U.S. FDA grants the use of Novavax COVID-19 Vaccine, Adjuvanted as a booster for adults

INDIANANovavax’s Covid-19 vaccine is now available in the United States for use as a first booster dose for people 18 and older.

The US Food and Drug Administration authorized the booster shot Wednesday for adults who are at least six months past a primary Covid-19 vaccine series, and the US Centers for Disease Control and Prevention recommended its use.

Stanley C. Erck
Stanley Erck

“The U.S. now has access to the Novavax COVID-19 Vaccine, Adjuvanted, the first protein-based option, as a booster,” said Stanley C. Erck, President, and Chief Executive Officer, Novavax. “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.”

The company said its booster is for adults for whom a Pfizer/BioNTech or Moderna updated booster vaccine is not accessible or clinically appropriate, and for adults who elect to receive the Novavax vaccine because they would otherwise not get 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, and unlike the others, it uses a protein-based technology.

Protein-based vaccines like the Novavax shot teach 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.

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 ages 12 to 17.

The vaccine is based on more traditional technology than the mRNA vaccines from Pfizer and Moderna or the adenoviral vectors used in the Johnson & Johnson vaccine.

The company believes that its vaccine generates a broad antibody response because of the type of technology it uses.

The most common side effects reported with the Novavax booster were pain or tenderness at the injection site, fatigue, muscle pain, and headache.

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