13/14 October 2021
On February 22, the FDA responded to the emergence of variants of SARS-CoV-2 viruses by issuing guidance for developers of vaccines, diagnostics and therapeutic products. This is intended to address current and future variants of the SARS-CoV-2 virus, the pathogen causing COVID-19. FDA Acting Commissioner Janet Woodcock, M.D. herself states:
"The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Janet Woodcock, M.D. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts. We need to arm health care providers with the best available diagnostics, therapeutics and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines."
The FDA has been preparing in advance for the possible emergence of SARS-CoV-2 variants and changes to the virus. This has included past experience with influenza and HIV, for example. The FDA is already in contact with relevant developers and manufacturers and has updated a number of guidelines for better transparency and assistance.
Regarding vaccines, the guidance document entitled "Emergency Use Authorization for Vaccines to Prevent COVID-19" from October 2020 has been updated to include recommendations for vaccine developers. It also applies to those manufacturers who have already received an emergency authorization and are seeking a change to that authorization, such as in the case of a need to adjust the vaccine to new variants....
For manufacturers of COVID-19 tests, the FDA has also published a guidance document entitled "Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests" which addresses the evaluation of what impact any variants of SARS-CoV-2 virus may have on existing test systems. There is preliminary evidence here for some tests being affected by emerging viral mutations, although the impact does not appear to be significant at this time.
FDA's guidance, "Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency," also responds to the potential impact on products to treat COVID-19. The FDA has also revised another guidance that covers drugs and biological products more broadly for COVID-19: "COVID-19:" Developing Drugs and Biological Products for Treatment or Prevention".
For more details, please see "Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants."