The U.S. Food and Drug Administration (FDA) has released new guidance for developers of products for COVID-19 diagnostics, vaccines, and treatments, with a particular emphasis on addressing coronavirus variants.
Among other documents, the agency has issued a policy for evaluating impact of viral mutations, which explains the effect of variants on test performance, due to a number of factors including the type of variant and test design. The guidance document provides instruction for test developers on how to design products with variants in mind and to monitor performance over time as new mutations of the virus emerge.
The guidance follows a safety alert from the agency in January warning of the risk for false-negative results on coronavirus tests due to variants.
The FDA also issued an updated version of its previously released emergency use authorization for vaccines to prevent COVID-19 guidance document. This document provides advice on modifying vaccines to ensure effectiveness against variants through clinical immunogenicity studies. It's possible that in the future, clinical studies may not need to be submitted to support use of modified versions of authorized vaccines, according to the agency.
Other guidance addresses therapeutics for the coronavirus, such as development of monoclonal antibody products targeting SARS-CoV-2, including addressing the effect of emerging variants during the COVID-19 public health emergency.