FDA authorizes Novavax COVID-19 vaccine for use as a first booster shot

By Jacqueline Howard, CNN

The US Food and Drug Administration on Wednesday authorized Novavax’s COVID-19 vaccine for use as a first booster dose among adults 18 and older, at least six months after completing a primary COVID-19 vaccine series.

The company announced that it has received emergency use authorization to provide a first booster dose of its vaccine to adults for whom an FDA-authorized Pfizer/BioNTech or Moderna updated booster vaccine is not accessible or clinically appropriate, and to adults who elect to receive the Novavax vaccine because they would otherwise not receive a booster dose of a COVID-19 vaccine.

Previously, the Novavax vaccine was used only as a two-dose primary series. It is the fourth coronavirus vaccine available in the United States. Unlike the others, it uses a protein-based technology.

“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 Wednesday. “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.”

In July, the FDA authorized Novavax’s COVID-19 vaccine for use as a two-dose primary series in adults, and the authorization was expanded in August to adolescents ages 12 to 17.

Novavax executives have long suggested that their COVID-19 vaccine could be used as a booster dose, even for people who got another vaccine type as their primary series.

Protein-based vaccines use a more traditional approach than mRNA vaccines like Pfizer’s and Moderna’s COVID-19 shots, teaching the immune system to recognize little modified pieces of the virus that the vaccine is targeting. In this case, that means fragments of the coronavirus spike protein. The vaccine was created out of a genetic sequence of the original strain of the coronavirus. This technology is also used for vaccines for conditions such as hepatitis B and pertussis.

As of Monday, about two-thirds of the US population (68%) is fully vaccinated with at least their initial series of COVID-19 vaccine. But only about a third (33.5%) of the population has received a booster dose of vaccine.

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