Editor’s note: For the latest news on COVID-19, visit http://bit.ly/AAPNewsCOVID19.
The Food and Drug Administration (FDA) has authorized Novavax’s updated COVID-19 vaccine for people ages 12 and older.
The protein-based vaccine is seen as an alternative to the mRNA vaccines from Moderna and Pfizer-BioNTech that received authorization last week. All of the updated vaccines are monovalent and are intended to better match circulating virus strains.
Novavax’s vaccine targets the omicron JN.1 strain of SARS-CoV-2, while the Moderna and Pfizer-BioNTech vaccines target omicron KP.2, which comes from the JN.1 lineage. Earlier this summer, the FDA’s vaccine advisers recommended using JN.1, but the FDA called on manufacturers to target KP.2 if feasible.
While COVID-19 levels vary by state, wastewater testing by the Centers for Disease Control and Prevention (CDC) indicates COVID levels are very high nationally and especially in the South and West. The CDC recommends everyone 6 months and older get an age-appropriate updated 2024-’25 vaccine as protection from last season’s vaccines likely has waned.
“COVID-19 continues to be a very real risk for many people, and we encourage individuals to consider getting an updated COVID-19 vaccine when eligible,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a press release Friday. “Today's authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”
The FDA provided the following dosing guidance for the updated Novavax vaccine.
- People 12 years and older who have never been vaccinated with any COVID-19 vaccine are eligible to receive two doses of the updated Novavax vaccine three weeks apart.
- People who have been vaccinated with one dose of any Novavax COVID-19 vaccine are eligible to receive one dose of the updated Novavax COVID-19 vaccine at least three weeks after the previous dose.
- People who have been vaccinated with a prior formula of a COVID-19 vaccine from another manufacturer or with two or more doses of a prior formula of the Novavax COVID-19 vaccine are eligible to receive a single dose of the updated Novavax COVID-19 vaccine at least two months after the last dose.
- For people who are immunocompromised, an additional dose of Novavax COVID-19 vaccine may be administered at least two months following the last dose of a 2024-’25 COVID-19 vaccine. Additional doses of Novavax vaccine may be administered at the discretion of the health care provider, taking into consideration the individual’s clinical circumstances.
The FDA said it expects side effects to be similar to previous versions of the Novavax vaccine. The vaccine comes in boxes of 10 prefilled syringes and is available for clinicians to order through several retailers. The 2023-'24 Novavax COVID vaccine is no longer authorized for use.
Resources
- AAP COVID-19 vaccination resources
- AAP COVID-19 dosing guide
- CDC COVID-19 Vaccination Field Guide
- AAP/Health and Human Services COVID vaccine toolkit
- Information for parents on COVID vaccines from HealthyChildren.org
- Information from the FDA on the Novavax COVID-19 vaccine
- CDC clinical considerations for administering COVID-19 vaccines
