Novavax COVID-19 vaccine wins belated U.S. authorization

First announced in January 2020, Novavax’s (Nasdaq:NVAX) NVX-CoV2373 COVID–19 has won FDA authorization for primary immunization. However, it is presently not authorized as a booster.

NVAX shares ticked up 0.27% to $69.95.

Novavax is late to the COVID-19 vaccine partner, scoring authorization more than a year and a half after Moderna (NYSE:MRNA) and Pfizer (NYSE:PFE) won emergency use authorization for their respective COVID-19 vaccines.

Gaithersburg, Maryland–based Novavax had received a $1.75 billion federal contract to develop and manufacture NVX-CoV2373.

In August, the federal government said it would not provide money for further production until Novavax addressed quality concerns.

Now that the vaccine is authorized, CDC will convene an advisory panel to advise who should obtain the two-dose vaccine.

Before the omicron and delta waves, the Novavax vaccine was 90.4% efficacious in preventing COVID-19 of any severity in. Phase 3 trial. There were no cases of moderate or severe COVID-19 in those who received the vaccine.

Before authorizing the Novavax vaccine, FDA regulators had pondered whether the vaccine could pose a risk of myocarditis. The vaccine will carry a warning that the vaccine may have a small risk of myocarditis or pericarditis.

The federal government recently ordered 3.2 million doses of the NVX-CoV2373 vaccine.

“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Dr. Robert M. Califf in a news release. “Today’s authorization offers adults in the United States who have not yet received a COVID-19 vaccine another option that meets the FDA’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

Similar to the Pfizer-BioNTech vaccine, the vaccine is administered 21 days apart.

In December, Novavax won marketing authorization in Europe for the vaccine. In Europe, 12.6 million Novavax vaccine doses have been distributed since then.

According to a survey from Morning Consult, 77% of unvaccinated adults didn’t plan on obtaining Novavax’s protein-based COVID-19 vaccine.