FDA asks Novavax for post-approval data on COVID vaccine, raising hopes for green light
- Shidonna Raven
- 10 minutes ago
- 2 min read
April 23, 2025
Source: Reuters
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Shares rise about 19% as analyst points to "increased odds" of approval
Novavax plans to work "expeditiously" to address agency's request
Post-approval studies conducted to further test the safety of vaccines or treatments
April 23 (Reuters) - Novavax (NVAX.O), opens new tab said on Wednesday the U.S. Food and Drug Administration had asked the company to produce more data on its COVID-19 vaccine if it was approved, sending its shares soaring after an earlier missed deadline raised doubts about the shot's future.
The company is seeking to convert the vaccine's emergency use authorization received in 2022 into a full approval that would allow for expanded use of the shot and position it better against messenger RNA shots from rivals Moderna (MRNA.O), opens new tab and Pfizer (PFE.N), opens new tab-BioNTech ..
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Novavax said it would work with the agency to "expeditiously" address its request and "move to approval as soon as possible." Its shares rose 19% to $7.45 in morning trading.
There were previously questions over the FDA's review of the vaccine, especially after the agency's missed April 1 deadline and with Health and Human Services' secretary Robert F. Kennedy Jr. attributing the delay to the shot's composition in a CBS interview earlier this month.
"I think the odds for approval went up quite a bit," B Riley analyst Mayank Mamtani said, adding that the FDA request gave investors clarity on the path to approval in light of comments from Kennedy, a former environmental lawyer and longtime vaccine critic.
Novavax's protein-based technology offers an alternative to mRNA vaccines, which have received traditional approval after being authorized for emergency use in 2021.
Postmarketing commitments are studies or clinical trials that a company has agreed to conduct after a vaccine or drug is approved, to further test their safety or optimal use.
The FDA's request comes at a time of mass layoffs at the agency, including of high-ranking scientists, as part of a major overhaul under Kennedy.
The restructuring has prompted concerns that the regulatory review of treatments and vaccines could be disrupted.
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