Novavax, Inc. (NASDAQ:NVAX) said its Covid-19 vaccine was recommended for approval by the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee.
The committee voted to recommend Emergency Use Authorization (EUA) for the Novavax Covid-19 vaccine (NVX-CoV2373) for people aged 18 years and over, the biotechnology company said in a statement.
The FDA usually follows the committee’s recommendations, though it is not obligated to do so. The agency could clear the Novavax vaccine for distribution in the US as soon as this week, CNBC reported.
If the FDA approves the EUA, the Novavax shot would become the first protein-based Covid-19 vaccine available in the US.
"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based Covid-19 vaccine developed using an innovative approach to traditional vaccine technology," said Stanley C Erck, president and CEO of Novavax.
“Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision," he added.
The Novavax Covid-19 vaccine has been approved for use in individuals aged 18 and over in more than 40 countries, in addition to Emergency Use Listing from the World Health Organization.