The WHO has signed off on its first generic version of Paxlovid, granting prequalification to Hetero of India.
A study shows that a booster dose of an mRNA vaccine from Moderna or Pfizer produces a more durable antibody response.
After three years of requiring visitors to quarantine, China will lift the restriction on Jan. 8.
Please read below for the latest updates. Daily COVID-19 tracker entries from April 14 to Aug. 31 can be found here.
UPDATED: Tuesday, Dec. 27 at 11:25 a.m. ET
Hetero has received approval from the World Health Organization for Nirmacom, its generic version of Pfizer’s COVID-19 oral antiviral Paxlovid. The sanction comes through the WHO’s prequalification of medicines program. It is the first generic version the WHO has signed off on. Hetero will manufacture Nirmacom—which is a combination of nirmatrelvir and ritonavir—and provide it to 95 low- and middle-income countries. Hetero was among several companies around the world which reached licensing agreements nine months ago with the Medicines Patent Pool to acquire the intellectual property to produce the drug.
A booster dose of an mRNA vaccine from Pfizer-BioNTech or Moderna provides longer lasting antibodies for all recipients, even those who have recovered from a COVID-19 infection, according to a study at the University of Virginia. The study followed 117 university employees who were boosted, comparing their antibody levels to 228 after their primary vaccination series. Contrary to what researchers expected, a booster dose did not immediately increase antibody levels but it did provide longer-lasting antibodies.
Inbound travelers will be free to enter China without going into quarantine starting Jan. 8, the government said. The move is a major step toward opening its borders after three years of restrictions. The country also has downgraded the COVID threat from its top level, Category A, to Category B as the virus has become less lethal.
UPDATED: Thursday, Dec. 22 at 10:45 a.m. ET
The FDA has granted a full approval to Roche’s antibody therapy Actemra for hospitalized COVID-19 patients. The treatment, for those on oxygen support and with severe symptoms, has been in use in the U.S. since June of 2021 when the FDA blessed it on an emergency basis. The new nod covers patients 18 and older. The emergency use authorization applies to patients as young as age 2. The approval comes as other antibody drugs for COVID have been taken off the market as they have been proven ineffective against emerging variants. Story
Life expectancy in the United States fell in 2021 to its lowest level since 1996, with the reduction attributed to deaths from COVID-19 and opioid overdoses, said the CDC. The death rate in the U.S. increased by 5%, reducing life expectancy from 77 in 2020 to 76.4 last year. Before the pandemic, in 2019, life expectancy was at 78.8 years. The leading causes of death last year were heart disease, cancer and COVID-19, with the latter accounting for 416,893 deaths, up from 350,831 in the first year of the pandemic.
UPDATED: Wednesday, Dec. 21 at 10:05 a.m. ET
Germany has shipped a clutch of Pfizer and BioNTech’s COVID-19 vaccine to China for German expatriates living there, multiple news outlets have reported. The Chinese government let Berlin know in a diplomatic note that German citizens in China can be vaccinated with the mRNA shot, which otherwise isn’t authorized in the country, AP News points out. In a prophylactic quid-pro-quo, Germany is allowing Chinese citizens in Germany to get the Chinese-made Sinovac shot, which isn’t approved in the European Union.
2023 is shaping up to be a tough year for drugmakers who’ve garnered major pandemic sales hauls in 2021 and 2022. And for now, major players are staying mum on their future COVID-19 revenue expectations. Some, like Moderna, have estimated that the annual COVID-19 booster market could resemble that for flu shots in the U.S. But at least one analyst—Third Bridge’s Lee Brown—disagrees. He predicted the yearly U.S. COVID shot market could be “as low as one-third the size of the flu market.” Story
Sanofi’s COVID-19 vaccine VidPrevtyn Beta has scored another nod, this time winning the blessing of the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) as a booster in patients ages 18 and older. The single-dose shot is known as a heterologous booster, which means people who received a different vaccine—either mRNA or viral-vectored—can still receive Sanofi’s product as a supplemental shot.
UPDATED: Tuesday, Dec. 20 at 9:55 a.m. ET
The Clinical and Economic Review (ICER) suggests a fair price for Pfizer’s antiviral Paxlovid ranges from $563 to $906 per course. The U.S. is currently spending around $530 per treatment course of Paxlovid, ICER explained. The watchdog’s report comes as “negotiations ensue” around payment schemes for Paxlovid in commercial insurance systems.
Vaxess Technologies, which recently ginned up $23 million for the development of a needle-free COVID-19 vaccine, has generated early clinical evidence in support of its delivery patch, linking the device to seroprotection rates of over 90% when used to administer an influenza vaccine in a phase 1 trial. Known as the MIMIX patch, Vaxess sees the technology as a way to elicit a stronger, more durable immune response, eliminate the need for refrigeration and simplify vaccine administration. Story
Hong Kong has given Fosun Pharmaceutical Group the thumbs up to sell BioNTech’s COVID-19 vaccine in-country, multiple local news outlets reported Tuesday. In both Hong Kong and Mainland China, Fosun Pharma’s shares climbed as much as 1.7 percent before falling, Yicai Global points out. The green light covers both Comirnaty and BioNTech’s Omicron-busting booster shot for patients ages 12 and up.
UPDATED: Monday, Dec. 19 at 11:00 a.m. ET
The World Trade Organization has extended its deadline for a decision on whether to expand an intellectual property rights waiver for COVID-19 vaccines to therapeutics and diagnostics. The WTO said it will take up to six months to come up with an answer. In June of this year, the WTO agreed to a TRIPS waiver, allowing developing nations to override patent restrictions on COVID vaccines for five years.
The Pfizer and BioNTech COVID vaccine has been linked to higher incidences of adverse effects in people age 65 and older, the FDA said, while adding that the advantages of the shot outweigh the risks. Data collected up until January of this year from 25 million people showed that 0.06% of those 65 and older developed a blood clot in the lungs.
UPDATED: Friday, Dec. 16 at 9:15 a.m. ET
The White House is restarting its shipments of free COVID-19 tests to U.S. households, Fierce Med Tech reports. Starting Thursday, each household can order up to four antigen test kits. The program started last winter, but Congressional funding dried up in September. Now, the Biden administration is calling this a "limited round" of shipments.
The Centers for Disease Control and Prevention provided researchers at the Washington University School of Medicine in St. Louis a $12.5 million grant to research the real-world effectiveness of flu and COVID vaccines, Pharmafile reports.
In late January, the FDA plans to host an advisory committee meeting to review whether primary COVID-19 vaccination shots should be adjusted. Independent experts and members of various government agencies will be in attendance.
UPDATED: Thursday, Dec. 15 at 9:55 a.m. ET
Under a new deal, China Meheco Group will import and distribute Pfizer's antiviral Paxlovid in China, Reuters reports. The deal runs through November 2023. Paxlovid won approval in the country back in February, but it hasn't been available through retail channels there.
Axcella cut 85% of its staff and is retaining the rest of its employees to investigate AXA1125 as a long COVID drug. But in this setting, the drug failed a phase 2a trial this summer, Fierce Biotech reports. Along with the news, Axcella ended its research in nonalcoholic steatohepatitis.
UPDATED: Wednesday, Dec. 14 at 9:10 a.m. ET
Roche and Pfizer are teaming up to help patients access information about COVID-19. On a Pfizer website, covid19knowmore.com, people can learn about risk factors for severe COVID-19 and the importance of timely testing. Roche markets an at-home test for the infection, while Pfizer sells the popular antiviral Paxlovid.
Speaking of Pfizer, the company's proposed commercial price tag for Comirnaty has drawn the ire of Sen. Elizabeth Warren and Rep. Peter Welch. The lawmakers recently penned a letter to Pfizer CEO Albert Bourla singling out the company for its "pure and deadly greed." Pfizer has suggested it could sell its COVID shot for $110-$130 per dose on the private market, likely starting sometime in 2023. The move could potentially be deadly for uninsured and underinsured Americans, who will likely struggle to afford the commercial shot, the lawmakers argued.
As cases continue to climb in China, Pfizer said it is working on boosting Paxlovid supplies there.
UPDATED: Tuesday, Dec. 13 at 10:05 a.m. ET
Lower COVID revenues? No problem. That’s the word according to Pfizer executives, who said at an investor event Monday that annual sales of the company’s mRNA vaccines could reach $10 billion to $15 billion by 2030. Pfizer’s big bet on its non-COVID-19 mRNA projects comes as coronavirus-related sales are expected to plunge over the next few years, Reuters reports. Pfizer didn’t break down specifical sales projections for each of its mRNA contenders, though the company noted its respiratory syncytial virus (RSV) shot, pegged for launch in 2023, could peak in 2027 with revenue above $2 billion.
Speaking of COVID-19 vaccines, the shots have kept more than 18.5 million people in the U.S. out of the hospital and saved more than 3.2 million lives, according to a new study from researchers at the Commonwealth Fund and Yale School of Public Health. The study’s investigators created a computer model of disease transmission leveraging demographic information, personal risk factors, infection dynamics and general information about vaccination, CNN points out. The study suggests that without coronavirus shots, the U.S. would have suffered 1.5 times more infections, 3.8 times more hospitalizations and more than 4 times the number of deaths than it did between Dec. 2020 and Nov. 2022.
