Novavax Files Final Data on Covid Vaccine to U.S. Regulators

(Bloomberg) -- Novavax Inc. submitted the final data package for its Covid-19 vaccine candidate to U.S. regulators, bringing it one step closer to clearance.

The submission to the Food and Drug Administration included details on chemistry, manufacturing and controls for the shot known as NVX-CoV2373, Novavax said in a statement. The company expects to file a request for emergency use authorization in one month, in line with the FDA’s guidance around such filings.

If authorized, the shot would become the fourth Covid vaccine cleared in the U.S. and the first of its kind. European regulators and the World Health Organization cleared the product this month after months of delays. Novavax has grappled with manufacturing problems despite securing some of the largest funding from the Trump administration in the early stages of the pandemic. 

Shares of the Gaithersburg, Maryland-based company slipped 7.6% to close at $143.07 in New York. The stock has fallen more than 50% since closing at a record on Feb. 8.

The Novavax product is a protein-based shot, unlike messenger RNA and viral vector vaccines that were cleared earlier.

“Novavax is committed to delivering our protein-based vaccine in the United States, where the Covid-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting,” Chief Executive Officer Stanley Erck said in a statement.

The company’s filing includes only one manufacturing site, the Serum Institute of India. Novavax said it expects to file data from other sites at a later date.

The shot could prove useful in supplying countries that have struggled to get enough doses to vaccinate their populations. However, Politico reported on Friday that Biden administration officials are concerned about the company’s ability to produce enough doses in the year ahead.

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