Novavax’s Covid-19 Vaccine Moves Closer to FDA Authorization Decision
…Clearance in the U.S. isn’t imminent because the Food and Drug Administration must sort through a large amount of study data from several countries, a person familiar with the matter said. A decision is getting closer, however, since Novavax formally submitted an authorization request in late January.
If the shot is rolled out in the U.S., it could boost vaccination efforts that have flagged among the hesitant, according to Novavax and doctors.
…Yet Novavax struggled to match the pace of the larger and more experienced Pfizer and the richer biotech Moderna, said Roger Song, a Jefferies biotech analyst. “All the major players were much better funded,” said Dr. Song. “Novavax was an underdog and did not have the capital to do this.”
Novavax had to expand its workforce quickly and find partners to boost its manufacturing capability. By the end of 2020, it had quadrupled its workforce to around 690, then doubled it last year to more than 1,500 employees.
Novavax’s biggest challenges were in showing the FDA that it could reliably and consistently manufacture its vaccine on a mass scale, said Novavax Chief Medical Officer Filip Dubovsky.
…To win FDA authorization, Novavax had to show that its spike protein and adjuvant were the same in every manufacturing batch. The process took longer than expected, but Novavax has been able to resolve it, Dr. Dubovsky said.
“That’s why we were delayed compared to some of the other platforms,” said Dr. Dubovsky. “Because it was more difficult to convince the regulatory agencies that we had it figured out.”
…The FDA was intent on making sure Novavax’s manufacturing was up to U.S. standards, a person familiar with the matter said, after millions of Johnson & Johnson vaccines doses were ruined in 2021 because of quality-control problems at its contract manufacturer Emergent BioSolutions Inc. in Baltimore.
Yet pandemic safety protocols made it more difficult for FDA inspectors to get to Novavax’s overseas manufacturing sites, the person said.
…Novavax said that its vaccine loses some of its potency against the Omicron variant after two doses, but that a third booster shot should provide strong protection. The company is also working on an Omicron-specific vaccine, but the company said it isn’t sure yet if it will be needed.
…The FDA will review Novavax’s application “as expeditiously as possible,” an FDA spokeswoman said. The agency plans to hold an advisory-committee hearing before it makes a decision on authorizing Novavax’s vaccine, she said. A date hasn’t been scheduled.
www.wsj.com/articles/...iTSR0q89-_HFuWnvk6crA-NREws0NXxH5unO8
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