The FDA has given Novavax's COVID vaccine emergency use authorization for adolescents
The two-dose vaccine uses a protein-based technology, unlike the mRNA approach used in vaccines made by Pfizer and Moderna. CDC approval is still needed for ages 12-17.
The Food and Drug Administration on Friday announced that Novavax’s COVID-19 vaccine has received emergency use authorization for ages 12 to 17.
The protein-based vaccine’s emergency use must still be approved by the Centers for Disease Control and Prevention.
In July, the Novavax vaccine for adults was granted emergency authoritization by the FDA and later endorsed by the CDC.
The two-dose vaccine uses a protein-based technology, unlike the mRNA approach used in vaccines made by Pfizer and Moderna.
The Novavax vaccine injects copies of the spike protein that are grown in a lab and packaged into nanoparticles that to the immune system resemble a virus. Another difference: An ingredient called an adjuvant, that's made from the bark of a South American tree, is added to rev up the immune response.
The Moderna and Pfizer versions uses a genetic code to train the body to fight COVID by recognizing the virus’s outer coating, the spike protein, and essentially turn cells into a temporary vaccine factory. The lesser-used Johnson & Johnson option uses a cold virus to deliver those instructions.
Protein vaccines have been used for years to prevent other diseases including hepatitis B and shingles.
CDC officials said between 26 million and 37 million adults haven't had a dose of the mRNA vaccines, a population Novavax is targeting.
Safety data from a pediatric expansion of the Novavax vaccine showed it to be generally well-tolerated by adolescents, the Maryland-based company said.
"We hope that our vaccine, developed using an innovative approach to recombinant protein vaccine technology, may have a special role in adolescent vaccination based on parents' and caregivers' familiarity with protein-based vaccines used in other disease areas," Stanley C. Erck, Novavax’s president and CEO, said in a news release.