USA – FDA working on guidance to address coronavirus variants

The US Food and Drug Administration is actively monitoring and assessing how current vaccines, therapeutics, and diagnostics are impacted by emerging COVID-19 variants and will issue guidance for ongoing medical product development against these variants.

In a recent statement, US Food and Drug Administration (FDA) acting commissioner Janet Woodcock, MD, said FDA has been monitoring potential new coronavirus variants since the start of the COVID-19 pandemic, and the agency has been actively working with medical product sponsors and international partners to evaluate the impact new COVID-19 variants have on authorized medical products.

The agency is continuing to take an “all-hands-on-deck” approach to the pandemic, she said. “As the public health agency responsible for regulating medical products, we must ensure that health care providers have the most up-to-date diagnostics, treatments and vaccines in their toolbox to fight this pandemic.”

Several SARS-CoV-2 Variants of Concern (VOC) emerged at the end of 2020 and beginning of 2021, and are responsible for a sharp increase in COVID-19 across the globe, including variants identified in the United Kingdom (VOC 202012/01, lineage B.1.1.7), South Africa (Variant 501Y.V2, lineage B.1.351) and Brazil (Variant P.1, lineage B.1.1.28)…