Meanwhile, researchers have found a link between COVID-19 infection and the heart condition postural orthostatic tachycardia syndrome, or POTS, according to a new study published in Nature Cardiovascular Research. POTS, which has been diagnosed in some patients with long COVID, can lead to rapid heart rate, low blood pressure, fainting and lightheadedness. The study also linked vaccination with an mRNA shot to the condition, albeit to a lesser degree. In fact, getting Covid was connected to a five times greater risk of POTS than vaccination.
If you’re planning to carouse with friends and loved ones in Manhattan for the holidays, make sure you bring a mask. Friday, the New York City Department of Health and Mental Hygiene issued and advisory urging people to wear masks indoors and in crowded outdoor spaces, regardless of their vaccination status. Health officials in Washington State and Oregon have posted similar indoor mask recommendations in recent days, U.S. News & World Report wrote. The precautions are being redeployed as influenza, COVID and RSV converge to create a “tripledemic” in the States, putting pressure on hospitals around the nation.
UPDATED: Monday, Dec. 12 at 9:18 a.m. ET
The European Medicines Agency told healthcare workers to "consider alternative treatments" to antibody therapies if certain variants become prevalent, Reuters reports. The agency recommended treatments such as Pfizer's Paxlovid and Gilead's remdesivir as alternatives. Already in the U.S., the FDA has pulled the last antibody therapy authorization over efficacy concerns.
Officials in China are eliminating some measures to curb the spread of the virus and are now bracing for a surge in cases, CNN reports. On Monday, officials announced they're doing away with a mobile tracking app that flagged "high-risk" areas of travel.
After the FDA authorized new boosters for babies as young as 6 months old, the CDC has signed off on the updated shots, CNBC reports.
UPDATED: Friday, Dec. 9 at 8:47 a.m. ET
Pfizer and Moderna scored FDA emergency use authorizations for their updated bivalent boosters in children ages 6 months through 5 years. Pfizer said "consistent hospitalization rates" in the age group, plus a "surge" in respiratory illnesses in young children created an "urgent need to make updated COVID-19 vaccines available." The company and its partner BioNTech plan to start shipping doses immediately.
Speaking of Pfizer and BioNTech, the mRNA partners on Friday said their single-dose COVID-19 and flu vaccine scored an FDA fast track designation. The regulatory tag is intended to "facilitate the development and expedite the review" of products that the agency deems a priority, the companies said. The program is in phase 1 testing.
UPDATED: Thursday, Dec. 8 at 9:02 a.m. ET
Government-funded courses of Pfizer's antiviral Paxlovid are expected to run out in the coming months, Kaiser Health News reports. That means the people who most need the drug, including uninsured people and seniors, could lose access. Already, nearly 6 million people in the U.S. have taken Paxlovid courses.
Amid a new COVID-19 outbreak, Beijing is running out of certain medical supplies, The Financial Times reports. Some hospitals have started rationing ibuprofen and paracetamol, which are used to treat fevers and pain. Rapid antigen tests are also out at certain locations, according to the report.
VBI Vaccines is researching "multivalent coronavirus shots," otherwise known as "Coronavirus X" vaccines, which could potentially fight COVID and future coronaviruses. The work has yielded new support from the Coalition for Epidemic Preparedness Innovations.
UPDATED: Wednesday, Dec. 7 at 11:15 a.m. ET
Cases of myocarditis that are associated with use of COVID-19 vaccines from Pfizer-BioNTech are less severe than non-vaccine-related cases of the heart inflammation disorder, according to researchers at the University of Hong Kong. Comparing data from myocarditis patients prior to the pandemic to cases related to use of the Pfizer vaccine showed that the vax recipients had a 92% lower relative risk of death. Rates of heart failure and dilated cardiomyopathy also were lower in the vaccine group.
China is loosening restrictions in a sign that the country is shifting away from its controversial zero-COVID policy that has paralyzed some cities for stretches over the last three years and sparked protests. The most significant adjustments are allowing home quarantine and ending a requirement to present a QR code to enter public buildings.
Members of the United States military will not have to submit to COVID-19 vaccinations if an annual defense bill passes a Congressional vote this week. House minority leader Kevin McCarthy (R-Calif.) has lobbied President Joe Biden over the restriction, saying the vaccine mandate has hindered recruitment and retention efforts.
UPDATED: Tuesday, Dec. 6 at 11:05 a.m. ET
Pfizer has partnered with Clear Creek Bio to develop COVID drugs against SARS-CoV-2's Papain-like protease, a protein that's critical to viral replication and assembly. PLpro lacks obvious binding pockets for a drug to act on, but Clear Creek believes it has the technology to overcome that. Pfizer will work with the biotech to identify a PLpro candidate to move into the clinic and then take full control. Story
Moderna in August sued Pfizer for patent infringement related to its mRNA vaccine technology. Now, Pfizer and BioNTech are fighting back in a new lawsuit. The pair are asking to dismiss Moderna's lawsuit in a Boston federal court and to invalidate the Moderna patents invovled, Reuters reports. In their filing, Pfizer and BioNTech argued that Moderna's lawsuit is "revisionist history" and that the patents "far exceed its actual contributions to the field."
The World Trade Organization is supposed to reach a decision on whether to expand a patent waiver currently covering COVID vaccines to include therapeutics and diagnostics as well. But the U.S. government said it won't back an expansion at the moment, Bloomberg reports. Instead, U.S. Trade Representative Katherine Tai said her office supports delaying the deadline, and that it plans to ask the U.S. International Trade Commission to launch an investigation into the matter.
UPDATED: Monday, Dec. 5 at 10:15 a.m. ET
Pfizer and BioNTech on Monday wrapped up their FDA application seeking an emergency nod for a third dose of their BA.4/BA.5-adapted bivalent shot as part of the primary series in kids ages 6 months through 4 years old. The shot is currently authorized as a booster for kids ages five and older in Europe and the U.S. If authorized in younger kids, children would get a primary shot series consisting of two 3-µg doses of Comirnaty followed by a third dose of the Omicron BA.4/BA.5-adapted bivalent vaccine.
Speaking of Pfizer, the company is rounding out a pair of European manufacturing investments with a $750 million outlay at its massive plant in Kalamazoo, Michigan. The site is a cornerstone in Pfizer’s Comirnaty production network. The project, which is expected to create around 300 new jobs, will specifically focus on augmenting sterile injectable production. The company says it’s eyeing project at the plant that will incorporate mRNA and “ultra-low temperature storage.” Story
Elsewhere on the COVID production front, Japanese CDMO Takara Bio is building another pandemic vaccine factory to boost production capacity at its home base in the country’s Shiga prefecture, Nikkei Asia reports. The goal is to help Takara crank out 73 million doses of COVID-19 vaccines in fiscal year 2027, which would make the company one of the biggest vaccine contractors in Japan.
Over in China, meanwhile, officials may unveil 10 new COVID-19 easing measures as soon as Wednesday, Reuters reports. The news agency points out that China’s recent attempts to wrangle the virus—which have included zero-tolerance measures like border shutdowns and frequent lockdowns—are largely at odds with the rest of the world, which has decided to live with COVID-19. Discontent around the country’s zero COVID policy sparked protests late last month, though the demonstrations largely subsided in the face of a heavy police presence across major cities, Reuters points out.
UPDATED: Friday, Dec. 2 at 11:30 a.m. ET
China can’t control the spread of COVID-19 with its current domestically developed vaccines, the U.S. has warned. In an interview with the Financial Times, U.S. COVID response chief Ashish Jha said that President Joe Biden told Beijing that it needs to import foreign-made mRNA vaccines from Pfizer-BioNTech and Moderna to get the virus under control. Biden also told officials that the AstraZeneca shot is superior to those made in China. The warning comes in response to lockdowns that have paralyzed some parts of the country.
Bharat Biotech has won approval in India for its COVID-19 nasal vaccine, which the company claims in the first of its kind in the world. It is approved for adults 18 and older as a two-dose primary series and as a booster.
Vaxxinity’s COVID-19 vaccine UB-612 has produced a superior immune response as a booster dose to those from AstraZeneca and Sinopharm, the company said. As for comparison with Pfizer and BioNTech’s mRNA shot, Vaxxinity’s protein-based shot provided a non-inferior response. The study included 944 participants in the U.S., Panama and Philippines.
UPDATED: Thursday, Dec. 1 at 11:25 a.m. ET
As Catalent contends with a COVID-19 revenue crash, the CDMO has confirmed it’s laying off more than 210 employees in Texas and Maryland. Elsewhere, at Catalent’s sprawling site in Bloomington, Indiana, the company is reducing its headcount by 400. Given the “current phase” of the pandemic and other challenging elements, Catalent says it’s made the tough call to reduce or delay certain projects and shrink its workforce “in certain areas,” a company spokesperson told Fierce Pharma. Story
For now, the era of COVID-19 antibody treatments has ended in the U.S. Wednesday, the U.S. FDA pulled the emergency use authorization for Eli Lilly’s bebtelovimab, citing data showing the antibody struggles against omicron subvariants BQ.1 and BQ.1.1. Lilly concurs and has paused commercial distribution of its med until further notice. Evolving virus variants previously forced out antibody therapies from Regeneron, GSK and Lilly. Story
People in Hong Kong can now get a Pfizer-BioNTech Omicron-specific COVID booster, and elderly residents are first in line, South China Morning Post reports. Specifically, those patients can receive the mRNA shot as their fourth dose at community vaccination centers, vaccine stations, hospitals and clinics, the news outlet explained.
