As Pfizer and Merck reportedly near U.S. FDA authorizations for their oral antivirals, the companies have agreed to supply more courses to the U.K.
Novavax is kicking off a booster study of its protein-based vaccine.
The worldwide case count is at 276 million Wednesday morning, with over 5.3 million reported deaths, according to Johns Hopkins University's COVID-19 dashboard.
UPDATED: Wednesday, Dec. 22 at 8:40 a.m. ET
After Bloomberg on Tuesday reported that Pfizer and Merck are nearing FDA authorizations for their oral antibodies, the companies each inked deals to provide the U.K. with additional courses. Pfizer expects to supply 2.75 million courses through the end of 2022, while Merck has agreed to supply 2.23 million courses in total. Meanwhile, France has canceled an order for Merck's antiviral, Reuters reports.
As Novavax works to gain authorizations around the globe for its protein-based vaccine, the company has kicked off a booster study. All participants in the company's phase 3 Prevent-19 study are now eligible to receive their booster doses, the company said Wednesday.
Amid omicron concerns in Israel, health officials are planning to offer a fourth vaccine dose to elderly people and healthcare workers, The Wall Street Journal reports. The fourth shots are to be administered at least four months after a person's third dose.
UPDATED: Tuesday, Dec. 21 at 9:35 a.m. ET
The European Union expanded the use of Gilead’s Veklury (remdesivir) to COVID-19 patients who do not require supplemental oxygen and are at risk of progressing to a severe case of the disease. The antiviral drug has been in use as a last-resort medication. The approval is based on a study of 562 participants, which showed an 87% reduction in hospitalization or all-cause death by day 28. The decision comes as antibody treatments from Regeneron and Eli Lilly have shown in lab studies to be ineffective against omicron. In the DisCoVeRy trial, which was conducted between March 2020 and January 2021, Veklury was shown to be ineffective in the later stage of the disease.
Moderna hopes to begin clinical trials early next year on a vaccine to protect against the omicron variant, CEO Stephane Bancel said in an interview with Swiss newspaper TagnesAnzeiger, but for now is focusing on a booster dose vaccine. “It only needs a minor adjustment for omicron. I don’t expect any problem,” said Bancel, who added that regulatory approval could slow the process. “Some authorities want a study. Others are still undecided. In my opinion, it depends very much on how severely the disease progresses,” he said.
Protection from the AstraZeneca vaccine wanes after three months of receiving a second dose, according to a study published in The Lancet medical journal. The study was drawn from databases in Scotland and Brazil, which showed a five-fold increase in the likelihood of hospitalization or death five months after vaccination as compared to two weeks after. The decline begins to happen after three months. Four months after vaccination, a three-fold increase in hospitalization and death was observed. The results were consistent between the countries despite the delta variant being the dominant variant in Scotland and gamma being the dominant strain in Brazil.
UPDATED: Monday, Dec. 20 at 10:00 a.m. ET
The European Medicines Agency on Monday recommended conditional marketing authorization in the European Union for Novavax’s two-dose, protein-based COVID-19 vaccine. If the vaccine wins a thumbs up in the EU, it will be marketed under the name Nuvaxovid. The update comes less than a week after the shot won emergency use listing from The World Health Organization (WHO), teeing up shipments to the agency’s equitable vaccine access scheme COVAX. Story
Pfizer’s COVID-19 vaccine and its oral antiviral Paxlovid could together generate peak sales of between $50 billion and $60 billion, Cantor Fitzgerald analysts wrote in a recent note to clients. Looking ahead, Pfizer’s BioNTech-partnered COVID-19 vaccine, Comirnaty, could reach $25 billion in sales in 2027, Cantor Fitzgerald’s Louise Chen predicted. That’s a huge increase on her previous projection of $10 billion. “I see COVID continuing to have new variants and coming back each season,” Chen wrote in an email to Fierce Pharma. Story
In lab tests, a third dose of Moderna's mRNA vaccine appears to offer protection against Omicron, Reuters reports. While just two doses generated low neutralizing antibodies, a 50-microgram third dose increased anti-COVID antibodies 37-fold, Reuters said. A 100-microgram booster dose caused antibody levels to rise even higher. The U.S. authorized Moderna’s 50-microgram booster in October. Governments and regulators will have to decide whether they want the potential enhanced level of protection that a 100-microgram booster might offer, Paul Burton, M.D., Ph.D., chief medical officer at Moderna, told Reuters.
