FDA panel recommends Novavax COVID-19 vaccine be the fourth allowed for use in US

A 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.

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.

A 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. 

According to polling data, 73% of Americans want more vaccine choices.

Dr. 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.

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Before 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. Then, a Centers for Disease Control and Prevention panel and the CDC's director must sign off on the vaccine. That process is likely to take a few weeks at least.

Novavax said it has millions of doses available and ready to be shipped once it receives authorization.

The Novavax vaccine would be authorized for use in adults only in two doses. The company submitted a request, which the FDA is considering, to provide the same vaccine as a booster dose.

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The two-dose Novavax vaccine was shown to be safe and 90% effective in a large study conducted in late 2020 and early 2021. 

Coronavirus variants have emerged since the vaccine was tested, but Novavax officials said they are confident the vaccine will be effective. 

"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. "If an omicron-specific vaccine is required in the fall, we are confident we will be ready with our vaccine."

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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.

The company is prepared to "pivot" to protect against other variants as they emerge, according to the statement.

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.

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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. 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.

The Novavax vaccine is a protein-based vaccine and includes an adjuvant to boost its effectiveness. The protein-based technology has been used in other vaccines. 

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 immune system learns to recognize this spike protein and to attack it when seen again on the virus. 

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. Although mRNA technology was developed before the pandemic, it was first used at large scale against COVID-19.

The J&J vaccine uses a harmless virus to deliver the same spike protein.

The 22-member committee voted 21-0 in favor of authorizing the vaccine. One member, Dr. 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.

"We need insights into performance, not just science that tells about its promise," he said in explaining his vote.

Dr. Michael Nelson, chief of the Asthma, Allergy and Immunology Division at UVA Health and UVA School of Medicine in Charlottesville, Virginia, said he supports providing another vaccine option for people who are allergic to existing vaccines. 

He said he expects people will need three doses of the Novavax vaccine to provide the same kind of protection seen after boosting with the mRNA shots. 

Dr. Cody Meissner, who directs the pediatric infectious disease unit at Tufts University School of Medicine in Boston, supported the idea of providing another option to the public.

"mRNA vaccines are a great gift to humanity," he said, but "there's always an opportunity to improve."

Contact Karen Weintraub at kweintraub@usatoday.com.

Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.