Due to drug overdoses and COVID-19 deaths, life expectancy in the U.S. has dropped for the second straight year.
Japan has become the first nation to sanction the use of AstraZeneca’s Evusheld as a treatment for those infected with COVID-19.
Please read below for the latest updates. Daily COVID-19 tracker entries from Jan. 4 to April 13 can be found here.
UPDATED: Wednesday, Aug. 31 at 11:15 a.m. ET
For the second straight year, life expectancy in the United States has dropped, according to the CDC. This drop—from age 77 to 76.1 years—is chalked up to early deaths from COVID-19 and drug overdoses. It was a smaller decrease in life expectancy than in 2020, when it fell by 1.8 years. It is the largest combined drop over a two-year span since the 1920s.
Japan has approved AstraZeneca’s Evusheld for both treatment and prevention of COVID-19. This is the first nod worldwide for the antibody combo to be used for those who have been infected. Evusheld has attracted use by immunocompromised people who can’t generate an adequate response from vaccines.
The FDA has issued emergency use authorizations for omicron-tweaked COVID-19 vaccines from Moderna and Pfizer/BioNTech. The nod makes people 12 and older eligible for the updated Pfizer booster and those 18 and older eligible for the new Moderna shot.
SaNOtize has raised a $24 million series B round, giving it the cash to fund its ongoing phase 3 COVID-19 prevention trial and other research into its nitric oxide nasal spray (NONS). While drugs and vaccines have blunted the impact of COVID-19, SaNOtize sees a continued need for new tools for managing the coronavirus. Story
With federal funding exhausted in the United States for COVID-19 vaccines and treatments, the government is turning over distribution of products to the commercial market. On Tuesday, HHS convened more than 100 representatives of government, health care providers, insurers, pharma companies, manufacturers and patient advocates to begin planning for the pathway to commercialization. Government distribution of vaccines is expected to end by January of next year.
UPDATED: Tuesday, Aug. 30 at 11:53 p.m. ET
The FDA is expected to authorize omicron boosters by Pfizer-BioNTech and Moderna on Wednesday, Politico reports, citing three people with knowledge of the matter. The Biden Administration plans to roll out a combined 175 million doses of the omicron boosters, a federal plan shows.
But AstraZeneca CEO Pascal Soriot argued that annual widespread boosting is "not a good use" of taxpayer money, The Telegraph reports.
The U.S. government will halt its free COVID test distribtuion program on Friday, Sep. 2, citing a lack of funding. The initiative started in January and is currently in its third round, but "Congress hasn't provided additional funding to replenish the nation's stockpile of tests," the ordering website shows.
Valneva has provided a longer-term analysis of a phase 3 trial of its inactivated, adjuvant COVID shot, VLA2001. At day 71 after primary immunization, neutralizing antibody titers induced by VLA2001 were non-inferior to AstraZeneca's Vaxzevria, the company said. Reported COVID infections were also similar between the two arms during a time when the Delta variant was prevalent.
UPDATED: Friday, Aug. 26 at 10:55 a.m. ET
Moderna has filed patent infringement lawsuits in the U.S. and Germany alleging Pfizer and its partner BioNTech violated patents Moderna says it filed between 2010 and 2016. The Cambridge, Massachusetts-based biotech says it’s seeking to “protect the innovative mRNA technology that we pioneered, invested billions of dollars into creating, and patented during the decade preceding the COVID-19 pandemic,” according to a statement from Moderna CEO Stéphane Bancel. Pfizer says it hasn’t “fully reviewed the complaint.” A spokesperson said Pfizer is “surprised by the litigation” and stressed that its mRNA shot Comirnaty was developed using the partners’ own tech. Story
Speaking of Pfizer and BioNTech, the partners on Friday wrapped up their submission to the European Medicines Agency for an omicron-adapted booster candidate for adults and teens ages 12 and older. The filing for the omicron BA.4/BA.5-adapted bivalent vaccine follows a similar submission for Pfizer’s BA.1-adapted booster back in July. Both booster prospects would be ready to ship “shortly after” their respective authorizations and could be available for use as early as next month, Pfizer said in a release.
UPDATED: Thursday, Aug. 25 at 11:30 a.m. ET
According to the results of a 109,000-patient Israeli study, Pfizer’s Paxlovid appears to provide “little to no benefit” for younger adults, the Times of Israel reports. The pill does reduce the risk of death and hospitalization for higher-risk seniors by roughly 75%, the study said. Patients in the study between the ages of 40 and 65 saw no measurable benefit, researchers found. The study does have limitations. Instead of enrolling patients in a randomized study, researchers compiled data from a large Israeli health system.
Emails from 2020 that were recently released show how Dr. Oz, the Republican Senate nominee in Pennsylvania, promoted an anti-malaria drug as a COVID-19 treatment directly to Donald Trump’s White House in the pandemic’s early stages. The emails, revealed Wednesday in a report from the select house committee on the coronavirus crisis, show Oz was urging former senior White House advisors Jared Kushner and Deborah Birx to push hydroxychloroquine as a treatment for COVID-19, Yahoo News reports.
Recent Long COVID-19 studies show that the odds of children developing the disease are low, Scientific American reports. One 2021 study in the U.K. showed that out of 1,734 children who tested positive for COVID-19, 98.2% recovered by eight weeks and most kids reported feeling better after six days. However, other risks remain as a recent CDC study showed that after COVID-19 infection, children were twice as likely to have an acute pulmonary embolism, myocarditis, and cardiomyopathy than children who weren’t infected.
UPDATED: Wednesday, Aug. 24 at 10:30 a.m. ET
Moderna has completed its FDA application for its bivalent omicron-targeting booster vaccine. The application is for a 50-µg dose and is based on preclinical data as well as clinical trial data from the company’s BA.1 omicron-targeting booster candidate, which proved “superior neutralizing antibody response” against the variant, according to a company statement.
While Pfizer’s COVID-19 vaccine was 73% effective in protecting children younger than 5, only about 6% of kids ages six month to four years old received at least one vaccine dose by mid-August, PBS reports, citing the American Academy of Pediatrics. Among the 351 children who received dummy shots in the trial, 21 caught infections, compared to 13 among the 794 who got three doses of the vaccine. The company is also working on updated vaccines for kids under 12 to protect them against omicron.
UPDATED: Tuesday, Aug. 23 at 10:50 a.m. ET
Pfizer, one day after filing its omicron-targeted booster dose for an emergency nod in kids ages 12 and older, is back with more positive news on the pediatric prophylactic front. Tuesday, the BioNTech partner unveiled updated results from a phase 2/3 study weighing a three-dose series of its primary shot Comirnaty in children between the ages of 6 months and 4 years old. Vaccine efficacy in the group, for which Comirnaty was granted an EUA in June, clocked in at 73.2%. Meanwhile, in even younger kids between 6 and 23 months old, the vaccine proved 75.8% effective.
Following yesterday’s FDA endorsement, the Centers for Disease Control and Prevention has recommended expanding the use of Novavax’s protein-based vaccine as a two-course regimen for teens between the ages of 12 and 17 years old. The FDA gave Novavax’s shot its emergency nod in July, while the CDC previously recommended its use in adults ages 18 and up.
Come December, Anthony Fauci, M.D., will part ways as the director of the National Institute of Allergy and Infectious Diseases (NIAID). Fauci will exit other public service positions at the same time, including his role as chief medical adviser to the president. Fauci became a household name during the course of the COVID-19 pandemic, speaking directly to the public as a key member of the government’s coronavirus response team. Fierce Healthcare
Mexico plans to protest the United Nation’s failure to deliver COVID-19 shots purchased through the WHO, CEPI and Gavi-backed access troika COVAX, Reuters reports, citing comments made by President Andres Manuel Lopez Obrador. Mexico has ordered more than 51.5 million doses from COVAX, but has so far received just 24.6 million shots, according to a U.N. delivery-tracking website seen by Reuters. In turn, the country is owed some $75 million, Lopez Obrador said Monday.
UPDATED: Monday, Aug. 22 at 11:15 a.m. ET
Pfizer and BioNTech have submitted an application to the FDA for emergency use authorization of their COVID-19 booster dose, which is designed to defend against infection from the omicron BA.4/BA.5 subvariants. The request is for authorization in people ages 12 and older. The companies also have initiated the application process with the European Medicines Agency, they said.
Canada has signed on with Moderna to secure 12 million doses of its omicron-taming COVID-19 booster. The agreement includes 6 million doses of its current COVID vaccine contract to be converted to the updated version. The agreement is contingent upon approval by Health Canada. The country has donated 2.6 million doses of the Johnson & Johnson vaccine to Nigeria, the Primary Health Care Development Agency revealed in a Facebook post.
The FDA has endorsed Novovax’s COVID-19 vaccine for kids ages 12 to 17. The slow-to-win-sanction shot was authorized for adults on July 13. Novavax CEO Stanley Erck said in a release that he hopes the shot will “have a special role in adolescent vaccination based on parents’ and caregivers’ familiarity with protein-based vaccines used in other disease areas.”
The FDA has directed Pfizer to examine if a second five-day course of Paxlovid would help prevent COVID rebound cases. The oral antiviral has come under increased attention with President Joe Biden's recent COVID infection, which included a rebound. Story
UPDATED: Thursday, Aug. 18 at 11:15 a.m. ET
The World Health Organization endorsed French drugmaker Valneva’s COVID-19 vaccine. The agency also signed off on the use of a second booster shot for adults who have a high risk to progress to a severe form of the disease.
British rock singer Lord Zion died of a brain injury due to complications from the AstraZeneca vaccine, a coroner ruled. The 48-year-old lead singer of the band Spit Like This died in May, two weeks after he received the vaccine. After developing a migraine headache a week later, he was advised to check into a hospital but declined.
The Duke University Clinical Research Institute scored a contract to be the Clinical Trials Data Coordinating Center for trials of long COVID therapeutics. The center is part of the National Institutes of Health's Researching COVID to Enhance Recovery (RECOVER) initiative.
CureVac kicked off a phase 1 study of its modified COVID-19 vaccine candidate, CV0501, as a booster designed specifically to protect against the omicron variant, the German company said. The shot was developed in collaboration with GSK. Story
UPDATED: Wednesday, Aug. 17 at 10:05 a.m. ET
As many people in America wait for new versions of the vaccine to get their next booster, White House COVID coordinator Dr. Ashish Jha predicted those updated shots will be available in about three weeks, ABC News reports. Before being available to people in the U.S., the shots need to get clearance from the FDA and CDC.
After retiring from Amgen once and Moderna once, Moderna's CFO David Meline is finally set to step down. The mRNA specialist named James Mock as its next finance chief.
Despite the fact that AstraZeneca is based in the U.K., the country doesn't plan to buy more of the company's vaccine for its booster effort, The Guardian reports. Instead, officials are counting on more mRNA doses to help protect people going into the winter.
UPDATED: Tuesday, Aug. 16 at 1:50 p.m. ET
First Lady Jill Biden has tested positive for COVID-19, her communications director Elizabeth Alexander said in a statement. After testing negative on a rapid antigen test, a PCR test for the double-vaccinated and twice-boosted First Lady came back positive. She has been prescribed a course of Paxlovid and will isolate for “at least five days” at a private residence in South Carolina, where she will remain until two consecutive negative tests.
The U.K. government will not purchase AstraZeneca’s Evusheld due to “insufficient data”, BMJ reports. But government officials will meet with AstraZeneca to determine if any “new real-world data has emerged” that they should consider.
Early research suggests that Sanofi and Regeneron's Dupixent may benefit patients hospitalized with COVID-19, according to a study published in the August issue of Open Forum Infectious Diseases. A phase 2a randomized study showed two deaths in the Dupixent group compared with five in the placebo group. The next step is a large multi-institution study to validate the results, which if successful will “open a new window to the treatment of COVID-19,” researcher Jennifer Sasson, M.D., said in a statement, Health Day reports.
UPDATED: Monday, Aug. 15 at 10:10 a.m. ET
Pfizer CEO Albert Bourla tested positive for COVID-19 and is experiencing "very mild symptoms," he said on Twitter. The helmsman has received four doses of the company's vaccine and is starting a course of its antiviral Paxlovid, he added.
Moderna's omicron-containing bivalent booster won a conditional approval from the U.K.'s Medicines and Healthcare products Regulatory Agency. The bivalent vaccine contains the company's initial shot, Spikevax, plus a vaccine candidate targeting the original omicron strain, BA.1.
Novavax's shot has gotten off to a slow start in the U.S., but the company is pressing ahead with its launch. The company on Monday said it submitted a booster application to the FDA for people 18 and older who received the Novavax vaccine or another COVID-19 shot for their original series.
UPDATED: Friday, Aug. 12 at 9:30 a.m. ET
Rebound COVID infections after taking Pfizer's Paxlovid have famously hit Anthony Fauci, Stephen Colbert and even President Joe Biden. Now, virologists are looking at whether a longer treatment course could thwart the reemergence of a positive coronavirus test result, Time reports. “The virus is rather persistent,” David Ho, a professor of medicine at Columbia University, told the publication, adding that he believes “five days of treatment is not enough…” Ho and his colleagues estimate an extra three to five days of Paxlovid treatment could reduce the risk of rebound 10-fold.
Schools and businesses will no longer have to require unvaccinated people exposed to the coronavirus to quarantine at home, the CDC said Thursday. Instead, the agency now recommends those people wear “a high-quality mask for 10 days and get tested on day 5.” The CDC still recommends that people with COVID-19 should isolate from others no matter their vaccination status. “This guidance acknowledges that the pandemic is not over, but also helps us move to a point where COVID-19 no longer severely disrupts our daily lives,’ Greta Massetti, Ph.D., a CDC epidemiologist, said in a release.
Emergent BioSolutions’ vaccine manufacturing woes keep getting worse. On top of nearly 400 million coronavirus shot doses the company was reported to have scrapped as of May, Emergent had to designate for destruction another 135 million Johnson & Johnson doses produced in Baltimore between Aug. 2021 and Feb. 2022, according to new evidence from the House of Representative’s Select Subcommittee on the Coronavirus Crisis. Those doses were made after the company’s Bayview plant had “purportedly addressed earlier deficiencies and resumed manufacturing,” the subcommittee said.
A hacker claims to be holding the personal information of some 48.5 million people hostage. The data purportedly came from a COVID health code mobile app run by the city of Shanghai, Reuters reports. The news service points out this is the second claim of a data breach at China’s financial hub in just over a month. Back in 2020, Shanghai established its Suishenma health code system, which collects travel data to give people a red, yellow or green rating tied to their likelihood of having the virus.
UPDATED: Thursday, Aug. 11 at 11:39 a.m. ET
Inspired by a plunge in vaccination rates during the pandemic’s first year, GSK and IQVIA are developing a platform dubbed Vaccine Track to keep tabs on the uptake of shots across the U.S. The idea is to pitch the tracker to public health officials, industry leaders and medical professionals to “strengthen vaccination data transparency, raise awareness and publicly share vaccination trends to aid improvements in routine adult vaccinations to create healthier communities across the U.S.,” GSK said. The tracker currently includes information from Jan. 2019 through Dec. 2021, and it will be updated on a quarterly basis. Story
France’s Valneva is the latest vaccine maker to suffer a downturn in COVID shot demand, slashing its full-year revenue outlook following a European contract modification in July. Valneva now expects to generate sales between 340 million euros and 360 million euros for the year, down from a previous range of 430 million euros to 590 million euros. In July, the European Commission slashed its order for Valneva’s shot to just 1.25 million doses from a previous target of 60 million, Reuters reports. The EC at the time said countries were already well-supplied with other COVID vaccines and cited a slowdown in immunization programs.
