccine manufacturing push back in 2020, the company on Wednesday inked a 10-year contract extension with Moderna. Rovi will continue to help produce Moderna's COVID-19 vaccine, plus it'll help with production on potential new medicines from the mRNA specialist. The deal will allow Rovi to expand capacity at its Madrid facilities.

BioNTech is joining the industry's Africa vaccine manufacturing effort. On Wednesday, the company unveiled modular BioNTainer factories that it plans to ship to Rwanda, Senegal and potentially South Africa to help bolster local production efforts. Story

Eying a windfall from its COVID-19 vaccine success, Moderna is looking east for expansion. The company plans to set up offices in Singapore, Hong Kong, Taiwan and Malaysia and kick off a hiring spree to support growth in AsiaStory

UPDATED: Tuesday, Feb. 15 at 3:15 p.m. ET

Vaccination with an mRNA shot during pregnancy appears to protect newborns from admission to the hospital for COVID-19 during the first six months of life, The New York Times reports, citing a new study from the Centers for Disease Control and Prevention. Maternal vaccination proved 61% effective at preventing infant hospitalization, the study found. Vaccination after the first 20 weeks of the pregnancy appeared to confer better protection.

Across the pond, Oxford University scientists have said they’ll study the effects of new coronavirus variants on pregnant women and newborns, along with the effects of COVID-19 vaccination on complications during pregnancy and after birth, Reuters reports. Less than a year ago, the university reported that pregnant women with COVID-19 and their newborns faced higher risks of complications like premature birth and organ failure.

South Korea is gearing up to dole out a fourth COVID-19 vaccine dose this month, as well as provide millions more home test kits amid a surge in omicron infections, Reuters reports. High-risk groups will be the first to get the fourth dose, the country’s health minister said Monday.

Just 4% of some 10 billion COVID-19 vaccine doses manufactured last year have reached low-income countries, Yahoo News reports, citing a study from Amnesty International. Those ten billion doses would have been sufficient to reach the World Health Organization’s 40% global vaccination target for 2021, Yahoo notes. Nevertheless, Pfizer, BioNTech and Moderna supplied fewer than 2% of their vaccines to low-income countries.

UPDATED: Tuesday, Feb. 15 at 9:00 a.m. ET

Novavax’s COVID-19 vaccine has won an interim authorization in Singapore. The first batch of the shot, dubbed Nuvaxovid, is expected to arrive in the country in the next few months, Singapore’s Health Sciences Authority said Monday, as reported by Reuters.

The U.S. is donating 5 million doses of Johnson & Johnson’s COVID-19 vaccine to Africa, U.S. Secretary of State Antony Blinken said in a statement Monday. Alongside shots provided together with COVAX, the U.S. has donated more than 155 million doses to the continent. “The first five million doses are already shipping to countries across the continent,” Blinken said.

mRNA is well-suited to technology transfer, according to a recent analysis from Médecins Sans Frontières and AccessIBSA. That’s because other vaccine tech often uses weakened viruses, while mRNA-based shots rely on lab-created mRNA. Removing the reliance on biological materials makes the manufacturing process more straightforward, Medicines Law & Policy reports. Study authors pinpointed 120 manufacturers with the technical and quality requirements in place to start manufacturing mRNA shots across Asia, Africa and Latin America.

Meanwhile, technology transfer and African vaccine manufacturing will be at the center of an upcoming summit between the African and European Unions, Politico reports. Europe is looking to support “full-fledged African health sovereignty, in order for the continent to respond to future public health emergencies,” according to draft documents seen by Politico. Still, some experts wonder if the EU’s proposals are enough, the publication notes.

Researchers and historians think a late-19th century respiratory virus—dubbed the Russian flu—could have been driven by a coronavirus, with some believing the pathogen may still exist, The New York Times reports. If a coronavirus were the culprit behind the Russian flu, which had reported symptoms like lingering exhaustion and loss of smell and taste, its descendants could be circulating as one of the four coronaviruses that cause the common cold, the publication states.

UPDATED: Monday, Feb. 14 at 3:45 p.m. ET

With new cases of omicron dropping rapidly in the United States, the stock market is reacting. Moderna shares dropped by 13% by 3:20 p.m., while Pfizer’s shares fell 2.4% and Pfizer’s partner BioNTech saw a 9.3% drop. Novavax’s shares also posted an 11.1% reduction. On Sunday, the Johns Hopkins University tracker said the seven-day weekly average in the U.S. was 175,000 new cases, a fall from 800,000 in mid-January. Last week, the U.S.’s top infectious disease expert Anthony Fauci said that the U.S. was leaving the “full-blown pandemic phase.”

A booster of the Pfizer-BioNTech vaccine helps defend against hospitalization and death from COVID-19 after one month, says a Kaiser Permanente study published Monday in The Lancet. After two vaccine doses, effectiveness of 85% against hospitalization and death waned to 49% after seven months. But a month to three months after a booster dose provided 88% protection against infection and 97% against hospitalization. The results came from a pool of 3.1 million members of the Kaiser system in Southern California.

Combining an experimental drug with two either of two FDA-authorized COVID-19 treatments—Gilead’s remdesivir or Merck’s molnupiravirmakes these drugs more potent, according to a study done by researchers at the University of Maryland and University of Pennsylvania. The investigational drug is Clear Creek Bio’s cancer treatment brequinar. The combo drugs stunted the growth of the virus in mice. The team's effort identified 122 antiviral drugs that were active against SARS-CoV-2 and tested them in a variety of combinations.

The FDA has approved Eli Lilly’s new COVID-19 monoclonal antibody treatment bebtelovimab, granting it emergency authorization. Bebtelovimab is for the treatment of mild-to-moderate COVID-19 and has been shown to be effective against the omicron variant. Last month, Lilly’s antibody cocktail of bamlanivimab and etesevimab was banned by the FDA because it was shown to be ineffective against omicron. Regeneron’s antibody, REGEN-COV, also was grounded that day for the same reason. Story

UPDATED: Monday, Feb. 14 at 9:45 a.m. ET

Roche's arthritis drug Actemra has been in high demand during the pandemic because of its efficacy against COVID-19. Now, the World Health Organization has prequalified the treatment in COVID patients who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation. The WHO distinction means that the agency recognizes the drug's safety and efficacy, and it allows another route of access for low- and middle-income countries, Roche said. 

AstraZeneca and the U.S. government have expanded their Evusheld supply deal. On Monday, the company said the U.S. government has contracted for another 1 million doses of the antibody combination. The deal brings AZ's total supply contract with the U.S. government to 1.7 million doses. 

Pfizer's oral antiviral Paxlovid has scored a conditional nod from drug regulators in China. It's not immediately clear whether the company and country are in talks over supply of the drug, Reuters reports.

Meanwhile, Merck is accelerating imports of its antiviral in Japan. The company plans to deliver 800,000 courses of molnupiravir to Japan by March, Reuters reports, an increase from a prior pledge of 600,000 courses. 

UPDATED: Friday, Feb. 11 at 4:50 p.m. ET

Johnson & Johnson and Merck's heartburn drug Pepcid has been shown to benefit COVID-19 patients, according to research at the Feinstein Institutes for Medical Research in New York. Those who took the drug had reduced inflammation and symptoms were tamed. The results were published in the journal Gut.

The European Medicines Agency is reopening an investigation of a possible link between irregular menstrual periods and mRNA vaccines produced by Pfizer-BioNTech and Moderna. There have been reports of more than 50,000 cases of late periods or other menstrual effects in the U.K. alone. The EMA has ruled out a link between the vaccines and infertility.

Waiting for data on a third dose, Pfizer and BioNTech are extending the FDA submission for their COVID-19 vaccine in children younger than five. The FDA has likewise delayed its expert advisory panel for the pediatric vaccine, which was originally scheduled for Feb. 15. Pfizer says it expects to have data on a three-dose regimen in young kids by early April. Story

The U.S. has agreed to a $720 million deal for Eli Lilly's bebtelovimab, the company announced on Thursday. The company will supply 600,000 courses of the treatment for high-risk patients with mild-to-moderate COVID-19. Story

The Defense Department organized the bidding and announced in mid-January, after a limited competitive process, that three companies—iHealth Labs, Roche Diagnostics and Abbott—were awarded contracts totaling nearly $2 billion for 380 million over-the-counter antigen tests, all to be delivered by March 14. Story

UPDATED: Friday, Feb. 11 at 11:10 a.m. ET

The U.S. is ready to roll out 10 million doses of the Pfizer-BioNTech COVID-19 vaccine once the shot is approved for kids ages 6 months to 5 years, according to a CDC document. The alert, posted online, tells providers to be ready to accept shipments of shots by Monday, February 21. An FDA advisory committee meets Tuesday, Feb. 15, to consider approval of the shot for this age group.

