FDA to issue guidance for vaccine developers about new variants


The U.S. government plans to provide additional guidance about new strains of SARS-CoV-2 to companies that have developed or are developing new tests, treatments, and vaccines. The Food and Drug Administration said Thursday it’s already discussing with companies how the new variants may affect the efficacy of their products. This includes makers of monocolonol antibodies, which are thought to be negatively affected by B.1.351, a more infectious strain that emerged from South Africa. Eli Lilly & Co.
and Regeneron Pharmaceuticals Inc.
both have authorized COVID-19 antibody treatments. The regulator also said it believes that currently available vaccines still prevent infections with the virus and that most currently available tests are also still effective at detecting the coronavirus. It previously said that three tests may be impacted by new variants. “We do not believe there will be the need to start at square one with any of these products,” the FDA said. “We recognize we are in a pandemic.”


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