A new COVID-19 vaccine, manufactured by biotech company Novavax, could be available soon in the U.S. The U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously (with one abstention) to approve the vaccine for people 18 or older, bringing it one step closer to receiving emergency use authorization (EUA). The VRBPAC vote doesn’t automatically make the Novavax vaccine available; the FDA still has to make a final decision based on the committee’s recommendation and the Centers for Disease Control and Prevention (CDC) also has to approve it. If cleared for EUA, the Novavax vaccine would be administered similarly to the Moderna and Pfizer-BioNTech vaccines: Two doses would be given 21 days apart, per a statement on the VRBPAC meeting from Novavax.
The VRBPAC members considered data from a phase 3 clinical trial on Novavax, published in the New England Journal of Medicine (NEJM) in February. The randomized, placebo-controlled trial featured 29,949 participants from December 2020 to February 2021. Over a period of three months, 77 cases of COVID-19 were reported: 14 among people who received the vaccine and 63 among people who received the placebo.
The Novavax vaccine wasn’t created to specifically protect against omicron, the subvariants of which are currently dominant in the U.S., Thomas Russo, MD, infectious disease expert at the University of Buffalo Jacobs School of Medicine and Biomedical Sciences, tells SELF. People who receive the Novavax vaccine—if cleared by the FDA and CDC—could still experience a breakthrough infection, meaning they could be infected with SARS-CoV-2, the coronavirus that causes COVID-19, even if fully vaccinated. The NEJM report said that most breakthrough infections noted during the clinical trial were caused by “contemporary” variant strains, possibly highly transmissible subvariants of omicron. That said, no severe cases of COVID-19 were reported among vaccine recipients, and the Novavax vaccine efficacy was found to be 90.4%. The study concluded that the Novavax vaccine was “safe and effective for the prevention of COVID-19.”
The Novavax vaccine is different than the Moderna and Pfizer-BioNTech vaccines in that it isn’t an mRNA vaccine. Nor is it a viral vector vaccine, as is the Janssen/Johnson & Johnson COVID-19 vaccine. The Novavax vaccine is instead a protein subunit vaccine, which works by using parts of SARS-CoV-2 (harmless proteins) to stimulate the immune system to develop antibodies that will fight the virus should you become infected with it, per the Mayo Clinic.
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The EUA of the Novavax vaccine could be a game-changer for people who have been holding out for another vaccine option, Dr. Russo says. He explains that some people were reluctant to get an mRNA vaccine, falsely believing that it could somehow alter their DNA (or other inaccurate claims circulated widely online). Given that the two mRNA vaccines we have (Pfizer-BioNTech and Moderna) are recommended over the only other vaccine currently available (J&J, which has been restricted), the new Novavax vaccine has the potential to raise vaccination rates in the U.S. because it relies on a more traditional vaccine platform. “There’s been a segment of the population that’s been hesitant that [may] go ahead and get vaccinated,” Dr. Russo says.
The way the Novavax vaccine is distributed and stored could also make a difference, Dr. Russo says. Unlike the Pfizer-BioNTech and Moderna vaccines, the Novavax vaccine doesn’t require specific cold storage. “It may improve access in certain rural parts of the country where cold storage is problematic, [such as] smaller community health centers that don’t have that capacity,” Dr. Russo says.
Last year, President Biden said that the authorization of Novavax and other vaccines could help provide COVID-19 protection globally, noting that the development of Novavax could help “countries in real need.”
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Source: SELF
