The FDA’s decision on Novavax’s Covid shots may be delayed

The Food and Drug Administration must review changes to Novavax’s manufacturing process before it can authorize the biotech company’s Covid-19 vaccine in the United States, an agency spokesperson said Wednesday.

The FDA’s committee of independent vaccine experts voted overwhelmingly to recommend the use of the Novavax vaccine in the United States on Tuesday, after a full-day meeting where they reviewed data on the vaccine’s safety and efficacy in the United States. prevent Covid.

During the pandemic, the FDA moved quickly to clear the Covid strikes after the committee gave its approval. Pfizer, Modern Other Johnson & Johnson the vaccines received FDA clearance the day after the committee recommended their use in the US FDA clearance of the Novavax vaccine may take longer.

The FDA, in a statement to CNBC, said Novavax informed the agency of the changes to its manufacturing process on June 3, days before the committee was scheduled to review its vaccine’s safety and efficacy data.

“The FDA will carefully review this and any additional information submitted by the company as part of its ongoing evaluation and before authorizing the vaccine for emergency use,” FDA spokeswoman Abby Capobianco told CNBC.

The FDA is not obligated to follow the committee’s recommendation with its authorization, although the agency normally does. Capobianco said the FDA will consider the committee’s recommendation when deciding on the authorization of the Novavax vaccine.

FDA clearance would allow Novavax to begin shipping doses to the United States from its manufacturing partner Serum Institute of India. However, the Centers for Disease Control and Prevention would still have to approve the vaccine before pharmacies and other health care professionals can begin administering the shots.

Novavax was one of the original participants in the US government’s rush to develop a Covid vaccine in 2020, receiving $ 1.8 billion from Operation Warp Speed. However, the small Maryland biotech company struggled to build a manufacturing base from scratch, and its clinical data came much later than Pfizer or Moderna, which launched their shots at breakneck speed.

Novavax asked the FDA to authorize its two-dose vaccine in late January. Dr Doran Fink, a senior official in the FDA’s vaccines division, told CDC advisors in April that the review of Novavax’s application was “incredibly complex” because it involves clinical and manufacturing data.

Novavax, in a statement, said it shared updated manufacturing data with the FDA as it became available.

While the vaccine is still pending authorization in the United States, Novavax has begun rolling out its vaccines around the world. The biotech company’s shots have been licensed in more than 40 countries, including Australia, Canada and the European Union. Dr Peter Marks, who heads the FDA’s vaccines division, said the United States has high regulatory standards when it comes to vaccines and does not base its decisions on licensing in other countries.

“We take manufacturing very seriously,” Marks told the FDA committee on Tuesday. “We don’t compare ourselves to other countries when it comes to manufacturing, we believe we have a very high standard, which is why we are often considered a gold standard for our production, and particularly in the vaccine area.”

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