On that note, a “growing body of preliminary evidence” suggests that only Pfizer's and Moderna’s shots, when bolstered by a booster, appear to stop Omicron infections, The New York Times reports. While those shots are available in the U.S. and Europe, much of the world is relying on more traditional vaccines from companies like Johnson & Johnson and AstraZeneca alongside vaccines manufactured in China and Russia. All of those shots appear to provide significant protection against serious illness from Omicron, but only Pfizer's and Moderna’s shots, when reinforced by a booster, appear to stop infections with the troubling variant, NYT said.
While most of those findings are based on lab experiments, "it’s clear that there is a drop in effectiveness,” Emer Cooke, executive director of the European Medicines Agency, told the Financial Times. “Whether [the drop] can be compensated by boosting we don’t know, so for us it’s too early,” she added.
UPDATED: Friday, Dec. 17 at 8:45 a.m. ET
The European Union is planning to buy 180 million doses of Pfizer and BioNTech's vaccine specifically targeted toward the omicron variant, Reuters reports. The partners started work on the omicron-tailored shot in late November and have said it could be ready by March.
CDC vaccine advisors recommend people in the U.S. get mRNA vaccines from Pfizer and Moderna over the Johnson & Johnson shot. The move comes after 9 people died from blood clots connected to the J&J shot through September, according to reports. Story
The European Medicines Agency recommends the use of GlaxoSmithKline and Vir Biotechnology's Xevudy in COVID-19 patients 12 and older who don't require supplemental oxygen, but who are at a high risk of progressing to severe disease. Xevudy becomes the third recommended antibody in Europe, following Celltrion's Regkirona and Roche's Ronapreve.
A study conducted by a unit of Vir Biotechnology found that the Johnson & Johnson, Sinopharm and Sputnik V vaccines didn't have any neutralizing activity against omicron, Reuters reports. The study has not been peer reviewed. Other vaccines retained reduced activity, the report said.
UPDATED: Thursday, Dec. 16 at 9:45 a.m. ET
The CDC will meet today to discuss placing limits on the Johnson & Johnson COVID-19 vaccine, the Washington Post reports. New data shows more of the rare blood clot issues that hindered the rollout of the shot earlier this year. The condition has largely affected young and middle-aged females. In April the FDA halted distribution of the vaccine for 10 days. Since then, nine deaths have been linked to the shot, an official told the Post. The highest incidence of the condition (1 in 100,000) has been among women aged 30 to 49, according to FDA data.
Last month, a failed trial of a COVID-19 drug compelled Roche to abandon its $350 million development deal with Atea. But the small biotech is going forward, testing the therapeutic with other compounds in an effort to develop a medicine that could treat emerging variants. Story
Takeda has submitted an application for Novavax's vaccine in Japan. Takeda will manufacture the shot and aims for distribution in Japan in early 2022, pending regulatory approval. The shot has received approval in Indonesia and the Philippines. Applications have been filed in several other countries including India, Australia, the U.K. and the European Union.
A global program by Gavi to provide COVID-19 vaccines to tens of millions of migrants has run into a roadblock because of legal concerns by some major manufacturers over harmful side effects, Reuters reports. Many COVID-19 vaccine manufacturers have required that countries indemnify them from adverse effects of their shots, said the United Nations. But where governments are not in control—in places such as Ethiopia, Myanmar and Afghanistan where residents have been displaced—the same government protections for manufacturers aren’t in place.
