Novavax appealed to the Food and Drug Administration on Monday to provide authorization to its COVID-19 vaccine, insisting that it is an effective answer to the Omicron variant.

To date, the FDA has authorized COVID-19 vaccinations from Pfizer-BioNTech, Johnson & Johnson and Moderna for use, Novavax is already in use in over 100 countries, but it has not yet received a green light for emergency use by the FDA despite the available medical studies on the vaccine that has been published.

In one study published in the New England Journal of Medicine in December that found two doses of Novavax’s vaccine, given 21 days apart, were safe and highly effective against moderate to severe disease. Unlike the existing COVID-19 vaccines, Novavax's vaccine does not rely on the same mRNA technology and instead uses older synthesized coronavirus proteins to kick-start the body’s immune system.

In a statement, Novavax said that its vaccine demonstrated a 90% efficacy against COVID-19.

Stanley Erck, President and CEO of Novavax, expressed confidence that the FDA would look favorably upon the data it has provided for an emergency use authorization.

"We're extremely proud of the work of our teams and we look forward to FDA's review of our EUA request. 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," said Erck.

Last June, Novavax said that its vaccine had an overall efficacy of 90.4% in a Phase 3 trial conducted across the U.S. and Mexico. After the Omicron variant emerged in late November last year, Novavax announced that it would be working on a vaccine specific to Omicron but said that their two-dose vaccine proved to be effective against Omicron based on early trials.

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