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# Woodcock Addresses Covid Variants’ Impact on Products
- URL: https://www.fdaweb.com/woodcock-addresses-covid-variants-impact-on-products/
- Published: 2021-02-05T12:00:00.000Z
- Updated: 2026-09-14T16:45:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148604

FDA says it is developing guidances for developers of Covid-19 diagnostics, therapeutics and vaccines to help guide their need to adapt and pivot as new variants of coronavirus (Covid-19) are identified. “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** is [quoted in a release](https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-important-work-support-medical-product-development-address?ref=fdaweb.com) as saying.  

The agency expects modifications to products based on experience with other evolving infectious diseases. “Influenza vaccines and diagnostics are often modified each year to address the predicted predominant strains circulating globally,” Woodcock explained. “The agency has created and used regulatory processes that facilitate these updates. We will utilize our experience with influenza to help inform a path forward if SARS-CoV-2 variants emerge against which currently authorized vaccines are not sufficiently effective. Similarly, the FDA also has vast experience with HIV developing resistance to antiviral drugs and will follow regulatory pathways to quickly enable new antiviral drug development for resistant virus.”

Specifically for therapeutics (e.g., virus-targeting monoclonal antibodies), Woodcock said FDA is considering approaches to help expedite drug development in this key area, 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,” she said. “Relying on our growing experience with this class of drugs, our teams are discussing approaches to the generation and evaluation of pre-clinical, clinical and chemistry, manufacturing and controls data.”

For diagnostics, FDA believes 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,” she said.

And for authorized vaccines, FDA is discussing internally types of data needed to support changes in the composition of the vaccine due to the variants, either through altering the existing vaccine or through the addition of new vaccine components, “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.