In vitro studies of Gilead’s COVID-19 drug Veklury show that it retains activity against 10 coronavirus variants including omicron, the company said. The results are consistent with other lab studies conducted in Europe. The studies also show that Veklury will be effective against the BA.2 subvariant, because the “viral RNA polymerase that remdesivir targets does not contain any additional unique mutations,” said Tomas Cihlar, Gilead’s SVP of virology research.

In a pediatric expansion of Novavax’s trial of its COVID-19 protein-based vaccine, teens age 12 to 17 had comparable efficacy to adults, the company said. Efficacy overall was 90% in the trial, including 82% against the delta variant. Immune responses were two to three times higher in adolescents than adults. The expansion included 2,247 teens in the U.S.

The World Health Organization is warning again of more coronavirus variants to come. On a tour of manufacturing facilities in South Africa on Friday, WHO chief scientist Soumya Swaminathan said, “we know there will be more variants, more variants of concern, so we are not at the end of the pandemic.”

UPDATED: Thursday, Feb. 10 at 3:35 p.m. ET

After taking its next-gen beta variant vaccine into phase 2/3 last year, AstraZeneca is now pulling the plug on the project. In recent months, beta has fallen down the list of the most worrying variants, prompting the drugmaker to dump AZD2816. Story

In the next phase of the pandemic, Africa will have to learn to live with the virus, the World Health Organization's regional director for the continent said during a virtual news conference. As wave after wave of COVID-19 hit the continent over the last couple of years, healthcare systems have adapted, she said, adding that there's "light at the end of the tunnel," according to The New York Times.

In other AstraZeneca news, the company reported $4 billion in COVID-19 vaccine and drug sales last year. But don't expect that level of revenues from the franchise this year, as the company expects those sales to slip by around 20% in 2022. Story

UPDATED: Thursday, Feb. 10 at 9:14 a.m. ET

On Pfizer's fourth-quarter earnings call earlier this week, CEO Albert Bourla said the company is following a tiered pricing strategy for Paxlovid. That means high-income countries pay more for the drug, while the company is providing the oral antiviral "at cost" for lower-income countries. The U.S. got a lower price than other high-income countries because of its large order, the CEO said. Pfizer is in discussions to supply the medicine with more than 100 countries around the world, biopharma chief Angela Hwang said on the call. 

After Novartis last month licensed ensovibep from Molecular Partners in a bid to speed manufacturing and regulatory advances, the partners on Thursday said their drug has been submitted to the FDA for an emergency use authorization. The submission includes clinical and preclinical data and centers on the phase 2 Empathy study in 407 symptomatic patients. 

In a final analysis of Johnson & Johnson's phase 3 vaccine study that enrolled more than 39,000 participants, investigators said the shot's efficacy landed at 56.3% against moderate-to-severe COVID-19 at least 14 days after administration. In addition, the team found the shot was 52.9% effective at least 28 days after administration. The investigators followed participants for a median of 4 months.

In a bioRxiv preprint study, scientists found that the newly identified omicron subvariant BA.2 "exhibited marked resistance to 17 of 19 neutralizing monoclonal antibodies," including GlaxoSmithKline and Vir Biotechnology's sotrovimab. Vir, for its part, says its drug retains activity against the subvariant. The company plans its own research within a week.

UPDATED: Wednesday, Feb. 9 at 3:15 p.m. ET

Moderna sold another 10.8 million doses of its mRNA-based vaccine to Colombia, the company said this week. In 2021, the biotech supplied Colombia with 10 million vaccine doses. Moderna says it expects to deliver 1 million doses in the first quarter of 2022, followed by 6 million doses in the second quarter and 3.8 million doses in the third.

Hospital and qualified non-hospital outpatient facilities can now order Gilead Sciences’ antiviral Veklury, also known as remdesivir, the company said Tuesday. The access boost follows the FDA’s recent approval of Veklury in non-hospitalized COVID-19 patients at high risk of progressing to severe disease, including hospitalization or death. Leveraging outpatient facilities should help Gilead meet “the unprecedented demand” for early treatment prompted by the current COVID-19 surge, the company said.

Generics juggernaut Teva Pharmaceutical continues to feel the pandemic squeeze. The company’s total 2021 sales clocked in at $15.9 billion, down about 6% versus the previous year. Fourth quarter sales landed at $4.1 billion, marking an 8% decline from the $4.45 billion Teva made during the last three months of 2020. Teva blamed the downturn in part on the endurance of COVID-19: Patients making fewer trips to the doctor during the pandemic weighed on prescribing patterns, the company said. Story

COVID-19 disrupted basic health services—like vaccination programs and treatment of diseases like AIDS—in 92% of 129 countries polled by the World Health Organization late last year, Reuters reports. The survey, which rolled out between November and December, suggested services were “severely impacted” with “little or no improvement” from early 2021, Reuters said. Emergency care, such as ambulance and ER services, as well as elective operations like hip and knee replacements, were among the services that faced disruptions.

UPDATED: Wednesday, Feb. 9 at 9:25 a.m. ET

GlaxoSmithKline racked in $1.9 billion in sales of its COVID-19 antibody, sotrovimab. That sales figure for the treatment, which was developed along with Vir Biotechnology, included $1.12 billion in the fourth quarter. The sales surge was in response to the omicron variant, which sotrovimab is active against. GSK said it expected similar sales for the treatment in 2022.

Doctors Without Borders and the People’s Health Movement are asking South Africa to seek the revocation of patents owned by Eli Lilly and Moderna. Lilly’s patent in South Africa for baricitinib, the active ingredient in Olumiant, is limiting access to generic versions of the treatment for those with a severe form COVID-19, say the organizations. The drug goes for $270 for a 14-day treatment course as opposed to $7 for generic baricitinib from India and Bangladesh. There also is a longer-range access concern, with three patents issued by South Africa to Moderna for its COVID-19 vaccine.

SaNOtize and Glenmark Pharmaceuticals have gained approval in India for an antiviral nitric oxide nasal spray that was found to be effective in a phase 3 trial against mild-to-moderate COVID-19. The spray reduced viral load in 94% of patients within 24 hours and 99% within 48 hours.

A Florida court has joined others from Texas, Delaware, New York and Michigan in refusing to force a hospital to treat a COVID-19 patient with the controversial horse parasite medication ivermectin. The suit was brought by the family of a patient who is in a coma and on a ventilator and was being treated at the Mayo Clinic, which prohibits the off-label use of medications that aren’t supported by medical evidence.

UPDATED: Tuesday, Feb. 8 at 2:01 p.m. ET

Johnson & Johnson's move to pause vaccine manufacturing at a plant in the Netherlands could reduce output by hundreds of millions of doses, a person familiar with the decision told The New York Times. The pause surprised the company's largest customers at the African Union and the global vaccine consortium Covax, the newspaper reports.

After Pfizer unveiled 2022 sales projections for its COVID-19 vaccine and antiviral pill, the company's CEO said Pfizer doesn't see the virus going away for the "foreseeable future." That’s because the virus’ global distribution makes it difficult to contain, Pfizer CEO Albert Bourla told analysts on the company's fourth-quarter conference call. The virus also has the ability to “mutate often,” which makes it tough for companies to “stay ahead,” he said. Story

UPDATED: Tuesday, Feb. 8 at 10:48 a.m. ET

Pfizer has projected sales of its COVID-19 vaccine Comirnaty and oral antiviral Paxlovid will total $54 billion in 2022. Pfizer expects to generate $32 billion in sales from the vaccine with “less potential upside,” than the company had entering 2021, CFO Frank D’Amelio said. While projecting $22 billion in sales for Paxlovid, the company said that number is more subject to potential growth. The company sees revenue for the year coming in at between $98 billion and $102 billion. It also anticipates making 4 billion doses of the vaccine, compared to 3 billion in 2021 when sales of the shot came in at $36.8 billion.

Merck and Ridgeback have completed delivery of 3.1 million contracted courses of their COVID-19 oral antiviral molnupiravir to the United States, the companies said. Delivery was accomplished within seven weeks of receiving emergency authorization from the FDA. The companies produced 10 million courses at-risk by the end of 2021 and expect to produce at least 20 million courses in 2022, they said.

Illegally imported rapid antigen COVID-19 tests have been recalled from the U.S. by Roche partner SD Biosensor, while the South Korean company and the FDA are investigating how the tests reached the U.S. The FDA said that it is unlikely the tests—which have yet to be approved in the U.S.—have reached consumers, MedTech Dive reports.

