A new COVID-19 variant, the omicron variant, could soon cause a global surge, the World Health Organization said.Those who received the Johnson & Johnson vaccine are often opting for other vaccines as a booster, reports FiercePharma.
Omicron
A new variant of COVID-19, the omicron variant, was discovered in South Africa last week. The WHO said the variant could quickly surge around the globe with “severe consequences”.
The WHO said no deaths linked to the omicron variant have been reported, and there is currently no information that suggests symptoms differ from those associated with other variants.
The new variant caused the World Trade Organization’s new director, Ngozi Okonjo-Iweala, on Friday to postpone indefinitely the organization’s conference scheduled for Tuesday in Geneva. The goal of the meeting was to reach a compromise among nations over vaccine patents, Politico reports.
Vaccination approval
Johnson & Johnson’s single-dose COVID-19 vaccine has been granted full approval by Health Canada, its first major regulatory approval, MarketWatch reports. In the U.S., it has only been granted emergency use authorization so far.
The U.S. could have access to a new antiviral pill from Merck within a few weeks and a second option from Pfizer to follow, Kaiser Health News reports. Both pills are under federal review now.
Pfizer and BioNTech announced that they’ve asked the European Medicines Agency to expand the use of their COVID-19 vaccine to people between the ages of 12 and 15.
AstraZeneca said it still plans to submit its vaccine for emergency authorization in the U.S.
The FDA is expected to authorize Pfizer’s COVID-19 vaccine, which it created alongside BioNTech, for adolescents 12 to 15 years old by early next week, The New York Times reports, citing federal officials.
Moderna has received its first full approval for its COVID-19 vaccine, dubbed Spikevax, in Canada for people aged 12 and older. Health Canada’s full approval was based on a final analysis of Moderna’s late-stage clinical trials, which enrolled more than 30,000 people, that found the shot was 93% effective and durable for six months after a second dose.
Eli Lilly has scored an expanded FDA nod for its antibody combo, a mix of its bamlanivimab and etesevimab, as a post-exposure prophylaxis treatment for those who have been recently exposed to the virus. The cocktail can now be used in people as young as 12 who are considered high risk and haven’t been vaccinated or are not expected to mount an adequate immune response.
FDA documents released ahead of the agency’s meeting on Friday to discuss Pfizer’s booster shot application indicate the agency’s staffers believe that the shots are working just fine, although they acknowledged “some observational studies” suggest immunity wanes over time. The FDA’s Vaccines and Related Biological Products Advisory Committee plans to review the data and make recommendations to the agency
Booster shots
As more and more people receive their booster shots, many who received Johnson & Johnson’s single-dose vaccine are opting for a different vaccine for their booster, The Wall Street Journal reports.
Of the 15.7 million people who got Johnson & Johnson’s vaccine, about 1.7 million have received an additional dose. Of those, 26% stayed with Johnson & Johnson for their second dose, the CDC reported. Some 31% received a Pfizer-BioNTech booster, and 43% got the Moderna vaccine. Meanwhile, a majority of those who received the Moderna or Pfizer-BioNTech vaccine stuck with the same shots for their boosters.
As scientists and officials debate the need for boosters, Moderna said the latest breakthrough infection data support the case for follow-up doses. Moderna’s vaccine remains “highly effective” even amid the delta surge, the company said, but data show that people who were vaccinated more recently were less likely to experience a breakthrough case.
Issues with the vaccine
The U.K.’s drug regulator on Thursday said it had received another 41 reports of rare blood clots in people after they received AstraZeneca’s COVID-19 vaccine.
Canada’s National Advisory Committee on Immunization (NACI), which makes recommendations for the use of vaccines, advised residents to weigh the risk of rare but serious blood clots reported among some Johnson & Johnson vaccine recipients and, if considered necessary, wait for a different shot.
J&J’s vaccine, which has now been recommended for people 30 and older in Canada, is expected to be distributed across the country soon.
A study of more than 32 million vaccine recipients in England showed that people given the AstraZeneca vaccine were at a slightly increased risk of an extremely rare nerve-damaging disorder, Guillain-Barré syndrome (GBS), The New York Times reports. Although, researchers said the risk of the disorder is smaller than COVID-19 itself. U.K. drug regulators added the disorder as a potential side effect of the AstraZeneca vaccine last week.
mRNA vaccines
Moderna has increasingly heard from a mix of governments, public health officials and scientists that mRNA vaccines are the best way forward as variants of the coronavirus emerge, president Stephen Hoge, M.D., told Fierce Pharma in an interview. That’s because as variants spread, drugmakers are forced to “update their vaccines really quickly,” and mRNA offers the necessary speed for that response, Hoge said.
