A federal advisory committee Tuesday recommended a fourth COVID-19 vaccine be authorized for use in the Unites States, this one from Novavax, a Gaithersburg, Maryland-based company.
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 now been recommended as a second choice, because of an extremely rare, but potentially lethal side effect.
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.
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 also sign off on the vaccine. That process is likely to take a few weeks at least.
Novavax has said it has millions of doses available and ready to be shipped once it receives authorization.
At this point, the Novavax vaccine would be authorized only for use in adults and only for the initial two doses. The company has already submitted a request, which the FDA is considering, to provide the same vaccine as a booster dose.
The original two-dose Novavax vaccine was shown to be safe and 90% effective in a large study conducted in late 2020 and early 2021.
New variants have emerged since the vaccine was tested, but Novavax officials said they are confident the vaccine will continue to 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.”
Novavax is currently conducting research to see if 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 also 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 that is seen after infections and also, less commonly, after some of the COVID-19 vaccines.
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 an open question. Panel members said they support some 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 a adjuvant to boost its effectiveness. The protein-based technology has also been used in other vaccines.
The spike protein found on the surface of the coronavirus that causes COVID-19 is manufactured in insect cells and then delivered, along with the adjuvent, inside a nanoparticle. The immune system learns to recognize this spike protein and attack it when seen again on the actual 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 then trains the immune system. Although mRNA technology was being 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 combatting 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 still 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, also supported the idea of providing another option to the public.
“mRNA vaccines are a great gift to humanity,” he said. But, he added “there’s always an opportunity to improve.”
Contact Karen Weintraub at firstname.lastname@example.org.
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