FDA advisory committee recommends EUA for Novavax COVID vaccine

Novavax’s two-dose vaccine against COVID-19 moved closer to Emergency Use Authorization (EUA) from the Food and Drug Administration yesterday when the FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 (with one abstention) to recommend the EUA, the biotechnology company said in a press release.

Already authorized for use by the WHO and more than 40 countries, NVX-CoV2373 is “a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, created using Novavax’s recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein.”

“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” Novavax President and CEO Stanley C. Erck said earlier this year, according to Good Day Bio.

Considered an alternative for people hesitant to get an mRNA vaccine, the vaccine called Nuvaxovid, is “similar in design to a flu shot that’s been available in the U.S. since 2013,” as we previously reported. The vaccine “has demonstrated 90.4% efficacy with “serious and severe adverse events were low in number and balanced between vaccine and placebo groups,” says Novavax.

Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research (CBER), told POLITICO that “having a protein-based alternative may be more comfortable for some in terms of their acceptance of vaccines.”

EUA considered likely

CNBC pointed out in mid-May that “an endorsement from the committee, which is made up of independent experts, would mean the drug regulator is almost certain to quickly authorize the two-dose vaccine for use in the U.S.”

Although FDA is not required to follow the advisory committee’s recommendation, it usually does, and EUA could be granted as soon as this week, according to Good Day BIO.

Meanwhile, Novavax has initiated “its Phase 3 strain change trial to determine if its Omicron variant-specific vaccine, NVX-CoV2515, induces superior antibody responses against the Omicron variant compared to its Wuhan prototype vaccine,” as we previously reported.

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