FDA Offers Guidance to Vaccine, Therapeutics Companies on SARS-CoV-2 Variants

By Kelly Young

Edited by David G. Fairchild, MD, MPH, and Jaye Elizabeth Hefner, MD

The FDA has published guidance regarding SARS-CoV-2 variants for companies making vaccines, treatments, and diagnostic tests.

For instance, the agency is encouraging vaccine makers to study the effects of COVID-19 vaccines modified to target a variant both in non-vaccinated people and people already vaccinated with the original vaccine. While modified vaccines will need to be tested for their ability to provoke an immune response, they will not require randomized clinical trials with at least 2 months' follow-up like their original counterparts did.

The FDA also provided guidance on developing monoclonal antibodies that may be more effective against newer variants. Some authorized monoclonal antibodies have not been as active against certain variants. In the guidance, the FDA "strongly recommends that individual monoclonal antibody products be developed with the expectation that they will be combined with one or more monoclonal antibody products that bind to different epitopes to minimize the risk of losing activity against emergent variants."