Public health leaders in the U.K. bungled their test-and-trace response during the first winter and spring of the pandemic, before vaccines were available, The Guardian reports, citing leaked evidence from a senior test and trace official. Specifically, the U.K. was slow to act on repeated warnings that contact tracing and isolation should be imposed right after a lateral flow test result. That means people may have spread the virus to friends and family because they weren’t legally required to quarantine and have their contacts traced following a positive test result, The Guardian explained.
UPDATED: Wednesday, Nov. 30 at 11:10 a.m. ET
The U.K. is only slightly better prepared for future pandemics than it was for COVID-19, Kate Bingham, the former head of Britain’s coronavirus vaccine taskforce, said Wednesday. Bingham flagged a present lack of leadership on deck to prepare for new coronavirus variants, and she also noted some local manufacturing capacity had been mothballed. "We've got the capabilities and yet systematically things are being dismantled that we put in place," Bingham said, as quoted by Market Screener and others.
China’s stringent zero-COVID policies—which sparked rare local protests over the weekend—may be undermining the rest of the world’s faith in the country’s industrial supply chains, economics professor Li Daokui told CNBC. While the nation’s supply chains are unlikely to take a hit in the short term as factories continue operating, “long run impact might be already shaped,” Li said, suggesting “the international economic community [is] thinking twice about the stability of supply chains in China.”
Meanwhile, the Chinese cities of Guangzhou and Chongqing on Wednesday eased COVID-19 restrictions a day after demonstrators in southern Guangzhou clashed with police amid a spate of protests, Reuters reports. In Chongqing, the city will allow close contacts of people with COVID-19 who fulfill certain conditions to quarantine at home.
Amid many changes to Twitter under the new Elon Musk regime, the imploding social media platform has rolled back its coronavirus misinformation policy, The Washington Post and other news agencies have reported. Twitter introduced the policy banning COVID misinformation in 2020 during the pandemic’s early days. In the time since then, Twitter has suspended more than 11,000 accounts and purged more than 100,000 pieces of content for violating the policy, according to a company report.
UPDATED: Tuesday, Nov. 29 at 10:39 a.m. ET
BiondVax found proof of concept in a preclinical study of its NanoAb, an inhaled nanosized antibody therapy, after testing the drug in two groups of hamsters. The study compared weight loss in the two groups of hamsters that had been infected with COVID-19, finding that the treatment group experienced much less weight loss than the control group. Other parameters tracked included heart rate and social behaviors that indicated that the group treated with NanoAbs experienced a milder and shorter illness. The company is now planning to start a phase 1/2a trial in 2023, the company said in a statement.
While a new report shows that more people who have been vaccinated against COVID-19 died in August than people who have not been vaccinated, experts stress that despite this finding, an individual’s chances of dying from COVID-19 is much greater if they’re unvaccinated. Story.
A new global survey conducted on behalf of GSK found that 44% of expert healthcare professionals surveyed across seven countries reported that the COVID-19 pandemic, coupled with other factors, prevented some people living with systemic lupus erythematosus (SLE) from getting optimal care over the past two years, which increases their risk of organ damage. The survey included 648 healthcare professionals. Some reported that 23% of their patients experienced an increase in lupus flares compared to pre-pandemic, GSK found.
As anti-lockdown protests across China criticize the country’s strict COVID-19 measures, the chief spokesperson for the German government suggested that China use Pfizer/BioNTech and Moderna’s vaccines, noting during a press briefing that “Europe and Germany have had very good experience with administering mRNA vaccinations,” the Telegraph reports. While health officers of the two countries are having discussions regarding sharing vaccine technology, so far, the only offer on the table is giving the vaccines to Germans living in China.
UPDATED: Monday, Nov. 28 at 11:02 a.m. ET
India’s regulatory authorities have granted emergency use authorization to Bharat Biotech’s booter dose of its nasal COVID vaccine, dubbed iNCOVACC. The vaccine is India’s first nasal spray against COVID-19 and was approved as a primary dose in September. The third dose is approved for adults only, the Hindu BusinessLine reports.
Ashish Jha, President Joe Biden’s pandemic response coordinator, said on ABC’s “This Week” that it will be “very, very difficult” for China to contain COVID-19 through its Zero Covid strategy, recommending instead that the country makes sure everybody, particularity the elderly, receive a vaccine. Jha added that lockdowns and the Zero Covid strategy will be “very difficult” to sustain, Bloomberg reports. White House medical advisor Anthony Fauci added that the prolonged lockdown “really doesn’t make public health sense.”
Speaking of Fauci, the infectious disease expert also said in an interview with NBC’s “Meet the Press” that between 300 and 400 people are still dying of COVID-19 every day and that the country is “certainly” still in a pandemic. The uptake of the latest vaccine booster was less than 15%, he added.
After Pfizer’s CEO Albert Bourla said in an interview last December that the benefits are in favor of vaccinating children against COVID-19, UK pharmaceutical watchdog the Prescription Medicines Code of Practice Authority (PMCPA) received a complaint from parent campaign group UsForThem. After a review, PMCPA concluded that the company did breach the country's pharma code in several ways, including making unsubstantiated claims. Story
UPDATED: Wednesday, Nov. 23 at 10:20 a.m. ET
It’s Novavax v. Gavi round 2 as the Vaccine Alliance on Tuesday rebuffed Novavax’s claim it had breached an advanced purchase agreement for 350 million doses of the company’s protein-based shot. To date, Novavax has been unable to make a single dose of its COVID-19 vaccine available to COVAX from contractually stipulated sites, Reuters reports. "We think a legal battle will ensue and that this will ultimately get determined by the lawyers," one analyst told the news outlet.
While Omicron-busting boosters offer some protection against COVID-19 infections, it isn’t as robust as the defense offered by the original vaccines against earlier coronavirus variants, according to a new real-world evidence study. Still, those data are “really quite good,” NIAID director Anthony Fauci said, as quoted by CNN, adding that it’s still important for people to get updated COVID-19 shots as soon as they are eligible.
Speaking of Fauci, the outgoing infectious disease expert gave his last briefing to reporters Tuesday before he steps down from the government at the end of the year. "My message—and my final message, maybe the final message I give you from this podium—is that please for your own safety, for that of your family, get your updated COVID-19 shot as soon as you're eligible to protect yourself, your family and your community," he said, as quoted by ABC News. Later reflecting on his career in public health, Fauci added that he “gave it all I got for decades."
UPDATED: Tuesday, Nov. 22 at 9:54 a.m. ET
Novavax has ended a vaccine supply deal with Gavi, the Vaccine Alliance, citing a "material breach" of the agreement by the organization. The parties entered their deal in May 2021 but Gavi failed to buy the 350 million vaccine doses stipulated under the supply agreement, according to Novavax. The contract was aimed at providing doses for low- and middle-income countries.
Japan has approved a homegrown COVID-19 antiviral. The drug is called Xocova and was developed by Shionogi, The Wall Street Journal reports. The company is also seeking U.S. approval.
Officials in Beijing and Shanghai are ratcheting up anti-pandemic measures as cases continue to climb in China, Reuters reports.
UPDATED: Monday, Nov. 21 at 11:30 a.m. ET
Nine former Takeda employees from Massachusetts who were fired for not getting vaccinated against COVID-19 have sued the company after their attempts to gain religious exemptions were denied. The former employees are represented by Norm Pattis, the attorney who defended conservative political commentator Alex Jones, who was ordered to pay $965 million to the families of victims in the Sandy Hook school shooting for claiming the massacre was a hoax.
In the throes of a COVID-19 surge in its major cities, China has reported the deaths of three people from the virus. It is the first time in six months that China has acknowledged a COVID death. All were in Beijing. Sunday was the sixth consecutive day when new cases exceeded 20,000 in the country.
Two nonprofit organization coalitions, Oxfam and the People’s Vaccine Alliance, are pointing to inequity in the supply of Pfizer’s COVID-19 drug Paxlovid. So far, rich countries have secured 74% of the supplies of the oral antiviral, according to Airfinity. The two groups out that low- and middle-income countries account for 84% of the world’s population. Story
UPDATED: Friday, Nov. 18 at 10:35 a.m. ET
Under a proposed World Health Organization deal designed to fight future pandemics, pharmaceutical companies could be forced to publicly disclose their vaccine or therapeutic supply agreements with countries, Reuters reports. The proposed accord is aimed at preventing future infectious disease outbreaks from becoming as devastating as COVID-19.
Novavax's Nuvaxovid scored an authorization in Canada to be used as a booster in adults. In February, the vaccine won an endorsement in the country to be used as a primary vaccination series.
Pfizer and BioNTech touted a new analysis showing their new bivalent booster elicits a stronger response against new omicron sublineages than their original shot. The companies said the new booster may protect against omicron's BA.4 and BA.5 sublineages, plus others.
