A key U.S. FDA committee has recommended nearly unanimously that the agency grant an emergency authorization to a COVID19 vaccine from Novavax, opening the way for the first protein-based COVID-19 vaccine to become available to people in the U.S.
A key committee of advisers to the U.S. Food and Drug Administration today recommended nearly unanimously that the agency grant an emergency authorization to a COVID-19 vaccine from Novavax, opening the way for the first protein-based COVID-19 vaccine to become available to people in the United States.
Still, Gellin said, “This vaccine has incredible potential.” It is easy to store and transport, lasting at refrigerator temperatures for months, unlike the dominant messenger RNA vaccines. Just days before today’s meeting, the company’s stock price tumbled when FDA published data indicating that the vaccine may rarely cause myocarditis and pericarditis, a problem that has also dogged mRNA vaccines from Moderna and Pfizer-BioNTech. Perhaps in response to the volatility, NASDAQ froze trading of the stock today before the meeting opened.
Novavax’s vaccine, which is produced in insect cells and combined with an immune-boosting substance called an adjuvant, has already been authorized in more than 40 countries including the United Kingdom, Canada, Germany, and Australia; it has also won emergency authorizations from the European Union and the World Health Organization.
Novavax countered that collectively across all of its clinical trials, the risk of myocarditis and pericarditis was not significantly different in the vaccine group and in the placebo groups . “We believe that the totality of the clinical evidence here is not enough to establish an overall causal relationship with the vaccine,” Denny Kim, Novavax’s chief safety officer, told the FDA advisers.
“Having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccines,” Marks replied, noting that the law “allows us some leeway” to address unmet needs. “Anything we can do to get people … to be able to accept these potentially lifesaving medical products is something that we feel we are compelled to do.”
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