Alongside plans to roll out omicron-targeted COVID shots this fall, Moderna expects to develop a triple-threat COVID, flu and respiratory syncytial virus shot over the next “three to five years,” CEO Stéphane Bancel told CNN Business. Bancel likened the evolution of Moderna’s shot to Apple’s ubiquitous smartphone. "You don't get the amazing camera, amazing everything the first time you get an iPhone, but you get a lot of things," he told the publication. Then, over time, the product improves, he added. Story
The Supreme Leader has done it again. Thursday, North Korea’s Kim Jong Un declared victory over COVID-19, Reuters reports, citing the hermit kingdom’s news agency KCNA.
UPDATED: Wednesday, Aug. 10 at 11:00 a.m. ET
The European Medicines Agency (EMA) launched a review of Pfizer and BioNTech's adapted booster shot that targets the omicron subvariants BA.4 and BA.5, Euractiv reports. It aims to approve the shot this fall, shortly after the expected approval of Pfizer and Moderna’s omicron targeted vaccines. The EMA has previously said that the first omicron adapted shots could be approved as early as September.
Aspen Pharmacare will stop producing COVID-19 vaccines at its Gqeberha, South Africa, plant due to a lack of orders for the Johnson & Johnson shot. The company reached a deal in March to produce and sell its own brand version of the J&J shot for African markets, Fin24, a South African financial news site, reports. J&J hasn’t ordered from the company past August, and Aspen hasn’t had any orders for its Aspenovax vaccine. Without new orders, the company’s COVID-19 production line would have to be converted to manufacture anesthetics, and Africa would lose its COVID vaccine capacity, the “only one really that exists on the continent,” Stavros Nicolaou, a senior executive at Aspen, told Reuters.
Monkeypox is not linked to any of the COVID-19 vaccines, infectious disease specialists say after a viral social media post claims the disease is a side effect of the vaccines. None of the three COVID-19 vaccines currently available in the U.S. contain any live viruses or monkeypox virus DNA that can transmit the disease in a person, infectious disease specialist Dr. Scott Roberts told USA Today.
UPDATED: Tuesday, Aug. 9 at 11:00 a.m. ET
Moderna has tweaked its vaccine pact with Europe to supply updated booster candidates in lieu of contracted Spikevax doses, the company said Tuesday. Shipments of the updated vaccines are expected to arrive in Europe this year, assuming they pass muster with regulators. Additionally, the European Commission has bought another 15 million Omicron-containing bivalent booster candidates from Moderna, the company said.
After Eli Lilly last week said it would soon sell its monoclonal antibody bebtelovimab on the U.S. commercial market, the company has received an FDA all-clear. Friday, the regulator updated bebtelovimab’s authorization letter, nixing the requirement that distribution remain under the control of the U.S. government. This will enable Lilly to start selling its med the week of Aug. 15, which it will accomplish via its sole distributor, AmerisourceBergen Specialty Distribution.
Following a solid showing in the first quarter, Novavax’s protein-based COVID-19 vaccine hit a wall in Q2, turning in revenues of $78 million for the second three months of the year. That haul fell short of Novovax’s own expectations, CEO Stanley Erck said on a call with investors Monday. Further, Erck warned that Novavax expects to generate “no new revenues in ’22 from the U.S. or from Covax.” Story
Pfizer manufacturing workers in Australia recently walked off the job to protest a “substandard” pay raise by the company, labor union United Workers Union said Tuesday. The production staffers acted after Pfizer’s “refusal to consider a wage increase in line with the cost-of-living," UWU said. Story
UPDATED: Monday, Aug. 8 at 10:55 a.m. ET
Coming to grips with a demand slump for mRNA shot Comirnaty, BioNTech reported second-quarter revenues of 3.2 billion euros ($3.3 billion), down 40% from the same period last year and nearly a 50% plunge from the company’s first-quarter 2022 sales of 6.4 billion euros. Pandemic fluctuations have prompted “rephasing of orders” that has led to “fluctuations in quarterly revenue,” BioNTech’s chief financial officer Jens Holstein told investors Monday. The Pfizer partner blamed much of the sales shortfall on delays in vaccine deliveries to the European Union. Story
That BioNTech downturn caused the company’s U.S. listed shares to sink 8.2% in premarket trading Monday, MarketWatch reports. Despite revenues that clocked in below expectations, BioNTech is sticking by its full-year COVID-19 revenue forecast. BioNTech expects its Pfizer-teamed shot to pull down sales between 13 billion euros ($13.27 billion) and 17 billion euros ($17.35 billion) for the entire year.
Speaking of Pfizer and BioNTech, the partners’ BA.4 and BA.5 sub-variant-targeted shot could be ready by October, pending regulatory approval, Forbes reports. Pfizer and BioNTech plan to kick off trials of their updated COVID shot later this month, BioNTech said Monday. BioNTech and Pfizer have already started production on their bivalent vaccine, Forbes added.
A triad of Eli Lilly’s Olumiant (baricitinib), Gilead Sciences’ Veklury (remdesivir) and the steroid dexamethasone slashed the risk of death by nearly 50% in patients on oxygen support hospitalized with severe COVID-19 pneumonia, News Wise reports, citing a study from Rutgers University. The trial weighed outcomes for 110 patients on remdesivir and dexamethasone against those from 81 patients on the triple combination with baricitinib. The triple combo wasn’t shown to shorten the time patients spent on ventilators or in the hospital.
President Joe Biden, after suffering a symptomless COVID-19 rebound following treatment with Pfizer’s Paxlovid, tested negative for COVID-19 the second day in a row on Sunday, Reuters reports. After two weeks of isolation in The White House, the president ended his quarantine with a trip to his vacation home in Delaware, plus a reunion with his wife, first lady Jill Biden, the news service added.
UPDATED: Friday, Aug. 5 at 11:25 a.m. ET
Moderna forecasts its COVID vaccine sales this year will still be $21 billion, as previously projected, despite low demand from the COVAX program for low- and middle-income countries, Reuters reports. But the company does have new orders for updated vaccine boosters targeting the omicron variant, including a $1.74 billion deal signed a few days ago with the U.S. government for 66 million doses.
Johnson & Johnson's vaccine has been directly linked to a death case in South Africa, Reuters reports. The person came down with the rare neurological disorder Guillain-Barre Syndrome (GBS) soon after receiving the J&J shot and later died, according to press reports. GBS is a known side effect of J&J's shot, and the company noted the coronavirus behind COVID can also trigger the disease. "The benefit of vaccination still far outweighs the risk," Boitumelo Semete-Makokotlela, chief executive of the South African Health Products Regulatory Authority, told reporters. "In our context we have administered about 9 million (doses) of the Janssen vaccine, and this is the first causally linked case of GBS."
A phase 2 trial of Akebia Therapeutics' HIF-PHI anemia drug vadadustat failed to hit its goal of preventing or treating acute respiratory distress syndrome in serious patients with low blood oxygen saturation levels. At day 14, 13.3% of vadadustat takers were in a more severe COVID stage, versus 16.9% for the placebo group. The improvement narrowly missed statistical significance. Still Akebia was "extremely encouraged by the data and believe they support further developing vadadustat as a treatment for ARDS due to COVID-19 or other causes, CEO John Butler said. Story
UPDATED: Thursday, Aug. 4 at 10:25 a.m. ET
Eli Lilly’s COVID-19 antibody bebtelovimab is headed for the commercial market this month, multiple news outlets reported Wednesday. Eli Lilly says it plans to sell its therapeutic to U.S. states, plus hospitals and other healthcare providers from August 15, Reuters pointed out. Back in June, Lilly struck a deal with the U.S. to supply the nation with another 150,000 bebtelovimab doses. That supply is expected to run out as early as the week of Aug. 22. Without funds from Congress, the U.S. government does not have the cash on hand to purchase more of Lilly’s drug, the company told Reuters. Lilly added that it doesn’t plan to seek a full approval for its antibody.
Novavax has revved up its phase 2b/3 Hummingbird trial testing its protein-based COVID shot in kids between the ages of six months and 11 years. Hummingbird will weigh the shot’s efficacy and safety at two doses, followed by a booster shot six months after the primary vaccination series, Novavax said in a release. Initial results from the study, which is enrolling patients in the U.S., Mexico, Colombia, Argentina, Spain, the U.K., South Africa, Philippines and Brazil, are expected in 2023’s first quarter.
Thermo Fisher, marching ahead with a $650 million bioprocessing upgrade, has cut the ribbon on a $76 million expansion at its dry powder media manufacturing plant in Grand Island, New York. The move arms Thermo Fisher with “redundant capacity” and expands the site's production arsenal to include technology and materials used in the development and commercial production of biologic drugs and vaccines, including COVID-19 shots. The expansion is also expected to create around 100 new jobs at the Grand Island site, which currently employs more than 1,600 staffers, Thermo Fisher said Thursday. Story
UPDATED: Wednesday, Aug. 3 at 10:37 a.m. ET
Regulators are Europe recommend that Novavax's vaccine be tagged with warnings about the risk of myocarditis and pericarditis after a small number of cases were recorded, Reuters reports. The U.S. FDA reached a similar decision back in June, according to the news service. So far, just 250,000 doses of the shot have been administered in Europe.
While around 7 million people in the United States who have weaker immune systems are eligible for AstraZeneca's COVID-19 antibody Evusheld, few are actually receiving it, Bloomberg reports. The treatment is intended to help protect people who do not produce a strong response to vaccination. So far, health care providers have ordered just 800,000 courses of the treatment, the news service reports, citing federal data.
Along with recording $4.7 billion in second-quarter sales, Moderna said it had written off nearly $500 million in unusable inventory during the period, CNBC reports. The company also lost $184 million on certain purchase commitments and recorded $131 million in expenses for unused capacity, according to the news site.
UPDATED: Tuesday, Aug. 2 at 2:20 p.m. ET
In a phase 2a trial of patients with long COVID, Axcella's AXA1125 failed to meet the primary endpoint of phosphocreatine recovery rate versus placebo. Despite the fail, the company touted an improvement in fatigue scores versus placebo, so it's talking with regulators about next steps. Story
The European Commission inked a deal allowing EU member states to buy up to 250 million doses of a new COVID-19 vaccine developed in Spain, Medicial Xpress reports. The vaccine, known as PHH-1V, has yet to be approved by the European Medicines Agency (EMA). If approved, the vaccine would be used as a booster shot for adults with receding immunity after their initial shots.
Regeneron cancelled four clinical trials assessing its antibody cocktail REGEN-COV, leaving Pfizer’s Paxlovid to continue dominating the COVID-19 drug market. The termination comes half a year after the FDA pulled the cocktail from the market. Read the full story here.
UPDATED: Monday, Aug. 1 at 10:35 a.m. ET
President Joe Biden has tested positive again. The incident provides a high-profile example of so-called “rebound” COVID positivity that’s been observed in some patients who were given Pfizer’s oral antiviral Paxlovid. Over the weekend, The White House published a letter from Biden’s doctor stating the president’s symptoms hadn’t reemerged and that he continued to feel “quite well.” The President logged another positive result Sunday morning, though again, he was reported to be doing well.
Pfizer and Moderna’s latest deals to furnish the U.S. with at least 171 million doses of their revamped, variant-specific COVID-19 vaccines this fall won’t be enough for everyone living in the U.S., the Department of Health and Human Services (HHS) warns. Last week, the Biden Administration locked up 66 million doses of Moderna’s bivalent booster candidate, as well as 105 million bivalent booster doses from Pfizer and BioNTech. The deals provide the US with the option to acquire 300 million more vaccines from each manufacturer, but “these options can only be exercised with additional funding from Congress,” HHS said. Story
AstraZeneca’s COVID-19 shot helped thwart COVID-19 infections linked to Omicron when given as a fourth booster dose, The Manila Times reports, citing new data from Thailand’s Chiang Mai University. The real-world evidence study showed AZ’s vaccine was 73% effective against the coronavirus’ Omicron variant when given as a fourth shot on top of any previous primary vaccine or booster. Meanwhile, a fourth dose of any of the COVID-19 vaccines studied proved 75% effective in staving off Omicron infection. The data bode well for the effectiveness of heterologous or “mix and match” vaccination schedules, which could help enhance access to booster doses around the globe, The Manila Times points out.
UPDATED: Friday, July 29 at 11:50 a.m. ET
Moderna will provide 66 million doses of its bivalent COVID-19 booster candidate, a version of Spikevax that is meant to protect against infection from the omicron BA.4/5 subvariant. The contract comes with options to secure an additional 234 million doses. This is one of two bivalent vaccines that Moderna is developing. The other protects against the BA.1 omicron subvariant. This latest supply order comes on top of the U.S. signing with Pfizer for 105 million doses of its omicron-tweaked booster candidate. Both shots are scheduled to arrive early in the fall.
The Biden administration will push this fall to get Americans to accept a booster vaccination that is expected to provide better protection against the omicron subvariant. The roll out of shots from Pfizer and Moderna is set to begin in September. The decision comes amid a surge of the virus, which infected Biden.
When AstraZeneca reported its second-quarter earnings, sales of Evusheld came in at $445 million—a startling decline from the $469 million it generated in the first quarter. Still, the company is predicting sales of the one-of-its-kind COVID product will increase in the second half. Story
Some U.S. states surveyed by the Medicaid and CHIP Payment and Access Commission said having an established end date for the COVID-19 public health emergency can help them prepare for the unwinding along with the major task of redetermining Medicaid eligibility. Story
Even if government contracts for COVID-19 antivirals and vaccines dry up, Pfizer is primed and ready to maintain its pandemic sales dominance with its Comirnaty vaccine and Paxlovid oral antiviral, the company’s chief executive said on an investor call Thursday. Story
UPDATED: Thursday, July 28 at 11:50 a.m. ET
Patients who are given Pfizer’s COVID-19 treatment Paxlovid are about five times less likely to be hospitalized and 10 times less likely to die than those who are infected and not provided the oral antiviral. Those are the findings of Epic Research, which also says the United States’ Test to Treat initiative has led to a notable increase in uptake of the drug.
Zenara Pharma of India has a green light to produce and market a generic version of the Pfizer pill. The company has dubbed its Paxlovid copycat Paxzen, and its factory in Hyderabad has been blessed by the FDA. Many companies around the world won access to the intellectual property to manufacture Paxlovid through the Medicines Patent Pool. But Zenara gained its approval through the Indian government to help meet the need in that country. Hetero is the only other company in India sanctioned by the government to produce the treatment.
Sales of Merck’s COVID-19 oral antiviral Lagevrio dropped from $3.2 billion in the first quarter to $1.2 billion in the second quarter, the company said. Merck added that most of the sales of its pill now are in Japan and the U.K. The fall wasn’t a surprise to the company, which is sticking to Lagevrio's annual sales projection of between $5 billion and $5.5 billion. Story
UPDATED: Wednesday, July 27 at 11:50 a.m. ET
Pfizer and BioNTech have launched a phase 2 trial of a bivalent COVID vaccine candidate, BNT162b5, covering both the original SARS-CoV-2 virus and an omicron variant. The new shot includes mRNAs encoding enhanced spike prorteins for the viruses with the goal to increase the magnitude and breadth of an immune reponse. Story
InflaRx's C5 inhibitor vilobelimab previously failed a phase 3 study in terms of 28-day death rate over placebo among critically ill COVID patients. But after "constructive interactions" and receiving "helpful guidance" from the FDA, the company decideds to file for an emergency use authorization by the end of September anyway. Story
President Joe Biden is leaving strict isolation after testing negative on an antigen test twice since Tuesday evening, his White House physician said in a letter. He was on isolation for five days. The President has taken Pfizer's Paxlovid and discontinued use of Tylenol for the past 36 hours. But acknowledging past report of disease rebound after Paxlovid treatment discontinuation, the physician said Biden will increase his testing frequency.
The Biden administration may not push for second boosters among younger adults this summer, the NPR reports. Instead, the U.S. government plans to focus on speeding up the development of next-generation boosters in the fall to prepare for a potential surge during winter. The FDA could make a final decisio next week, according to NPR.
UPDATED: Tuesday, July 26 at 11:35 a.m. ET
China has given the thumbs up to its first locally developed antiviral pill, teeing up a potential showdown with Pfizer’s Paxlovid. The green light was awarded to Henan-based Genuine Biotech, whose med Azvudine was previously used to treat HIV. Meanwhile, Genuine has forged a pact with a unit of Fosun Pharma, which will oversee marketing of the COVID pill in mainland China. Fosun could eventually lock up rights to commercialize the drug overseas, too, Bloomberg reports.
Pfizer and BioNTech are challenging a CureVac lawsuit in a Massachusetts District Court. The partners argue there’s an “actual, immediate, substantial and justiciable controversy” at play over whether the partner’s mRNA vaccine Comirnaty has infringed or will infringe three patents at the center of CureVac’s case. CureVac said it was suing Pfizer and BioNTech earlier this month, adding that it did not plan to scuttle the production, sale or distribution of Pfizer’s shot. A CureVac victory could land the German mRNA specialist $500 million in “potential upside” based on a royalty rate of 2% to 3% in an “optimistic scenario,” Berenberg Capital Markets analysts wrote in a recent note to clients. Story
Following last week’s revelation that the Commander in Chief tested positive for COVID-19, President Joe Biden’s condition has improved “significantly,” his physician wrote in a letter to the White House’s press secretary, Karine Jean-Pierre. As of Sunday, the president had completed his third course of Paxlovid, with his predominant remaining symptom being a sore throat, the President’s physician said.
UPDATED: Friday, July 22 at 11:30 a.m. ET
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has signed off on use of Moderna’s COVID-19 vaccine as a booster for kids ages 12 to 17. It also agreed that Spikevax remains stable for 12 months under certain conditions. Additionally, the CHMP has given a thumbs up for the Moderna shot to be produced at a facility in Madrid, Spain.
An experimental oral vaccine for COVID-19, made by Vaxart of San Francisco, has shown early promise. In a study of 35 volunteers, the pill was shown to produce antibodies in both the blood and in the tissues of the nose, which is the first line of defense against the virus. In addition, antibody levels were higher in recipients than in people who were recently infected by the virus and protection lasted for six months.
Those who are infected with COVID-19 and have high blood pressure are more than twice as prone to hospitalization with the omicron variant, according to a study of 912 at Cedars-Sinai Medical Center in Los Angeles. Among factors commonly cited for an increased risk of severe infection—including heart failure, kidney disease and old age—hypertension was associated with the highest magnitude of risk.
After a sales peak in 2022, Pfizer's Paxlovid revenues are due to decrease from 2023 onward, thanks to a second round of booster vaccines and predications of fewer cases that require hospitalization, data and analytics outfit GlobalData predicts. Story
UPDATED: Thursday, July 21 at 10:38 a.m. ET
President Joe Biden tested positive for COVID-19 Thursday morning, the White House said in a press release. The president is experiencing "very mild symptoms," according to the release, which notes Biden is fully vaccinated and has received two booster doses. Additionally, Biden has started taking Pfizer's antiviral pill Paxlovid.
Pfizer is planning to spend $470 million to expand its vaccine research facility 25 miles outside of New York City, Bloomberg reports. The company has been riding the success of its BioNTech-partnered mRNA vaccine for COVID-19, Comirnaty, and it's hoping to keep its momentum going in the burgeoning field.
In a study involving more than 7 million adults, researchers found that two doses of the Pfizer or AstraZeneca vaccines protect against severe COVID-19 for at least six months. The University of Bristol team used National Health Service records to conduct the study, which included data from more than 5 million vaccinated individuals and more than 2.4 million unvaccinated adults in the U.K.
AstraZeneca signed a deal to supply Switzerland's government with 1,200 doses of its antibody combination of tixagevimab and cilgavimab, Pharmaceutical Technology reports. This deal follows an earlier supply agreement, and the new doses are expected to be made available in August.
Valneva worked through delays to score a vaccine approval in Europe, but even after the nod, officials are slashing their orders. After previously inking a deal to buy up to 60 million doses, officials in Europe now plan to buy 1.25 million doses, with an option for 1.25 million more, Reuters reports.
UPDATED: Tuesday, July 19 at 10:30 a.m. ET
As Europe battles the latest COVID surge, officials are turning to a familiar tool. The European Commission signed a deal to purchase up to 2.25 million vials of Gilead's antiviral Veklury, Reuters reports. Nearly 2 dozen member states are participating in the joint procurement deal.
Novavax, right on the heels of its U.S. vaccine authorization, is now amping up its focus on omicron-tailored vaccines. The company expanded a manufacturing deal with SK biosciences to potentially produce omicron-tailored shots in prefilled syringes. Aside from the omicron-specific work, SK biosciences will also make commercial doses of the company's authorized shot starting in 2023.
Pfizer and BioNTech are reportedly nearing a deal to delay certain COVID-19 vaccine deliveries to Europe until 2024, Proactive Investors reports. Their current deal ends in 2023, but the parties seem amenable to an extension amid the current glut in vaccines, according to the publication.
UPDATED: Monday, July 18 at 2:25 p.m. ET
Dr. Anthony Fauci, President Joe Biden’s chief medical advisor and director of the National Institute of Allergy and Infectious Diseases (NIAID), will “very likely” retire by the end of Biden’s current term in office, CNN reports. Fauci said on CNN’s “At This Hour” that it is “extremely unlikely—in fact, for sure—that I am not going to be here beyond January 2025.” After serving more than five decades, he said he feels that he has established a good system at NIAID to facilitate a smooth transition and that he wants to pursue other career opportunities upon leaving.
Many Americans who have received three doses of COVID-19 vaccines wonder if they should wait for new, variant-tweaked boosters or boost again with an available shot. Even the experts can’t agree. Professor of infectious diseases Dr. Carlos del Rio says that the public isn’t hearing enough about the original vaccines’ value in preventing severe disease, while Dr. Paul Offit, a member of the FDA’s vaccine advisory committee, is skeptical that the fourth jab is needed by anyone but seniors and immunocompromised people. However, top federal health officials say to not wait for an omicron-tailored shot, especially for those who are immunocompromised, Kaiser Health News reports.
Oxford Science Enterprises has raised £250 million ($300 million). The company was a founding investor in Vaccitech, the biotech that co-developed AstraZeneca’s COVID-19 vaccine. That vaccine accounts for 98% of shots provided by the World Health Organization’s vaccine initiative COVAX. Read the full story here.
UPDATED: Friday, Juy 15 at 11:20 a.m. ET
Canada has cleared Moderna’s COVID-19 vaccine for children 6 months and older. Spikevax becomes the first COVID shot authorized for kids under age 5. The nod makes 1.7 million Canadian children eligible for vaccination with a dosage that is one-quarter the size sanctioned for adults.
The European Union’s ombudswoman has called the bloc’s failure to publish texts between Pfizer CEO Albert Bourla and EU commissioner Ursula von der Leyen “maladministration” and a “wake-up call” for accountability. The texts in question were sent when Pfizer was negotiating a COVID-19 vaccine deal with the bloc. The EU ruled that it was not obliged to catalog such texts.
Codexis has agreed with Pfizer to continue to supply an enzyme used to manufacture nirmatrelvir, a key ingredient in Pfizer’s COVID-19 oral antiviral Paxlovid. The pandemic has stressed the system, Codexis said, by requiring “unprecedented” levels of the type of enzymes it produces.
UPDATED: Thursday, Juy 14 at 11:20 a.m. ET
After much delay, Novavax has finally won an FDA emergency use authorization for its adjuvanted, recombinant protein-based shot. The vaccine has shown it was 90.4% effective at preventing mild, moderate or severe COVID in an ongoing phase 3 study in the U.S. and Mexico.The company also plans to seek full approval by year-end. Story
But just as Novavax celebrates the U.S. green light, the European Medicines Agency said it has identified severe allergic reactions as potential side effects of the shot, Reuters reports. The agency said it will also add unusual or decreased feeling in the skin as another side effect.
COVID-related travel restrictions have delayed the FDA's review of another closely watched drug. The FDA has postponed its decision for Novarits and BeiGene's PD-1 inhibitor tislelizumab in second-line esophageal squamous cell carcinoma because regulators couldn't conduct inspections in China, BeiGene said. No new target decision date has been provided. Story
Humanigen's lenzilumab has failed in NIH's ACTIV-5 basket trial. In hospitalized patients who also received Gilead's Veklury, the rate of patients who were alive and without mechanical ventilation were statistically the same between lenzilumab and a placebo on day 29, the study found. The lenzilumab portion of the trial has therefore missed its primary endpoint. Humanigen was counting on the results to convince the FDA to authorize the medicine after the agency previously rejected the drug. Story
Drug-resistant infections in U.S. surged during the initial wave of COVID, a CDC report has found, The New York Times reports. Deaths caused by drug-resistant infections rose 15% in 2020 compared to 2019. The increase was attributed partly to misuse of antibiotics for viral lung infections in severely ill patients during the early days of the pandemic
UPDATED: Wednesday, July 13 at 10:45 a.m. ET
A new analysis from London-based data firm Airfinity found that AstraZeneca’s COVID-19 vaccine saved 6.3 million lives in the first year of the rollout, with Pfizer and BioNTech’s shot saving 5.9 million. Coronavirus vaccines together saved about 20 million lives in the first year, more than half of them in wealthier countries, Bloomberg reports. Airfinity determined that Sinovac and Moderna vaccines saved about 2 million and 1.7 million lives, respectively.
A phase 3 clinical trial published in the Lancet Regional Health Southeast Asia showed that SaNotize Research & Development Corp’s nitric oxide nasal spray (nons) reduced viral load by 94% in COVID-19 patients within 24 hours of treatment. A 99% reduction of viral load was observed after 48 hours. The study was conduced during the delta and omicron surges. In all, 306 patients were enrolled, with 46% being vaccinated. The spray is not yet approved in the US or Canada, but is approved in Thailand, Indonesia, Israel, Bahrain, Singapore, Nepal, and Hong Kong.
COVID-19 hospitalizations have doubled since May, CDC director Dr. Rochelle Walensky said Tuesday at a media briefing. The increase can be attributed to BA.5, which accounted for 65% of new cases as of last week. The subvariant is more transmissible and immune evading than previous strains. However, the subvariants do not appear to be associated with greater disease severity, Dr. Anthony Fauci said at the briefing. Rising hospitalizations could be due to the “sheer number” of newly infected people, NBC News reports.
UPDATED: Tuesday, July 12 at 11:25 a.m. ET
The FDA is making second boosters for all adults a “high priority,” and health officials are making a plan to allow the boosters for younger adults, CNN reports. While second boosters are authorized for adults aged 50 and older, some experts are concerned that younger adults may have waning immunity with the rise of the omicron BA.5 subvariant. As of Thursday, about half of Americans 18 and up have gotten the first booster and just over a quarter of those over 50 have gotten the second, according to the CDC.
President Biden outlined a plan to manage BA.5, including ensuring access to vaccines, treatments, and tests. The administration pledged to drive uptake of booster shots, particularly among those over 50 years old, and make treatments (including Pfizer's Paxlovid), at-home tests, and high-quality masks available for those who need them. The president also committed to prioritizing protections for immunocompromised individuals and will make a hotline available in the coming weeks to help individuals access AstraZeneca's pre-exposure prophylactic Evusheld.
COVID-19 cases have been wildly undercounted, leading to concerns as BA.5 takes hold. While cases are escalating, there doesn’t seem to be as many ICU admissions and deaths as previous variants, CNN reports. An estimate from the Institute for Health Metrics suggests that actual infection numbers in the first week of July were about seven times higher than reported. Experts say that to gauge individual risks of contracting infection, it might be better to account cases among friends and family as opposed to going off official data.
UPDATED: Monday, July 11 at 11:25 a.m. ET
The federal government will buy 3.2 million doses of Novavax’s COVID-19 vaccine, pending a FDA authorization. The vaccine would be available as a primary two-dose vaccine. Novavax hopes that its protein-based shot will appeal to the 1/3 of Americans who have declined vaccination with mRNA technology. Vaccine advisors to the FDA recommended that the shot be authorized, and the agency is still deliberating, The New York Times reports.
A new omicron subvariant dubbed BA.5.21 has been discovered in Shanghai. According to Zhao Dandan, the vice-director of the city’s health commission, the infection was linked with a case from overseas, Reuters reports. Residents in major Shanghai districts will undergo two rounds of COVID-19 tests to control new outbreaks.
The European Union recommended a second booster for those over 60 years of age and those with medical vulnerabilities. The recommendation has been updated from the previous guidance that only those older than 80 should receive the second booster jab. The decision reflects increasing cases, plus hospital and intensive care admissions, Reuters reports.
UPDATED: Friday, July 8 at 11:10 a.m. ET
Scientists at UT Southwestern say they have developed a rapid test to determine which COVID-19 variant is present in infected persons. The test, called CoVarScan, is said to reveal the variant within a few hours. The test is a vast improvement—speed-wise and cost-wise—on the current method of determining variants through whole genome sequencing.
A study from Pew Research shows that Americans have lost faith in government leaders and public health experts based on how they’ve handled the coronavirus pandemic. The study also showed that people in the U.S. are much less concerned about COVID-19. Opinions varied widely depending on political affiliation as 72 percent of Democrats said they believe officials had performed well in response to the pandemic versus 29 percent for Republicans who were surveyed.
New York City nurse Sarah Lindsay, who was the first person in the United States to receive a COVID-19 vaccination outside of a clinical trial, has been awarded the Presidential Medal of Freedom. She was vaccinated on Dec. 14 of 2020. Lindsay, 53, said she received the shot to “inspire people who look like me, who are skeptical in general about taking vaccines.” Another Medal recipient, actor Denzel Washington, was absent from the White House ceremony because of a recent positive test for COVID-19.
