FDA OKs Novavax COVID Vaccine as First Booster Shot

Americans will now have another choice if they want a COVID booster shot.

On Wednesday, the U.S. Food and Drug Administration approved Novavax Inc.'s protein-based vaccine as the first booster dose. Until now, it had only been approved as a two-dose primary series.

"The U.S. now has access to the Novavax COVID-19 Vaccine, adjuvanted, the first protein-based option, as a booster," Novavax President and CEO Stanley Erck said in a news release. "According to CDC data, almost 50 percent of adults who received their primary series have yet to receive their first booster dose. Offering another vaccine choice may help increase COVID-19 booster vaccination rates for these adults."

Only 35,300 people have received Novavax’s shots as a primary series so far in the U.S., according to data from the CDC. By comparison, some 372.5 million Pfizer shots, 235.8 million Moderna doses and 18.9 million Johnson & Johnson shots have been administered across the U.S. so far.

Who's eligible for the Novavax booster?

The Novavax booster could be used by adults who can't find or are not able to use an mRNA booster from Pfizer or Moderna. It's also available to people who prefer this vaccine for a booster over the mRNA options. The Novavax booster can be given at least six months after the primary series.

What makes Novavax different from the others?

The Novavax vaccine uses a more traditional approach to fighting the virus, teaching the immune system to recognize modified fragments of the coronavirus spike protein.

Scientists created the vaccine from a genetic sequence of the original strain of the virus. Vaccines that fight hepatitis B and pertussis are also made in this way.

Protein-based vaccines like the Novavax shot teach the immune system to recognize little modified pieces of the virus that the vaccine is targeting. When this happens, fragments of the coronavirus spike protein. The vaccine was created out of a genetic sequence of the original strain of the coronavirus.

News of the FDA’s authorization of Novavax’s boosters comes as millions of Americans have already received Pfizer’s and Moderna’s new bivalent shots that target the dominant omicron BA.5 subvariant and the original strain of COVID.

Novavax’s newly authorized booster, on the other hand, is a monovalent shot and was developed against the original strain of COVID. However, the company believes its protein technology provides durable protection across different variants of the virus.

In fact, Novavax said its booster doses triggered robust antibodies against omicron BA.1, BA.2 and the dominant BA.5 subvariant in studies that observed adults who received the third shot 8 to 11 months after receiving their Novavax primary series.

The booster dose also induced an immune response in participants who received Moderna, Pfizer and Johnson & Johnson as their primary series, according to the company.

The company believes that its vaccine can continue to provide durable protection even as the virus continues to evolve.

“We think we have a product that has a broad immune response, so we’re not going to be chasing the virus each time a new a new variant crops up. That needs to be proven but that’s our hypothesis,” according to Dr. Filip Dubovsky, Novavax’s chief medical officer.

What side effects can you expect?

The most common side effects of Novavax’s vaccine are pain at the injection site, fatigue, headache, muscle pain, nausea and vomiting, according to the Centers for Disease Control and Prevention.

The FDA has also warned that Novavax’s primary series appears to carry a risk of heart inflammation called myocarditis. Pfizer’s and Moderna’s shots also carry an elevated risk of myocarditis primarily in young men and adolescent boys after the second dose.

Public health officials are encouraging people to get their boosters. About 68% of U.S. residents have had an initial COVID vaccine series, but only 33.5% have received boosters, CDC data shows. Novavax's vaccine is one of four options available in the United States now.

For more on COVID-19 vaccines, visit the CDC.