UPDATED: Thursday, Nov. 17 at 10:00 a.m. ET
Pfizer's former head of vaccine R&D, Kathrin Jansen, Ph.D., said at the STAT Summit that the world will inevitably face another flu pandemic. The question, she said, is whether it comes "tomorrow or 50 years from now?” At Pfizer, Jansen led the company's work to create COVID mRNA shot Comirnaty, among other projects.
After reports flagged possible irregularities during the regulatory process for Bharat Biotech's Covaxin, the company said it condemned the "targeted narrative" against the vaccine. Bharat said there was no "external pressure to accelerate development" of the vaccine.
A panel of vaccine experts in Germany said that children ages six months to four years should only receive Pfizer and BioNTech's vaccine if they are at risk of severe disease from COVID-19, Reuters reports.
UPDATED: Wednesday, Nov. 16 at 9:26 a.m. ET
A new study, published in the Journal of American Medical Association, found that 48 out of 158 patients who were not hospitalized, and who received a placebo treatment, had a recurrence of their symptoms. This led the study authors to conclude that COVID-19 rebound is possible regardless of treatment with Pfizer's Paxlovid.
GeNeuro, a biopharma company that focuses on neurodegenerative and autoimmune diseases, recruited its first patients in a phase 2 trial assessing the antibody temelimab against long-COVID. The study will recruit 200 patients who have tested positive for the presence of pathogenic W-ENV protein in their blood and test the treatment over six months. Investigators will be looking for improvement in cognitive impairment or fatigue.
NanoViricides said in its quarterly report that it has sufficient funds to complete initial trials of its lead drug candidate, NV-CoV-2, to treat both COVID-19 and long-COVID. It expects the drug, in the form of oral syrup or oral gummies, to be useful in patients of all age ranges who have mild to moderate COVID-19. In the form of injections, infusions, and inhalations, the drug is designed to help severely ill, hospitalized patients, according to the company.
UPDATED: Tuesday, Nov. 15 at 8:55 a.m. ET
In a trial of around 5,000 Japanese adults, Daiichi Sankyo's mRNA booster shot DS-5670 met its primary endpoint, Reuters reports. Those who received the Daiichi Sankyo vaccine developed COVID antibodies at a level that was similar or better to those who received other mRNA vaccines. The company plans a regulatory filing early next year.
Regulators in India approved Bharat Biotech's Covaxin despite discrepancies in records and changes to trial protocols, Stat News reports. Experts told the publication that the vaccine may have been approved too soon. Company execs responded that the process reflected the challenges of working in a pandemic situation.
Pfizer's bivalent booster vaccine has scored an approval in Australia, but officials are holding off on a third booster rollout in the country for now.
UPDATED: Friday, Nov. 11 at 9:21 a.m. ET
Asked about whether the COVID-19 pandemic is over at the Hindustan Times Leadership Summit, Novartis CEO Vas Narasimhan said it's important to be "extremely alert" about pandemic risks but that it's time to "let society function normally," as quoted by the publication. He added that the biopharma industry must invest in R&D over the long term to come up with scientific advances such as mRNA vaccines.
After years of research on their protein-based adjuvanted COVID-19 vaccine, Sanofi and GSK have finally scored an approval. Thursday, regulators in Europe endorsed their VidPrevtyn Beta vaccine as a booster for people 18 and older.
Even as new cases spike, officials in China have eased some of the country's strict anti-COVID measures, The Wall Street Journal reports. Authorities shortened quarantine requirements for some but didn't completely abandon the "zero-COVID" strategy.
UPDATED: Thursday, Nov. 10 at 10:55 a.m. ET
An FDA advisory committee voted 8 to 5 against the benefit-risk profile of Veru's VERU-111, or sabizabulin, in hospitalized COVID-19 patients who are at high risk for acute respiratory distress syndrome. Experts on both sides expressed uncertainties around the drug's efficacy and safety because of its limited clinical data. Story
AstraZeneca has decided to withdraw an FDA application with the FDA for COVID vaccine Vaxzevria, CEO Pascal Soriot said during a press briefing. The U.S. market is already well supplied, and the demand for vaccines is declining, he said. Instead, the British pharma will focus on its long-acting COVID antibody Evusheld, Soriot said, including pursuing an updated version of the therapy to tackle emerging variants. Story
After long delay, a COVID collaboration between two of the world's largest vaccine makers, Sanofi and GSK, has finally received its first approval. The partners' protein-based adjuvanted shot, VidPrevtyn Beta, has won European Commission approval as a booster for adults.
The European Medicines Agency has recommended a omicron-targeted bivalent version of Pfizer/BioNTech's Comirnaty for use in children ages 5 to 11. The updated shot is currently already authorized in EU for people 12 years of age and above.
Facing a significantly limited COVID vaccine opportunity, Valneva has decided to cut 20% to 25% of its current workforce in a bid to save about €12 million in annual costs. After the restructuring, Valneva's headcount will still be 25% above its pre-COVID level, the company noted. For 2022, Valneva expects COVID product sales to come in between €30 million and €40 million.
UPDATED: Wednesday, Nov. 9 at 11:30 a.m. ET
The FDA authorized (PDF) an arthritis drug developed by Swedish Orphan Biovitrum AB (Sobi) to treat some hospitalized COVID-19 patients. Kineret is an Interleukin-1 (IL-1) receptor antagonist that was found to reduce severe lung inflammation. It has been blessed for use in a limited population—those with the virus and with pneumonia requiring supplemental oxygen who are at risk of progressing to severe respiratory failure and are likely to have an elevated suPAR.
The U.K. authorized the Pfizer-BioNTech omicron-adapted COVID-19 vaccine for booster use. It also signed off on the Novavax vaccine as a booster. The Novavax endorsement allows for its use to boost those who received mRNA shots as their primary series. The Pfizer booster was tweaked to defend against the BA.4 and BA.5 omicron subvariants. Moderna was first to the finish line in the U.K. with its adapted booster, gaining its sanction in August.
Australia-based Vaxxas kicked off a phase 1 trial of a COVID-19 vaccine patch, which the company says could defend against all virus variants and could be ready by 2025. The patch is designed to deliver a version of the spike protein used in currently approved vaccines. The protein trains the immune system to recognize and combat infection.
COVID cases reached a five-month high in Beijing as China continues to battle the virus. Meanwhile, Guangzhou locked down a third district. The city has logged more than 1,000 new cases each of the last four days.
UPDATED: Tuesday, Nov. 8 at 8:47 a.m. ET
FDA commissioner Robert Califf tested positive for COVID-19 while traveling on agency business over the weekend. He is up to date on his vaccines and experiencing mild symptoms, according to the agency. Additionally, he hasn't been in close contact with President Joe Biden or Vice President Kamala Harris recently.
A Novavax phase 3 study provides support for a potential shift to a new strain vaccine using the company's platform, the company said, but it showed "no benefit for a bivalent vaccine" using the technology.
A study published in Journal of the American College of Cardiology found that the incidence of myocarditis is 2- to 3-times higher after a second dose of Moderna's COVID-19 vaccine compared with the Pfizer/BioNTech rival. The mRNA company told UPI that the vaccine's benefits "significant outweigh" the risks.
UPDATED: Monday, Nov. 7 at 9:27 a.m. ET
After stopping production earlier this year, Bharat Biotech could soon see a large portion of its COVID-19 vaccine stockpile expire, Firstpost reports. Up to 50 million doses of Covaxin could expire because of low demand, according to the report.
Pfizer's mRNA partner BioNtech posted a big revenue decline in the third quarter. After reporting that sales fell 43% to €3.46 billion, the company said in its earnings release that "the course of the pandemic remains dynamic and led to fluctuations in quarterly revenues."
China reported 4,420 new local COVID-19 cases on Saturday, a six-month high, Reuters reports. Amid rumors that the country might soon ease its antivirus measures, health authorities this weekend committed to their current "zero-COVID" strategy.
UPDATED: Thursday, Nov. 3 at 10:55 a.m. ET
Pfizer and BioNTech have dosed the first patient in a phase 1 trial of their combination vaccine prospect for influenza and COVID-19, the partners said Thursday. The shot weds Pfizer’s phase 3 quadrivalent modRNA-based influenza candidate with the partners’ authorized, omicron-adapted bivalent COVID-19 vaccine, both of which are underpinned by BioNTech’s mRNA platform.
Elsewhere on the mRNA front, Moderna will have to face a patent infringement lawsuit over its vaccines after a Delaware federal judge ruled Wednesday that the company failed to show the U.S. government should have been targeted instead. Arbutus Biopharma and Genevant Sciences sued Moderna for royalties on its vaccine in February, Reuters reports. The companies argued the lipid nanoparticles used to deliver the shot violated patents they held. Moderna in May argued the lawsuit should have targeted the U.S. government since its development efforts were part of the U.S.’ nationwide vaccination push.
Meanwhile, it wasn’t all good news for Pfizer and BioNTech this week, as Swiss regulator Swissmedic reported the appearance of “bubbles” during preparation of the partners’ omicron-busting vaccine boosters. Swissmedic says it’s investigating possible causes with the companies, as well as analyzing samples in its own laboratory.