WuXi Biologics units in Wuxi and Shanghai have been included in a list of 33 Chinese entities added to the U.S. Commerce Department’s “unverified list,” which requires U.S. exporters to undergo additional procedures before shipping goods. Wuxi CEO Chris Chen blamed the pandemic for preventing inspectors from travelling to China during the last two years.

Novavax has delayed some first-quarter shipments of its COVID-19 vaccine to Europe and other countries, according to a report in Reuters. The company blamed regulatory delays for some of the delivery shortfalls, saying shots are in warehouses waiting to be sent. It also said export limitations on manufacturing partner Serum Institute of India have played a role.  

UPDATED: Monday, Feb. 7 at 3:45 p.m. ET

RedHill Biopharma’s opaganib showed a 70.2% mortality benefit for those hospitalized with a severe case of COVID-19 when provided on top of standard of care (Veklury plus cortiocosteroids), the company said. The drug also showed a 34% benefit in helping patients to recovery by day 14. The Israel-based company said it is advancing regulatory discussions in multiple countries with authorization applications planned for the first half of this year. Opaganib is an SK2 inhibitor with proposed anti-inflammatory and antiviral activity.

Low reimbursement payments to dispense COVID-19 antiviral pills from Merck and Pfizer have convinced some pharmacies in the United States that they can’t afford to stock them. In some cases, pharmacies are getting as little as $1 to dispense the pills, according to a report in Axios. The government has instructed pharmacy benefit managers to pay an adequate dispensing fee but PBMs have responded with a wide range of fees, from Prime Therpeutics ($1) and Humana ($2) to CVS Caremark ($10) and OptumRx ($10.50). Low fees have drawn the ire of the American Pharmacists Association, which says that takes up to 45 minutes to properly screen customers.

The FDA resumed domestic inspections on Monday, ending the pause it established late last year in response to the spread of the omicron variant. While the pause was in effect, the FDA continued to conduct mission-critical inspections domestically and abroad. Story

Recommended vaccinations—aside from COVID-19 shots—are still lagging because of the pandemic, a study commissioned by GlaxoSmithKline found. From January 2020 to July 2021, monthly vaccine claims decreased by 32% for adults and 36% for adolescents, the study found. Story

UPDATED: Monday, Feb. 7 at 11:35 a.m. ET

Is Shionogi of Japan ready to challenge Pfizer and Merck with its own COVID-19 oral treatment? On Monday, the company said it was ready to apply for approval of its drug, which has been shown to be effective against omicron in a phase 2 trial. The company said it hopes to be able to supply 400,000 to 500,000 doses to the country by the end of this month and 1 million doses by the end of March.

An Oxford scientist who helped develop the AstraZeneca COVID-19 vaccine is blaming politicians and scientists for damaging the reputation of the shot and contributing to the death of “hundreds of thousands of people.” In a BBC documentary on the vaccine, John Bell claims that Britain’s exit from the European Union made many in the bloc anxious to discredit the vaccine, resulting in overblown reports about blood clots and manufacturing problems.

President Joe Biden’s top science adviser and Cabinet member Eric Lander has been reprimanded for demeaning subordinates at the Office of Science and Technology Policy, a recent White House investigation concluded. Among those who were bullied by Lander was his former general counsel Rachel Wallace. Several other women in the organization have complained of negative interactions with Lander, who offered a written apology on Friday after he was alerted about an investigation and story by Politico, which ran on Monday.   

An inhaled COVID-19 antibody cocktail therapy by Celltrion of Korea is moving into phase 3. The company has filed an application to study the treatment in a trial of 2,200 patients with mild to moderate COVID. Celltrion acquired the technology from Inhalon Biopharma and accelerated its development in response to the emergence of omicron and the ineffectiveness of other antibody drugs. Story

UPDATED: Friday, Feb. 4 at 2:45 p.m. ET

Almost all $350 billion of the Department of Health and Human Services’ Public Health and Social Services Emergency fund has been tapped out, thanks to the Biden administration’s recent omicron-fighting efforts, The Washington post reports. The U.S. has been leveraging the program since 2020 to boost COVID-19 testing, drugs and vaccines. Officials have suggested they’ll be able to weather the current surge but may need to seek approval of additional aid from Congress moving forward.

The U.S. Postal Service has delivered "tens of millions" of free COVID-19 tests over the past two weeks, The Washington Post reports. The Biden administration started offering up to four free coronavirus tests per U.S. household on Jan. 19. Some 60 million households have requested tests, a USPS spokesperson told the post. Biden has pledged to ship out 500 million test kits free of charge. 

Automated molecular tests taken at the point of care, like those used to diagnose COVID-19, could help hepatitis C patients start treatment the same day they’re diagnosed, The New York Times reports. This sort of hep C test is already used overseas, but no device makers have sought FDA approval for one in the U.S., the newspaper notes. Some 2.4 million Americans have hepatitis C, and more than 14,000 people in the U.S. died from the disease in 2019, NYT said.

Roche’s 2022 financial guidance assumes a mix of vaccines and widespread omicron infection could protect people against COVID-19 for years. That means major diagnostics sales in the first quarter, less in the second quarter, and even less in the second half of the year. That prediction would also translate into lower sales of Ronapreve, Roche’s Regeneron-partnered antibody, and Actemra, which is used to fend of immune system overreactions in hospitalized COVID patients. Story

UPDATED: Friday, Feb. 4 at 11:15 a.m. ET

After Sanofi and partner GlaxoSmithKline initially targeted a first-half 2021 approval for their COVID-19 vaccine, the partners have run into delays and are hoping to finalize their phase 3 trial by the end of March. Sanofi reiterated its expected trial timing in fourth-quarter results released Friday.

Speaking of Sanofi, the company blamed prioritization of COVID-19 boosters for a fourth-quarter flu vaccine sales slump in the U.S. For the last three months of the year, flu shot sales were down some 48% in The States. That's because COVID-19 boosters relegated flu shots to the sidelines in November and December, Thomas Triomphe, Sanofi's head of vaccines, said on an earnings call Friday. Additionally, Triomphe flagged “a lot of confusion with different age indications being licensed at the same time and a lot of discussion on the boosters.” Those factors are unlikely to cause problems in 2022, he said. Story

Researchers in England are pursuing a data-driven approach to quickly finding potential new COVID-19 combo therapies. The £1.6 million project will be led by Queen’s University Belfast and seeks to identify combinations of existing antivirals that can fight the virus.

After an FDA ruling 11 days ago that banned Regeneron's COVID-19 antibody treatment for use in patients infected by the omicron variant, the company says it doesn't expect to generate any sales of the drug in the first half of 2022. Story

UPDATED: Thursday, Feb. 3 at 3:55 p.m. ET

PhRMA has told the U.S. Trade Representative that the WHO and other agencies, including the WTO, were no longer reliable stewards of intellectual property rights. The industry lobbying group accused the WHO of promoting “harmful policies” that it says would hurt incentives for drug and vaccine makers. The message comes as the U.S. Trade Representative is preparing its 301 Watch List, which the industry uses to identify countries that don’t protect patent rights.

A biotech in South Africa, Afrigen Biologics and Vaccines, says it has created a near copy of Moderna’s mRNA COVID-19 shot without help from the Massachusetts company. Many steps remain before the copycat version could be distributed.

In its fourth quarter earnings report, Roche said its testing sales grew 29% in 2021 to $19.4 billion, with COVID-19 diagnostics accounting for about a quarter of the year’s total. A further breakdown saw a dramatic rise in point-of-care testing sales, more than doubling from $1.2 billion to $2.8 billion. The division’s main growth driver was its COVID-19 antigen test sold in Europe, the Middle East and Africa. Story

Thermo Fisher said in its fourth quarter earnings report that a major chunk of its surge in 2021 revenue came from sales of COVID-19 diagnostics, which hauled in $9.23 billion. Story

UPDATED: Thursday, Feb. 3 at 11:13 a.m. ET

Novavax is moving along in its quest to gain regulatory authorizations for its COVID-19 shot. It has now scored a conditional nod from the U.K.'s Medicines and Healthcare Products Regulatory Agency. And in Germany, an expert panel on vaccines has recommended the shot for adults, Reuters reports.