UPDATED: Wednesday, Dec. 15 at 9:30 a.m. ET
Sanofi and GlaxoSmithKline had to go back to the drawing board with their original COVID-19 vaccine, but that same shot—which failed to generate enough immune response in the elderly—works well as a booster, the companies say. In a phase 3 study, a single booster dose of the recombinant adjuvanted vaccine candidate triggered an elevated antibody response, regardless of the primary vaccine or the age group. The shot was tested as a booster for the AstraZeneca, Johnson & Johnson, Moderna and Pfizer/BioNTech vaccines. The companies added that sera from the trial’s participants is being tested against the omicron variant.
Research by Kaiser Permanente in Southern California shows that Moderna’s original COVID-19 two-shot vaccine series retains its protection up to five months, with 87% efficacy against infection, 86% against hospitalization and 98% against death. A key aspect of the study—which compared 352,878 vaccinated people to the same number of unvaccinated participants—was its ethnic and racial diversity. The shot’s efficacy remained consistent across age, race and ethic groups. Hospitalization occurred among 13 vaccinated and 182 unvaccinated patients. There was one death among the vaccinated participants compared to 25 who were unvaccinated.
The European Union’s drug regulator has recommended that a second dose of the Johnson & Johnson COVID-19 vaccine may be provided at least two months after the first dose. The shot was promoted as a single-dose vaccine but studies showed a second dose boosted immunity and was safe. In October, the FDA similarly signed off on its use as a booster. The J&J vaccine can also be used as a booster for the Pfizer-BioNTech and Moderna vaccines, the EU regulator said.
President Joe Biden had high praise for Pfizer’s COVID-19 antiviral pill Paxlovid, which has shown to reduce the risk of hospitalization or death by 89% if given to high-risk adults within a few days of showing symptoms. “This news provides another potentially powerful tool in our fight against the virus, including the omicron variant,” Biden said in a statement, while also reinforcing that getting vaccinated and receiving a booster dose remains “the most important tools we have to save lives.” Biden added that if the pill is authorized it will provide “a significant step forward in our path out of the pandemic.”
Merck and Ridgeback’s oral treatment for those with COVID-19 might not be safe for pregnant women, the FDA said in a briefing. Recent data showed the molnupiravir pill was 30% effective in reducing hospitalization or death in high-risk patients who had been infected within a few days. The results stood in contrast to earlier results from the trial which showed 50% efficacy. In animal studies, molnupiravir caused abnormal bone formation with incomplete and delayed ossification.
UPDATED: Tuesday, Dec. 14 at 9:20 a.m. ET
Pfizer's oral antiviral hopeful Paxlovid has gone toe-to-toe with omicron in lab tests, the company said Wednesday. The drug has shown consistent in-vitro antiviral activity against a rogues' gallery of variants (alpha, beta, delta, gamma, lambda, and mu), and it has also "potently inhibited" the 3CL protease associated with omicron in an in vitro biochemical assay, the company said. Meanwhile, the pill was 89% effective at curbing the risk of hospitalization and death in adults at high risk of severe COVID-19, and 70% effective at slashing those risks in adults at low risk of severe disease, results from two separate phase 2/3 studies showed.
Meanwhile, two shots of Pfizer and BioNTech's mRNA-based vaccine Comirnaty seem to provide 70% protection against hospitalization, recent real-world results from a South African trial showed, as reported by Reuters. The study looked at more than 211,000 positive COVID-19 test results, around 78,000 of which were attributed to omicron. That doesn't mean all 78,000 results are confirmed omicron cases, Reuters pointed out. South African scientists have so far confirmed around 550 positive tests as the variant of concern.
Speaking of omicron, the variant could be on the rise in Washington State, The New York Times reports. Researchers testing coronavirus samples in The Evergreen State have logged a swift rise in cases with a mutation characteristic of the troubling variant. Specifically, 13% of 217 positive case specimens collected Wednesday had the mutation, NYT said. That marks a jump from the 7% of samples with the mutation researchers tested the day before, and 3% the day before that.
Samsung Biologics and AstraZeneca are taking their manufacturing partnership to the next level. Starting next year, the CDMO will start to produce a cancer immunotherapy, as well as AZ's long-acting COVID-19 antibody combo AZD7442, Reuters reports.