After authorizing Pfizer’s COVID-19 oral antiviral Paxlovid to be prescribed by pharmacists, the FDA said it will not extend the same privilege to Merck and Ridgeback’s antiviral pill Lagevrio. The regulator cited Lagevrio’s side-effect profile as reason to leave the decision in the hands of physicians. Story
UPDATED: Thursday, July 7 at 10:45 a.m. ET
As the omicron BA.5 subvariant gains steam in the U.S., researchers at Yale University believe the pandemic will shift to an endemic phase in around 2 years. That shift only applies to people who have been vaccinated, though, NBC Connecticut reports.
African health officials revealed a memorandum of understanding with Pfizer to gain supplies of the company's oral antiviral Paxlovid, Reuters reports. Under the deal, African countries could access the treatment at cost, according to the news service.
Speaking of Paxlovid, the U.S. FDA on Wednesday changed the drug's emergency use authorization to allow pharmacists to prescribe it. Pfizer said the change will broaden access to the therapy. Story
UPDATED: Wednesday, July 6 at 11:15 a.m. ET
Tens of millions of COVID vaccine doses have been wasted amid lagging demand, The Wall Street Journal reports. In the U.S., about 90.6 million doses have been wasted, WSJ reports, citing data from the CDC. The German government has discarded about 3.9 million doses in a federal warehouse as they expired in June. Canada has thrown away 1.2 million expired doses of Moderna's vaccine, and is set to discard about 13.6 million expired doses of AstraZeneca's shot, WSJ reports.
After CureVac filed a lawsuit accusing BioNTech of infringing on its mRNA technology, BioNTech is now considering legal steps against CureVac, Reuters reports. "We are looking at all legal options," a BioNTech spokesperson told the news service.
Shionogi has started filing its oral COVID antiviral, S-217622, with Chinese authorities through a joint venture with local insurance giant Ping An. The company has also requested a meeting with Chinese drug reviewers to facilitate the filing, it said. Meanwhile, back in its home country, Shionogi is facing a review delay in Japan amid questions over its efficacy and safety. Release, Chinese
UPDATED: Tuesday, July 5 at 11:10 a.m. ET
The European Commission (EC) has given a thumbs up to Novavax’s protein-based COVID-19 vaccine Nuvaxovid for teens between the ages of 12 and 17. The green light comes after last month’s endorsement of an approval in teens by the European Medicines Agency’s Committee for Medicinal Products for Human Use. The authorization leveraged data from the ongoing pediatric expansion of Novavax’s late-stage PREVENT-19 study. Europe blessed Nuvaxovid with a conditional marketing approval in adults back in December.
BioNTech is being sued by its German mRNA compatriot CureVac, which claims the company’s Pfizer-partnered shot Comirnaty infringes on CureVac-held intellectual property. The lawsuit, filed in Germany, covers four patents linked to the engineering of mRNA molecules, including “sequence modifications to increase stability and enhance protein expression, as well as mRNA vaccine formulations specific to SARS CoV-2 vaccines,” CureVac said in a release. CureVac isn’t angling to stop the sale or distribution of Comirnaty. Instead, the company is looking for recognition and compensation for its technology, which it claims was essential in BioNTech’s development process. Story
The closing of public testing sites, plus the decline of daily data updates from states, has obscured the spread of SARS-CoV-2 across the U.S., The New York Times reports. Thanks to the testing slowdown, lab-based PCR testing capacity for July will only be half of what it was in March, The Times said, citing a recent estimate by research and consulting outfit Health Catalysts Group. Meanwhile, positive results from most popular home test kits aren’t included in official data, and not everyone who gets infected by the virus knows or receives a test, NYT added. The hazy picture comes as some scientists estimate the current wave of cases is the second largest of the pandemic, the publication pointed out.
UPDATED: Friday, July 1 at 10:50 a.m. ET
New York City will begin offering prescriptions for Pfizer’s COVID-19 antiviral pill Paxlovid at mobile test-and-treat sites, providing immediate treatment for those who are infected. The units, which will be stationed outside of pharmacies, will test and provide the prescriptions, which then can be used at the pharmacy. The initiative will begin with three locations and then spread to 30 by the end of July.
AstraZeneca and Amref Health Africa are launching a fleet of mobile vaccination clinics in a push to reach “last-mile” communities with COVID-19 shots in Kenya. The goal is to reach 1,000 people daily when the fleet of 10 clinics is fully operational. At present, 31% of Kenya’s adults have been vaccinated.
Oxford Biomedica has revealed an extension of its contract with AstraZeneca to produce COVID-19 vaccines through 2025, but only on an “as needed basis,” the company said. This comes just nine months after Oxford announced a $68 million investment from the over-strapped Serum Institute of India to increase its ability to manufacture vaccines for AZ at its Oxbox facility. Story
For a second time, the FDA has declined to authorize NRx Pharmaceuticals’ Zyesami (aviptadil) as a treatment for those with a severe form of the coronavirus. The regulator first rejected Zyesami last year. Two months later, NRx filed again, zeroing in on COVID-19 patients who are at immediate risk of death from respiratory failure despite treatment with approved therapies including Gilead’s Veklury. Story
UPDATED: Thursday, June 30 at 11:10 a.m. ET
After running six months on an emergency use authorization for Paxlovid, Pfizer is now seeking a full FDA approval for the COVID antiviral in patients who are at high risk for progression to severe illness regardless of their vaccination status. When taken within five days of symptom onset, Paxlovid cut the risk of hospitalization or death from any cause by 86% in non-hospitalized, high-risk patients, according to final results from the phase 2/3 EPIC-HR study. Pfizer's application package also includes data from the EPIC-SR study, which didn't hit its goal in vaccinated patients with, and unvaccinated patients without, risk factors for severe COVID. Release
The FDA has authorized a new dosing regimen of AstraZeneca's COVID antibody Evusheld. Back in February, the agency allowed an increased dosing of the combo drug as an initial treatment to prevent COVID in immunocompromised people and certain individuals unfit for existing vaccines. At that time, the agency stopped at recommending a timing for a redosing, citing uncertainties over which omicron subvariant would become dominant. Now, the FDA is authorizing the doublet to be given every six months at 300-mg for each of the antibody component because "[n]onclinical data and pharmacokinetic modeling suggest that activity against" several circulating omicron subvariants may be retained at that dosing level.
Meanwhile, the FDA is now recommending vaccine developers to add an omicron BA.4/5 spike protein component to the current vaccine composition to make bivalent booster shots. But this new demand shouldn't delay the companies' regulatory plans for their current booster shots containing an BA.1 element, the FDA said.
Vaxart has tapped hVIVO Services to help it lay the groundworks for a potential human challenge study of Vaxart’s oral COVID vaccine pill candidate. The CRO will help make the challenge virus copying the omicron variant and establish a proper dose. The phase 2 study is expected to begin in 2023. Release
UPDATED: Wednesday, June 29 at 10:25 a.m. ET
Dr. Anthony Fauci, the chief medical advisor to President Joe Biden, had his COVID-19 symptoms rebound after an original course of Pfizer's antiviral Paxlovid, Bloomberg reports. He is fully vaccinated and has had two boosters, but he contracted COVID-19 earlier this month. He said at a summit this week that his symptoms after the virus returned were "much worse" than the first time around.
Just as antibody supplies were dwindling in the United States, officials have inked a deal with Eli Lilly for 150,000 doses of bebtelovimab. The deal is worth about $275 million.
Amid a dispute with the European Union's own watchdog, officials at the European Commission say they don't have a responsibility to locate texts between European Commission president Ursula von der Leyen and Pfizer CEO Albert Bourla from earlier in the pandemic, The Guardian reports.
UPDATED: Tuesday, June 28 at 10:55 a.m. ET
In a new scorecard published by the The Pharmaceutical Accountability Foundation, COVID-19 vaccine and drug makers failed to live up to human rights principles outlined by the group. None met all of the group's metrics, and most need to take "big steps" to ensure access and affordability, the foundation said.
A new study published in JAMA Network Open found higher rates of myocarditis and pericarditis for the Moderna vaccine compared with the Pfizer-BioNTech rival, CIDRAP reports. The researchers at Public Health Ontario, the University of Toronto, and nonprofit ICES also said rates were lower for both vaccines if the two doses were given farther apart.
Cue Health has made the "difficult decision" to let go of 170 manufacturing workers, a spokesperson told Fierce Med Tech. The company attributed layoffs to "economic challenges that are impacting many industries, as well as the U.S. government’s recent decision to reduce funding for COVID-19 testing.” Story
UPDATED: Monday, June 27 at 9:35 a.m. ET
Congress still hasn't passed any new COVID funding packages, so the leading vaccine players are now eying the private market in the U.S., The Wall Street Journal reports. Moderna's CEO Stéphane Bancel is weighing a price of about $60 per dose for insurance reimbursement, according to the newspaper. That's about three times the price the company has been getting from its government contracts.
Pfizer and its mRNA partner BioNTech shared positive immune response results for their monovalent and bivalent omicron-adapted mRNA vaccines. The news comes one day before the FDA holds an advisory committee meeting to discuss recommendations for updated COVID-19 vaccines. Ahead of that meeting, FDA staffers gave a positive review of the Pfizer and BioNTech prospects, Endpoints News reports.
China's Clover Biopharmaceuticals touted data showing that a booster dose of its SCB-2019 elicited a 19-fold increase in neutralizing antibody levels against omicron BA.2 subvariant compared with prebooster levels. The company is developing its shot as a primary vaccination series and as a "universal" booster that could be used after another original vaccine course.
UPDATED: Friday, June 24 at 10:20 a.m. ET
In a first, Sanofi and GSK said their recombinant protein vaccine has turned in a successful efficacy result against omicron. In a phase 3 trial, the beta-specific vaccine achieved 72% protection versus the now-dominant variant. The vaccine turned in 64.7% efficacy versus symptomatic COVID-19, and the figure rose to 72% in omicron-confirmed symptomatic cases. Story
New data from researchers at the Beth Israel Deaconess Medical Center at Harvard Medical School show that the omicron subvariants BA.4 and BA.5 appear to evade antibody responses in people with prior infections and in those who are fully vaccinated, CNN reports.
After U.S. health officials endorsed mRNA vaccines for children under the age of 5, Florida-based grocery chain Publix says it will not offer those vaccines "at this time," The Hill reports. This comes after the state did not order any vaccines for children 5 and under from the federal government.
UPDATED: Thursday, June 23 at 11:50 a.m. ET
Valneva’s inactivated whole virus COVID-19 vaccine has been recommended for marketing authorization from the Committee for Medicinal Products for Human Use, a key committee of the European Medicines Agency. Next, the European Commission will review the recommendation and decide on an authorization. If granted, the COVID-19 vaccine will be the first in Europe to be authorized with the standard marketing authorization. The vaccine has already received conditional marketing authorization in the United Kingdom and emergency use authorizations in the United Arab Emirates and Bahrain.
A Japanese health ministry panel postponed a decision on granting emergency approval for Shionogi’s COVID-19 pill, saying more discussion is necessary. the drug is the first domestically developed treatment for the virus and is intended for use in patients with light to moderate symptoms. It’s been up for panel evaluation since May, when the company applied for approval under a new emergency authorization system. Panel members were divided and could not reach a conclusion on several points, including the drug’s efficacy and safety. The panel will meet again in July before deciding. The government has already agreed to buy 1 million courses upon approval, the Japan Times reports.
After last week's FDA emergency use authorization for Moderna and Pfizer COVID-19 vaccines in young children, 2.7 million doses were delivered to administration centers and another one million doses are on the way, Reuters reports.
According to new survey data, nearly 1 in 5 American adults who previously contracted COVID-19 are still having long COVID symptoms. 1 in 13 adults have had long COVID symptoms lasting for three months or more. Younger adults were found more likely to have persistent symptoms, with women more likely to have long COVID more frequently than men. Kentucky and Alabama reported the highest percentage of adults with lasting symptoms, while Hawaii, Maryland and Virginia reported the lowest. The survey was collected early June by the U.S. Census Bureau and analyzed by the CDC, Reuters reports.
UPDATED: Wednesday, June 22 at 10:30 a.m. ET
Moderna’s COVID-19 variant vaccine will be ready to ship in August, CEO Stéphane Bancel told Reuters. The company has been producing shots ahead of the vaccine’s approval. Bancel said that the bottleneck is regulatory approval and “from a manufacturing standpoint” the company is ready to go. Clinical data show that the vaccine elicits neutralizing antibody responses against Omicron subvariants BA.4 and BA.5 in participants regardless of prior infection. Meanwhile, Pfizer’s CEO Albert Bourla told MSNBC today that the company will be “able to quickly adapt shots” as the virus mutates, Reuters reports.
COVAX, the World Health Organization's global vaccine initiative, is asking for vaccine manufactures to cut or slow deliveries to curb wasted doses, Reuters reports. The organization wants between 400 and 600 million fewer doses than initially contracted from six companies. Donations from wealthy nations, output from manufactures, delivery challenges and vaccine hesitancy in some countries have led to worldwide oversupply.
WHO approved India's Biological E Limited to make COVID-19 vaccines for Johnson & Johnson. The U.S. government said last year that it would spend $50 million to help expand the site’s production capacity, the New Indian Express reports.
In a strategy to curb the spread of COVID-19, Denmark plans to offer a fourth COVID-19 dose in the fall to individuals over 50 years old. The BA.5 subvariant of Omicron has spread quickly in the country. Prime Minister Mette Frederiksen said that vulnerable groups would be able to get another booster this week, Reuters reports.
UPDATED: Tuesday, June 21 at 10:30 a.m. ET
Millions of children under the age of 5 will be eligible to receive vaccinations starting today. Last week, the FDA and the CDC signed off on Moderna and Pfizer/BioNTech’s COVID-19 vaccines for children under 5 years old. Children can get their vaccines at pediatricians’ offices and pharmacies, CNN reports. CVS will begin administering Pfizer/BioNTech vaccines today and Walgreens will start carrying vaccinations for the age group starting on June 25 at select locations.
Recent data show that despite infection rates surging throughout the country, hospitalization and death rates have not substantially increased. Experts say this is likely the result of COVID-19 vaccines and booster shots, ABC News reports. Approximately 300 COVID-19 related deaths are being reported each day, which is far below the January 2021 peak of 3,400 deaths reported each day. According to the CDC, unvaccinated adults are six times more likely to die from infection compared to those who are vaccinated.
UPDATED: Friday, June 17 at 11:20 a.m. ET
The FDA has authorized emergency use of Moderna and Pfizer/BioNTech’s COVID-19 vaccines in children down to six months of age. Moderna’s EUA was amended to include the use of the vaccine in children 6 months old to 17 years old, while Pfizer/BioNTech’s was amended to include children 6 months to 4 years of age. The agency determined that the benefits of the vaccines outweigh the risk in the population. Pfizer/BioNTech’s vaccine is a three-dose series, whereas Moderna’s is two doses.
Bharat Biotech’s COVID-19 vaccine, Covaxin, has proven to be safe and well tolerated in the 2-18 years old age group in a phase 2/3 study published in Lance Infectious diseases. The study was conducted from June to September of 2021. No serious adverse events were reported, although there were 374 reported adverse events that were generally mild and nature and resolved within a day. Neutralizing antibodies were found to be 1.7 times higher than in adults, according to a recent company statement.
