Bruce Gellin, chief of Global Public Health Strategy for the Rockefeller Foundation, said he didn't vote yes because he felt that the study data, collected in 2020-2021, was outdated for combating the omicron variant and he wanted to see more recent real-world data. The 22-member committee voted 21-0 in favor of authorizing the vaccine. The J&J vaccine uses a harmless virus to deliver the same spike protein. Although mRNA technology was developed before the pandemic, it was first used at large scale against COVID-19. The Moderna and Pfizer-BioNTech vaccines, instead, are based on so-called mRNA technology, which triggers the body to manufacture its own spike protein, which trains the immune system. The immune system learns to recognize this spike protein and to attack it when seen again on the virus. The spike protein found on the surface of the coronavirus that causes COVID-19 is manufactured in insect cells, then delivered, along with the adjuvent, inside a nanoparticle. The protein-based technology has been used in other vaccines. The Novavax vaccine is a protein-based vaccine and includes an adjuvant to boost its effectiveness. Panel members said they support language on the vaccine label clarifying that most COVID-19 vaccines appear to increase the risk for myocarditis, particularly among young men. Novavax officials said they don't think the rate of myocarditis is any higher among trial participants than the general population, but FDA officials said it remains a question. The committee spent several hours Tuesday discussing the safety of the Novavax vaccine, particularly as it relates to myocarditis, an inflammation of the heart muscle after infections and, less commonly, after some COVID-19 vaccinations. The company is prepared to "pivot" to protect against other variants as they emerge, according to the statement. Novavax is conducting research to see whether an omicron-specific vaccine or a shot that protects against both the original strain and omicron would be more protective than the current formulation. "If an omicron-specific vaccine is required in the fall, we are confident we will be ready with our vaccine." "While we will be prepared to switch to a variant strain vaccine based on omicron, it is not yet clear if an omicron-specific vaccine will be required," the company said in a statement. The two-dose Novavax vaccine was shown to be safe and 90% effective in a large study conducted in late 2020 and early 2021.Ĭoronavirus variants have emerged since the vaccine was tested, but Novavax officials said they are confident the vaccine will be effective. The company submitted a request, which the FDA is considering, to provide the same vaccine as a booster dose. The Novavax vaccine would be authorized for use in adults only in two doses. Novavax said it has millions of doses available and ready to be shipped once it receives authorization. That process is likely to take a few weeks at least. Then, a Centers for Disease Control and Prevention panel and the CDC's director must sign off on the vaccine. Peter Marks, head of the Food and Drug Administration's vaccine review division, opened Tuesday's meeting by saying that because of vaccine hesitancy – which has left about 23% of the public unvaccinated – the government should do everything within its power to offer more options.īefore the vaccine can become available, the head of the FDA must agree with the advisory panel that the benefits of Novavax's vaccine outweigh its risks. The vaccine, which was supported by $1.8 billion in taxpayer funding, relies on a more traditional approach than the vaccines from Moderna and Pfizer-BioNTech, which have been used by more than three-quarters of Americans.Ī third vaccine, from Johnson & Johnson, was used in more than 16 million people, but has been recommended as a second choice because of a side effect that's extremely rare but potentially lethal.Īccording to polling data, 73% of Americans want more vaccine choices.ĭr. Watch Video: Novavax aims to bring new COVID shot option to USĪ federal advisory committee recommended Tuesday that a fourth COVID-19 vaccine be authorized for use in the USA, this one from Novavax, a company based in Gaithersburg, Maryland.
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