UPDATED: Wednesday, Nov. 2 at 9:09 a.m. ET
Following numerous reports of people coming down with COVID again after receiving a full course of Pfizer's oral antiviral Paxlovid, the commissioner of the FDA is speaking up. In a series of tweets, FDA chief Robert Califf, M.D., explained that the agency issued the emergency use authorization because of a "substantial reduction in death and hospitalization for high-risk patients" associated with use of the drug. The authorization was not based on "change in duration of symptoms or viral load reduction," he added.
Scientists are looking into drugs that target human proteins as one strategy to fight against the coronavirus' evasive abilities, The Washington Post reports. At the federal level, the work is being done by a National Institutes of Health program named ACTIV. The scientists say more treatment options are needed as the situation around the pandemic evolves.
Meanwhile, experts are also fearing a "tripledemic" in the U.S. this upcoming winter. Those concerns involve a situation where COVID-19, flu and RSV would all surge in tandem. RSV is already on the rise ahead of its typical season, according to reports.
UPDATED: Tuesday, Nov. 1 at 9:46 a.m. ET
After generating $4.4 billion in third-quarter COVID-19 vaccine sales, Pfizer upped its full-year estimate to $34 billion, Reuters reports. Sales for the company's vaccine came in way higher than analyst estimates, but antiviral Paxlovid slightly missed Wall Street forecasts.
AstraZeneca's Vaxzevria won a full approval in Europe after snagging a conditional nod back in early 2021. AZ and its partners have delivered more than 3 billion doses worldwide, the company said.
Moderna picked up an approval in Japan for a vaccine targeting the BA.4 and BA.5 subvariant of omicron, Kyodo News reports. The regulatory move follows a similar approval for Pfizer's competing bivalent booster.
UPDATED: Monday, Oct. 31 at 11:30 a.m. ET
Codagenix of New York has initiated dosing in a phase 3 trial of its intranasal COVID-19 vaccine CoviLiv, which is being co-developed by the Serum Institute of India. The effort is supported by a World Health Organization program to develop a second-generation vaccine with greater efficacy, greater protection against variants of concern, longer duration of protection, improved storage and simplified delivery.
Researchers at the University of California San Diego have found that symptoms of those who are infected with COVID-19 can return, regardless of whether patients have been treated for the virus. The study was done in response to reports of rebound cases from patients who used Pfizer's antiviral Paxlovid, where patients who received the drug saw a return of symptoms. The study found that more than a third of 158 untreated patients saw their symptoms return within 29 days.
A Disney theme park in Shanghai has become the latest venue to abruptly lock down in China as the county battles another COVID surge. Fences to the amusement park were locked with little notice, trapping visitors inside. People will be freed once they produce a negative COVID test. The unusual tactic is part of the country’s controversial zero-COVID policy.
UPDATED: Friday, Oct. 28 at 11:45 a.m. ET
The National Institutes of Health is testing Pfizer’s antiviral drug Paxlovid against long COVID, a condition that has largely eluded researchers. The clinical trial will include 1,700 volunteers age 18 and older and will be run by Duke University’s Clinical Research Institute. Many patients who have taken Paxlovid have reported long COVID symptom improvements. The trial will begin on Jan.1.
In third quarter earnings reports on Thursday, Gilead reported $925 million in sales of COVID treatment Veklury, a 52% decline from the same period in 2021, but a large increase from the figure in the previous quarter, $445 million. Meanwhile, Merck's COVID antiviral Lagevrio generated sales of $483 million, down from $1.2 billion in the previous period.
The European Medicines Agency has recommended adding heavy menstrual bleeding to the list of side effects for mRNA COVID-19 vaccines made by Moderna and Pfizer. Reports of heavy periods, bleeding characterised by increased volume and/or duration, have been observed in clinical trials and in the real world.
UPDATED: Thursday, Oct. 27 at 11:30 a.m. ET
The Department of Health and Human Services (HHS) is reaching out to Black and Hispanic communities in its latest COVID booster push. The “On Point” 30-second TV spot debuted Monday and is specifically aimed at Black audiences, while omitting specific boosters by name or the companies that make them. A second ad, also funded by the HHS, is a Spanish-language and soccer-themed commercial called “No te pierdas el juego,” or “Don’t Miss the Game.” An English version of the ad is scheduled for release next month during the FIFA World Cup and focuses on people missing out on sports and social events because of COVID—something that can be avoided by getting boosted. Story
As for whether the COVID-19 pandemic has better prepared the healthcare industry for future waves of new infections, the answer is a little bit yes and a little bit no, according to a recent panel discussion on the post-pandemic future of diagnostics at AdvaMed’s Medtech Conference in Boston. Of particular concern, the U.S. is beginning to see widespread respiratory syncytial virus (RSV) cases, as well as an early increase in flu infections, with COVID potentially making a triple-threat not far behind, experts warned. Story
Meanwhile, as winter creeps up, The University of Washington predicts daily COVID-19 infections are projected to rise slowly to about 18.7 million globally by February from a current 16.7 million daily case average, Reuters reports. The report suggests there will be far fewer cases this winter than last, when the estimated peak daily average in January was about 80 million cases.
French biotech Inotrem is touting data from the phase 2 ESSENTIAL study evaluating its peptide nangibotide in ventilated COVID-19 patients in the ICU. Using a seven-point ordinal scale to assess clinical status, the study found nangibotide helped severe COVID-19 patients chart improved status from baseline to the 28th day of treatment, allowing the trial to hit its main goal. The data also demonstrated a statistically significant 12% absolute and 43% relative reduction in death on Day 28. Story
UPDATED: Wednesday, Oct. 26 at 9:30 a.m. ET
A small study conducted by Columbia University and the University of Michigan shows that the bivalent COVID-19 booster shots developed by Moderna and Pfizer-BioNTech failed to raise the level of neutralizing antibodies against the dominant omicron strain any more than four doses of their original vaccine. Researchers compared the antibody levels of 21 people who received the omicron-adjusted vaccines versus those of 19 people who had received four doses of the original vaccine series.
Amid the slow roll out of booster shots in the United States and increased warnings of a winter COVID surge, President Joe Biden received his updated dose in a White House event on Wednesday and then urged other Americans to follow suit.
Sanitation workers who were fired in New York City for refusing COVID vaccinations must be rehired, a state judge has ruled. The suit was brought by 16 workers who refused to comply with a city-wide, Oct. 2021 mandate for municipal employees and were fired in February of this year.
Shanghai is kicking off its rollout of the world’s first inhaled COVID-19 vaccine, CanSino’s Biologics’ Convidecia Air. The recombinant adenovirus vector vaccine is available to adults who are six months removed from receiving the primary two-shot vaccine series from Sinopharm or Sinovac or a one-shot primary dose of CanSino’s intramuscular vaccine.
Dallas-based Vaxxinity has completed enrollment of a phase 3 trial of its heterologous COVID-19 booster candidate for mRNA, adeno-vectored and inactivated primary series vaccinations. The shot has been designed to defend against omicron subvariants. The company is on track to report topline data before the end of this year and has already requested authorization of the shot in Australia.
Of multiple sclerosis patients who were treated with Bristol Myers Squibb’s Zeposia, 92% mounted an immune response following COVID-19 vaccination. Among those with previous exposure to the virus, 100% had antibody responses, the company reported. Results were consistent regardless of vaccine type—mRNA or non-mRNA. The study was done in response to reports that vaccines drew no response from recipients of other S1P modulators.
UPDATED: Wednesday, Oct. 19 at 11:25 a.m. ET
Lab tests show that Moderna’s COVID-19 new booster shot designed to defend against the BA.1 subvariant of omicron generates a strong immune response, with antibody levels high for at least three months. The company already has won authorization in the U.S. and other countries for its booster that has been adjusted to omicron’s BA.4 and BA.5 subvariants.
The U.S. is sending shipments of Gilead’s COVID-19 antiviral Veklury—which was co-developed by Mapp Biopharmaceutical—to Uganda in response to an Ebola outbreak that has killed 44. This is the Sudan variant of the virus, for which a treatment or vaccine has not been developed. This is different from the Zaire version of Ebola, which ravaged parts of Africa from 2014 to 2016.
UPDATED: Tuesday, Oct. 18 at 10:55 a.m. ET
A year after Ronapreve and Actemra gave Roche a sales boost, the COVID-19 therapies have started to slip. Sales from Regeneron-partnered antibody Ronapreve and anti-inflammation med Actemra fell nearly 1 billion Swiss francs year over year in the first nine months of 2022, with about 900 million Swiss francs of that plunge recorded in the third quarter alone, Roche’s CEO Severin Schwan said on a conference call. Ronapreve logged a 92% revenue decline, while Actemra’s sales plummeted 42% for the period. Story
Biden health officials are quickly weighing their options as the efficacy of AstraZeneca’s Evusheld—the sole monoclonal antibody cleared to protect against COVID-19—falters in the face of the BA.4.6 variant, which now makes up some 13% of COVID-19 cases, Stat News reports. Health officials earlier this month met with patient groups to talk through potential preventative options for people with weakened immune systems, reportedly laying out timelines for as many as six alternatives currently in the pipeline.