A globetrotting coalition of regulators recommends a mix of in-person and remote inspection activities, even after the pandemic has ended, STAT News reports. In a "reflection paper," the International Coalition of Medicine Regulatory Authorities (ICMRA) acknowledged the limitations of remote inspections, but concluded that "remote approaches could continue to be a tool in the inspection 'toolkit' of regulatory authorities, post pandemic." Still, the coalition stressed that digital tech "has not replaced the need for on-site inspections." Regulators will likely always have an easier time sussing out problems in-person, and certain rooms, such as sample rooms or refrigerators lined with metal, simply don't work with virtual tours given Wi-Fi and mobile phone interference.
UPDATED: Monday, Dec. 13 at 10:05 a.m.
Anticipating a "tidal wave" of omicron cases in England, officials plan to offer boosters to everyone 18 and above by the end of the year, U.K. prime minister Boris Johnson said.
Two doses of the Pfizer and AstraZeneca vaccines induce lower levels of antibodies to omicron, a University of Oxford study found.
Moderna signed an agreement in principle to set up a COVID-19 vaccine manufacturing site in Australia. The plant in Victoria is expected to come online by 2024 and produce up to 100 million doses per year.
UPDATED: Friday, Dec. 10 at 4:00 p.m.
A booster dose of the Pfizer-BioNTech COVID-19 vaccine, Comirnaty, significantly increases protection against infection and severe disease progression—and does so across all age groups 16 and older—according to two studies conducted in Israel and published in the New England Journal of Medicine. The data was collected from July 30 to Oct. 10 and included nearly 5 million individuals—split equally between those who received a booster dose and those who didn’t get a third shot.
The Centers for Disease Control and Prevention reported on Friday it has received 43 reports of omicron variant infections in the United States. One of the infections resulted in a brief hospital stay, and there have been no deaths, though there is generally a lag between infection and severe progression of the virus, the CDC said. The 43 cases are spread over 22 states.
One in 10 Americans say that receiving a COVID-19 vaccine would be counter to their religious beliefs, according to a survey from the Public Religion Research Institute and the Interfaith Youth Core. The survey also found that 60% of people believe that too many are using religion as an excuse to avoid vaccine mandates. Earlier this month, four Bristol Myers Squibb employees who were to be fired for refusing vaccination filed a lawsuit against the company claiming their religious rights were being infringed.
UPDATED: Friday, Dec. 10 at 10:55 a.m.
Moderna will supply an additional 20 million doses of its COVID-19 vaccine to COVAX this month, the company said. It also has bumped up its supply plan to the worldwide relief effort for next year, guaranteeing delivery of an additional 20 million doses by the second quarter. The added doses bring Moderna’s 2021 supply to COVAX to 54 million.
The United States' top infectious disease expert Anthony Fauci told STAT that he believes current vaccines will offer enough protection against the omicron variant that COVID-19 vaccine makers will not need to produce an omicron-specific version of their shots. “The companies are going to be making variant specific boosters,” Fauci said. But “what I think is something that we need to keep our eye on [is] it could be that things turn out better than we expected.”
With a doubling of omicron cases every three days, Britain is tightening restrictions and warning of a new COVID-19 wave. Cases are still relatively small—817 reported Thursday—compared to the daily average of 48,000 new cases overall. But the increase is troubling to authorities who are warning that omicron could account for 50% of those infected within “the next two to four weeks,” said the Health Security Agency.
With concerns rising over the spread of the omicron variant, Germany will require healthcare workers to be vaccinated. The move, which goes into effect in mid-March, promises to be controversial in a country where COVID-19 restrictions have been met with resistance. Germany joins several other European countries that have issued similar mandates, following the lead of France and Italy.
UPDATED: Thursday, Dec. 9 at 4:00 p.m.
As Omicron spreads, the U.S. Food and Drug Administration has blessed a booster dose of Pfizer and BioNTech’s COVID-19 vaccine, Comirnaty, for older teens. The expanded emergency use authorization (EUA) allows people 16 and older to receive a third dose of the mRNA-based shot at least six months after their second. The label update comes about three weeks after the FDA simultaneously expanded EUAs on both Pfizer and Moderna’s vaccines to be used as boosters in adults ages 18 and up.
