Updated mRNA COVID-19 Vaccines Approved

The U.S. Food and Drug Administration has approved and granted emergency use authorization for updated mRNA COVID-19 vaccines (2024-2025 formula) to include a monovalent component that corresponds to the Omicron variant KP.2 strain of SARS-CoV-2 coronavirus.

Announced on August 22, 2024, the mRNA COVID-19 vaccines have been updated with this formula to more closely target currently circulating variants and provide better protection against serious consequences of COVID-19, including hospitalization and death.

“Vaccination continues to be the cornerstone of COVID-19 prevention,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release.

These FDA actions relate to updated mRNA COVID-19 vaccines manufactured by ModernaTX Inc. and Pfizer Inc.

On August 19, 2024, Novavax Inc. announced, 'We are working productively with the FDA as they complete their review, including providing additional information as needed, and the FDA has committed to moving swiftly on regulatory authorization.'

'We expect authorization (protein-based vaccine) for peak vaccination season.'

The FDA states that vaccination is one of the most effective ways to prevent infectious diseases, disabilities, and deaths. In the U.S., routine childhood vaccines prevent many diseases, and immunization has reduced the occurrence of most vaccine-preventable diseases by over 95%.