FDA Authorizes Novavax’s Updated COVID-19 Vaccine for Emergency Use

Authorization Date:
The FDA authorized the updated Novavax COVID-19 Vaccine, Adjuvanted for emergency use on August 30, 2024.

Target Population:
The vaccine is authorized for individuals aged 12 years and older.

Variant Targeted:
The vaccine specifically targets the Omicron variant JN.1 strain of SARS-CoV-2.

Administration Guidelines:

For individuals who have never been vaccinated with any COVID-19 vaccine, one dose is administered at least 2 months after receipt of the last previous dose of an original monovalent or bivalent COVID-19 vaccine.
For individuals who have been vaccinated only with one dose of any Novavax COVID-19 Vaccine, Adjuvanted, one dose is administered at least 3 weeks after receipt of the previous dose.
For individuals 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 Novavax COVID-19 Vaccine, Adjuvanted, one dose is administered at least 2 months after the last dose of the COVID-19 vaccine.

Significance:
This 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.

Previous Authorizations:
The FDA previously authorized the Novavax COVID-19 Vaccine, Adjuvanted for use as a first booster dose in individuals 18 years of age and older in October 2022.