As wealthy nations rev up booster campaigns to keep variants at bay, the World Health Organization on Thursday repeated its warning that the push could jeopardize global vaccine equity. “Broad-based administration of booster doses risks exacerbating inequities in vaccine access,” Alejandro Cravioto, chairman of WHO’s Strategic Advisory Group of Experts on Immunization, told reporters, as quoted by The New York Times. Most current infections are cropping up in the unvaccinated. Therefore, getting doses to those who have no protection should be top priority, WHO said.
Despite that suggestion, the World Health Organization on Thursday recommended booster doses for the immunocompromised and those who received an inactivated COVID-19 vaccine, like the ones made by Sinovac, Sinopharm and Bharat Biotech. Johnson & Johnson’s one-and-done shot remains effective after a single dose, but the company’s clinical data does show a clear benefit for a second dose, WHO’s Alejandro Cravioto said in a press briefing.
Two of Philips’ IntelliVue patient monitoring devices, first rolled out under an emergency use authorization during the pandemic’s early days last June, have snagged 510(k) clearance from the FDA. This means the devices can continue to be marketed even after the regulator determines the public health emergency caused by COVID-19 is over. Both models, dubbed MX750 and MX850, offer continuous patient monitoring in intensive care units and beyond. The monitors are also designed with hospitals’ and patients’ cybersecurity in mind, complete with encryption services for remote display data and all other info gathered by the devices. Fierce Biotech
UPDATED: Thursday, Dec. 9 at 9 a.m.
AstraZeneca’s two-drug antibody cocktail AZD7442, now branded as Evusheld, has been authorized in the U.S. as the first therapy to prevent COVID in immunocompromised individuals before an exposure. AZ has also reported that the drug could prevent progression to hospitalization or death in mild-to-moderate COVID outpatients, an indication that’s not yet authorized. Story
Meanwhile, Brii Biosciences’ COVID antibody combo of BRII-196 and BRII-198, also known as amubarvimab and romlusevimab, has won an approval from China’s National Medical Products Administration to treat patients with mild and “normal type” of COVID-19 at high risk for progression to severe disease. It marks the first approval for a COVID neutralizing antibody therapy in the country. The drug reduced hospitalization or death by 80% over placebo through 28 days in the NIH-sponsored ACTIV-2 trial. Brii is also seeking an FDA authorization for the combo.
While not at the forefront of creating new therapeutics and vaccines against COVID-19, Novartis is working on a main protease inhibitor drug that has shown preclinical activity across many coronaviruses. The company is on track to start human testing in 2022, Jay Bradner, M.D., president of the Novartis Institutes for BioMedical Research, told Fierce Biotech. Story
UPDATED: Wednesday, Dec. 8 at 4 p.m.
Pfizer-BioNTech's vaccine, Comirnaty, provides less protection against the omicron variant than it did against wild-type COVID and other variants, the companies said, but boosters can improve the response. Story
In the U.K., Prime Minister Boris Johnson announced new restrictions amid the spread of the omicron variant, urging people to work from home, extending a mask mandate and requiring proof of vaccination for some indoor venues, The New York Times reports.
UPDATED: Wednesday, Dec. 8 at 10 a.m.
Pfizer CEO Albert Bourla said the omicron variant appears milder than other strains but appears to spread faster and could lead to more mutations in the future, CNBC reports. “I don’t think it’s good news to have something that spreads fast,” Bourla said. “Spreads fast means it will be in billions of people and another mutation may come. You don’t want that.”
Pfizer said a booster dose of its vaccine provides protection against the omicron variant, AP reports. A lab study showed an additional dose increased antibody protection 25-fold compared to the initial two-dose series.
In India, the world's largest vaccine maker by doses, Serum Institute of India, will halve output of the AstraZeneca vaccine as demand declines, Reuters reports.
UPDATED: Tuesday, Dec. 7 at 3:30 p.m.
