Novavax Inc. has received an emergency use authorization (EUA) from the U.S. FDA allowing adults to receive the adjuvanted vaccine to ward off severe acute COVID-19.

Now it’s up to the CDC to weigh in. Once a policy recommendation from the CDC is received, the vaccine will be available. The agency’s Advisory Committee on Immunization Practices meets July 19 to discuss the vaccine.

Along with vaccines from Moderna Inc., Pfizer Inc.-Biontech SE and Johnson & Johnson, this is the fourth vaccine that is available in the U.S. The vaccine (NVX-CoV2373), containing the SARS-CoV-2 spike protein and the Matrix-M adjuvant, has a two-dose primary series, each dose given three weeks apart.

The U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met June 7 to discuss the requested EUA, with the FDA’s Doran Fink noting myocarditis was not at the level seen with the mRNA vaccines. The committee voted 21-0, with one abstention, to support the EUA based on data showing more than a 90% efficacy rate against all disease and 100% against moderate and severe infections.

Enthusiasm for the vaccine was high during the June 28 VRBPAC meeting due to data showing protection against omicron BA.5, the latest subvariant in the U.S., even though Nuvaxovid is based on the ancestral viral strain.

The vaccine was assessed in an ongoing randomized, blinded, placebo-controlled study at sites in the U.S. and Mexico. About 17,200 participants received the vaccine and about 8,300 received a saline placebo. Data showed the vaccine was 90.4% effective in preventing mild, moderate or severe COVID-19. Seventeen cases of COVID-19 occurred in the vaccine group and 79 cases showed up in the placebo group. No cases of moderate or severe COVID-19 were found in participants who received the vaccine, compared to nine cases of moderate COVID-19 and four cases of severe COVID-19 reported in the placebo group.

In the subset of participants 65 and older, the vaccine was 78.6% effective. The study was conducted before the delta and omicron variants appeared.

The protein-based vaccine has demonstrated broad immune response against omicron BA.4/5. On July 1, the company said its variant program is well underway and it will accelerate its focus on a bivalent booster in keeping with the FDA’s guidance. Novavax said it expects to have additional preclinical data on omicron BA.4/5 in the late summer and fall and should be able to provide the bivalent booster in the fourth quarter of the year.

The Gaithersburg, Md.-based company requested the EUA in January and inked an agreement with the U.S. Department of Health and Human Services earlier this week to secure an initial 3.2 million doses of the vaccine, should it receive the EUA and a recommendation from the CDC.