The U.S. is getting another COVID-19 vaccine choice as the Food and Drug Administration on Wednesday cleared Novavax shots for adults.
Novavax makes a more traditional type of shot than the three other COVID-19 vaccines available for use in the U.S. — and one that’s already available in Europe and multiple other countries.
Nearly a quarter of American adults still haven’t gotten their primary vaccinations even this late in the pandemic, and experts expect at least some of them to roll up their sleeves for a more conventional option — a protein-based .
The FDA has approved Novavax's initial two-dose series for people 18 and older. Tens of millions of Americans still need booster shots for the coronavirus. The company hopes its shots can become a top booster choice in the U.S. and beyond.
“I encourage anyone who is eligible for, but has not yet received, a COVID-19 vaccine to consider doing so,” FDA Commissioner Dr. Robert Califf said in a statement.
Novavax CEO Stanley Erck expects the U.S. to expand use of the vaccine beyond unvaccinated adults fairly quickly. Before shots begin, the Centers for Disease Control and Prevention must recommend how they should be used. The decision is expected next week.
The Biden administration has bought 3.2 million Novavax doses so far, and vaccinations should begin later this month. Already the FDA is evaluating it for those as young as 12, Erck says. The company also has submitted data on booster doses, including "mix-and-match" use in people who'd earlier received Pfizer or Moderna vaccinations.
Sharon Bentley of Argyle, Texas, is one of the holdouts. Bentley was hesitant about the first COVID-19 vaccines but then her husband volunteered for a Novavax trial, getting two doses and later a booster.
Her husband’s positive experience with a more tried-and-true technology, “that convinced me,” Bentley said, adding that she planned to tell some unvaccinated friends about the option, too.
The Novavax vaccine is made of copies of the spike protein that coats the coronavirus. It's packaged into nanoparticles that to the immune system resemble a virus. The less-used Johnson & Johnson option uses a harmless cold virus to deliver spike-making instructions.
Typical vaccine reactions are mild, including arm pain and fatigue. FDA did warn about the possibility of a rare risk, heart inflammation.
The Novavax vaccine was tested long before the omicron variant struck. U.S. regulators are planning for a fall booster campaign using Pfizer and Moderna shots. An updated version of the vaccine could be available late in the year, Erck says.
Earlier manufacturing difficulties held up the vaccine, although Erck said those have been solved and Novavax can meet global demand. Much of the company’s vaccine, including doses for the U.S., are being produced by the Serum Institute of India, the world’s largest vaccine manufacturer.