Amid reports that COVID-19 antibody treatments from Regeneron and Eli Lilly lose their effectiveness against the omicron variant, GlaxoSmithKline and Vir Biotechnology say their antibody drug, sotrovimab, is effective against omicron’s full range of mutations. Story
A U.K. study found mixing the Moderna vaccine nine weeks after the first dose of either the AstraZeneca or Pfizer-BioNTech produces a better immune response, Reuters reports.
The U.S. is enforcing stricter travel requirements. Inbound travelers must now show a negative COVID-19 test result taken no more than a day prior to departure, The New York Times reports. The requirement took effect Monday.
UPDATED: Tuesday, Dec. 7 at 10 a.m.
A University of Oxford-led study found that combining the first dose of the AstraZeneca vaccine, named Vaxzevria, with a second dose of either the Moderna or Novavax vaccines produces higher levels of antibodies and T cells compared to two AstraZeneca doses, The Guardian reports. The strongest T-cell response was when a Novavax dose followed the AstraZeneca vaccine. Vaccine flexibility is great news for low- and middle-income countries as it allows for rapid deployment of the vaccines, and cold storage facilities for access to mRNA vaccines aren't needed.
Researchers in South Africa said that while the omicron variant is spreading quickly, it may cause less severe cases than other strains, The New York Times reports.
UNICEF and Clover Biopharmaceuticals signed a deal for the supply of the Clover vaccine to the COVAX Facility. The agreement will provide UNICEF with up to 414 million doses until the end of 2022.
The WHO rejected convalescent plasma treatment for COVID-19, Pharmafile reports. Convalescent plasma is plasma from patients who have recovered from COVID-19 and has antibodies. The FDA granted emergency use authorization for convalescent plasma as a treatment in August 2020.
UPDATED: Monday, Dec. 6 at 3:30 p.m.
Merck & Co. signed a deal under which molnupiravir production will be conducted at Thermo Fisher Scientific’s Ontario, Canada, facility. If approved, the drug supply will be distributed to Canada, the U.K. and markets in the European Union, Asia Pacific and Latin America. The Ontario plant is one of only three production sites for the therapy in the world. Story
As fast as COVID-19’s omicron variant is predicted to spread, diagnostics companies hope to be faster by quickly developing new tests to detect the coronavirus' newest mutations. Just 48 hours after completing its acquisition of its longtime infectious disease partner TIB Molbiol on Dec. 1, Roche has developed three research-only kits. Story
UPDATED: Monday, Dec. 6 at 10 a.m.
A phase 2 study of the Johnson & Johnson vaccine used as a booster dose following the two-shot regimen of the Pfizer-BioNTech vaccine posted positive results, the company reports. (PDF)
Sarah Gilbert, an Oxford University professor and academic who helped develop the AstraZeneca vaccine, said the next pandemic could be even more deadly than the current one, NBC reports. “The truth is, the next one could be worse. It could be more contagious, or more lethal, or both,” Gilbert said.
New York City Mayor Bill de Blasio announced a new vaccine mandate for all private employers in the city. The mandate, which takes effect Dec. 27, is an effort to combat the spread of the omicron variant, The New York Times reports.
Novartis CEO Vas Narasimhan said the company is working on a pill that could work broadly against coronaviruses, not just the one that causes COVID-19, Reuters reports.
UPDATED: Friday, Dec. 3 at 4 p.m.
The FDA expanded its emergency use authorization for Lilly's bamlanivimab and etesevimab to include certain high-risk pediatric patients from birth to under 12 years old.
Scientists in South Africa said the omicron variant is at least three times more likely to cause reinfection than previous variants such as delta, The Washington Post reports. The analysis of about 2.8 million positive COVID-19 samples in South Africa included 35,670 suspected to be reinfections.
UPDATED: Friday, Dec. 3 at 10 a.m.
The FDA is aiming for a rapid review of vaccines and drugs targeting the omicron variant. The agency has been meeting with drugmakers to set guidelines for studies and data needed to swiftly evaluate new products, The Wall Street Journal reports.
