Not so fast on Novavax COVID-19 vaccine nod: FDA says it still has to review recent manufacturing tweaks

Four months into the pandemic, in July of 2020, the United States awarded Novavax a $1.6 billion grant to hasten the tiny biotech’s development of a coronavirus vaccine.

Nearly two years later, the U.S. is still waiting for a return on its investment—and the 110 million doses the company agreed to supply in the deal.

Earlier this week, the Novavax shot appeared on the verge of its long-awaited approval as an independent FDA advisory panel voted 21-0 to recommend it for authorization.

But now the FDA says that it will have to sign off on changes Novavax recently made to its manufacturing process for the vaccine. The company informed the agency of these changes last Friday, the FDA told CNBC, four days before the agency's expert panel reviewed the application.

On Thursday, Novavax confirmed the June 3 submission, saying that it has shared relevant information with the FDA since applying for emergency use authorization back in January.

“The data is a part of the standard process improvements that have been made since submission,” a company spokesperson wrote in an email. “And on June 3, Novavax submitted an amendment with this updated manufacturing information for the EUA to the FDA for review.”

The Maryland-based company produces its vaccine with its manufacturing partner, the Serum Institute of India. The FDA conducted a successful inspection of the facility in April, Novavax added.

This could bring another in a series of delays for the vaccine, which the company originally said would be ready by May of 2021. Supply chain, manufacturing and regulatory issues have conspired to keep the jab from gaining authorization in the U.S.

In June of last year, Novavax reported 90% efficacy for the shot and 100% effectiveness in preventing severe disease. Developed with protein-based technology, the vaccine was lauded as a traditional alternative to the mRNA vaccines of Pfizer and Moderna.

But two months later, Novavax revealed in an SEC filing that the government had halted funding of the shot until the company refined its manufacturing processes.

Early this year, the company got its act together enough to win approval of the shot from the European Union and began fulfilling its pledge to supply the bloc with 100 million doses.