Moderna signed a supply deal with the global vaccine-sharing facility COVAX for up to 500 million doses of its mRNA shot with the option to procure an additional 466 million doses in 2022.
BioNTech’s CEO Ugur Sahin said he expects results by September from trials testing the company’s mRNA vaccine, developed alongside Pfizer, in babies as young as six months old citing an interview Sahin conducted German magazine Spiegel. Results from trials testing the vaccine in kids between the ages of five and 12 will be available in July, Sahin said.
Pfizer will begin shipping doses of its mRNA vaccine made in the U.S. to Canada starting next week, citing a senior official.
Moderna will more than double the size of its manufacturing facility in Norwood, Massachusetts, which will support a 50% increase in production for the company’s mRNA COVID-19 vaccine at the site.
Moderna has been forced to deal with contamination reports shrouding its vaccine vials in Japan, and now it’s Pfizer’s turn. Five unused vials of the company’s mRNA jab from the same lot were found to have white floating matter in them, although the company maintains the substance was likely ingredients that hadn’t fully dissolved.
Vaccine mandate
The Justice Department filed a motion Tuesday urging the U.S. Court of Appeals for the Sixth Circuit, in Cincinnati, to lift a hold on the Biden administration’s vaccine mandate for companies while it is being challenged in court, The New York Times reports. The federal mandate would start in January and mandates employers with more than 100 workers require vaccination or weekly testing.
According to guidance the White House released Monday, federal contractors will have broad leeway to enforce the federal vaccine mandate, giving them flexibility to determine how they enforce the vaccination requirements for workers who refuse to be vaccinated, CNBC reports.
President Joe Biden plans to meet with the CEOs of some of America’s largest corporations in an effort to push the administration’s recent nationwide vaccine mandate. The president will appear alongside the chiefs of Microsoft, Disney and Walgreens, among others.
The vaccine mandate for federal workers and employees at large companies was expected to cause an uproar from Republican challengers. Now, Arizona has launched the first lawsuit over the White House’s order issued last week, claiming the administration is “flouting our laws and precedents to push their radical agenda,” according to the state’s Attorney General Mark Brnovich.
Merck
As Merck looks to provide access to its oral COVID-19 antiviral, molnupiravir, worldwide, the European Medicines Agency has started the rolling review process in anticipation of Merck filing a formal marketing authorization application once data are ready. This follows Merck’s application for emergency use authorization to the FDA.
Merck is in talks with several drug manufacturers to provide voluntary licenses for its oral antiviral, molnupiravir, and it also plans to join the UN-backed Medicines Patents Pool (MPP), to expand global access to the investigational drug, Mint reports, citing Merck’s India managing director Rehan Khan. The drugmaker has already inked deals with eight Indian generic drugmakers to make the drug.
India’s Hetero Labs is seeking an emergency use nod for Merck’s oral COVID-19 drug molnupiravir with local regulators after interim late-stage data showed the treatment reduced hospital admissions, led to faster recovery times early negative SARS-CoV-2 RT PCR results, Reuters reports. Merck inked production deals with several Indian drug manufacturers to expand the drug’s production, which has not yet scored regulatory approval.
Japanese drugmaker Shionogi has started testing a once-a-day COVID-19 pill that’s designed to thwart the virus before it progresses, the Wall Street Journal reports. Shionogi’s drug joins the race for an oral treatment against the virus, joining similar pills from Pfizer and Merck.
Merck’s highly anticipated oral treatment molnupiravir is now under a rolling regulatory review in Canada, the company announced. The Ridgeback Biotherapeutics-partnered drug is currently undergoing phase 3 testing in newly infected, high-risk patients.
COVID infodemic
Twitter is rolling out a feature that will make it easier for users to report vaccine misinformation. The move comes weeks after U.S. officials pushed social media giants to do more to remove false info on their platforms, the Verge reports.
The U.S. surgeon general chastised social media companies for not doing enough to prevent vaccine misinformation from disseminating online. Dr. Vivek Murthy wrote that the misinformation is a “serious threat to public health.”
Facebook defended itself from President Joe Biden’s claim that social media giants were “killing people” by allowing vaccine misinformation to proliferate online.
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Source: FiercePharma