BioNTech's CEO said a new COVID-19 vaccine may eventually be needed to fight against the omicron variant, The Washington Post reports. Uğur Şahin said the vaccine could be adapted "relatively quickly," but more research is still required.
Roche's TIB Molbiol has developed three new test kits to help researchers detect mutations in the new omicron variant, Reuters reports.
New York has confirmed five cases of the omicron variant, The New York Times reports. This follows cases detected in California, Minnesota, Hawaii and Colorado.
UPDATED: Thursday, Dec. 2 at 3:30 p.m.
As the newly discovered omicron variant of the novel coronavirus spreads across the globe, the Biden administration is updating its COVID-19 action plan to include an extended mask mandate, new travel requirements and full reimbursement of at-home diagnostics by private insurers. Story
A second case of the omicron variant was reported in Minnesota, NPR reports.
Following the FDA advisory panel's recommendation for Merck's antiviral molnupiravir, health researchers say access to the pill could be made difficult due to prescription requirements, Bloomberg Law reports.
Aspen Pharmacare is nearing a deal with Johnson & Johnson to license and sell the company's single-dose vaccine in Africa. The deal, which would allow Aspen to price, distribute and sell the shot in Africa under the moniker Aspenovax, could help bridge the vaccine inequality divide that's plagued the continent throughout the pandemic, an Aspen executive told Fierce Pharma. Story
Germany implemented a nationwide lockdown for those who are unvaccinated, barring them from all but the most essential businesses such as grocery stores and pharmacies, CNN reports. Officials are weighing plans for mandatory vaccinations, which could take effect as early as February if passed through the parliament.
UPDATED: Thursday, Dec. 2 at 10 a.m.
In the U.K., the MHRA approved the monoclonal antibody Xevudy, or sotrovimab, for people with mild-to-moderate COVID-19 who are at high risk of developing severe disease. The treatment was found to reduce hospitalization by 79%. The GlaxoSmithKline and Vir Biotechnology antibody is the second to be approved for use in the U.K. behind Ronapreve.
AstraZeneca is ditching plans to test its vaccine as a booster in a U.S. study, Bloomberg reports. The U.K. drugmaker does not have approval to sell its shot in the U.S. yet and urged participants to seek a third dose elsewhere.
Researchers in the U.K. and U.S. may have found the possible trigger behind the rare blood clot complications linked with the AstraZeneca vaccine, The Guardian reports. Scientists said the reaction, a condition known as vaccine-induced immune thrombotic thrombocytopenia, may be sparked by the way the adenovirus used by the vaccine to move the coronavirus' genetic material into cells binds with a protein in the blood, platelet factor 4.
Amid news of the omicron variant and a push for boosters, the U.K. agreed to deals to buy 114 million more doses of the Pfizer-BioNTech and Moderna vaccines. The deal includes an additional 54 million Pfizer-BioNTech shots and 60 million Moderna doses, Reuters reports. It also includes access to any modified vaccines if needed to combat any new strains.
Gilead Sciences said new findings of its antiviral Veklury, a.k.a. remdesivir, showed the treatment is expected to remain effective against the omicron variant, Fox Business reports. An analysis of more than 200 available sequences of the strain, including those from South Africa, Asia and Europe, found no new mutations present in the variant expected to alter the viral RNA polymerase the antiviral targets. The biotech will continue to conduct in vitro lab testing of remdesivir against the omicron variant.
UPDATED: Wednesday, Dec. 1 at 3:30 p.m.
The first case of the omicron variant in the U.S. was confirmed in California Wednesday, AP reports.
A federal judge temporarily blocked the Centers for Medicare & Medicaid Services (CMS) from enforcing its vaccine mandate for healthcare workers. The ruling applied nationwide, except in 10 states where the CMS was already prevented from enforcing the mandate due to an order from a federal judge in St. Louis. Trump-appointed judges from Louisiana and Illinois, who issued preliminary injunctions against the vaccination mandates this week, agreed the requirements will harm plaintiff states and are unlikely to hold up in court. Story
Additionally, U.S. District Judge Gregory Van Tatenhove in Kentucky blocked the Biden administration from enforcing a regulation that government contractors' employees get vaccinated, Reuters reports.
