Novavax Asks FDA To Approve Coronavirus Vaccine

News Times Link: Novavax asked the FDA on Monday to approve a protein-based vaccine for COVID-19 for adults.
The vaccine is already available in at least 170 countries, but will become an alternative to popular mRNA-based vaccines from PfizerBioNTech and Moderna once emergency use is approved in the United States.
In certain groups of people, especially young men, mRNA vaccines slightly increase the risk of a heart disease called myocarditis. Novavax is not associated with myocarditis.
The decision will now be communicated to FDA, which is expected to take several weeks to review the application. Novavax CEO Stanley Erk said it could get US regulatory approval as early as February.
Results from a clinical trial published in the New England Journal of Medicine in December showed that two doses of Novavax given 21 days apart were safe and highly effective for moderate to severe disease.
The Gaithersburg, a biotech company based in Gaithersburg, Maryland, said two doses of the vaccine elicited a strong immune response against the micromicron coronavirus variant, but three doses were better. However, Novavax said it is developing a modified version of the vaccine designed to protect against highly contagious strains.
Unlike mRNA vaccines, which trick the body into generating harmless viral fragments to trigger an immune response, Novavax vaccines activate the body’s immune system by injecting synthesized coronavirus proteins. It uses old technology used in other commonly used vaccines, such as flu shots.
The biotech company’s FDA request comes from the fact that more than 211 million Americans have already been fully vaccinated with doses of Pfizer BioNtech and Moderna vaccines. But the Novavax vaccine offers another alternative for people who cannot or will not get an mRNA injection, experts say.
A vaccine expert at Philadelphia Children’s Hospital, Dr. Paul Offit said a broad selection of coronavirus vaccines is important, especially because mRNA injections are associated with a rare risk of myocarditis and Johnson & Johnson’s vaccine is associated with a rare risk of blood clots.

“It seems more enjoyable than that,” he said. “The more vaccines you have, the more you can find differences in a particular age group. High-risk conditions, such as people with weakened immunity, may have other benefits. You may have a different security profile.”
In 2020, the US government and Novavax have agreed to supply 110 million doses of the vaccine. Since then, the company has experienced repeated delays in increasing vaccine production and obtaining regulatory approval.
Novavax said Monday that additional studies to evaluate the safety and efficacy of a third dose of the vaccine are ongoing, as well as a study in adolescents aged 12 to 17 years.

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