Test maker BD reported $185 million in testing revenues in its quarter that ended December 31, prompting the company to double its full-year forecast for pandemic testing sales. Story

Despite concerns over the safety and efficacy of Merck's oral antiviral, molnupiravir, the company expects $5 billion to $6 billion in 2022 sales from the medicines. Merck splits profits with its partner Ridgeback. Story

UPDATED: Wednesday, Feb. 2 at 3:50 p.m. ET

It was more than three months ago that the FDA approved the Pfizer-BioNTech vaccine for children age 5-11 but only 21.8% of kids in the age group are fully vaccinated and just 30.5% have received at least one dose, according to the CDC. A poll taken last month by the Kaiser Family Foundation showed that 52% of parents of kids of the age group were either opposed or unsure about vaccinating their children. 

San Francisco health authorities are defying the CDC and allowing people to receive a third COVID-19 dose—a second booster—if their initial shot was from Johnson & Johnson. The CDC allows a single booster shot after initial J&J vaccination but has yet to rule on a second booster shot. The second booster shot has been termed a “supplemental” dose, according to San Francisco health director Grant Colfax. It must be from Moderna or Pfizer-BioNTech and come no sooner than five months after being boosted.

This week, France will become the first country in Europe to administer Pfizer’s oral antiviral Paxlovid. The country said it has received a shipment of 10,000 doses of the treatment and pharmacies will be stocked for sale on Friday.

In an unusual move, the FDA has asked Pfizer to adjust its submission for emergency use approval of its vaccine to include younger children. The current submission is for kids ages 2-4. The FDA wants the company to include kids ages 6 months to 2 years in the request. Last month Pfizer revealed that its shot performed better in those aged 6-24 months. The company however wants to tweak the formulation of the shot so that the results even out among both age groups.

UPDATED: Wednesday, Feb. 2 at 11:03 a.m. ET

Gilead's COVID-19 antiviral, Veklury, rang up (PDF) $1.4 billion in fourth-quarter sales, far exceeding the Wall Street consensus estimate of $864 million. The company said the omicron wave triggered high demand for the treatment in December. In addition, the U.S. vaccination rate plateaued, execs noted, contributing to more hospitalizations than Gilead had expected. Story

The U.S. has recorded more COVID-19 deaths than other wealthy countries—particularly during the omicron wave—and has a lower vaccine rate than its peers, an analysis from The New York Times found.

Several European countries are easing or dropping pandemic restrictions as citizens push leaders toward an endemic approach to COVID-19, The New York Times reports. That trend could accelerate in the U.S., as well, the newspaper notes.

UPDATED: Tuesday, Feb. 1 at 3:59 p.m. ET

After a long reign by AbbVie's Humira atop the hospital pharma spending rankings compiled each year by Vizient, Gilead's Veklury took the top spot in 2021, according to Reuters. The group didn't say exactly how much hospitals spent on the medicine last year, but Vizient did say that Gilead's antiviral could hold the top spot through the middle of next year. Gilead reports fourth-quarter 2021 sales today after the market close.

UPDATED: Tuesday, Feb. 1 at 8:59 a.m. ET

Pfizer and BioNTech are planning to submit a two-dose regimen of their vaccine, Comirnaty, to the FDA for use in children under 5, The New York Times reports. The filing could come as soon as Tuesday, and the shot could be available for young children by the end of the month on an emergency use basis. 

It's common knowledge that the pandemic has widened health inequities, but a new Harris Poll survey commissioned by Teva Pharmaceuticals and the Morehouse School of Medicine in Atlanta shows just how bad the situation is. In the poll, 34% of Black, Indigenous or people of color said they found it difficult to access a high-quality doctor or hospital, compared to only 19% of white respondents. Story

After Reuters ran a story on Monday citing an "antiviral effect" from ivermectin against COVID-19 in a phase 3 trial, the news agency corrected its report. In its correction, Reuters noted that the finding came from nonclinical research. 

UPDATED: Monday, Jan. 31 at 3:45 p.m. ET

The FDA has granted Moderna’s COVID-19 vaccine a full approval for those 18 and older. Moderna’s shot joins the vaccine from Pfizer-BioNTech as the only programs fully approved in the United States. Moderna's shot was initially authorized for emergency use on Dec. 18, 2020. More than 204 million doses have been administered in the U.S., the company said.

The long wait for Novavax's COVID-19 vaccine FDA filing is finally over. On Monday, the company filed with the FDA for emergency use authorization for adults. In response to the news, shares of the company’s stock increased 8% after tumbling 59% over the last year as the protein-based shot stalled in development.

Empowered Diagnostics of Florida has recalled at least 284,575 rapid antigen at-home COVID-19 tests that were sold in the United States without approval from the FDA last year. The tests have been approved in Canada and Europe. Story

In a span of a few months, some states have gone from donating surplus at-home COVID-19 tests to hoarding them, Kaiser Health News reports. The reversal is due to skyrocketing demand in response to the spread of the omicron variant. A year ago, for example, North Dakota donated one million of its stock of 2.7 million test kits—or three per resident—to other states. But early this month, North Dakota was back to hoarding even expired stock as it held onto 600,000 kits. Story

UPDATED: Monday, Jan. 31 at 8:55 a.m. ET

As America faces the omicron surge, doctors, pharmacies and healthcare systems told Reuters that Pfizer's Paxlovid is the most sought-after therapy right now. GlaxoSmithKline and Vir Biotechnology's sotrovimab is also in high demand, followed by Gilead Sciences' Veklury. Merck's COVID pill is the last choice for patients in the U.S., the news service reports, but that drug is seeing some use around the world.

After officials at the World Trade Organization missed a December deadline on a potential COVID-19 intellectual property waiver, discussion on the topic is ramping back up, Endpoints News reports. Last week, World Trade Organization director-general Ngozi Okonjo-Iweala called on members to reach a consensus on an IP waiver by the end of February.

While the U.S. is still recording high numbers of cases and deaths, some governors are calling for the country's pandemic response to shift to an endemic strategy, The New York Times reports. New Jersey Gov. Philip Murphy of New Jersey said on NBC News' Meet the Press that "we're not going to manage this to zero" and that we have to "learn to live" with the virus. Also on the program, Arkansas Gov. Asa Hutchinson called on the federal government to ramp up access to tests and treatments.

UPDATED: Friday, Jan. 28 at 3:15 p.m. ET

As of Friday, the world has reached the 10 billion mark in vaccinations administered according to the Our World in Data project at the University of Oxford. But that total obscures lots of disparity among the world’s 7.9 billion people. In some low-income countries, less than 10% of the population have received one dose. “Ten billion doses is a triumph of science but a complete failure of global solidarity,” Madhukar Pai, a professor of epidemiology and biostatistics at McGill University in Montreal, told the New York Times.

Of children hospitalized with multi-system inflammatory syndrome (MIS-C), a serious condition associated with COVID-19, 98% were unvaccinated, according to a study from Epic Research. The study revealed that unvaccinated children with mild COVID-19 symptoms were more at risk for MIS-C. Of the 1,499 pediatric hospitalizations for MIS-C, 1,474 (98%) were unvaccinated. This is a factor as the FDA considers approving Pfizer’s COVID-19 vaccine for children 4 and younger.

The newly discovered subvariant of omicron, BA.2, has a greater growth rate than the original version, and transmission in households is likely to be higher, said the U.K. Health Security Agency. There is no indication yet that vaccines would offer any less protection against symptomatic disease from BA.2 than the original omicron variant. The organization warned that data this early in the cycle of a variant are unreliable

Screening rates for breast, cervical and colon cancers are still slightly behind where they were before the pandemic, according to data from Epic Research. And the flood of “catch-up” screenings that researchers and some public health officials predicted has yet to materialize, thanks in part to the surge of the omicron variant. Story

UPDATED: Friday, Jan. 28 at 11:15 a.m. ET

Six preclinical lab studies show that Merck and Ridgeback’s oral antiviral, molnupiravir, is active against the omicron variant of COVID-19. The studies were conducted independently in the U.S., Belgium, Czech Republic, Germany, Poland and the Netherlands. The findings provide additional “confidence in the potential of molnupiravir” to treat high-risk individuals with mild-to-moderate COVID-19, Merck Research Laboratories chief Dean Li, said in a release.

Walvax Biotechnology of China has recruited most of the 28,000 needed in a trial of the country’s first mRNA COVID-19 vaccine. The study has taken on urgency, as the two vaccines in use in China—produced by Sinopharm and Sinovac—have shown to be ineffective against the omicron variant. The country has not imported mRNA vaccines. Walvax has the potential to produce the bulk substance for 400 million vaccines a year and is working to secure more capacity, the company said.

European Commission president Ursula von der Leyen has been cited for “maladministration” by a European Union watchdog over her failure to file text messages in an internal record of documents. The discovery was made after the EU ombudsman asked to see texts between von der Leyen and Pfizer CEO Albert Bourla in attempting to gain information about COVID-19 vaccine negotiations. The commission claimed that it didn’t know that texts were covered under EU transparency laws.