A peer-reviewed UK study found that the Omicron variant is less likely to cause long COVID-19 than previous variants. Researchers at King’s College London found that the odds of developing the condition after infection were 20-50% lower during the Omicron wave in the UK compared to the Delta variants, Reuters reports. The study is believed to be the first showing that Omicron does not present as great a risk of long COVID-19. 438,000 people in the UK have contracted long COVID-19 after infection with the Omicron variant, which represents 24% of all patients suffering from the ailment.
UPDATED: Thursday, June 16 at 11:30 a.m. ET
Canada has thrown away nearly 15 million expired COVID-19 vaccines doses, including more than 13.5 million AstraZeneca shots that the country tried to donate to COVAX but couldn’t because the worldwide relief program was already overloaded with a surplus. The report comes amid of similar stories in the U.S. of expired vaccines being discarded.
Bavarian Nordic will redesign a phase 3 trial of its COVID-19 booster vaccine, pitting it versus the Pfizer-BioNTech booster, the company said. The trial will begin in August with a 2023 target for potential approval.
The World Trade Organization may adopt an agreement that would waive patent enforcement during pandemic emergencies, making it easier to produce COVID-19 vaccines. But critics of the measure say it lacks effectiveness until other COVID products—such as antivirals and antibody treatments—can be included.
A study from Norway, Denmark and Finland shows an increased risk of thromboembolic events with the AstraZeneca COVID-19 vaccine compared to mRNA shots from Moderna and Pfizer. The study confirms previous research that shows an increased risk—though still slight—that comes with adenovirus vaccines such as those produced by AZ and Johnson & Johnson.
An FDA advisory committee has recommended by a unanimous vote that the Pfizer and Moderna COVID-19 vaccines be sanctioned for preschoolers. While the blessing sets up the Comirnaty and Spikevax vaccines for long-awaited authorizations, questions remain about how effective the shots will be given the rapidly evolving virus. Story
UPDATED: Wednesday, June 15 at 11:10 a.m. ET
Pfizer has nixed enrollment in the EPIC-SR study evaluating its oral antiviral Paxlovid in standard-risk patients, the company said Tuesday. The clinical trial previously missed its primary goal, showing Pfizer’s med was no better than placebo at sustaining symptom relief for four consecutive days. Now, the New York-based Big Pharma is axing the study after finding it hard to read any sign of potential benefit, which it credited to an already low rate of hospitalization or death in the standard-risk population. Pfizer stressed that it “will continue to evaluate treatment in populations with high unmet need.” Story
Speaking of Pfizer, a variant-adapted version of the company’s BioNTech-partnered mRNA shot Comirnaty is now part of a rolling regulatory review in Europe, the European Medicines Agency said Wednesday. To start, the review will home in on chemistry, manufacturing and controls (CMC) tied to the shot’s production. Under the rolling review, Pfizer will supply the EU regulator with more data as they become available, including immune response results and data on the adapted shot’s efficacy against Omicron subvariants, EMA said. “The rolling review will continue until there is enough data for a formal application,” the regulator added.
Elsewhere on the mRNA front, an FDA advisory committee unanimously backed the U.S. agency’s authorization of Moderna’s COVID-19 vaccine Spikevax for children and teenagers between the ages of 6 and 17. The committee of outside experts is set to meet Wednesday to weigh the shot for children younger than 6, too, Reuters reports. At the same time, the experts will consider whether to recommend Pfizer and BioNTech’s shot for children under 5 and as young as 6 months.
UPDATED: Tuesday, June 14 at 10:04 a.m. ET
The CDC found that Moderna’s COVID-19 vaccine, Spikevax, may lead to a higher risk of heart inflammation in certain age groups than Pfizer/BioNTech’s shot, Comirnaty. According to data from the Vaccine Safety Datalink, heart inflammation stands at a rate of 97.3 cases per million doses for Moderna’s vaccine in males aged 18-39, while for Pfizer’s jab, the rate was 81.7 per million doses, Reuters reports.
Governments in the European Union are putting pressure on Pfizer and other vaccine makers to renegotiate COVID-19 vaccine contracts to mitigate the impact of unneeded supply. The matter is being discussed today at an EU health minister meeting in Luxembourg. Poland, a country with over 30 million vaccines in stock, is leading the charge to revise contracts. An anonymous EU official told Reuters that the countries would likely lose any further legal case to edit the contracts. Story.
Health expert Professor Jung Ki-seok of the Department of Pulmonology at Hallym University Sacred Heart Hospital strongly recommended using pneumococcal vaccines to battle COVID-19 and long COVID. Professor Jung cites research finding that secondary infection with pneumococcus increases after respiratory viral infection. He said that Korea needs to consider pneumococcal vaccination, much like the CDC, the Netherlands and Spain have.
UPDATED: Monday, June 13 at 10:20 a.m. ET
Valneva is hoping to keep its supply deal with the European Commission on the books, but there doesn't seem to be much interest from member states. In a Monday statement, the company said "unofficial volume indications" don't appear to be "sufficient to ensure the sustainability of Valneva’s COVID-19 vaccine program." The vaccine is under regulatory review in Europe with a vote expected next week.
Vaccine giants Sanofi and GSK missed out on the initial COVID-19 vaccination market, but now they're angling for a piece of the booster pie. In data released Monday, the partners said their beta-specific vaccine can induce a stronger response against the omicron variant than their first-generation products can. Story
In Australia, Novavax's Nuvaxovid has been authorized as a booster for adults regardless of their COVID-19 vaccine history. The company is still awaiting a potential U.S. authorization.
UPDATED: Friday, June 10 at 10:39 a.m. ET
The European Medicines Agency (EMA) published a list of critical medicines to fight the COVID-19 pandemic, Korea Biomedical Review reports. The list includes five vaccines and nine EU-approved treatments. Companies whose products made the list include Pfizer/BioNTech, Roche, Johnson & Johnson, Novavax, Sobi, AstraZeneca, Gilead, Moderna, Pfizer, GSK, and Korea’s Celltrion. The EMA asked that marketing authorization holders of these drugs regularly update the agency with relevant information, includes shortage data and forecasts of supply and demand.
Having diabetes may increase the risk of contracting long COVID-19, according to seven studies presented at the annual American Diabetes Association’s Scientific Sessions (ADA 2022). Three studies showed that people with diabetes were up to four times more likely to develop long COVID-19 compared to those without it, Reuters reports. While the findings are preliminary, researchers said that diabetes appears to be a “potent risk factor” for the long-term condition. More studies are needed to determine the risk factor of diabetes.
The Biden administration will not require pre-departure COVID-19 tests for international air travel, a senior administration official told Reuters. The source cited science and data saying that the requirement is no longer necessary. The administration will reassess the decision in 90 days.
UPDATED: Thursday, June 9 at 9:10 a.m. ET
Ahead of a potential COVID vaccine authorization for kids younger than 5 years later this month, the White House said pharmacies have already ordered millions of doses, The Associated Press reports. There are about 19 million youngsters under 5 who would be eligible pending an FDA authorization later this month, but AP notes it's not immediately clear how popular the vaccinations will be in the age group.
Even after Novavax scored an FDA committee's endorsement for its vaccine, manufacturing problems could trigger another delay, CNBC reports. An FDA spokesperson said the agency still need to review manufacturing changes proposed by the company last week.
A few months after revealing its plan to make BioNTainers for local mRNA production in Africa, BioNTech says it plans to start production on one of the modular factories in Rwanda later this month.
A day after touting positive new data for Evusheld, AstraZeneca is asking authorities in Japan for regulatory clearance there.
UPDATED: Wednesday, June 8 at 11:10 a.m. ET
In a phase 2/3 trial, Moderna's bivalent COVID booster candidate, mRNA-1273.214, bested the company's original Spikevax in generating a neutralizing antibody response against omicron. The company is planning a regulatory submission in time to meet the fall booster season. Story
AstraZeneca's Evusheld significantly reduced progression to severe COVID-19 or death from any cause compared to placebo in a phase 3 trial. In the trial, investigators tested the drug in non-hospitalized adults with mild-to-moderate COVID-19 who had been symptomatic for one week or less. Among participants, 90% were at a high risk of progression to severe disease.
In the new real-world data from South Africa, a health and life insurer says Pfizer's vaccine provided strong protection against hospitalization from the omicron sub-lineagues BA.4 and BA.5, Bloomberg reports.
UPDATED: Tuesday, June 7 at 10:36 a.m. ET
AstraZeneca’s CEO Pascal Soriot told The BBC that the company “wouldn’t do anything differently” in its push to develop a COVID vaccine. The vaccine is linked with slightly increased risk of some bleeding disorders and is yet to be approved in the U.S. Soriot said that “despite the setbacks, we delivered three billion doses [of the vaccine] and saved a million lives.”
New data from Merck and Ridgeback Biotherapeutics’ phase 3 trial testing Lagevrio, an oral antiviral to treat mild-to-moderate COVID-19 in adults who are at high risk of progressing to severe infection, shows patients treated with the drug had an earlier hospital discharge time of nine days compared with the placebo group’s median time of 12 days. Patients who received Lagevrio also required fewer respiratory interventions than the placebo group.
Veru submitted an emergency use authorization application to the FDA for its oral treatment for patients with moderate to severe COVID-19 at a high risk of developing acute respiratory distress syndrome. The submission follows positive results from a phase 3 clinical trial in which the drug showed a 55.2% reduction in death in hospitalized patients. The company is now scaling up manufacturing of the capsules and is seeking approvals with regulatory agencies around the world.
UPDATED: Monday, June 6 at 11:50 a.m. ET
The FDA raised concerns about a possible risk of heart inflammation from Novavax’s COVID-19 vaccine. In response, the company said that “natural background events of myocarditis can be expected in any sufficiently large database.” Four cases of heart inflammation were tracked within 20 days of taking the shot in a trial consisting of nearly 30,000 patients. The FDA asked the company to flag heart inflammation as an “identified important risk” in its materials, which it has not yet agreed to do, Reuters reports.
Contract manufacturer Emergent BioSolutions said Johnson & Johnson breached an agreement between the two by failing to buy the minimum quantity of COVID-19 vaccines. In an SEC filing, Emergent said that J&J failed to provide required forecasts for the amount of vaccines it needed and that instead of fulfilling minimum requirements, the company wound down the agreement. If the deal gets terminated, the manufacturer will owe J&J roughly $125 to $420 million.
The Western U.S. region has surpassed the Northeast for the nation’s highest case rates. In California, 13 counties have high case levels, and the CDC recommends people living in these areas wear masks in public settings. The number of cases across the country stands at about 100,000 a day, which is about four times the level the country was at two months ago. Epidemiologists say this number is understated, as most people use at-home tests that aren’t usually tracked. Counties in New York City and Boston have seen lower case numbers recently, as well as less deaths and hospitalizations. Hospitalizations nationwide have remained at historically low levels, The Wall Street Journal reports.
UPDATED: Friday, June 3 at 9:11 a.m. ET
If COVID vaccines are approved for children younger than 5 years old, the first doses could go into arms as early as June 21, The New York Times reports, citing comments from Ashish Jha, President Joe Biden’s coronavirus response coordinator. Pfizer and BioNTech this week asked the FDA to approve a third dose of their mRNA shot Comirnaty in younger kids. At the same time, FDA is evaluating a request to authorize two doses of Moderna’s vaccine for children younger than 6.
Pfizer’s Paxlovid curbed the risk of hospitalization and death in both vaccinated and unvaccinated COVID patients ages 65 and older, The Globe and Mail reports, citing a new study out of Israel. Despite that win in older adults, Pfizer’s antiviral pill failed to prevent severe illness in younger adults, research from Israel’s Clalit Health Services shows. The study looked at data from nearly 110,000 participants between Jan. 9 and March 10, when the omicron variant was raging in Israel.
While lingering questions over Paxlovid remain, use of the antiviral has soared in the U.S., with more than 1 million courses administered as of June 1, The Washington Post said. Roughly one-third of those courses have been prescribed since May 17. Still, studies to help determine which patients benefit most from the drug are progressing at a crawl, forcing U.S. regulators to rely on other countries for data on the drug’s effectiveness in the real world, The Post explained.
Novavax’s long-awaited—and often delayed—COVID-19 vaccine reduces the risk of mild-to-severe disease and could likely offer some level of protection against omicron, Reuters reports, citing comments made by the U.S. Food and Drug Administration Friday. Novavax’s 30,000-patient study, which enrolled adults in Mexico and the U.S., showed its vaccine had an efficacy of about 90%.
COVID-19 variants are behind some 460,000 U.S. deaths since the start of the pandemic, a new preprint study from the Yale School of Public Health and Public Citizen contends. In total, more than 40% of COVID-19 deaths were caused by three variants that first surfaced outside the States: Those are alpha, delta and omicron. Greater efforts are needed to stem the tide of coronavirus variants, the study argues. Productive measures might include global COVID-19 vaccination, treatment, and outbreak mitigation.
UPDATED: Thursday, June 2 at 11:15 a.m. ET
Pfizer and BioNTech Wednesday put in their bid with the FDA to authorize three doses of their mRNA shot Comirnaty for children younger than 5. The partners recently revealed that three doses of their shot were 80% effective at preventing symptomatic COVID and spurred a robust immune response in children between the ages of 6 months to five years old, The Wall Street Journal reports. The FDA could give Pfizer’s booster the thumbs up in young kids before the end of the month. At the same time, the regulator is evaluating a request to authorize two doses of Moderna’s vaccine for children younger than 6.
Speaking of Pfizer, the Big Pharma will soon have a new head of vaccine R&D in Annaliesa Anderson, Ph.D., who’s picking up the torch from Kathrin Jansen, Ph.D., on Aug. 1. Anderson’s official title will be senior vice president and head of Pfizer’s vaccine research and development organization, Pfizer said in a release. Anderson joined Pfizer by way of Wyeth back in 2007. Most recently, she served as VP and chief scientific officer for bacterial research and hospital within Pfizer’s vaccine R&D unit.
Elsewhere on the mRNA front, Moderna has tweaked its vaccine delivery schedule with Europe to push supplies into late 2022 or early 2023, following a similar move from Pfizer and BioNTech. Now, doses that were originally due to arrive in the second quarter can be delivered “later in calendar year 2022 or early calendar year 2023,” Moderna said in a release, adding that European Union member states would have the option to receive supplies in the form of an updated bivalent booster shot, assuming it passes muster with the bloc’s drug regulator.
Despite North Korea's claims, COVID-19 is likely getting worse—not better—in the country, Reuters reports, citing the World Health Organization. North Korean state media, for their part, says the country’s COVID situation is now under control after daily numbers of people with fevers topped 390,000 about to weeks ago, Reuters explained. The country has never directly confirmed how many people have tested positive for the virus, prompting fears of underreporting. "We have real issues in getting access to the raw data and to the actual situation on the ground," WHO emergencies chief Michael Ryan said in an interview with Reuters.
UPDATED: Wednesday, June 1 at 10:57 a.m. ET
After Takeda helped Moderna reach the Japan market with its COVID-19 vaccine, the Japanese pharma will transfer marketing rights to the mRNA specialist at the start of August. In a statement, Moderna CEO Stéphane Bancel said his company is "happy to take this important step as we continue to build and strengthen our own commercial organisation in Japan, and we look forward to continuing our partnership with Takeda in 2022." Takeda will continue to provide help with distribution during a transition period.