President Joe Biden on Tuesday unveiled a new strategy to parry biological threats and bolster pandemic readiness in the U.S. The strategy has five goals. Those are: detect pandemics and other biological threats; prevent outbreaks from turning into epidemics and prevent biological incidents before they happen; prepare for pandemics and other biological incidents; rapidly respond to outbreaks when they occur; and recover from a pandemic or biological incident. The plan represents a “a whole-of-government effort” spanning 20 federal agencies.
UPDATED: Monday, Oct. 17 at 11:20 a.m. ET
The European Public Prosecutor’s Office (EPPO) said it has opened investigation into the EU's procurement of COVID-19 vaccines. The announcement follows recent attention on alleged text exchanges between Pfizer CEO Albert Bourla and European Commission President Ursula von der Leyen in the lead-up to a procurement contract for up to 1.8 billion doses of the Pfizer/BioNTech vaccine Comirnaty. The EPPO didn't specify who or which specific deal is under investigation but said it comes after "extremely high public interest."
Moderna has canceled its existing COVAX supply deal. Instead, the company will supply its updated, omicron-targeted vaccines to COVAX in 2023 at the lowest price in its tiered pricing structure. COVAX was established to provide low-income countries with vaccines at no or low cost. Story
Bavarian Nordic said its virus like particle-based COVID booster candidate, ABNCoV2, showed promising longer-term effects in a phase 2 trial. Six months after the booster shot, neutralizing antibody titers were six times higher than pre-boost titers against the original SARS-CoV-2 virus and nearly 10 times higher than that for the omicron BA.1 subvariant. The antibody decay appears less sharp compared with mRNA vaccines, the company said, suggesting the candidate may offer better long-term protection.
UPDATED: Friday, Oct. 14 at 11:10 a.m. ET
Fujifilm has decided to end development of flu drug Avigan in COVID, Reuters reports. The Japanese government stockpiled the antiviral during the early days of the pandemic after the drug showed positive signs. But it never won emergency authorization in Japan, and a phase 3 trial run by Apilli Therapeutics in the U.S., Brazil and Mexico last year found Avigan couldn't significantly improve time to sustained clinical recovery in moderate to severe patients. Then, Fujifilm this March halted enrollment in a Japanese phase 3, citing omicron and difficulty in assessing the drug's effectiveness in preventing severe disease because the variant mostly causes mild symptoms.
Pfizer's Paxlovid may cause dangerous drug-drug interactions with some common cardiovascular disease drugs, an article published in the Journal of the American College of Cardiology says. Taking Paxlovid and certain blood thinners together may cause an increased risk of bleeding, the study says. Interactions between Paxlovid and some cholesterol medications such as widely used statins may lead to liver toxicity, according to the study. Therefore, "dose adjustment or temporary interruption of these medications may be required" when using Paxlovid, the researchers said.
China's failure to approve mRNA vaccines by Moderna and BioNTech is "mind-boggling," BeiGene's R&D chief Lai Wang, Ph.D., told the Fiinancial Times. Wang said he thought the Chinese government might be trying to “somewhat protect some of the China vaccines . . . which is unfortunate.” BeiGene has signed partnerships working on the mRNA technology but for cancer vaccines. Wang said the company doesn't plan to get into COVID vaccine because the field is already crowded.
UPDATED: Thursday, Oct. 13 at 11:05 a.m. ET
Nearly 8% of COVID-19 vaccine recipients reported seeking medical attention after receiving their shots, according to a smartphone-based reporting system set up by the CDC, Reuters reports. Approximately 10 million used the service. The CDC promised in August to provide the data on its website by Sept. 30, but missed the deadline, sparking a Freedom of Information Request from ICAN, a Texas-based non-profit government watchdog.
Pharmacy giant Walgreens reported a 5.3% drop in revenue year-over-year in the third quarter, attributed largely to a precipitous decline in demand for COVID-19 vaccines. In the third quarter of 2021, Walgreens administered 13.5 million shots versus 2.9 million in the recently-completed quarter.
UPDATED: Wednesday, Oct. 12 at 10:20 a.m. ET
The FDA has lowered the age bar for its authorizations of Pfizer/BioNTech's and Moderna's bivalent omicron booster shots to 5 and 6, respectively. The two shots were previously allowed for people aged at least 12 and 18, respectively. The CDC's vaccine advisory committee is scheduled to meet next week to decide whether to recommend the shots for younger kids. The FDA cleared the boosters based on clinical data from a similar shot against the omicron BA.1 subvariant, which the agency said is "relevant and supportive" of vaccines against the BA.4 and BA.5 leniages. The agency also considered other data.
Testing giant Roche unveiled the launch of its next-generation SARS-CoV-2 rapid antigen tests in countries that accept CE Mark authorizations. The company plans to start distribution in the coming weeks and says it can ship tens of millions of tests per month.
South Africa is experiencing low demand for COVID-19 vaccination, so the government is trying to cancel a contract with Johnson & Johnson, Cape Talk reports. Under the 2021 deal, South Africa is still owed more than 11 million doses thanks to late vaccine deliveries, but it now wants to cancel the order, citing low demand.
Authorities in Hong Kong have approved a baby version of the BioNTech COVID-19 vaccine, Reuters reports. The toddler shot contains just one-tenth of the adult dosage.
UPDATED: Monday, Oct. 10 at 8:51 a.m. ET
Ahead of a major Communist Party meeting that starts on Sunday, some areas in China are locking down after detecting a rise in new COVID cases, CBS News reports. Fenyang city was the latest to lock down, according to the report.
After the U.K. government decided against buying doses of AstraZeneca's Evusheld, immunocompromised patients are asking the government to reconsider, BMJ reports. The plea comes amid a rise in cases and ahead of the winter, a time of year when risks from the pandemic typically rise.
UPDATED: Thursday, Oct. 6 at 10:50 a.m. ET
It would be “a bit cavalier” to say the pandemic has ended, NIAID director Anthony Fauci, M.D., said on a recent panel by the University of Southern California’s Annenberg Center for Health Journalism on COVID-19. “I don’t think we can say the end of COVID is in sight,” he said, as quoted by NJ Spotlight News. Fauci is also chief medical advisor to President Joseph Biden. His comments come shortly after Biden said the pandemic “is over” during a September interview.
Roughly one month after pharmacies and other vaccination sites started distributing updated boosters against COVID-19, CDC vaccination stats show less than 4% of the U.S. population of about 333.1 million people has received the latest shot. Specifically, the CDC says 7.6 million people have received a re-tooled booster dose, accounting for some 2.3% of the country’s population. Still, that number could be an underestimate, some local news outlets have reported, noting that the data omit people who received the updated Pfizer-BioNTech boosters in Idaho and Texas.
Ocugen is paying The Washington University an initial license issuance fee of $1 million to snag the rights to an intranasal COVID-19 vaccine in the U.S., Europe and Japan. The biotech is also in line to pay an annual license maintenance fee and regulatory and commercial milestones of up to $37 million. Story
UPDATED: Wednesday, Oct. 5 at 9:57 a.m. ET
After hearing feedback from the FDA, Eiger BioPharmaceuticals said it doesn't plan to seek an emergency use authorization for peginterferon lambda to treat mild-to-moderate COVID-19. Eiger's stock was down about 8% after the news on Wednesday.
Japan has approved Pfizer's updated vaccine targeting the BA.5 subvariant of omicron, Kyodo News reports. Additionally, regulators there blessed the company's original shot in kids 6 months to 4 years old.
In the U.S., an even newer variant, BA.4.6, now makes up around 13% of cases, according to new CDC data. The variant made up a bigger portion of cases—22%—in a region that includes Iowa, Kansas, Nebraska and Missouri.
UPDATED: Tuesday, Oct. 4 at 11:13 a.m. ET
Following Pfizer and Merck & Co., Shionogi has signed a volunatry license agreement, making its COVID antiviral candidate ensitrelvir (S-217622) available to qualified generic manufacturers through the Medicines Patent Pool. The goal is to expand access of the drug, pending regulatory authorizations, to low- and middle-income countries. The drug just succeeded in a phase 3 trial in Asia, showing it can significantly reduce the time to resolution of typical omicron-related symptoms.
The FDA has sent out an alert warning the public of reduced power by AstraZeneca's Evusheld at preventing COVID caused by certain coronavirus variants. But unlike other COVID antibodies for treating disease, Evusheld gets to keep its emergency use authorization as the only option for preventing COVID in immunocompromised people and individuals who aren't suitable to receive a COVID vaccine.
In a new editorial, The Lancet Respiratory Medicine argued that now is not the time to declare the pandemic over and to stop government-funded vaccination and treatment, "as this could discourage compliance with COVID-19 measures currently in place." The editorial team pointed to people who are uninsured, rising inflation and ongoing healthcare inequities as reasons to continue support the government's COVID funding.
The U.S. Supreme Court has declined to hear a challenge by 10 states to President Joe Biden's COVID vaccine mandate for healthcare workers at federally funded facilities, a rule that has been in place since November 2021, Reuters reports.