UPDATED: Thursday, Jan. 27 at 3:15 p.m. ET

The European Medicines Agency has conditionally approved the use of Pfizer’s COVID-19 antiviral pill, Paxlovid, for those with the virus who do not require oxygen and are at risk to progressing to a severe form of the disease. A decision on Merck’s oral antiviral, molnupiravir, is expected early next month. The U.S. approved use of the treatment in December.

The U.S.' top infectious disease expert Anthony Fauci said that when the Pfizer vaccine is approved for children ages 4 and younger, it likely will require a three-shot series. During the White House press briefing, coronavirus response coordinator Jeff Zients added that the supply of Pfizer’s antiviral COVID-19 pill will increase over the next few months and will become more plentiful by June.

A study measuring the risk of carditis associated with the Pfizer-BioNTech vaccine, Comirnaty, showed that a second dose of the shot can raise the risk of the heart inflammation disorder, albeit very slightly, according to a study at the University of Hong Kong. In comparison, Sinovac’s vaccine showed an incidence of .31 cases out of 100,000 versus an incidence of .57 per 100,000 cases for the Pfizer shot. The study was written up in the Annals of Internal Medicine.   

Texas federal judge Mark Pittman will conduct a hearing on Friday to consider whether to allow Pfizer to participate in the redaction and release of information about the development of Comirnaty. A group of scientists and doctors took their Freedom of Information Act request to court and won a favorable ruling earlier this month that would require the FDA to provide documents on the approval of the vaccine starting on March 1. Story

UPDATED: Thursday, Jan. 27 at 9:35 a.m. ET

In a tight race to develop an omicron-specific vaccine, Moderna has launched a phase 2 trial to test its candidate as a booster. The trial will enroll about 600 people in the U.S. All participants will have already received two doses of Moderna's authorized shot. One cohort will include people who have received a booster shot, while the other haven't. Story

Abbott enjoyed COVID-19 testing-related sales of $2.3 billion in the fourth quarter, with $2.1 billion from its rapid testing platforms. But the company is only predicting $2.5 billion in COVID testing sales for the entire 2022. Abbott said the forecast could change quarter-to-quarter as demand fluctuates. Story

Pfizer is asking to join the process of a lawsuit around the publication of documents the FDA used to license Comirnaty. The New York pharma said it wants to help the FDA avoid "inappropriately" disclosing trade secret and confidential commercial information, Reuters reports. A hearing for that request is scheduled for Friday.

In adults who had previously received a full course of an FDA-authorized COVID-19 vaccine an additional booster dose of any of the vaccines was safe and prompted an immune response, a study by the National Institutes of Health has found. The findings previously supported CDC's and the FDA's recommendations for mix-and-match booster shots.

The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the conditional marketing authorization Pfizer's Paxlovid oral pill for high-risk patients who do not require supplemental oxygen. A formal conditional nod by the European Commission is expected imminently.

UPDATED: Wednesday, Jan. 26 at 11:20 p.m. ET

BioNTech will boost its staff at its sprawling factory in Marburg, Germany, adding 250 people to its current roster of 500 to increase capacity as it tries to meet the demand for its COVID-19 vaccine, developed along with Pfizer and called Comirnaty. The move is part of a $56.5 million investment to boost production. The Marburg site has supplied more than 1.2 billion doses of the shot.

With emergency use authorizations for their COVID-19 vaccines, companies such as Moderna and Johnson & Johnson are not required to release data on their shots. But the British Medical Journal is demanding that companies do so, saying “data should be fully and immediately available for public scrutiny.” The BMJ added that refusal to release data is “morally indefensible.” Pfizer has provided the data, as required by its full approval.

Scientist at the University of Washington and Vir Biotechnology have discovered changes in the spike protein of omicron, which could lead to the design of vaccines and treatments that would be more effective against the variant. The findings were published in the journal Science.

The Biden administration is withdrawing its attempt to have the Occupational Safety and Health Administration enforce a mandate to require employees to be vaccinated or tested. The move was largely a formality after the Supreme Court overturned the OSHA requirement on Jan. 13. The door is still open for a refined mandate that would affect some types of jobs.

UPDATED: Tuesday, Jan. 25 at 3:40 p.m. ET

Florida governor Ron DeSantis said he will fight the FDA’s decision on Monday to sideline COVID-19 antibody treatments by Eli Lilly and Regeneron because they are ineffective against the omicron variant. Earlier this month, DeSantis criticized President Biden for temporarily halting the supply of the antibodies. DeSantis’ top donor is Citadel hedge fund CEO Ken Griffin. His company has $15.9 million in Regeneron shares.

Researchers at the University of Minnesota are close to finishing a trial of three drugs repurposed to treat COVID-19, including the controversial anti-parasite medicine ivermectin. The other drugs are antidepressant fluvoxamine and diabetes treatment metformin. Various combinations of all three drugs are being assessed for their efficacy against the virus.

A study in England shows that people who had survived hospitalization for COVID-19 for more than a week were twice as likely to die or return to the hospital than the general population. The findings were published in the open-access journal PLOS Medicine.

Forty-four percent of adults in the U.S. have ordered at-home COVID-19 testing kits provided by the government, according to an Axios/Ipsos poll. The kits became available last week through the government or postal service, with four available per household. Only 1 in 5 unvaccinated respondents said they had taken advantage of the giveaway versus half of vaccinated adults.

There are 140 COVID-19 vaccines in development. But the window to contribute to the vaccine fight is closing. What does the future hold for the vaccine hopefuls? Several companies still believe they have much to offer in the way of delivering vaccines that are an improvement over the current selection. Story  

UPDATED: Tuesday, Jan. 25 at 9:30 a.m. ET

Pfizer and BioNTech have started a study to evaluate an omicron-specific mRNA vaccine candidate in healthy adults. The trial aims to enroll 1,420 participants to evaluate the safety, tolerability and immunogenicity of the new shot. The study includes three cohorts: One includes people who've got two doses of the pair's current vaccine, Comirnaty, and will receive one or two doses of the new shot; participants in the second cohort have received three doses of Comirnaty and will get one dose of the experimental vaccine; the third group are for COVID vaccine-naïve people, who will get three shots of the new jab. Story

The FDA is restricting the use of Eli Lilly's and Regeneron's antibody drugs to patients who have been infected with or exposed to a variant that is susceptible to the treatments. As data suggest the two therapies don't work against omicron, which makes up 99% of all new cases in the U.S., the drugs are practically irrelevant for the current fight against COVID. Story

Mammoth Biosciences, which was born out of the work by Nobel laureate Jennifer Doudna, Ph.D., has won FDA emergency use authorization for a CRISPR-based high-throughput COVID-19 test. The DETECTR Boost diagnostic kit offers PCR-rivaling accuracy and automation capabilities, according to the company. Story

A booster dose of Pfizer and BioNTech's Comirnaty, or AstraZeneca's Vaxzevria or Johnson & Johnson's vaccine significantly increased the antibody levels in people who'd previously received Sinovac's CoronaVac, an inactivated vaccine, researchers from Brazil and the University of Oxford have found. The responses were also high against delta and omicron variants, the team reported in the Lancet. 

Arcturus Therapeutics said its self-amplifying mRNA vaccine candidates, when given in a low dose at least five months following initial vaccination with Comirnaty, triggered robust increases in neutralizing antibody responses against omicron in a phase 1/2 trial. 

UPDATED: Monday, Jan. 24 at 9:30 a.m. ET

Pfizer CEO Albert Bourla believes annual vaccinations are the ultimate answer for defending against COVID-19, instead of a series of more frequent booster shots. His comments come as the vaccine produced by Pfizer and BioNTech was shown to be effective at preventing death and hospitalization but not against transmission of the omicron variant. “Once a year—it is easier for people to do it. It is easier for people to remember,” Bourla said in an interview with Israel’s N12 News. “We are looking to see if we can create a vaccine that covers omicron and doesn’t forget the other variants and that could be a solution.”

A report from the International Coalition of Medicines Regulatory Authorities says multiple booster doses at short intervals is not a sustainable approach to combatting COVID in the long term. The ICMRA urges development of vaccines that target two or more variants of the virus at a time. The report highlights an assessment of the effectiveness of vaccines against the omicron variant.

