FDA ruling on Novavax Covid injections may be delayed to review manufacturing changes

A health worker prepares a dose of the Novavax vaccine as the Netherlands Health Services Organization begins the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.

Patrick Van Katwijk | Getty Images

The Food and Drug Administration must review changes to Novavaxbefore the biotech company’s Covid-19 vaccine can be authorized in the United States, an agency spokesperson said on Wednesday.

The FDA’s Independent Vaccine Expert Panel voted overwhelmingly on Tuesday to recommend the use of Novavax’s vaccine in the United States, after a day-long meeting in which they reviewed data on the vaccine safety and its effectiveness in preventing Covid.

During the pandemic, the FDA moved quickly to authorize Covid injections after the committee gave its approval. Pfizer, Modern and Johnson & Johnson’s the vaccines received FDA clearance the day after the committee recommended their use in the United States. FDA clearance of Novavax’s vaccine could take longer.

The FDA, in a statement to CNBC, said Novavax notified the agency of the changes to its manufacturing process on June 3, days before the committee was due to review safety and efficacy data for its product. vaccine.

“The FDA will carefully consider 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 told CNBC. Capobianco.

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

Novavax, in a statement, said it has shared updated information with the FDA on improvements to its manufacturing process. The biotech company did not provide further details.

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 need to approve the vaccine before pharmacies and other health care providers can begin administering the shots.

Novavax was an early entrant in the US government’s race to develop a Covid vaccine in 2020, receiving $1.8 billion from Operation Warp Speed. However, the tiny Maryland biotech company struggled to build a manufacturing base from the ground up, and its clinical data came much later than Pfizer or Moderna, which rolled out their moves at breakneck speed.

Novavax applied to the FDA to clear its two-dose vaccine in late January. Dr. Doran Fink, a senior official in the FDA’s vaccines division, told CDC advisers in April that reviewing Novavax’s application had been “incredibly complex” because it involved clinical and manufacturing data.

While the vaccine is still awaiting authorization in the United States, Novavax has begun rolling out its vaccines around the world. The biotech company’s injections 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 for vaccines and does not base its decisions on approvals 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 consider that we have a very high standard, and that’s why we are often considered a reference for our manufacturing, and in particular in the field of vaccines.”

CNBC Health and Science

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