FDA plans to address the impact of SARS-CoV-2 variants on medical products

Feb. 5, 2021

The U.S. Food and Drug Administration (FDA) said it is developing guidance documents and considering other regulatory steps to address the impact of SARS-CoV-2 variants on tests, therapeutics, and vaccines, according to a news release.

“We have been actively assessing the impact of new strains on authorized products and continue to work with medical product sponsors and our international partners to evaluate the impact that each variant may have on effectiveness or utility of authorized medical products,” Acting FDA Commissioner Janet Woodcock, MD, said. “We have already been communicating with individual medical product sponsors to provide information as they evaluate the impact of COVID-19 variants on their products,” Woodcock added.

Specifically, the FDA said it is taking the following steps:

  •         For therapeutics, particularly virus-targeting monoclonal antibodies, the agency is considering approaches to help expedite drug development, including discussing appropriate regulatory flexibilities. “We are aware that some of the neutralizing monoclonal antibodies that have been authorized or are under development are less effective against some of the COVID-19 variants that have emerged, and we are working with drug developers to accelerate the evaluation of new antibodies that could be effective against mutations,” Woodcock said.
  •           For diagnostics, the agency has been monitoring new mutations, identifying and working with developers of tests whose performance may be adversely impacted by them, and communicating with the public when helpful information becomes available. “At this time, we believe the risk that the currently known mutations will impact overall testing accuracy of molecular tests is low. Moving forward, we are considering expanding the role of in silico monitoring by sponsors prior to and following authorization to assess for mutations that impact the performance of the test, test designs to minimize the impact of new mutations and ways to label authorized products to be transparent about what we know the test can detect,” Woodcock said.
  •          For authorized vaccines, the agency is “currently deliberating and discussing the types of data needed to support changes in the composition of the vaccine, either through altering the existing vaccine or through the addition of new vaccine component(s), including how sponsors could demonstrate immune response to new variants through streamlined clinical programs that still gather the crucial data the FDA needs to demonstrate effectiveness, but can be executed quickly to gather this data,” Woodcock said.

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