FDA to streamline approval for vax updated to protect against virus variants

 Peter Marks, MD, director of the FDA's Center for Biologics Evaluation and Research, said the agency is working to streamline the process for authorizing COVID-19 vaccines after they have been updated to protect against new variants of the novel coronavirus, according to The Hill.

During a Jan. 29 webinar hosted by the American Medical Association, Dr. Marks said the agency would work to "get these variants covered as quickly as possible."

Dr. Marks also said updated COVID-19 vaccines would not have to complete another phase 3 trial to ensure efficacy. Rather, they will be required to go through "some small clinical trials" to ensure they incite an immune response and protect against both the new variants and earlier versions of the novel coronavirus.

Experts have not reached a consensus on whether updated vaccines are necessary, but the possibility is being pursued, as B.1.351, the variant first identified in South Africa, has shown it diminishes the effects of COVID-19 vaccines to varying extents.

Vaccines using the mRNA platform, like the ones developed by Moderna and Pfizer, are relatively easy to update for protection against new virus variants. However, experts recommend as many people as possible be vaccinated with current vaccines to slow the spread of the virus, which continues to spread and mutate.

https://www.beckershospitalreview.com/pharmacy/fda-to-streamline-process-to-approve-vaccines-updated-for-protection-against-virus-variants.html