(Reuters) -Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously delaying approval, the Wall Street Journal reported on Friday, citing people familiar with the matter. Shares of the vaccine maker fell nearly 6% to close at $6.67. The stock was down more than 1% in after-market trade. […]
Health
US FDA asks Novavax to complete new clinical trial for delayed COVID-19 shot, WSJ reports
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(Reuters) -Federal regulators have asked Novavax to complete an additional clinical trial on its COVID-19 vaccine after previously delaying approval, the Wall Street Journal reported on Friday, citing people familiar with the matter.
Shares of the vaccine maker fell nearly 6% to close at $6.67. The stock was down more than 1% in after-market trade.
The U.S. Food and Drug Administration asked the Maryland-based company to show its vaccine is effective with another study after appointees under Health and Human Services Secretary Robert F. Kennedy Jr. intervened in the approval process, the report added.
Novavax said the company has responded to FDA’s Post Marketing Commitment (PMC) request and is awaiting feedback from the agency.
The vaccine maker added that its application is approvable and it looks forward to moving to approval as soon as possible, without disclosing further details.
The FDA’s request for new data gives Novavax room to negotiate for a smaller, less expensive study, perhaps costing only a few million dollars, the newspaper reported.
The vaccine’s prospects were thrown into doubt after the FDA missed its April 1 deadline to approve the shot and Kennedy attributed the delay to the shot’s composition in a CBS interview earlier this month.
Novavax on Wednesday said U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full approval, easing concerns around the future of the shot and sending its shares soaring.
This comes amid mass layoffs, including high-ranking scientists, as part of a major overhaul under Kennedy that has prompted worries about potential disruptions to the regulatory review of treatments and vaccines.
The company wants to convert the vaccine’s emergency authorization from 2022 into a full approval that would allow for expanded use and to compete better against messenger RNA shots from rivals Moderna, Pfizer and BioNTech.
Novavax’s protein-based technology offers an alternative to mRNA vaccines from Pfizer-BioNTech and Moderna, which received full approvals in 2021 and 2022, respectively.
(Reporting by Sriparna Roy in Bengaluru and Michael Erman in New York; Editing by Alan Barona and Tasim Zahid)