Pfizer and BioNTech released data from two lab studies showing that three doses of their COVID-19 vaccine elicited antibodies that neutralize the omicron variant. Data from 51 vaccinated people showed that two doses of the vaccine may not be enough to prevent infection, but the companies do believe two doses induces protection against severe disease. A separate study showed samples taken one month after a third dose showed a 22-fold increase in neutralization titers against omicron versus titers before a third dose, around eight months after the first two-dose series. Titers against wild-type and omicron decreased by similar amounts after the third dose.

As evidence mounts that antibody treatments from Eli Lilly and Regeneron aren't effective against the omicron variant, the FDA is moving toward prohibiting their use, CNN reports, citing a source close to the deliberations. The NIH has itself issued guidelines advising clinics not to use the drugs. Over the last two weeks, according to data from the Department of Health and Human Services, 110,000 doses of these treatments have been distributed in the U.S. despite omicron accounting for more than 95% of current cases. GlaxoSmithKline and Vir’s antibody drug has shown to be effective against omicron but is in short supply.

The European Union is expected to decide whether to authorize Pfizer’s COVID-19 antiviral pill by the end of this month, said a European Medicines Agency source, with a decision on Merck and Ridgeback’s COVID antiviral coming in early February.

As part of a study, the U.K. will administer Merck and Ridgeback’s antiviral COVID-19 pill to patents hospitalized with a severe form of the virus. The trial will compare the effectiveness of the oral treatment to standard of care. The pill is approved for at-risk patients with a mild-to-moderate form of the disease.

UPDATED: Friday, Jan. 21 at 3:40 p.m. ET

A Texas federal judge has blocked President Biden’s mandate to have government employees vaccinated. Judge Jeffrey Vincent Brown called the mandate an overstep of authority, citing a recent Supreme Court decision to overturn a different administration mandate that applied to the private sector. The Justice Department immediately appealed the decision.

Recommended vaccinations—aside from COVID-19 shots—are still lagging because of the pandemic, a study commissioned by GlaxoSmithKline found. From January 2020 to July 2021, monthly vaccine claims decreased by 32% for adults and 36% for adolescents, the study found.

The World Health Organization has recommended the Pfizer-BioNTech vaccine for children ages 5 to 11. The dose for kids of this age group is a third the size of the adult dose. The WHO's Strategic Advisory Group of Experts said that vaccination for kids ages 5 to 11 should be a low priority except for those with underlying medical conditions. The committee also is recommending a booster dose 4 to 6 months after original vaccination.

UPDATED: Friday, Jan. 21 at 11:20 a.m. ET

Moderna COVID-19 vaccine recipients are less likely to have breakthrough infections compared to those who have been inoculated with the Pfizer-BioNTech shot, according to a study by Case Western Reserve University in Cleveland. The study also shows that among those who had breakthrough infections, Moderna users were less likely than Pfizer users to be hospitalized. The findings were published Thursday in the Journal of the American Medical Association. The study included 637,000 vaccinated patients from 63 healthcare organizations in the U.S. and was conducted from July to November of last year when the delta variant was the primary threat.

GlaxoSmithKline and Vir Biotechnology are scrambling to meet the soaring demand for their COVID-19 antibody treatment, which has been shown to be effective against the omicron variant. Previously, the companies were using only a WuXi plant in Shanghai, China, to produce the antibodies. Now they are racing to get a Samsung manufacturing facility ready as well, along with a fill-finish site in Parma, Italy. Story

China’s Sinovac COVID-19 vaccine provides undetectable antibody levels against the omicron variant, according to two lab studies at Yale University. The samples were taken from 101 people from the Dominican Republic who had two shots of the Sinovac jab. The shot has been approved in 50 countries and is the primary shot in use in several nations, including Chile.

UPDATED: Thursday, Jan. 20 at 4:25 p.m. ET

Children age 4 and younger are likely to be eligible for the Pfizer-BioNTech COVID-19 vaccine within the next month, according to U.S. infectious disease expert Anthony Fauci in an interview with the Blue Star Families magazine. The vaccine will likely be a three-dose series as a two-dose series did not elicit enough response in testing, Pfizer said last month.

Two doses of the Sputnik V vaccine build twice the neutralizing antibodies against the omicron variant than two doses of the Pfizer vaccine, said the Russian Direct Investment Fund. The study was conducted jointly by researchers in Italy and Russia and compared sera samples from individuals who were inoculated with the Sputnik V and Pfizer vaccines.

While new cases of the omicron variant are subsiding in some areas of the U.S. where it was first detected, deaths from the variant are on the rise, averaging just under 1,900 per day, a 42% increase from the previous two weeks. New cases also are on the rise throughout the U.S. in general, averaging 760,000 a day, a 30% increase over the past two weeks.

Thanks to their success in developing and suppling COVID-19 vaccines, Pfizer and Moderna are the two leading pharma companies in terms of public image according to a poll this month by research firm Leger. On the flip side, with the problems associated with the development of their vaccines, the reputation of AstraZeneca and Johnson & Johnson has plummeted. Story

In separate interviews during Fierce JPM Week, executives from Eli Lilly and Novartis lavished praise on Pfizer for development of its COVID-19 antiviral pill Paxlovid. Jay Bradner, the president of the Novartis Institutes for BioMedical Research, called the development “heroic” and added that the “molecule is breathtaking.” David Ricks, CEO of Lilly, also gave Pfizer high marks, saying “small molecule drug development is a tricky business.” Story

Some members of Congress are asking the Federal Trade Commission to investigate pandemic price gouging. Sens. Ed Markey (D-Mass.) and Richard Blumenthal (D-Conn.) cited prices double and triple of retail for at-home COVID tests. Story

Scientists from Northwestern University and the University of Texas have showed that some naturally occurring tiny vesicles isolated from COVID-19 patients could fight off an infection from various subtypes of coronaviruses. The findings could help in the fight against future variants. Story

UPDATED: Thursday, Jan. 20 at 9:55 a.m. ET

For his efforts in leading Pfizer in the development of a COVID-19 vaccine, CEO Albert Bourla is this year’s winner of the Genesis Prize and the $1 million award that comes with it. The honor is bestowed for humanitarian achievement and commitment to Jewish values. More than 200,000 people in 71 countries participated in the online vote. Bourla was commended for his “leadership, determination and especially for his willingness to assume great risks.”

While both paths to immunity provided significant defense, surviving a previous infection provided better protection against the delta variant than vaccination, a study by the CDC shows. Data from 1.1 million people in California and New York—collected between May and November of this year—also showed that those who were unvaccinated and had not caught the virus were far more likely to be infected.

The United Nations-backed Medicines Patent Pool said that it has agreements with 27 generic drugmakers in 11 countries to produce Merck and Ridgeback’s COVID-19 antiviral pill to supply Le105 developing countries. The deals permit the manufacturers to produce both the raw ingredients and finished product. 

Australia has approved the Novavax COVID-19 vaccine and has ordered 51 million shots for its 26 million residents. It is the fifth shot approved by the country after the Pfizer, Moderna, AstraZeneca and Johnson & Johnson vaccines. The government has purchased all but the J&J shot. For now, the two-dose Novavax shot will not be used as booster and is intended only for those who are not vaccinated.

Lab studies of the Valneva COVID-19 vaccine showed that three doses are effective in protecting against the omicron variant. Among 30 participants in the study, 87% of blood samples contained neutralizing antibodies. The vaccine is a traditional type using an inactivated form of the virus. The company anticipates that the shot will gain approval in Europe in the first quarter of this year and has a deal to supply 60 million doses to the EU.

UPDATED: Wednesday, Jan. 19 at 11:10 p.m. ET

Belgium will offer the Novavax COVID-19 vaccine to those who are allergic to or had side effects from the Pfizer and Moderna shots. Belgium has purchased 510,000 Novavax vaccines, which will be delivered by early March. Novavax’s vaccine was approved in Europe in December but has yet to get a nod as a booster dose.

The omicron variant is surging, and the world is wondering what’s next. But according to Novartis CEO Vas Narasimhan there is plenty of reason for optimism, saying during Bloomberg’s The Year Ahead summit that he believes the world is ready to “reach a state of normalcy.” To reach this state, governments will need to negotiate a “careful balancing act,” Narasimhan said, in order to slowly re-establish regular social contact.

