FDA decision on Novavax’s Covid shots could be delayed

A health worker prepares a dose of the Novavox vaccine as the Dutch health service launches the Novavox vaccine program on March 21, 2022, in The Hague, the Netherlands.

Patrick Van Katwijk | Getty Images

The Food and Drug Administration should review the changes NovavoxThe biotech company’s Covit-19 vaccine is in the manufacturing process before being approved in the United States, an agency spokesman said Wednesday.

On Tuesday, a panel of FDA’s independent vaccination experts voted overwhelmingly to recommend the use of Novavax’s vaccine in the United States.

During the epidemics, after approval by the committee, the FDA quickly moved to approve the Govt footage. Pfizer, Moderna, And Johnson & Johnson The vaccine was approved by the FDA the day after the panel recommended the use of the Novavox vaccine in US FDA approval.

The FDA reported to the CNBC on June 3, just days before Novavox’s review of the vaccine’s safety and efficacy data, that it had informed the agency of changes in its manufacturing process.

“The FDA will carefully review this and other information submitted by the company as part of its current assessment and before approving the vaccine for emergency use,” FDA spokeswoman Abby Capopianko told CNBC.

The FDA is not obligated to follow the panel’s recommendation with its approval, although the company usually does. Capobianco said it would consider the FDA panel’s recommendation when deciding whether to approve the Novavax vaccine.

Novavax, in a statement, shared updated information with the FDA about its manufacturing process improvements. Biotech will not provide any further details.

FDA accreditation will allow Novavox to launch shipping doses from its production partner, the Serum Institute of India, to the United States. However, the Centers for Disease Control and Prevention must sign the vaccine before dispensing pharmacies and other health care providers.

Novak was one of the original participants in the US government’s race to develop the Govt vaccine in 2020, earning $ 1.8 billion through Operation Warp Speed. However, the small Maryland biotech company struggled to create a new production platform and its medical data came much later than Pfizer or Moderna, which rolled their displays at astounding speed.

Novavox asked the FDA in late January to approve its two-dose vaccine. Dr. Doreen Fink, a senior official with the FDA’s immunization division, told CDC consultants that reviewing NovaVox’s application in April was “incredibly complicated” because it included medical and product data.

The vaccine is still awaiting approval in the United States, and Novavax has begun releasing its footage worldwide. The biotechnology company’s displays are recognized in more than 40 countries, including Australia, Canada, and the European Union. Dr. Peter Marx, head of the FDA’s immunization division, said the United States has high regulatory standards for vaccines and does not base its findings on recognition in other countries.

“We take production very seriously,” Marx told the FDA panel on Tuesday. “We do not rank ourselves against other countries when it comes to production. We consider ourselves to have the highest quality, which is why we are often regarded as the gold standard for our production, especially in the area of ​​vaccines.”

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