Moderna has suffered a blow in its patent feud with Arbutus Biopharma, exposing the mRNA specialist to a potential infringement suit on its megablockbuster COVID-19 vaccine. Story
UPDATED: Wednesday, Dec. 1 at 10 a.m.
An FDA advisory committee voted late Tuesday by the narrow margin of 13-10 to endorse Merck's molnupiravir for use in mild-to-moderate COVID-19 patients who are at high risk of progressing to a severe form of the disease. The recommendation comes despite a host of concerns including over efficacy and safety. Story
Regeneron CEO Leonard Schleifer said the omicron variant is of "great concern" and that variants will keep appearing until everyone is treated. Schleifer said its current antibody anticipated many mutations, which allowed it to remain effective against the delta variant. However, omicron's mutation outpaced what was anticipated in the current therapy. Schleifer said COVID-19 will last a "long, long time" and will require constant development of vaccines and therapies as it mutates, Seeking Alpha reports.
Sterling Pharma Solutions has teamed up with the University of Manchester Institute of Biotechnology to develop a low-cost manufacturing route to Merck's molnupiravir and widen access to the antibody to lower income countries, the company announced.
UPDATED: Tuesday, Nov. 30 at 4 p.m.
A Merck executive said the company's antiviral, molnupiravir, should be effective against any new COVID-19 variant, Reuters reports.
Similarly, BioNTech CEO Uğur Şahin told Reuters the Pfizer-BioNTech vaccine is likely to protect against severe COVID-19 from the new omicron variant.
Aspen Pharmacare has signed a non-binding term sheet with two of Johnson & Johnson’s Janssen subsidiaries, the company said in an emailed statement. If the agreement yields a definitive deal, Aspen will become the first African company to snag rights over distribution, pricing and branding of the Johnson & Johnson shot. Story
Dutch health authorities confirmed Tuesday they found the new omicron variant in cases dating back as long as 11 days, indicating the variant was already in Europe before cases were first identified in South Africa last Friday, CBS reports. The RIVM health institute said it found the omicron variant in samples dating from Nov. 19 and Nov. 23.
UPDATED: Tuesday, Nov. 30 at 10 a.m.
Pfizer and BioNTech are expected to request the FDA to authorize an additional shot of its vaccine for 16- and 17-year-olds. The approval could come as early as next week, Barron's reports.
An FDA advisory committee is meeting to discuss Merck and its partner Ridgeback's antiviral, molnupiravir, The Wall Street Journal reports. The panel, dubbed the Antimicrobial Drugs Advisory Committee, is expected to vote on whether to recommend the FDA approve the antiviral for emergency use. Endorsement of the pill could mean FDA authorization before the end of the year. If the FDA authorizes the antiviral, Merck has agreed to give the U.S. 3.1 million courses of the drug.
COVAX has allocated 4.7 million doses of the AstraZeneca vaccine for North Korea, one of few countries that haven't started vaccination, Reuters reports.
UPDATED: Monday, Nov. 29 at 4 p.m.
Producers of the world's top COVID-19 vaccines, including Moderna, AstraZeneca, Johnson & Johnson and Pfizer, say they are moving quickly to test their shots against the new omicron variant. They also are developing shots tailored to the new strain. Moderna said it has a three-pronged strategy to address the threat. Story
Amid news of the new variant, President Joe Biden downplayed the need for new lockdowns as the World Health Organization looks for more answers on the variant's impact. Story
Pfizer is boosting manufacturing capability and now expects to make 80 million courses of its oral COVID-19 drug Paxlovid by the end of 2022, Pfizer CEO Albert Bourla said. The drug awaits emergency use authorization from the FDA. Story
As for Merck's COVID-19 pill, molnupiravir, an FDA advisory group will vote Tuesday on whether to recommend that the FDA grant emergency use authorization, NBC reports. The company recently reported the risk reduction in hospitalization and death from the Ridgeback Therapeutics-partnered antiviral fell from 50% to 30% in the final analysis.