(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 7.14% to $6.57.
The Food and Drug Administration asked the Maryland-based company to show its vaccine is effective with another study after appointees under Health Secretary Robert F. Kennedy Jr. intervened in the approval process, the report added.
Novavax did not immediately respond to a Reuters request for comment.
The additional step goes beyond what other COVID-19 vaccine makers had to do to win approval, and could be an early sign of new challenges for drugmakers hoping to get approvals, the WSJ report said.
Shares of peer Moderna fell 1.4% to $27.
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, citing a person familiar with the matter said.
The vaccine’s prospects were thrown into doubt after the FDA missed its April 1 deadline to approve the shot and U.S. Health and Human Services secretary Robert F. Kennedy Jr., in a CBS interview earlier this month, attributed the delay to the shot’s composition.
Novavax on Wednesday said U.S. regulators asked the company to produce more data on its COVID-19 vaccine if it gets full approval, sending shares soaring and easing concerns around the future of the shot.
(Reporting by Sriparna Roy in Bengaluru; Editing by Alan Barona and Tasim Zahid)
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