After a spike in uptake for Pfizer's Paxlovid, some doctors are reconsidering prescribing the drug for low-risk patients after the CDC on Tuesday issued guidance that users should isolate for 5 days if symptoms return following the initial antiviral course.
UPDATED: Tuesday, May 31 at 12:04 p.m. ET
Patients who recover from COVID-19 after a course of Pfizer's antiviral Paxlovid might see their symptoms return or test positive again even after testing negative. COVID-19 rebounds have occurred 2 to 8 days after initial recovery, the CDC says. No Paxlovid rebound cases have resulted in severe disease, according to case reports. There is currently “no evidence that additional treatment is needed with Paxlovid” or other COVID-19 therapies for rebound cases, the agency said, but it does recommend patients re-isolate for at least five days.
Clover Biopharmaceuticals said Tuesday that it has dosed the first participants in a Phase 1 trial of its COVID-19 vaccine. The vaccine will include protection for the omicron variant, along with other mutations. Initial data from the trial is expected to come in the second half of 2022.
As each COVID-19 wave comes about, more people face reinfection. While experts doubt reinfection several times a year will be the norm, some, like epidemiologist Aubree Gordon, predicts reinfection “every three years or so,” the Atlantic reports. Post-vaccination and second infections are “significantly less severe,” as are third and fourth infections.
UPDATED: Friday, May 27 at 1:55 p.m. ET
Moderna CEO Stéphane Bancel, worth about $4.1 billion, will eventually donate most of the fortune he’s amassed thanks to his company’s massively successful COVID-19 vaccine. In an interview with Bloomberg, Bancel said he’s told his kids they’ll get a good education and the family home, “but the rest we’re going to give away.” Earlier this week, Bancel said he’d give about $355 million to charity by executing his first Moderna stock options and donating the proceeds. Story
Speaking of Moderna, Switzerland will destroy more than 620,000 expired doses of the biotech’s mRNA shot, Spikevax, Swiss broadcaster RTS first reported (French). The move will cost one franc, or about $1.05, per kilogram, Swiss news outlet SwissInfo added. At the World Economic Forum in Davos, meanwhile, CEO Bancel said he’s in the process of discarding 30 million doses, citing a “big demand problem,” as quoted by Endpoints News.
As booster uptake remains low in the U.S., the nonprofit patient safety group ECRI is calling on officials to establish a regular COVID-19 booster schedule. Only 30% of eligible Americans have received a booster, the group says. ECRI president and CEO Marcus Schabacker, M.D., Ph.D., said in a statement that a published schedule would help "increase clarity and confidence" around when people should get their booster.
As COVID-19 cases again climb in the U.S., White House officials are putting their efforts behind Pfizer's antiviral Paxlovid. The FDA and others are looking into addressing potential barriers for access to the medicine, The New York Times reports.
UPDATED: Thursday, May 26 at 11:20 a.m. ET
Novavax’s protein-based COVID shot is finally homing in on a U.S. authorization. As for who might use the vaccine, Novavax is targeting the tens of millions of Americans who aren’t yet vaccinated or would benefit from boosters, but who have avoided mRNA shots thanks to health concerns or conspiracy theories, KHN reports. “I do think there is a minority group who would take a protein vaccine over an mRNA vaccine,” Kathleen Neuzil, director of the Center for Vaccine Development and Global Health at the university of Maryland, told the publication. Neuzil was also a researcher in Novavax’s phase 3 study in Mexico and the U.S.
Use of Pfizer’s antiviral Paxlovid has surpassed other COVID therapeutics in the U.S., new data from the U.S. Department of Health and Human Services (HHS) show. More than 162,000 Paxlovid courses were administered across the country over the last week. Comparatively, just 20,000 courses of Merck & Co. and Ridgeback Biotherapeutics’ molnupiravir were used during that same period. For AstraZeneca’s Evusheld, around 16,000 courses of the antibody therapy were administered in the last seven days. As of May 24, meanwhile, more than 831,000 Paxlovid courses had been used by people living in the U.S. Story
Meanwhile, patients whose COVID-19 symptoms crop back up after completing their Paxlovid treatment course should re-isolate for five days, the U.S. Centers for Disease Control and Prevention said this week. The recommendation follows reports of rebounding COVID symptoms after receiving Paxlovid, which Pfizer suggests is rare. CDC itself noted that reports suggest mild symptoms can reappear after taking the antiviral, but there have been no reports of severe disease so far.
Tedros Adhanom Ghebreyesus, who’s helmed the World Health Organization throughout the COVID-19 pandemic, has been re-elected as the organization’s Director General for another five years, Reuters reports. The vote was largely a formality, as the incumbent Director-General was the only candidate running.
UPDATED: Wednesday, May 25 at 11:20 a.m. ET
In a familiar argument, Moderna told a Delaware court that it should be insulated from patent infringement charges from Alnylam because it supplied COVID vaccines to the government. In a different case earlier this month—where it faces the same infringement allegation from Arbutus Biopharma and Genevant Sciences—Moderna brought the same argument. That case has yet to be decided.
Pfizer CEO Albert Bourla said that the world will have to contend with “constant waves” of COVID-19 largely because of “complacency” about the threat of the virus. “When I discuss (COVID) with my friends, people are ready to compromise and lower the bar," Bourla told The Financial Times. “Maybe we can accept a few more old people dying, than have to work with a mask.”
UPDATED: Tuesday, May 24 at 11:27 a.m. ET
An FDA advisory committee will review filings for Moderna and Pfizer vaccines in young children on June 14 and 15, the agency said Monday. Moderna’s request for use in children ages 6 to 17 will take center stage on June 14. Then, the requests for use in younger children will feature on June 15.
Meanwhile, Germany’s vaccine advisory panel, STIKO, said one vaccine was enough for healthy 5-year-old to 11-year-old children, as most have already been infected. The panel added that children at risk of developing severe COVID-19 should get three shots and those who live with an at-risk person should get two, Reuters reports.
A small study suggests that the omicron variant does not have a negative effect on cardiovascular health in vaccinated young adults, contrary to earlier variants. Researchers compared 23 young adults with omicron with 13 who had never been infected and found no differences in any cardiovascular health parameters. The findings, published in the American Journal of Physiology- Heart and Circulatory Physiology, show that not all variants may be “detrimental to cardiovascular health in young, otherwise healthy adults,” the researchers said, but follow up studies will be needed to determine long-term outcomes.
UPDATED: Monday, May 23 at 10:00 a.m. ET
AstraZeneca snagged approval for a booster dose of its viral vector vaccine in the European Union. Under the green light, Vaxzevria can now be given as a third dose to patients who’ve completed their primary vaccination course with AZ’s shot or an mRNA vaccine.
Speaking of boosters, a third dose of Pfizer and BioNTech’s mRNA shot Comirnaty triggered a strong immune response in young kids, topline data from a phase 2/3 trial showed. Vaccine efficacy, which was a secondary endpoint in the study, clocked in at 80.3% in children 6 months to under 5 years old, Pfizer said Monday. The company based its descriptive analysis on 10 symptomatic COVID-19 cases ID’d after participants had received their third dose. A formal analysis will follow once at least 21 cases have cropped up. Final efficacy data will be shared once available, Pfizer said.
Cepheid has bagged an FDA emergency nod for a new-and-improved version of its rapid molecular test for COVID-19. The Xpert Xpress CoV-2plus diagnostic includes a third genetic target for SARS-CoV-2 and is designed to detect current and future viral mutations, the company said in a release. Cepheid plans to start rolling out the “plus” version of its test to U.S. customers this month.
The FDA has lifted the clinical hold on Ocugen’s phase 2/3 study of Bharat Biotech’s COVID-19 vaccine Covaxin, which is approved in India and boasts emergency nods in 25 countries. Last month, the FDA clamped down on Ocugen and Bharat’s immuno-bridging study amid manufacturing concerns from the World Health Organization. WHO on April 2 suspended supply of Covaxin after a March walkthrough of Bharat facilities uncovered production shortfalls.
UPDATED: Friday, May 20 at 11:30 a.m. ET
The White House canceled a vaccine supply contract with AstraZeneca in December, Stat reports. The U.S. government originally signed for 300 million doses of the shot but eventually only paid for 70 million. AZ had previously decided not to file the adenovirus vector vaccine, known as Vaxzevira, for an emergency use authorization with the FDA.
Meanwhile, European regulators have endorsed the AstraZeneca shot as a booster for adults who have been previously vaccinated by Vaxzevria or an mRNA vaccine, Reuters reports. About half of all EU citizens are fully vaccinated and boosted, Marco Cavaleri, EMA's head of biological health threats and vaccines strategy, said on May 5.
Following FDA go-aheads, the CDC Thursday recommended that children ages 5 to 11 receive mRNA shots from Pfizer-BioNTech or Moderna as a booster. It follows a vote of 11-1 in favor of the decision by the gency’s Advisory Committee on Immunization Practices. The booster is given five months after the primary series. However, only 29% of U.S. children in the age group have acutllay been fully vaccinated, The Wall Street Journal reports.
China's CanSino Biologics has received World Health Organization Emergency Use Listing for its adenovirus vector vaccine, Convidecia. Besides approvals in multiple countries as a pimary immunization regimen, the shot is also allowed as a heterologous booster vaccine in China, Argentina, Malaysia and Indonesia.
A recent WHO report suggests the world still needs to improve its approach to pandemics, The New York Times reports. In the new report, the Independent Panel for Pandemic Preparedness and Response said nothing much had really changed for political leadership, financing and surveillance systems. It also noted vaccine inequity as a major weak link in pandemic preparedness.
UPDATED: Thursday, May 19 at 10:52 a.m. ET
COVID-19 antiviral usage is increasing along with case numbers. Pfizer’s Paxlovid saw a whopping a 315% increase in use over the past month, according to U.S. health officials. Prescriptions for Merck’s Lagevrio grew 200% in the same time frame. The products are available at more than 50,000 locations across the country, and more than 88% of Americans live within five miles of an active oral antiviral dispensing site.
Scientific advisors to the Centers of Disease Control and Prevention will meet today to debate a recommendation for a Pfizer-BioNTech booster in the 5 to 11 age group, The New York Times reports. The shot recently gained FDA authorization for the age group, and CDC advisors are expected to give it their nod of approval. Studies have shown that two doses provide virtually no barrier against omicron variant infection in children aged 5 to 11, so the extra jab might boost immunity.
An observational study in the U.K. shows evidence that COVID-19 vaccinations can decrease a patient's likelihood of contracting long COVID. Researchers found that before vaccines were rolled out, the chances of contracting long COVID were constant after infection. The chances fell 13% after the first dose and an additional 9% after the second, the team found. The study, published in the British Medical Journal, says causality cannot be inferred but that “vaccination may contribute to a reduction in the population health burden of long COVID.” More data is needed to determine if vaccination can be considered a treatment for the condition, Pharmaphorum reports.
UPDATED: Wednesday, May 18 at 11:00 a.m. ET
Supplies of Eli Lilly’s monoclonal antibody bebtelovimab and AstraZeneca’s long-acting antibody combo Evusheld could dry up in the U.S. as early as this summer and fall, respectively, an anonymous Biden administration official told Bloomberg. Supplies of Pfizer’s antiviral pill Paxlovid, meanwhile, will last through the fall, but the government will need to purchase additional courses after that, the official said. The potential therapeutic shortfall comes as the feds gear up to extend the public health emergency that enables authorization and use of drugs and vaccines like Pfizer’s. The Biden administration has also been wrangling Congress to secure more pandemic response funds.
Speaking of Pfizer, the company’s tight grasp on Paxlovid supplies has prompted some researchers and advocacy groups to report they can’t get the med for studies that could maintain or improve its effectiveness and expand use, Bloomberg said. Pfizer, for its part, hasn’t started any combination trials in people, and the clinicaltrials.gov database lists no outpatient studies pairing Paxlovid with other antivirals or antibodies, Bloomberg noted. Pfizer is considering combinations, despite the fact that no such studies are currently underway, a Pfizer spokesperson told the news outlet.
The lack of demand for Aspen’s branded version of J&J’s COVID shot in Africa—where just 15.9% of the continent’s 1.2 billion population has completed a coronavirus vaccination course—sends an “incredibly bad message,” Stavros Nicolaou, Aspen’s head of strategic trade, told Bloomberg. “There were a lot of calls both from the West and from Africa that the best way to try and solve the problem was to establish our own local vaccine production capacity,” the executive said. Aspen inked a deal to help make J&J’s vaccine candidate back in the fall of 2020. In March, meanwhile, Aspen clinched a licensing deal to take over pricing and distribution in Africa, too. Story
An oral antiviral being developed by Junshi Biosciences and other Chinese institutes helped hasten the clearance of virus in COVID-19 patients in a small clinical trial, Reuters reports. The med, dubbed VV116, is a derivative of Gilead Science’s Veklury, also known as remdesivir, and it was approved for use in moderate to severe disease in Uzbekistan last year. The trial shedding period, or the duration between a first positive COVID test result and the first negative result, was 8.56 days for participants who received VV116, versus the 11.13 days seen in the control cohort.
UPDATED: Tuesday, May 17 at 10:41 a.m. ET
The FDA authorized a single Pfizer-BioNTech booster shot for children ages 5 to 11. The agency concluded that the known and potential benefits of the booster at least five months after recieving the primary vaccination series outweigh the known and potential risks. However, the age group has the lowest vaccination rate and experts are not expecting a rush to line up for the shot, The New York Times reports.
The FDA declined a request to authorize fluvoxamine maleate for emergency use as an outpatient treatment for COVID-19. The medicine is an inexpensive generic antidepressant and an obsessive-compulsive disorder medication. The agency said there was insufficient data showing that the medicine may be effective in the treatment of non-hospitalized patients with COVID-19 to prevent progression to severe disease, Infectious Disease News reports.
The death count from the pandemic has reached 1 million in the U.S., with at least 90% listing COVID-19 as the underlying cause of death. The remaining 10% list the virus as a contributing cause. Epidemiologists say the true death count is likely higher, The Wall Street Journal reports.
AstraZeneca acquired worldwide licenses from RQ Biotechnology for a suite of early-stage antibodies targeting COVID-19 in a $157 million deal. RQ Biotechnology is a UK-based startup with roots at the University of Oxford. Story
UPDATED: Monday, May 16 at 11:25 a.m. ET
Pfizer and BioNTech are pushing back vaccine deliveries to the EU scheduled for June through August by three months. The extra time will allow for potential variant-adapted shots to secure authorization and be included in the EU’s vaccine package. The doses will now arrive in the EU in September and continue deliveries through the fourth quarter of 2022. Story.
Switzerland's drug regulator Swissmedic authorized the use of Moderna’s COVID-19 vaccine for children aged 6 through 11 years old, Reuters reported. The approval covers the vaccine’s two dose series of 50 micrograms per dose.
If COVAX decides to provide North Korea with U.S.-made Pfizer vaccines, the US will support the effort, Korean Broadcasting System reports. The State Department said it is concerned about the outbreak in North Korea and strongly encourages efforts by the U.S. and international aid and health organizations to prevent the spread of the virus. It urged North Korea to work with the international community to vaccine its population.
UPDATED: Friday, May 13 at 11:15 a.m. ET
Generic versions of COVID-19 oral antiviral Paxlovid will be available in poor countries for less than $25 for a five-day course, according to the Clinton Health Access Initiative. The price compares favorably to the $530 Pfizer charges the United States. The CHAI did not disclose which manufacturers had agreed to the price ceiling.
