FDA Recommends Emergency Use for Novavax Coronavirus Vaccine

The FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) voted 21­­­­­ to 0 in favor of recommending the Novavax coronavirus vaccine for emergency use authorization (EUA). If the recommendation is approved, Novavax will become the 4th coronavirus vaccine available to adults in the United States.

VRBPAC members voiced their support for the vaccine after reviewing data from the promising Phase 3 clinical trial — PREVENT-19 — that enrolled 30,000 US and Mexican adults. Results from the North American and UK-based clinical trials demonstrated the vaccine’s strong efficacy and safety profile. Overall, the Novavax coronavirus vaccine boasted 90.4% efficacy and few serious adverse events.

The most common adverse reactions to the vaccine were headache, nausea, vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.

Similar to Pfizer and Moderna’s vaccines, Novavax has also been troubled by indications that their vaccine may produce myocarditis after four members of the experimental arm of their UK trial were afflicted with the condition. However, there is no significant statistical evidence supporting a relationship between the vaccine and myocarditis.

In another clinical trial, Novavax tested a booster dose of their vaccine and found a well-rounded antibody response that was effective against Delta and Delta subvariants of the coronavirus. 

The Novavax recommendation from VRBPAC will positively contribute to the FDA’s final decision on an emergency use authorization. In the past, the agency has acted quickly to decide on vaccine EUAs after the VRBPAC issued its recommendation. As it stands, Novavax has already received an emergency use listing from the WHO and is authorized in 40 countries.

Novavax’s vaccine was developed with the help of the Department of Health and Human Services (HHS) and the Department of Defense (DoD). Together, the company and HHS leveraged $1.6 billion in federal funding to build the vaccine program. Novavax also partnered with DoD for a smaller $70 million agreement. As a part of their deal, the federal government will receive 100 million doses of Novavax when the product becomes available.

The vaccine differs from the currently approved mRNA vaccinations available to US citizens. It is engineered from the genetic sequence of the first strain of SARS-CoV-2 and was created using recombinant nanoparticle technology. The vaccine is administered in a 0.5 mL dose and can be stored in a standard refrigerator rather than the freezing storage containers used for Pfizer and Moderna’s vaccines.

Novavax is also presently expanding its research to include a seasonal COVID/influenza shot that would be administered annually.