FDA authorizes updated Novavax COVID-19 vaccine

The Food and Drug Administration authorized for emergency use an updated Novavax COVID-19 vaccine for individuals aged 12 and older, providing a non-mRNA alternative to the Moderna and Pfizer vaccines. As part of the action, the original Novavax COVID-19 vaccine is no longer authorized for use. 

Under the updated emergency use authorization, people previously vaccinated against COVID-19 may receive one dose at least two months after the previous dose and unvaccinated individuals may receive two doses administered three weeks apart. Immunocompromised individuals may receive an additional dose at least two months later, and additional doses at the discretion of their health care provider. Novavax expects the vaccine to be available nationwide in the coming days.

Peter Marks, M.D., director of the FDA’s Center for Biologics Evaluation and Research, said the updated 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. As we head into the fall season and transition into 2024, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants.”