A health worker prepares a dose of the Novavax vaccine as the Dutch Health Service begins the Novavax vaccination program on March 21, 2022 in The Hague, Netherlands.
Patrick Van Katwick | Getty Images
A spokesperson for the agency said Wednesday that the Food and Drug Administration needs to review changes to Novavax’s manufacturing process before it can allow the biotech company to deliver a Covid-19 vaccine in the United States.
The US Food and Drug Administration’s panel of independent vaccine experts on Tuesday voted overwhelmingly to recommend the Novavax vaccine for use in the US, after a day-long meeting in which they reviewed data on vaccine safety and effectiveness in preventing Covid.
During the pandemic, the Food and Drug Administration moved quickly to allow Covid shots after the committee gave its approval. The Pfizer, Moderna and Johnson & Johnson vaccines received FDA clearance the day after the committee recommended their use in the FDA’s approval of Novavax, which could take longer.
The US Food and Drug Administration, in a statement to CNBC, said Novavax notified the agency of changes in the manufacturing process on June 3, days before the committee was scheduled to review the vaccine’s safety and efficacy data.
“The FDA will carefully review this information and any additional information the company provides as part of its ongoing evaluation and before authorizing emergency use of the vaccine,” FDA spokeswoman Abby Capobianco told CNBC.
The Food and Drug Administration is not obligated to follow the recommendations of the commission with its mandate, although the agency usually does. Cabobianco said the FDA will take the committee’s recommendation into account when deciding whether to license the Novavax vaccine.
Novavax, in a statement, said it has shared updated information with the Food and Drug Administration regarding improvements in the manufacturing process. The biotech company will not provide any further details.
FDA authorization will 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 will still need to sign off on the vaccine before pharmacies and other health care providers begin administering the vaccines.
Novavax was one of the original participants in the US race to develop a Covid vaccine in 2020, and has secured $1.8 billion from Operation Warp Speed. However, the small Maryland biotech company has struggled to build a manufacturing base from scratch, and its clinical data came in much later than Pfizer or Moderna, which released their photos by leaps and bounds.
Novavax asked the U.S. Food and Drug Administration to approve a two-dose vaccine in late January. Dr. Doran Fink, a senior official in the FDA’s Division of Vaccines, told CDC advisors in April that the Novavax app review was “incredibly complex” because it includes clinical and manufacturing data.
While the vaccine is still pending approval in the United States, Novavax has begun spreading its shots around the world. The biotech company’s footage has been authorized in more than 40 countries, including Australia, Canada and the European Union. Dr. Peter Marks, who leads the FDA’s vaccine division, said the United States has high regulatory standards when it comes to vaccines and does not base its decisions on licenses in other countries.
“We take manufacturing very seriously,” Marks told the Food and Drug Administration committee on Tuesday. “We don’t compare ourselves to other countries when it comes to manufacturing, we consider ourselves to have very high standards, which is why we are often considered the gold standard for our manufacturing, especially in the field of vaccines.”