New COVID-19 Vaccine Cleared Without Clinical Data

The U.S. Food and Drug Administration (FDA) has cleared a new COVID-19 vaccine without using clinical data.

The new Novavax vaccine serves as an alternative to the vaccines from Moderna and Pfizer. It was authorized for emergency use.

According to a press release from the FDA, the agency used “manufacturing and nonclinical data to support the change to the 2024-2025 formula.”

Despite the lack of clinical data, Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research, said that the new 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 authorization comes as the FDA recently approved updated mRNA COVID-19 vaccines for Moderna and Pfizer.

Novaxax declared in its own press release that the newly-authorized vaccine is the “only protein-based option available in the U.S. for use in individuals aged 12 and older to prevent COVID-19.”

The vaccine authorization follows the U.S. Department of Health and Human Services (HHS) announcing a new campaign to increase the distribution of COVID-19, influenza, and RSV vaccinations.