With their rapid success developing a COVID-19 vaccine, Moderna, BioNTech and Pfizer have provided a validated mRNA platform from which to develop new vaccines and therapeutics. So what comes next? In a panel discussion hosted during Fierce JPM Week, experts talked about the potential for mRNA technology. Story  

While drug supply chains have generally held up during the pandemic, it’s been no easy feat. COVID-19 showed the industry just how vulnerable the supply chain could become, and it spawned new efforts to regionalize manufacturing and double down on automation. In a panel discussion during Fierce JPM Week, five industry executives talked about how they met the challenges and how the landscape will be forever changed. Story

UPDATED: Tuesday, Jan. 18 at 3:00 p.m. ET

A CDC report shows that Hispanic people were 58% less likely to be provided monoclonal antibodies than non-Hispanics for COVID-19 infection. Data collected from 41 healthcare systems participating in the National Patient-Centered Clinical Research Network also found that black patients (22%), Asians (48%) and other race patients (47%) also were less likely to receive antibodies than white patients. The total patient pool included 805,276 who were infected. The study ran from November 2020 to August 2021. There also were racial disparities—though much less pronounced—in the use of the antiviral remdesivir and steroid dexamethasone.

Pfizer’s oral antiviral Paxlovid has been shown to be effective against the omicron variant, the company said. Three different lab studies confirmed the findings. The news comes amid reports that some monoclonal antibody treatments are ineffective against omicron infection.

Merck and Ridgeback will provide UNICEF up to 3 million courses of their oral antiviral COVID-19 treatment molnupiravir for distribution to 100 low- and middle-income countries in the first half of 2022, the companies said. Merck manufactured 10 million courses of the drug in 2021 and plans to produce 20 million this year. The companies will provide 3.1 million courses to the U.S.

Nonsurgical N95 and KN95 respirators provide better protection against omicron than cloth masks, the CDC said.

UPDATED: Tuesday, Jan. 18 at 9:15 a.m. ET

Pfizer will add a production facility in France which will manufacture its COVID-19 antiviral pill, the company said. Adding the site is part of a $594 million investment in France by the company over the next five years. Pfizer CEO Albert Bourla said last week during the J.P. Morgan Healthcare Conference that the company was building its capacity to produce the treatment, Paxlovid, which has shown to be 90% effective in preventing hospitalization and death in high-risk patients with the virus.

Novartis has in-licensed global rights of ensovibep, a COVID-19 antiviral, from Molecular Partners. The agreement triggers a milestone payment of CHF $150 million ($163 million) to Molecular. The agreement also specifies that Molecular will receive 22% in royalty payments on potential commercial sales.

Trial data from Israel show that a fourth dose of the Pfizer COVID-19 vaccine is ineffective in preventing infection from the omicron variant. The study of 154 medical personnel also showed that those who were infected had slight symptoms or none at all. More than 500,000 in Israel have received a fourth Pfizer dose.

The ACLU of Arkansas has filed a lawsuit against a detention center for deceiving inmates about a drug. Four inmates who were given ivermectin allege they were told the treatment consisted of “vitamins,” “antibiotics,” and/or “steroids.” The misuse of ivermectin can cause serious harm including “seizures, comas and even death,” according to the FDA. 

UPDATED: Friday, Jan. 14 at 9:30 a.m. ET

Moderna, Pfizer and BioNTech have said they are working on vaccines to defend against the COVID-19 omicron variant, but U.S. health experts don't believe a variant-specific shot will be needed, according to a report in The Wall Street Journal. “The reason to have an Omicron-specific vaccine is if you thought that was going to be the new normal—the new variant that is going to take over and continue to circulate over time,” Peter Marks of the FDA said. “By the time we get an Omicron-specific vaccine manufactured, this wave will be over.”

A study shows that a second, booster dose of the Johnson & Johnson COVID-19 vaccine is 85% effective in protecting against hospitalization from the omicron variant 1 to 2 months after administration, said South Africa’s Medical Research Council. The study included 477,234 healthcare workers who received the J&J shot as an original vaccine, and roughly half of them received booster doses. The booster reduced hospitalizations by 63% in the first two weeks after the booster and increased to 85% for between one and two months. South Africa has administered 7 million doses of the J&J shot, compared to 21 million of the Pfizer vaccine.

The World Health Organization will decide in early February whether to recommend use of Merck’s COVID-19 antiviral pill molnupiravir, soon to be followed by a decision on the Pfizer antiviral pill, an official said. On Thursday, the WHO recommended use of the COVID-19 antibody treatments by GlaxoSmithKline-Vir and Eli Lilly, which have shown effectiveness against the omicron variant.

The U.S. will buy 500 million more coronavirus tests for free distribution, President Joe Biden said on Thursday. The announcement comes amid criticism of the administration for its vaccine-centric response to the pandemic. The new purchase comes on top of the 500 million Biden pledged to buy in late December. Story

UPDATED: Thursday, Jan. 13 at 11:10 a.m. ET

GlaxoSmithKline and Vir Biotechnology have asked the FDA to expand its approval of their COVID-19 monoclonal antibody drug to allow it to be administered as a shot in the buttock. The treatment, sotrovimab, is currently provided through intravenous infusion to those with mild or moderate cases of the virus. A trial has demonstrated its effectiveness when injected. Expanding the approval would provide a more convenient option for administration, potentially saving patients a trip to the hospital. Sotrovimab also has been shown to perform effectively against the omicron variant. Earlier this week, the companies said that the United States had agreed to purchase 600,000 doses of the therapy on top of a previous agreement which brings total supply to the U.S. to 1.7 million doses.  

UPDATED: Thursday, Jan. 13 at 9:10 a.m. ET

Novartis is seeking approval of its experimental COVID-19 antiviral without waiting for results from a large clinical trial, CEO Vas Narasimhan said. Within the next month, the company plans to file for emergency use authorization with the FDA for ensovibep. Narasimham said that as the world gets through waves of variants, with more people vaccinated, he hopes an “equilibrium state,” can be achieved.

Preliminary trial data shows that AstraZeneca’s COVID-19 vaccine induces a higher antibody response against the omicron variant when used as a booster dose. The company said that the data supports its use as a third shot regardless of primary vaccination. AZ will send the data to regulatory authorities. Further analyses from the trial will be available in the first half of this year.

In March, Moderna will report data from a trial of its COVID-19 vaccine on kids age 2 to 5, the company said. If the data is "supportive," Moderna said it will proceed with regulatory filings. Moderna’s vaccine has yet to be approved in the U.S. for those 17 and younger. Europe, Canada, Australia and the U.K. have approved the shot for kids age 12-17.

Africa is working to secure doses of Pfizer’s COVID-19 antiviral pill, Paxlovid. Africa is “really close” to obtaining the treatment, said Africa’s CDC director John Nkengasong. The drug can be taken at home, keeping those who are infected out of the hospital. Nkengasong said that only 10% of people in Africa are fully vaccinated.

The U.S. purchased an additional 500,000 doses of AstraZeneca’s long-acting antibody cocktail Evusheld. That comes on top of the 700,000 doses the U.S. already ordered of the treatment, for a total supply of 1.2 million, the British drugmaker said. Unlike the antibody drugs from Eli Lilly, Regeneron and GlaxoSmithKline-Vir Biotechnology, AstraZeneca’s therapeutic is authorized for prevention before exposure to the virus. Story

UPDATED: Wednesday, Jan. 12 at 9:00 a.m. ET

A booster dose of Pfizer’s COVID-19 vaccine works alongside its pneumococcal conjugate shot Prevnar 20, the company said Wednesday. Prevnar 20 immune responses were “similar” whether patients also received the drugmaker’s mRNA vaccine or placebo, and the same was true of immune responses from the COVID-19 vaccine. The safety of the co-administration regimen “generally reflected that observed with the Pfizer-BioNTech COVID-19 vaccine booster dose,” the company said. Pfizer ran its co-administration study in 570 adults ages 65 and older. Release

The FDA revised the fact sheet for Johnson & Johnson’s vaccine to cite the “serious risk” of immune thrombocytopenia (ITP), which can cause easy or excessive bruising and bleeding. Specifically, it includes information about side effect reports after vaccination with the J&J shot that “suggest an increased risk of ITP during the 42 days following vaccination.” The FDA urged patients with a history of ITP to weigh the risk and the potential need for platelet monitoring post-vaccination. Release

South Korea gave a thumbs up to Novavax’s protein-based vaccine in people ages 18 and older. The shot, which will be marketed in the country as Nuvaxovid, will be manufactured and sold by Novavax’s partner SK bioscience. SK has inked an advance purchase agreement with South Korea for 40 million doses. Release

Meanwhile, Novavax expects demand for its vaccine to play out globally across all three key areas: primary vaccination, booster doses and the pediatric market, Silvia Taylor, senior vice president, global corporate affairs and investor relations at Novavax, said in an interview. There are currently some 5 billion “doses of demand” in the high-income market alone, Taylor said. Moving into middle- and lower-income countries, demand jumps to more than 6.5 billion, she added. On the booster front, Novavax’s shot is enrolled in studies assessing so-called heterologous boosting, when a person receives one vaccine to start and gets boosted with another. Story

UPDATED: Tuesday, Jan. 11 at 9:40 a.m. ET

GlaxoSmithKline and Vir Biotechnology will supply an additional 600,000 doses of their COVID-19 antibody treatment, sotrovimab, to the U.S., the companies announced. Delivery is scheduled for the first quarter of this year. While some other antibody treatments have shown to be ineffective against the omicron variant, sotrovimab retains its effectiveness against. The agreement brings the companies’ total supply to the U.S. to 1.7 million doses. Tuesday’s agreement comes with an option for the U.S. to buy additional doses in the second quarter.

