Novavax files data with FDA to support COVID vaccine

Novavax Inc. said it filed data Friday with the Food and Drug Administration to support clearance of its long-anticipated COVID-19 vaccine, a different kind of shot than current U.S. options.

Novavax said the data package is the last requirement before the company formally submits its emergency-use application next month to become the fourth U.S. COVID-19 vaccine. The announcement comes shortly after the European Commission and World Health Organization cleared use of the Maryland-based company’s two-dose shot.

Novavax developed a protein vaccine, similar to shots used for years against other diseases, and a strategy that might appeal to people hesitant to use COVID-19 vaccines made with newer technologies. But Novavax, a small biotech company, faced months of delays in finding manufacturers to mass-produce its vaccine.

The Serum Institute of India currently is manufacturing the vaccine. Novavax has lined up additional production facilities in the Czech Republic, South Korea, and elsewhere that are expected to eventually add to supplies.

In studies of tens of thousands of people in the U.S., U.K., and Mexico, the vaccine proved safe and 90% effective against symptomatic infection from earlier coronavirus variants. A booster dose six months later revved up protection against the recent delta variant. Novavax says it is currently testing how the shots hold up against the newest scourge, omicron.

The vaccine is made with lab-grown copies of the coronavirus spike protein and mixed with an immune-boosting chemical.