Gaithersburg, Maryland-based Novavax received federal approval for a booster dose of its COVID-19 vaccine, potentially increasing Novavax’s role in vaccinations in the U.S.
The emergency use approval of the Novavax booster means the booster shot can be taken six months after completing a primary vaccination with an authorized COVID-19 vaccine.
The Food and Drug Administration specified the additional Novavax shot was to be used as a first booster — not for people who’ve already had one or more booster doses already.
Novavax has reported preclinical data that suggests its booster shot induces an immune response against Omicron variants, including BA.4 and BA.5.
“The U.S. now has access to the Novavax COVID-19 vaccine, the first protein-based option, as a booster,” said Novavax president and CEO Stanley Erck. “According to CDC data, almost 50% of adults who received their primary series have yet to receive their first booster dose.”
The Centers for Disease Control and Prevention also signed off on the decision after the FDA.
Adding Novavax to the booster mix could increase vaccination rates among adults who have been hesitant to get mRNA vaccines.
The two-dose Novavax vaccine did not receive final emergency use approval until July of this year.
In August, the company cut its sales forecast for the year on slower-than-expected sales.
The Associated Press contributed to this story.