Novavax submits Covid vaccine data package to FDA, its last step before emergency use application
Novavax Inc. on Friday submitted what it says is its final data package on its Covid-19 vaccine to the Food and Drug Administration, the last step before submission of an application for emergency use authorization for the shot.
The data submission “fulfill[s] the prerequisites” for the emergency use authorization (EUA) application request, according to a press release. Novavax (NASDAQ: NVAX) said it intends to apply for the EUA in one month, the minimum amount of time allowed after submission of the data package, according to FDA guidelines.
That would mean that Novavax’s application for emergency use authorization could go in by the end of January, roughly six months after the first goalposts it set for that milestone.
The latest data package includes information on “the complete chemistry, manufacturing and controls module,” according to the press release. The manufacturing piece was one of the earlier hiccups that delayed Novavax’s submission, it said in SEC filings in 2021.
The Gaithersburg biotech has meanwhile pursued emergency authorizations in other parts of the world, however, landing those permissions in Indonesia, the Philippines, India and Europe, as well as from the World Health Organization.
The emergency authorization in India was received in conjunction with the Serum Institute of India Pvt. Ltd. (SII), which will manufacture the vaccine there for that market. The data the company submitted Friday to the FDA "leverages Novavax' manufacturing partnership" with SII, the local company said, and will be followed by additional submissions of supplemental data "from additional manufacturing sites across Novavax' global supply chain," Novavax said in the press release.
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