Novavax has become the next company to have an updated version of its Covid-19 vaccine approved in the US.
The Food and Drug Administration (FDA) amended the emergency use authorisation (EUA) of the Novavax Covid-19 Vaccine, Adjuvanted, for use in individuals 12 years of age and older to include the 2023-2024 formula.
Individuals 12 years of age and older previously vaccinated with a Covid-19 vaccine (and who have not already been vaccinated with a recently updated mRNA Covid-19 vaccine) are eligible to receive one dose and unvaccinated individuals receive two doses.
The updated vaccine addresses currently circulating variants to provide better protection against serious consequences of Covid-19, including hospitalisation and death.
Consistent with the totality of the evidence and input from the FDA’s expert advisors, the Novavax Covid-19 Vaccine, Adjuvanted, a monovalent vaccine, has been updated to include the spike protein from the SARS-CoV-2 omicron variant lineage XBB.1.5 (2023-2024 formula).
This authorisation follows the FDA’s recent approvals and authorisations of updated mRNA Covid-19 vaccines for 2023-2024 manufactured by ModernaTX and Pfizer.
“The Covid-19 vaccines have saved countless lives and have prevented serious outcomes of Covid-19 caused by the SARS-CoV-2 virus,” said Peter Marks, Director of the FDA’s Center for Biologics Evaluation and Research. “Today’s authorisation provides an additional Covid-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorisation.”