UPDATED: Monday, Oct. 3 at 10:26 a.m. ET
Moderna refused a request by officials in China to share its COVID-19 vaccine intellectual property, The Financial Times reports. Afterward, negotiations around a potential supply deal in China broke down. Moderna insists it is still interested in supplying vaccines to the country, according to the report.
Shortly after Europe published a report scrutinizing a large vaccine supply deal with Pfizer, the drugmaker's CEO Albert Bourla has pulled out of a special meeting to discuss the issue, Politico reports.
Roche launched a next-generation diagnostic in countries that accept the CE Mark authorization, Labiotech.eu reports. The new product is an update to the earlier version that launched in July 2020, and it's intended to be used in a wider range of patients.
UPDATED: Friday, Sept. 30 at 10:32 a.m. ET
Germany's InflaRx has submitted a request for emergency use authorization for vilobelimab to the FDA. The company is seeking an authorization for its drug to treat critically ill patients with COVID-19 after it had "encouraging interactions" with the agency.
Ahead of winter, bulk orders of coronavirus tests seem to be on the rise once again, Yahoo Finance reports. The CEO of iPromo, which sells two tests, told the publication that sales had surged recently compared with earlier summer months.
UPDATED: Thursday, Sept. 29 at 11:30 a.m. ET
Shionogi of Japan has reported positive results from a phase 3 trial of its COVID-19 oral antiviral Xocova. Among 1,821 mostly vaccinated patients who were infected within four days, the protease inhibitor resolved omicron symptoms by an average of 24 hours faster than placebo. Japan has agreed to buy 1 million doses of Xocova, pending its approval.
Ocugen will help develop, manufacture and commercialize a COVID nasal spray vaccine discovered by Washington University of St. Louis. Ocugen’s rights will extend to the US, Europe and Japan. The vaccine already has been approved in India.
The European Medicines Agency has accepted applications from Pfizer-BioNTech and Moderna for approval of their respective bivalent boosters formulated to defend against the BA.4 and BA.5 omicron subvariants. While Moderna’s application is for those 12 and older, Pfizer’s covers children ages 5-11.
Massachusetts-based VBI Vaccines has begun enrolling patients in a phase 1 trial of its multivalent enveloped virus-like particle (eVLP) coronavirus vaccine candidate designed to defend against all existing variants and subvariants of COVID-19.
After more than 430 emergency green lights for COVID-19 tests since the start of the pandemic, the FDA is beginning to wind down its expedited review programs for coronavirus diagnostics, instead urging developers to follow its traditional regulatory paths to market. Story
UPDATED: Wednesday, Sept. 28 at 8:47 a.m. ET
After CureVac recently sued vaccine giants Pfizer and BioNTech for alleged patent infringement, the mRNA partners are fighting back. In London court, the pair behind Comirnaty are seeking to invalidate two European CureVac patents, Law360 reports.
In a bid to expand the reach of its antiviral, Merck is partnering with Sinopharm for a rollout in China. Under the deal, Sinopharm will be responsible for producing and distributing Merck and Ridgeback's molnupiravir in China.
A study funded by the National Institutes of Health has linked COVID-19 vaccination with a small increase in menstrual cycle length. The study included data from more than 20,000 people and found that vaccines were associated with a menstrual cycle length increase of less than one day. The increase was usually temporary, researchers found.
UPDATED: Monday, Sept. 26 at 11:15 a.m. ET
Pfizer and BioNTech have completed their submission to the FDA for emergency use authorization of a 10- µg booster dose of their omicron BA.4/BA.5-adapted COVID-19 vaccine for children 5 through 11 years of age. The companies plan to finish an application in Europe in the ocming days. Meanwhile, a multiphase study is testing the safety, tolerability, and immunogenicity of different doses of the booster vaccine in children 6 months through 11 years of age.
Pfizer CEO Albert Bourla tested positive for COVID-19 over the weekend. It’s the second time he’s contracted the virus in as many months. The CEO said that he is “feeling well and symptom free,” Reuters reports. Bourla has received four doses of his company’s COVID-19 vaccine, but hasn’t yet taken the new bivalent booster, following CDC recommendations to wait three months since his previous COVID-19 case.
China has authorized another oral antiviral, made by Fujian Cosunter Pharmaceutical Co Ltd, for use in clinical trials, Global Times reports. The drug, called GST-HG171, will be used in trials for the treatment of mild-to-moderate COVID-19 in adults.
UPDATED: Friday, Sept. 23 at 10:05 a.m. ET
In the last two weeks, a new variant dubbed BF.7 has doubled in prevalence nationwide, representing 1.7% of total cases as of a recent CDC update. Right now, the variant is mostly concentrated in the Northeast United States. Fierce Healthcare story
Pfizer and U.S. officials have agreed to update a vaccine supply deal that focuses on shots bound for low- and middle-income countries. Responding to low demand and vaccine hesitancy in certain countries, the parties have agreed to slow deliveries, Bloomberg reports. The U.S. previously agreed to purchase the deals from Pfizer at a nonprofit price in order to donate them.
Several weeks after the U.S. authorized new, updated COVID-19 boosters from Pfizer and Moderna, millions of residents have opted to get the shots, Reuters reports. So far, more than 4 million have gotten the updated boosters.
UPDATED: Thursday, Sept. 22 at 11:20 a.m. ET
Pfizer will supply up to 6 million doses of its COVID-19 treatment Paxlovid to the NGO Fund for middle- and low-income countries. Aside from this effort, Pfizer also has made deals with generic drugmakers to produce the oral antiviral for poor countries.
A study from Epic Research shows that those who receive Pfizer’s Paxlovid are two times less likely to be hospitalized from COVID-19 and four times less likely to die than those who didn’t get the oral antiviral. The study included 567,560 patients diagnosed with COVID who were deemed to be high risk of advancing to a severe form of the virus. Additionally, fully vaccinated patients over age 50 who received Paxlovid were three times less likely to land in the hospital.
UPDATED: Wednesday, Sept. 21 at 11:15 a.m. ET
AstraZeneca is teaming up with The Dude and the duo behind The Big Sick to raise awareness of antibody treatments like the company's drug Evusheld for immunocompromised COVID patients. The British pharma’s “Up the Antibodies” campaign seeks to educate the public around the difficulties of living with an immunocompromised system and the available monoclonal antibody options to help the prevention of contracting COVID-19. Aside from actor Kumail Nanjiani and his wife and Hollywood writer Emily V. Gordon, the AZ campaign also features Jeff Bridges, Crystal King, who is a kidney transplant recipient, as well as transplant surgeon Dorry Segev, M.D., Ph.D. Story
COVID shot latecomer Clover Biopharmaceuticals is now pitching its first-gen adjuvanted protein vaccine as a “universal booster,” touting antibody levels against the omicron BA.5 subvariant to pad its case. In a phase 3 trial testing Clover’s shot as a booster against the original strain of SARS-CoV-2, Clover linked its prophylactic to fivefold higher neutralizing antibodies against the subvariant versus a third dose of its shot. Shanghai-based Clover aims to fill a different niche in the global vaccine market than Moderna and Pfizer but even so may struggle to make an impact. Story
Less than a month after Everest said its CEO Kerry Blanchard would disembark from the company, the Chinese drug developer has found a new leader in pharma veteran Rogers Yongqing Luo. Lou previously worked at Brii Biosciences as president and general manager for greater China. Further, Luo was CEO of Brii’s TSB Therapy unit, where he oversaw registration and commercialization of amubarvimab/romlusevimab, the first COVID-19 antibody regimen in that country. Story
Pulse oximeters—crucial for making treatment decisions during the COVID-19 pandemic—often yield inaccurate readings for people with darker skin tones, mounting evidence suggests. Now, the FDA has lined up a virtual meeting of its medical devices advisory committee to home in on the devices’ racial bias. Pulse oximeters are typically placed over the fingertip, where they emit light beams through the skin to assess a wearer’s pulse rate, plus the level of oxygen saturation in their blood. Story
UPDATED: Tuesday, Sept. 20 at 9:35 a.m. ET
Share prices for Moderna, BioNTech and Novavax all fell after President Joe Biden told 60 Minutes the pandemic "is over" on Sunday. The companies' share prices fell by as much as 9%, Yahoo! Money reports. As the publication notes, the U.S. is seeing an average of 60,000 new cases each day, with deaths averaging 500 daily.
After reporting a profit of £19.2 million in last year's first half, Oxford Biomedica has swung to a loss of £27.4 million in the first half of 2022, The Business Magazine reports. The company has been a key manufacturing partner for AstraZeneca, but the pharma giant's shot is seeing lower demand these days.
Even though Valneva was able to score a vaccine authorization in Europe, the shot has also suffered from low demand. Now the company has been forced to cut its manufacturing deal with IDT Biologika. Story
UPDATED: Monday, Sept. 19 at 9:15 a.m. ET
Speaking with Scott Pelley of 60 Minutes, President Joe Biden said he believes the pandemic is "over" but that COVID-19 is still a "problem." The comment came shortly after World Health Organization director-general Tedros Adhanom Ghebreyesus said the end of the pandemic was "in sight."
