© Reuters Novavax’s (NVAX) Covid-19 Vaccine Approval in the U.S. Could Be Delayed – CNBC
By Sam Boughedda
The U.S. Food and Drug Administration’s (FDA) decision on Novavax ‘s (NASDAQ:) Covid-19 vaccine could be delayed, according to a report by CNBC.
An FDA spokesperson told CNBC that the regulatory body will have to review modifications to the drugmaker’s manufacturing process before it is able to authorize the Covid-19 vaccine in the U.S.
On Tuesday, an FDA committee of independent vaccine experts voted to recommend the Novavax vaccine for use in the U.S. following a review of safety and efficacy data.
Novavax’s vaccine is already approved in Europe and the UK.
The FDA has previously authorized other vaccines fairly rapidly, however, Novavax’s vaccine could take longer for approval. The FDA reportedly told CNBC that Novavax informed them of manufacturing process changes on June 3, only a few days before reviewing its vaccine’s safety and effectiveness.
The FDA spokesperson quoted CNBC as saying it will “carefully review this and any additional information submitted by the firm.”
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