BioNTech and InstaDeep have developed a system that uses modeling of the spike protein and artificial intelligence to predict new high-risk variants using virus sequencing data. The Early Warning System, as it has been dubbed, assesses the immune escape and fitness metrics of newly identified variants. High-risk variants can be flagged in less than a day. In a trial, the system identified more than 90% of the WHO-designated variants by an average of two months in advance. The EWS detected omicron on the day its sequence was first uploaded. It was identified as the highest immune escaping variant from over more than 70,000 variants discovered from early October to late November.

One booster dose of CanSino Biologics’ inhaled COVID-19 vaccine, Inhalation Convidecia, for those who have received two doses of an inactivated COVID-19 vaccine can induce a higher level of neutralizing antibodies than a homogeneous booster of inactivated vaccine, a study showed. The inhaled vaccine provides unique advantages, training the immune memory function of the body by imitating the natural infection of the virus.

Adamis Pharmaceuticals is seeking fast-track designation from the FDA for Tempol, its oral drug to treat and prevent COVID-19. Touting Tempol’s anti-inflammatory and antiviral effects, the company says it could fulfil an unmet need. Patients in a phase 2/3 trial of the drug were dosed starting in September of last year.

Pfizer has bumped up its estimate for production of its COVID-19 antiviral pill Paxlovid. During the J.P. Morgan Healthcare Conference, CEO Albert Bourla said the company plans to manufacture 120 million courses of the treatment this year, which works out to 3.6 billion tablets. Boula also said that the figure could grow as countries have expressed an interest in stockpiling the drug which has a three-year shelf life. In early November, Pfizer said it planned to produce 50 million courses of the treatment. Later in the month, the company boosted the estimate to 80 million. Story.

UPDATED: Monday, Jan. 10 at 9:16 a.m. ET

While COVID-19 antibody sales didn't match up to mRNA vaccine revenues in 2021, they contributed a welcome boost to the toplines at companies such as Regeneron. The New York-based biotech reported unaudited sales of $2.29 billion for its Regen-Cov combo in the fourth quarter, bringing the drug's annual haul to nearly $6 billion.

Speaking at the virtual J.P. Morgan Healthcare Conference on Monday, Moderna CEO Stéphane Bancel said that he expects people 50 and older, plus the immunocompromised and others, may need annual COVID booster doses.

The United States' latest surge in cases could peak later this month, Dr. Ashish Jha, dean of the Brown University School of Public Health, said on ABC's "This Week." But the surge in cases comes as many hospitals face critical staffing shortages, CNN reports.

In some places, hospitals are being forced to leave beds empty in response to staffing shortages, The Wall Street Journal reports. That's considered a last resort for hospital administrators to maintain quality of care with the staff they have, according to the newspaper.

UPDATED: Friday, Jan. 7 at 8:20 a.m. ET

A single shot of the Johnson & Johnson COVID-19 vaccine offered protection for up to six months against COVID-19 hospitalizations, according to results from a real-world study, the company said. By comparison, mRNA vaccines by Pfizer-BioNTech and Moderna showed waning effects in months 2 and 3, respectively. The study analyzed records from 168 million vaccinated people last year between Jan. 1 and Sept. 7. Release

Rather than 500 pages per month as the FDA has requested, the agency must process and release 55,000 pages of documents it used to approve Pfizer and BioNTech's Comirnaty per month, a federal judge in Texas has ruled. The group is asking for altogether 450,000 pages of documents, which now means the FDA has about eight months to meet the FOIA request, Reuters reported.

Researchers have launched a trial in South Africa among health workers to compare Johnson & Johnson's and Pfizer-BioNTech's COVID shots as boosters, Bloomberg reported.

The CDC has relaxed its quarantine and isolation guidance for K-12 schools, The Wall Street Journal reported. Students can leave isolation five days after their initial positive test or the onset of symptoms, or if they are fever-free for 24 hours without the effect of fever reducer and their symptoms have improved.

UPDATED: Thursday, Jan. 6 at 9:20 a.m. ET

Pfizer has amended a clinical trial of its COVID vaccine in kids under the age of 5 to give a third dose to everybody at least eight weeks after their last dose, a Pfizer vaccine researcher said at a meeting of the CDC's Advisory Committee on Immunization Practices, Reuters reported. The company now expects to have data from the group in April.

Gavi, the Vaccine Alliance is in talks with Bharat Biotech for potential procurement of the latter's Covaxin for the COVAX vaccine distribution program, a Gavi spokesperson reportedly told Reuters. About 180 million Covaxin doses have been administered in India, plus another 3 million doses have been exported or donated. 

Gritstone bio has unveiled early data for its self-amplifying mRNA vaccine. In one cohort of the phase 1 CORAL-BOOST trial, a single dose of the shot as a booster triggered strong antibody and T-cell responses in ten healthy adults 60 or older who had received two prior doses of AstraZeneca’s COVID-19 vaccine. Release

The CDC followed up an FDA expanded authorization with a recommendation that adolescents age 12 to 17 should receive a Pfizer-BioNTech booster shot five months after their primary vaccinations. Release


UPDATED: Wednesday, Jan. 5 at 9 a.m. ET


The Biden administration doubled its order of Pfizer’s COVID antiviral, Paxlovid, bringing the total to 20 million courses. The U.S. government also aims to accelerate the delivery, with all doses expected to be shipped by September. Story

Meanwhile, India refused to include Merck’s COVID pill, molnupiravir, in its national treatment guideline out of "major safety concerns," a senior health official told a media briefing, as quoted by Reuters.

A fourth shot of Pfizer and BioNTech’s Comirnaty vaccine, given around five months after the third dose, triggered a fivefold increase in blood antibodies one week after the injection, according to data from Israel’s Sheba Medical Center, The Wall Street Journal reported. The finding came from a study in 154 medical workers.

The FDA halted manufacturing site inspections through Jan. 19 to cope with the threat of omicron. But the agency said it intends to continue conducting "mission-critical" domestic and foreign inspections. Release

NRx Pharmaceuticals refiled an application for FDA emergency use authorization of anti-inflammation drug Zyesami. The FDA last year rejected the drug. This time, the company is asking for a narrower indication in treating critical COVID patients at an immediate risk of death who were previously treated with Gilead Sciences remdesivir. Release

Shionogi has delayed a Japanese filing of its COVID pill, dubbed S-217622. The company was originally targeting a go-ahead by the end of 2021, but enrollment in a local phase 2/3 trial that started in September was slower than expected, news agency Jiji Press reported.

UPDATED: Tuesday, Jan. 4 at 10 a.m. ET

The FDA has expanded the emergency use authorization for a booster dose of Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty, to cover adolescents 12 to 15 years of age. Meanwhile, the FDA reduced the interval before an individual can receive a booster dose after the primary series. It's now five months instead of the previous six months. Release



A booster shot of Johnson & Johnson’s COVID vaccine was 85% effective against COVID-related hospitalization, a phase 3b study showed. The trial was conducted in South Africa in late 2021, when omicron was the dominant coronavirus variant in the region. Separately, another study from Beth Israel Deaconess Medical Center examined blood from 65 vaccinated individuals. The researchers recorded a marked increase in both neutralizing antibody and T-cell response for the J&J shot given as a booster after Comirnaty. Release



After much delay, Novavax filed the data on its COVID-19 vaccine's manufacturing process to the FDA on the last day of 2021. That completes its data package for NVX-CoV2373, but a formal request for an emergency use authorization won’t happen until a month later. Release



Robust activation of immune cells known as T follicular helper cells, which can last for up to six months, might explain why Comirnaty works so well against severe COVID, a new study published in the journal Cell shows. Story

India’s Dr. Reddy’s Laboratories will sell its generic version of Merck’s COVID antiviral molnupiravir at 35 rupees ($0.50) per capsule, Reuters reported. That adds up to about $20 for a five-day treatment course of 40 capsules. By comparison, Merck is selling the drug to the U.S. government at about $700 per course.