Novavax stock lost a quarter of its value Friday after a Food and Drug Administration brief ahead of its COVID-19 vaccine’s review next week raised concerns.
“Data from passive surveillance during post-authorization use in other countries indicate a higher-than-expected rate of myocarditis and pericarditis associated with the vaccine,” the briefing document noted.
“However, interpretation of these passive surveillance data is not straightforward, and further evaluation is need to inform the risk associated with the vaccine, and their outcomes, as additional data emerge over time.”
The document was supportive of the Novavax vaccine’s effectiveness, and it is still expected to be approved.
An independent advisory committee is expected to make its recommendation on emergency use authorization for the Novavax vaccine at a meeting on June 7. The committee includes independent physicians and scientists who make recommendations to the FDA, which most often follows those recommendations.
Bloomberg News, citing industry analysts, reports it is still expected to win advisory panel approval. Jeffries analyst Roger Song, who rates Novavax a buy, told Bloomberg he expects the review to be positive and nothing in the document is “really a deal breaker.”
Novavax completed its application for FDA emergency use approval more than five months ago, on Dec. 31, 2021.
The two-dose Novavax COVID vaccine is already approved for use in for use in several other countries in Asia and Europe.
If approved, the more traditional protein-based vaccine would differentiate itself from the mRNA vaccines already approved. Novavax has said some hesitant to get those vaccines may be more willing to take its vaccine.
Novavax was among early participants in the federal government’s Operation Warp Speed, receiving $1.6 billion in 2020 to develop and manufacture a COVID vaccine.
Novavax stock, which soared after it began developing its vaccine, is down more than 85% from its record high in February 2021.