The coronavirus is surging in North Korea, leaving six dead and 187,000 in quarantine, the state media said. The rare admission came from the country after it refused to recognize the virus as a threat and turned down humanitarian aid.
UPDATED: Thursday, May 12 at 10:03 a.m. ET
Moderna’s COVID-19 vaccine elicits a strong immune response in children aged 6 to 11, the New York Times reported. The trial resulted in high antibody levels in children who received the vaccine, slightly higher than those observed in young adults. The vaccine was estimated to have an efficacy of 88% against infections. Regulatory agencies in Canada and Australia have already approved the jab for the age group. Currently in the US, one in four out of the 28 million children aged 5 to 11 have received vaccines.
Pfizer and BioNTech’s COVID-19 vaccine production in Cape Town might be scaled back due to low demand, the head of the South African manufacturing partner said. 100 million doses are supposed to be filled at the plant, which would be the first in the Southern Hemisphere to use the messenger RNA technology. Demand is falling globally. Aspen Pharmacare, Africa’s biggest drugmaker, said it may close a line to make J&J’s vaccine in South Africa due to lack of orders. Story.
The U.S. helped raise over $3.1 billion in commitments to global pandemic response for the second global COVID-19 summit, Reuters reports. The virtual summit will be jointly hosted by the U.S., Belize, Germany, Indonesia and Senegal and will build on efforts made at the first summit in September. Congress is still being urged to provide more funding for the COVID-19 response. President Biden’s Congress ask for over $22.5 billion has not been passed.
UPDATED: Wednesday, May 11 at 11:35 a.m. ET
Existing COVID vaccines appear to require regular boosters, which can become cumbersome from a compliance perspective. "People will be less inclined to follow religiously the required [vaccine] recommendations," Pfizer CEO Albert Bourla said during Fortune’s Brainstorm Health conference on Tuesday. That why a vaccine that will last at least a year "is the holy grail right now," he said, adding that Pfizer is "very intensively researching this."
The CDC has squeezed in a new ACIP meeting, to be held on May 19. The meeting will discuss "the use of COVID-19 vaccines," and a recommendation vote is scheduled. Although the exact topic remains unclear, it could be about immunization of children 5 to 11 years of age after recent FDA go-aheads for mRNA shots. Federal Register post
During a manufacturing hiccup in 2021, CDMO Emergent BioSolutions tossed vaccine materials equivalent to nearly 400 million doses, according to a report from the House of Representatives' Select Subcommittee on the Coronavirus Crisis. That's way more than the 85 million doses the company and U.S. officials previously disclosed. Story
The FDA has granted a full approval to Eli Lilly and Incyte’s Olumiant for hospitalized COVID-19 patents,18 months after endorsing its combination with Gilead Sciences' Veklury in an emergency use authorization. Story
The FDA has agreed that Veru can file for an emrgency use authorization for sabizabulin in hospitalized COVID patients at high risk for acute respiratory distress syndrome based on its existing phase 3 data, the company said Wednesday. Veru said it now plans to file for an EUA by June.
The Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $19.3 million to support the development of a "variant-proof" COVID vaccine candidate. The money will go to India's Bharat Biotech, the University of Syndney and Switzerland's ExcellGene and will cover activities including immunogen design, preclinical studies, manufacturing process development and a phase 1 clinical trial.
UPDATED: Tuesday, May 10 at 10:10 a.m. ET
A third Pfizer-BioNTech jab significantly improved protection from infection, a new study by researchers at Sheba Medical Center and Tel Aviv University found. For the study, 12,290 healthcare workers who received the first two shots and hadn't been infected with COVID-19 were pooled in the study, The Jerusalem Post reports. Of them, just 407 of participants (3.3%) tested positive. While their increase in antibodies was relatively small, a six-fold increase in neutralizing antibody titers was recorded compared to the second vaccine dose.
BioNTech has completed a Phase 2 clinical trial of its COVID-19 vaccine in China but has yet to release results, a trial registry showed. The trial began in late 2020 and ended in January, according to a database managed by an agency under the US National Institutes of Health. The vaccine has yet to receive an approval in China, Reuters reports.
Norwegian health authorities said the country has a surplus of COVID-19 vaccines and has already discarded over 137,000 doses due to declining demand in low-income countries, The Associated Press reports. The country’s high vaccination rate combined with falling global demand for donations prompted the country’s Institute of Public Health to say it plans a further disposal if global demand does not change.
UPDATED: Monday, May 9 at 11:03 a.m. ET
Big COVID-19 vaccine makers are planning for a smaller, more competitive booster shot market as opposed to the mad rush to deliver initial doses, Reuters reports. Both Moderna and Pfizer will be focusing on the booster market as they believe most people who wanted a COVID-19 vaccine are in the more than 5 billion people that have already received the vaccine. Another promising market for the upcoming year, along with boosters, is vaccines for children, which are gaining regulatory approvals worldwide, the companies said. Pfizer and Moderna still will have a large piece of the pie, while AstraZeneca and Johnson & Johnson’s shots are expected to decline in popularity in the future market, Reuters reports.
FDA vaccine official Peter Marks told a congressional committee on Friday that children’s COVID-19 vaccines do not need to meet the same 50% threshold for efficacy required of adult vaccines for authorization. Marks told the House select subcommittee on the COVID-19 crisis that all COVID-19 vaccines currently authorized in the U.S. have “lost significant amounts of efficacy due to the omicron variant,” but remain effective at preventing severe disease, hospitalization and death, Endpoint News reports.
UPDATED: Friday, May 6 at 11:00 a.m. ET
U.S. researchers want to conduct clinical trials testing Pfizer’s Paxlovid for its ability to treat long COVID, an ailment as many as 30% of people who catch an infection develop. Researchers at the University of California, San Francisco, published a report detailing cases of three patients with long term symptoms who took the drug. The cases “provide evidence that we really need to study this soon and systematically, which means randomized trials,” said Dr. Michael Peluso in a Reuters report.
The FDA restricted the use of Johnson & Johnson’s COVID-19 vaccine due to the threat of rare but serious blood clots. Now, the only people who have access to the shot are those 18 years and older who cannot access other vaccines and those who would “elect to receive the Janssen COVID-19 vaccine because they would otherwise not receive a COVID-19 vaccine.” The vaccine was paused last year and resumed after the agency maintained that the benefits of the shot outweighed the risk, Fierce Pharma reports.
The European Union hopes to have variant adapted vaccines approved by September. Pfizer/BioNTech and Moderna’s mRNA vaccines are the furthest along with ongoing clinical trials. Moderna is working on a potential next generation booster targeting the omicron variant as well as the original strain and expects first trial data in June. BioNTech and Pfizer expanded their original trial in late March to include a booster that targets both omicron and the original COVID-19 strain, according to a Reuters report.
Moderna and other vaccine companies are preparing for waning immunity to become a concern come fall. “We are not done with this virus mutating,” said Moderna CEO Stéphane Bancel to Yahoo Finance. A new booster is needed, but the US is waiting on funding and for the FDA to determine which virus strain to target with boosters. Bancel said the biggest risk in the fall is the potential for hospitals to fill up again.
UPDATED: Thursday, May 5 at 10:00 a.m. ET
Medicago said phase 3 study results for of Covifenz, its COVID-19 vaccine featuring plant-based virus-like particles, were published in the New England Journal of Medicine. The two-dose regimen was authorized for use by Health Canada in February, making it the first authorized vaccine developed by a Canadian based company and the first that uses plant-based proteins.
A large study testing vaccination data and healthcare records in Massachusetts found that the risk of hospitalization and death are “nearly identical” between the omicron variant and other previously dominant COVID-19 variants.
Amid its COVID-19 lockdowns, China will launch support measures to help firms and stabilize employment, Reuters reported. The country’s economy slowed in this year’s second quarter due to a record number of COVID-19 cases and the subsequent lockdowns. The unemployment rate hit 58% in March.
UPDATED: Wednesday, May 4 at 11:20 a.m. ET
On its earnings call Wednesday, mRNA hotshot Moderna talked up the need for COVID vaccine boosters ahead of a potential shift to a private market this fall. “The slowing of booster uptake now means there will be individuals who are under-vaccinated and under-protected as we move into late spring and summer, when we thought we would have declining case counts,” Paul Burton, M.D., Ph.D., Moderna’s chief medical officer, told investors. Considering COVID-19’s infectious potential, the biotech is arguing for a “variant adapted booster campaign this fall,” its top scientist added. Burton’s comments came as Moderna posted $6.1 billion in first quarter revenues. Of that sum, sales of the company’s COVID shot Spikevax contributed $5.9 billion. Story
Regeneron recorded no sales of its COVID-19 antibody cocktail REGEN-COV in 2022’s first quarter—which was to be expected after the FDA in January revised its Emergency Use Authorization for the med to halt use in patients infected by omicron. “If, in the future, patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to REGEN-COV, then the limitation on use may be revised,” the company pointed out in an earnings release. Regeneron’s first quarter revenues increased 17% to $2.97 billion. Taking Regen-COV out of the mix, revenues increased 25%.
COVID-19 restrictions are tightening in Beijing, China, The New York Times reports. At the same time, the capital is aiming to avoid a full-scale lockdown like the one imposed in Shanghai. Beijing Tuesday ordered indoor museum exhibits to close, while commuters entering and exiting the city are now required to show proof of a negative coronavirus test within the past 48 hours. Or, commuters can instead show a green health code on a government app China uses to track individuals’ COVID risk, The Times explained.
South Africa’s Aspen Pharmacare, which is helping package and sell Johnson & Johnson’s single-dose COVID shot and distribute it across Africa, may have to shut down its factory because of a dearth of orders, Aspen senior director Stavros Nicolaou told Reuters. "If we don't get any kind of vaccine orders, then clearly there'll be very little rationale for retaining the lines that we're currently using for production," he said, referring to Aspen’s COVID-19 vaccine plant in South Africa.
UPDATED: Tuesday, May 3 at 10:55 a.m. ET
Pfizer’s Paxlovid failed to prevent people living with COVID-19 patients from catching the virus. New data from a Phase 2/3 trial showed that the antiviral's protection for people who had household exposure to the virus only garnered 32% and 37% risk reduction in those who took the pill for five days and 10 days, respectively. These results are not statistically significant. “While we are disappointed in the outcome of this particular study, these results do not impact the strong efficacy and safety data we’ve observed in our earlier trial for the treatment of COVID-19 patients at high risk of developing severe illness,” said Pfzier CEO Albert Bourla.
1.1 million COVID-19 vaccines that are reaching expiration date in Denmark will be discarded in the coming weeks, Danish health officials say. Attempts to donate the excess vaccines to developing countries have failed, according to Al Jazeera. The country has a surplus of vaccines, with 81% of the country fully vaccinated and 62% having received a booster shot. 9 million doses have been donated but considering “declining demand and lack of rollout capacity and willingness to be vaccinated in developing countries,” it has been difficult to find recipient countries for the extra shots, said Denmark’s Statens Serum Institut.
New findings from the Proceedings of the National Academy of Sciences show that people with allergic asthma may “erect a shield” around vulnerable airway cells, explaining why people with allergic asthma appear to be less suspectable to COVID-19 than those with other lung ailments. A protein called interleukin-13 (IL-13) fights off parasites and has been shown to protect those with allergic asthma against COVID-19, according to ScienceNews. The study is still preliminary research, and there is “way more to go” according to pathophysiologist Camille Ehre, who conducted the study along with colleagues.
UPDATED: Monday, May 2 at 9:56 a.m. ET
In April, Poland’s health minister said Warsaw had informed Pfizer and the European Commission that it would no longer pay for or take COVID-19 vaccines under a supply contract co-negotiated by the EU due to the influx of Ukrainian refugees. At the time, the country acknowledged the legal conflict the move would raise. A European Commission official today told Reuters that the country has “no coherent rationale” to invoke the force majeure clause in its contract. “The war in Ukraine did nothing to change Poland’s vaccination needs,” said the official. “If anything, it now needs to vaccinate refugees.” Poland said the supply under the contract would cost the country over $1.4 billion U.S. dollars (6 billion zlotys) until 2023, Reuters reports.
Yale School of Medicine is launching a nationwide trial studying the effect of vaccinations on long COVID, The Mercury News reports. Researchers will use immune profiling techniques to evaluate participants' cellular reaction to the shots. Survivor Corps, a COVID-19 patient group, proposed the study to the Yale team because people with long COVID were not included in vaccine manufacturers’ trials. Another long COVID study is ongoing at the University of California in San Francisco, but not enough time has passed to yield results.
UPDATED: Friday, April 29 at 10:16 a.m. ET
SK bioscience and GlaxoSmithKline have submitted their SKYCovione to regulators in South Korea after the program met its coprimary objectives in a phase 3 trial. The shot is a recombinant protein-based COVID-19 vaccine candidate that incorporates GSK's pandemic adjuvant. The companies plan filings in several markets.
After several delays, Novavax's vaccine is set to be considered by a group of independent experts convened by the FDA. The agency plans to hold a meeting of its Vaccines and Related Biological Products Advisory Committee on June 7 to discuss the application.
AstraZeneca is seeing demand for its COVID-19 vaccine wane as supplies pile up, but CEO Pascal Soriot said Friday there's still a role for the program, Reuters reports. The shot is easy to administer and distribute, the CEO said, so it should remain in the pandemic toolkit.
After Oxfam pressed Pfizer and Moderna to share vaccine technology, 29% of independent Moderna shareholders and 27% of Pfizer investors voted in favor of studying such a move. While the proposals didn't pass, Oxfam celebrated that a "significant number" of investors supported its efforts.
UPDATED: Thursday, April 28 at 9:05 a.m. ET
Moderna started a emergency use authorization request for its vaccine in children six months old to under six years. Positive results from the company’s Phase 2/3 KidsCOVE study showed a “robust neutralizing antibody response” and a favorable safety profile, the company said. The submission will be complete next week.
Merck garnered $3.2 billion in first-quarter sales from its COVID-19 oral antiviral molnupiravir. The company splits profits evenly with partner Ridgeback Therapeutics. The revenue contributed to Merck’s 50% growth in pharmaceutical sales from 2021’s first quarter, totaling $14.1 billion.
The Chinese University of Hong Kong’s Clinical Trial Centre is collaborating with CUHK Medical Centre on a clinical trial to assess a new oral treatment for early COVID-19 treatment in patients with mild to moderate infection, BioSpectrum Asia reports. The study will enroll 2,000 subjects globally who recently tested positive for COVID-19 and will be Hong Kong’s first COVID-19 oral treatment trial.
UPDATED: Wednesday, April 27 at 10:55 a.m. ET
A booster shot for children aged 5 to 11 may be on the way if the FDA approves Pfizer and BioNTech’s authorization request. Yesterday, the companies submitted new data to the agency showing a low dose of their mRNA shot can protect children against omicron, NPR reports. Demand for the booster in the group is unclear as less than a third of children ages 5 to 11 have received the first two shots. Experts have mixed opinions on the topic.