As part of a program by the World Health Organziation to advance a vaccine for low- and middle-income countries, Moderna allowed its vaccine to be studied as the comparison arm in a mouse study, Bloomberg reports. Pfizer rejected a similar request, the news service said. The World Health Organization has tapped Afrigen to develop a vaccine that, if successful, would be made at 15 production sites around the world.
UPDATED: Thursday, Sept. 15 at 9:30 a.m. ET
The European Court of Auditors wants to know how Europe secured its biggest vaccine deal—a 1.8 million-dose contract with Pfizer-BioNTech—but so far, the budget watchdog has been met with silence, according to a recent report. Despite request for details, “none was forthcoming,” the Court said in its report. The report also pressed European officials to again search for text messages between European Commission President Ursula von der Leyen and Pfizer CEO Albert Bourla. Story
Speaking of Pfizer and BioNTech, the companies’ South African partner Biovac has reportedly finished the first doses of the mRNA shot Comirnaty at its Cape Town manufacturing plant, according to Bloomberg. Before Biovac starts on its next production batch, the first set of shots will be evaluated by the South African Health Regulatory Products Authority, Morena Makhoana, Biovac’s CEO, said in an interview with the news outlet. Subsequent doses will be sold commercially starting next year. Story
“We are not there yet. But the end is in sight,” World Health Organization Director Tedros Adhanom Ghebreyesus said of the COVID-19 pandemic Wednesday, as quoted by Reuters. "Now is the time to run harder and make sure we cross the line and reap the rewards of all our hard work,” added the WHO chief. Looking ahead, countries should examine their policies and bolster them against COVID-19 and future health emergencies, he continued, according to Reuters. Ghebreyesus also urged countries to vaccinate 100% of their high-risk populations and continue COVID-19 testing efforts.
But it’s a different story in Africa, where the acting director of the continent’s Centers for Disease Control and Prevention warned Thursday that the “virus is still circulating.” Given low vaccination rates, “the pandemic is still very much with us here on the continent," Ahmed Ogwell Ouma said at a recent news conference. Ouma added that just over 22% of Africa’s population is fully vaccinated against COVID, noting that his agency will push to raise that number, according to Reuters.
UPDATED: Wednesday, Sept. 14 at 10:10 a.m. ET
Moderna's CEO Stéphane Bancel told Reuters the company has held conversations with the Chinese government about supplying its mRNA vaccine in the country, but that it's not immediately clear whether the sides will ink a deal. Additionally, Moderna believed its mRNA rival BioNTech infringed its patents early in the pandemic, the helmsman said.
More than half of U.S. adults plan to get a booster shot within the next year, a Morning Consult poll found. Further, 56% of adults plan to seek a booster dose each year.
Revive Therapeutics submitted an amended phase 3 study plan to the FDA. The company is studying bucillamine in patients with mild-to-moderate COVID-19. Revive says the drug is an oral medicine with anti-inflammatory and antiviral properties.
UPDATED: Monday, Sept. 12 at 11:20 a.m. ET
Europe has sanctioned use of Novavax’s COVID-19 vaccine as a booster regardless of previous vaccination history. The authorization of Nuvaxovid covers those 18 and older and comes nine months after Europe signed off on use of Novavax as a primary vaccine.
Vaxxinity of Dallas has kicked off a rolling submission to the U.K.’s Medicines and Healthcare products Regulatory Agency of its COVID-19 vaccine candidate as a booster. The shot is being tested as a booster for people who received a primary mRNA, adenovirus vector or inactivated virus vaccine.
UPDATED: Thursday, Sept. 8 at 11:15 a.m. ET
Pfizer donated 100,000 courses of its oral antiviral, Paxlovid, to the Covid Treatment Quick Start Consortium—a new group angling to improve access to the drug in low- and middle-income countries, Reuters reports. Set up by the likes of Duke University and the Clinton Health Access Initiative, the Consortium says it's working with health ministries in 10 countries to set up national test-and-treat programs.
Meanwhile, Pfizer has apparently been less generous in other areas, as researchers looking at next-gen COVID vaccines face hurdles accessing Pfizer’s Comirnaty and Moderna’s Spikevax, STAT News reports. Pfizer isn’t sharing its shot for research purposes, a spokesperson told STAT, while Moderna didn’t provide comment.
Speaking of coronavirus vaccines, new research out of Israel suggests the shots dramatically reduce the occurrence of long COVID, The Times of Israel reports. According to a peer-reviewed study, people who’ve received two doses of Pfizer and BioNTech’s vaccine saw at least a 50% reduction in 10 of the most common long COVID symptoms. Shortness of breath was slashed by 80%, for example.
Meanwhile, scientists from some of the top U.S. academic centers are uniting to suss out whether fragments of the coronavirus linger in the tissues of some people—which could shed light on the root cause behind long COVID, Reuters reports. Dubbed the Long Covid Research Initiative, the group is angling to streamline research and hustle potential treatments into the clinic. The effort includes scientists from Harvard University, Stanford University, the University of California, San Francisco and more.
The FDA is summoning a meeting of its Pulmonary-Allergy Drugs Advisory Committee to weigh Veru’s bid for emergency use authorization of sabizabulin for hospitalized COVID-19 patients at high risk for acute respiratory distress syndrome. The AdComm will meet on Oct. 6, the company announced early this week.
UPDATED: Tuesday, Sept. 6 at 11:15 a.m. ET
India authorized Bharat Biotech’s COVID-19 recombinant nasal vaccine for primary immunization of adults. A trial also is underway to determine the vaccine’s effectiveness as a booster for those who have already received the country’s two most common COVID-19 shots—AstraZeneca’s Covishield and Bharat’s Covaxin.
As China faces more COVID outbreaks and lockdowns, it has authorized CanSino’s inhaled vaccine for emergency use in the country as a booster. Last week, China also sanctioned Livzon’s COVID-19 shot as a booster. CanSino said that it now hopes for a government contract with China.
Chile has sanctioned a phase 2 clinical trial of Sinovac’s omicron-specific COVID-19 vaccine and its trivalent COVID-19 vaccine—which combines protection against ancestral, delta and omicron. The study will evaluate the effectiveness of the vaccines in those who have already received two booster doses of either Sinovac’s CoronaVac, mRNA or adenovirus-type vaccines.
Eiger BioPharmaceuticals of California says that its peginterferon lambda treatment for with mild-to-moderate COVID-19 is stalled in the submission process. The company says that it will provide additional information to the FDA that it believes could be supportive of an emergency use authorization. Story.
UPDATED: Friday, Sept. 2 at 10:50 a.m.
The CDC has signed off on the Moderna and Pfizer-BioNTech omicron-adjusted bivalent COVID-19 vaccines for booster use. The authorization for Moderna’s shot covers people 18 and older. For the Pfizer vaccine, the nod is for those 12 and older. The CDC is expected to expand booster use to the pediatric population, pending ACIP evaluation today.
Europe’s Committee for Medicinal Products for Human Use (CHMP) has recommended the Novavax COVID-19 vaccine for use as a booster in those 18 and older. The authorization would give adults in Europe the option to use a protein-based shot, regardless of the type of their previous vaccine. Also this week, the CHMP recommended the omicron-adjusted mRNA boosters from Pfizer-BioNTech and Moderna.
Pfizer and BioNTech have filed a motion against CureVac in the UK, saying their mRNA COVID-19 vaccine does not infringe on its patents and asking for dismissal of the case. The filing came in response to a lawsuit CureVac filed in July, asking for fair compensation for mRNA technology it developed. Moderna also has a claim of infringement against Pfizer and BioNTech, which was filed last week.
The FDA revised its authorizations for Lilly and Regeneron’s antibodies early in the year on data that suggested they weren’t effective against the omicron variant. Despite the FDA ban, hospitals and health systems administered more than 158,000 deauthorized monoclonal antibody doses in early 2022, a new JAMA study contends. Story
UPDATED: Thursday, Sept. 1 at 11:15 a.m.
One day after the FDA authorized the omicron-tweaked COVID-19 booster shots of Pfizer-BioNTech and Moderna, Europe’s Committee for Medicinal Products for Human Use (CHMP) has followed suit, recommending a nod from the European Medicines Agency. The one difference is that Moderna’s recommendation covers those 12 and older. The U.S. authorization for Moderna’s booster is for those 18 and older.
Vaxart has reported (PDF) positive data from the first of a two-part phase 2 study of its oral COVID-19 vaccine candidate, VXA-CoV2-1.1-S, which is designed to defend against omicron. Antibody levels rose after use of the pill, particularly in those who have already received an mRNA vaccine. Vaxart is the first company to advance a COVID-19 vaccine in pill form to phase 2.
Daiichi Sankyo has kicked (PDF) off a phase 3 trial of its mRNA COVID-19 vaccine DS-5670 in healthy, unvaccinated people. The trial of 322 people aims to show non-inferiority to Pfizer’s Comirnaty in terms of immunogenicity and seroconversion rate, the company said.
Another former Bristol Myers Squibb employee has sued the firm and human resources director Caitlin Freeland, alleging discrimination over her termination for refusing to be vaccinated against COVID-19. Oksana Chornomaz alleges that BMS acted unlawfully because vaccination was counter to her religious beliefs. In December of last year, four BMS employees filed a similar action, which remains unresolved.