The White House said doctors “shouldn’t think twice” about prescribing Paxlovid, ABC News reports. “Paxlovid will be widely available everywhere in America,” said Dr. Ashish Jha, the White House COVID-19 response coordinator. While the U.S. has ordered 20 million course, the administration warned that future deliveries are dependent on Congressional approval of additional COVID-19 funding. Kamala Harris, who tested positive for COVID-19 yesterday, was prescribed and took Paxlovid after consulting with her physician.
While China is weeks into a COVID-19 outbreak in Shanghai, mRNA vaccines are still unavailable in the country. In 2020, Shanghai Fosun Pharmaceutical Group agreed to market and distribute 100 million doses of Pfizer and BioNTech’s mRNA vaccine, yet the agreement has still not been greenlit by the government. Many analysts believe the delay is to give a local company time to develop an mRNA vaccine of its own, Bloomberg reports.
GlaxoSmithKline said its Vir Biotechnology-partnered antibody Xevudy generated £1.3 billion ($1.63 billion) in the first quarter of 2022. But the company warned of a slowdown throughout the rest of 2022.
UPDATED: Tuesday, April 26 at 10:02 a.m. ET
Amnesty International is urging investors to push COVID-19 vaccine manufacturers to universally supply their vaccines to ensure access around the globe. The organization is calling on investors ahead of Johnson & Johnson, Moderna, Pfizer and AstraZeneca’s annual meetings to vote in favor of shareholder proposals that would facilitate the universal distribution of vaccines. The World Health Organization (WHO) marked a global target of a 70% vaccination rate in every country by July 2022, which Amnesty International says is on course to be missed. Investors should ask the boards of COVID-19 vaccine companies what steps they are taking towards meeting the WHO vaccine target, Amnesty International said.
Experts are worried that boosters are increasingly being authorized without the evidence to prove they're necessary, Stat News reports. While the FDA approved second boosters for people 50 years and older, eligible people aren’t being urged to line up by the FDA or the Centers for Disease Control and Prevention. One expert told the publication there is “enormous pressure mounting” to move to a system of annual COVID-19 boosters. Americans might not be feeling the booster pressure, with only half of eligible people getting the first booster shot.
UPDATED: Monday, April 25 at 10:13 a.m. ET
Americans will soon be able to pick up Pfizer’s Paxlovid at pharmacies across the country, Bloomberg reports. The Biden administration will outline a plan next week to allow every pharmacy to order the antiviral from the federal government, according to an unnamed official. Paxlovid is currently available at 90% of Rite Aid stores across 17 states, with supplies varying by location. The U.S. government has ordered 20 million courses but is waiting on lawmakers’ authorization to complete the purchase. “We’re working to make sure doctors and patients know about Paxlovid,” White House spokeswoman Karine Jean-Pierre said Thursday. While the pill fell into limited supply after its December FDA approval, “that’s not the case anymore,” Jean-Pierre said. “It’s widely available, and the eligibility criteria are pretty expansive.”
Omicron’s BA.2 variant has dominated COVID-19 cases across the country, with a 50% rise in virus cases across the past two weeks. Despite the rise, hospitalizations are at their lowest point, leading White House COVID-19 response coordinator Ashish Jha to remain “confident that we’re going to get through this” without disruption, he said on CNN’s Sunday show “State of the Union.” With 200 million Americans vaccinated, the infection numbers “mean something different now than they did a year ago,” Jha said.
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) issued Valneva a list of questions about its vaccine candidate. Regulators are requesting additional data to justify a conditional marketing authorization for its inactivated COVID-19 vaccine candidate, VLA2001. Two weeks ago, the company was granted conditional marketing authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) of the U.K., following a March EUA from the Bahraini NHRA. Valneva expects an EMA authorization this quarter after it submits responses to the list of questions in the coming days. Thomas Lingelbach, Valneva CEO, commented that the company is “disappointed that the EMA has not considered our submissions sufficient to date,” noting that the vaccine candidate is the only inactivated COVID-19 candidate in Europe.
UPDATED: Friday, April 22 at 9:20 a.m. ET
Novavax has started dosing patients in a phase 3 booster trial in teens ages 12 to 17. The study is looking at the safety and immunogenicity of a third dose of the company’s protein-based COVID-19 vaccine. Novavax filed its shot for an emergency use nod in the U.S. earlier this year. Elsewhere, the company’s vaccine has been cleared in places like the U.K., Australia and Europe.
The World Health Organization issued a “strong recommendation” for Pfizer’s oral antiviral Paxlovid, branding it the “best therapeutic choice for high-risk patients to date.” That said, availability, lack of price transparency, Pfizer’s supply deals, plus the need for “prompt and accurate testing” before administration mean the drug is posing “a major challenge for low- and middle-income countries,” WHO said.
Meanwhile, WHO updated its recommendation for Gilead Sciences’ remdesivir, also known as Veklury. The organization previously suggested patients use Gilead’s med regardless of disease severity. With new clinical data on tap, WHO suggests remdesivir use be restricted to mild or moderate COVID-19 patients at high risk of hospitalization.
Serum Institute of India, the world’s largest vaccine manufacturer by doses, has halted production of new COVID shot batches after accumulating a stockpile of 200 million doses, Bloomberg News reports, citing comments made by SII’s chief executive Adar Poonawalla at the India Economic Conclave organized by Times Network on Friday. Serum Institute’s production pause comes as vaccine oversupply creeps up around the world, Bloomberg noted.
Regeneron CEO Len Schleifer, M.D., Ph.D., took home 95% less pay in 2021 versus 2020. But the compensation slump shouldn’t come as a shock. Most of Schleifer’s 2020 pay was tied to a front-loaded equity award. Under that compensation plan, Regeneron’s CEO and its top scientist, George Yancopoulos, M.D., Ph.D., won’t be handed more stocks until December 2025. Schleifer took home a total of $6.47 million last year. Story
UPDATED: Thursday, April 21 at 10:14 a.m. ET
A U.K.-wide study found prolonged “strong immune responses” 84 days after participants received a booster COVID-19 shot. The study, led by the University Hospital Southampton (UHS) and published in the Journal of Infection, tested immune responses after seven different vaccines used as a boosters 28 days after receiving two doses of AstraZeneca or Pfizer vaccines. While different initial vaccines yielded different results from the booster, “the rate that immune cell responses declined after third doses was similar between all the vaccine combinations and doses,” according to a UHS spokeswoman quoted in the Evening Standard. The study also found that a half dose of Pfizer’s vaccine prompts similar responses to a full dose at three months, which could “help in planning global vaccine supply and delivery,” according to Saul Faust, a professor of pediatric immunology and infectious diseases at the University of Southampton and director of the NIHR Southampton Clinical Research Facility.
CureVac and GlaxoSmithKline announced positive preclinical data from a study demonstrating immune responses and efficacy of a COVID-19 vaccine candidate combining two mRNAs encoded for the Beta and Delta variants. The vaccine “significantly reduced” the viral load in animals tested. New vaccine strategies, such as combining several variant-specific mRNAs within one vaccine, can be “essential to take over the COVID-19 virus dynamic and set new standards for broadly effective vaccines against other infectious diseases,” Dr. Igor Spawski, Chief Scientific Officer of CureVac, said in a statement.
Noubar Afeyan, Moderna's chairman and co-founder, predicts that annual COVID-19 boosters will become the norm. In an appearance on Bloomberg Surveillance, Afeyan referred to COVID-19 as a “battle royale” between two life forms running defenses and offenses. To combat the virus, which has “a mind of its own,” fourth boosters should be taken by people who want to avoid infection, Afeyan said.
UPDATED: Wednesday, April 20 at 10:37 a.m. ET
Arcturus Therapeutics shared topline data from an ongoing clinical trial evaluating the company’s self-amplifying mRNA COVID-19 vaccine candidate. The positive results revealed 95% efficacy overall for prevention of severe COVID-19 and 55% efficacy for preventing symptomatic COVID-19, according to a new press release. The next step for the vaccine candidate is advancing toward a pivotal booster study.
Clover Biopharmaceuticals released data showing its vaccinate candidate would be the first and only option to provide significant protection to people who have previously been infected with the virus, the company said in a release.
Amid China’s biggest COVID-19 surge since the start of the pandemic, efficacy issues with the country’s two homegrown vaccines have risen along with the omicron outbreak. Scientists recommend that China’s Sinovac vaccine be boosted with a more effective shot, The Financial Times reports. A recent study from the University of Hong Kong found that people over 60 who received Sinovac’s shot were three times more likely to die from COVID-19 than those who received two doses of the Pfizer/BioNTech vaccine.
Oxford Biomedica shares sank 7% after the company warned its revenue will suffer as it pauses the manufacturing of AstraZeneca’s COVID vaccine, Yahoo Finance reports.
UPDATED: Tuesday, April 19 at 10:30 a.m. ET
Poland has pulled out of contractual commitments to purchase the Pfizer/BioNTech COVID-19 vaccine, Politico reports. Health Minister Adam Niedzielski cited oversupply and financial strains due to the country’s influx of refugees fleeing Ukraine. The government invoked a clause refusing to pay for or take deliveries of future doses after attempting to comprise with vaccine suppliers.
Johnson & Johnson is suspending sales forecasts for its COVID-19 vaccine, a change from only a few months ago when it was predicting $3.5 billion from the shot. First-quarter earnings released today by the company noted global supply surplus and demand uncertainty led to the suspension of vaccine sales guidance. The vaccine brought the company $457 million in global sales during the first quarter, with $75 million coming from the U.S.
Takeda has received marketing and manufacturing approval from the Japan Ministry of Health, Labor and Welfare for recombinant protein-based COVID-19 vaccine Nuvaxovid. Distribution will begin as soon as possible, according to a new report from BioSpace. Novavax licensed and transferred its manufacturing technology to allow Takeda’s production of the vaccine at its Hikari facility. The approval was granted after Takeda’s new drug application submission which included positive interim results from a Phase 1/2 study in Japan.
UPDATED: Monday, April 18 at 10:05 a.m. ET
Bayer is facing a lawsuit from a former employee who claims he was fired for refusing to provide proof of COVID-19 vaccination, CBC reports. The employee, who is not named due to personal health information, worked at Bayer for 18 years and worked from home as a program manager both before and during the COVID-19 pandemic. According to the lawsuit, his employment contract did not mention an obligation to report vaccination status, despite Bayer’s January 2022 vaccination requirement. He is alleging that his employment was terminated without just cause. Bayer has not yet filed a statement of defense.
Ocugen and Bharat Biotech expanded their commercialization agreement for whole virus inactivated vaccine Covaxin to include Mexico.Covaxin is currently authorized for emergency use in more than 25 countries, and applications for pending use are pending in another 60 countries.
Novavax’s COVID-19 vaccine will be the fourth vaccine available in Japan once greenlighted, The Mainichi reported. The contract with the government includes supplies of 150 million doses, which will likely be used as booster shots. The vaccine’s mechanism differs from the country’s existing approved vaccines and is easy to transport and manage. Takeda applied for approval with the health ministry in December of 2021 and will be responsible for Novavax’s Japan vaccine distribution.
Johnson & Johnson’s one shot COVID-19 vaccine appears to prevent infections, hospitalizations and deaths as well as rival Pfizer/BioNTech and Moderna vaccines, Seeking Alpha reports, citing CDC data. The rates of infection in those who received J&J’s vaccine was ~18.8 per 100,000, whereas Pfizer and Moderna infection rates in those who received shots were ~31.6 and ~32.6 per 100,000, respectively. As of recent CDC data, J&J’s one shot has performed on par with rival vaccines in preventing COVID-19 mortality.
UPDATED: Friday, April 15 at 11:07 a.m. ET
The U.S. Food and Drug Administration issued an emergency use authorization for the InspectIR COVID-19 Breathalyzer, the first COVID-19 diagnostic test that can detect infection through breath samples. The device is about the size of a piece of carry on luggage and can provide results in less than three minutes, according to the FDA press release. InspectIR expects a production rate of approximately 100 instruments per week, which can each evaluate approximately 160 samples per day. The instruments will be used in doctors offices, hospitals, and testing sites.
A new study from the University of Virginia School of Medicine found that the antibodies generated by Pfizer’s COVID-19 vaccine rise slower and decline faster than those generated by the rival Moderna vaccine. The study also found that age of the vaccine recipient affected the antibody results for the Pfizer vaccine, with older recipients generating fewer antibodies than younger recipients. Age did not appear to be a factor in Moderna’s vaccine. The scientists found that while both vaccines are similar, there are differences in their formulation and mRNA levels, which could explain the difference in antibody responses between the two. However, both vaccines deliver peak levels of COVID-fighting antibodies.
Indian media and the country’s drug regulator have largely been mum on manufacturing issues surrounding Bharat Biotech’s vaccine Covaxin, which, while unclear, were severe enough for the World Health Organization to recently warn nations against obtaining the shot, Stat News reports. The plant behind WHO’s alert has a troubled past, as well, during which India’s Central Drugs Standard Control Organization (CDSCO) has at times “remained a mute spectator,” the publication said. The news outlet credited the silence to broad support behind Prime Minister Narendra Modi’s AatmaNirbhar policy, which broadly espouses economic self-reliance.
UPDATED: Thursday, April 14 at 9:15 a.m. ET
Pfizer and BioNTech announced positive results from a phase 2/3 trial evaluating the safety of a booster dose of their COVID-19 vaccine, Comirnaty, in children 5 through 11 years of age. Data demonstrated a strong immune response and no new safety signals. The next steps for Pfizer and BioNTech is submitting a request for Emergency Use Authorization of the booster in this age group, which the companies plan to do shortly.
Poorer nations have refused tens of millions of doses of the AstraZeneca COVID-19 vaccine, Vaxzevria, from the global vaccine sharing program COVAX, Reuters reports. Over 200 million doses were assigned to 61 less developed countries for six months through September, but many countries declined to receive nearly 35 million doses. A spokesperson for Gavi, speaking on behalf of COVAX, said that shelf-life preferences could not be met with available AstraZeneca supply. In contrast, requests for Johnson & Johnson and Pfizer vaccines were at 70 million and 40 million.
The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has granted conditional marketing authorization for Valneva’s whole virus COVID-19 vaccine in adults 18 to 50 years of age, according to a press release. CEO Thomas Lingelbach noted that the Valneva vaccine is the only inactivated whole virus COVID-19 vaccine approved in the UK, and this authorization could “pave the way for the availability of an alternative vaccine solution for the UK population.”
UPDATED: Wednesday, April 13 at 3:58 p.m. ET
Pfizer could develop a new vaccine that protects against various forms of COVID-19 as well as the omicron variant by fall, CEO Albert Bourla, Ph.D., said at a press conference held by the International Federation of Pharmaceutical Manufacturers & Associations. While it’s “easy to do something only against omicron,” it is more challenging for a vaccine to be effective against everything known so far, “so you don’t have two different vaccines for different variants,” Bourla said.
According to the latest estimates from the Centers for Disease Control and Prevention, omicron subvariant BA.2 was responsible for 86% of new COVID-19 cases nationwide last week, CNN reports. Despite the rising case numbers, U.S. hospitalizations are at record lows and continue to drop.
People 50 years and older are now eligible to receive the additional booster shot, but the Centers for Disease Control and Prevention isn’t pushing them to get in line. Many vaccine experts say healthy people under 65 years old can wait. One reason for the delay is limited understanding of T cells, an attack cell of the immune system, The Wall Street Journal reports.