Key TakeawaysThe FDA has been working with companies on evaluating new and updated vaccines, diagnostic tests, and treatments for COVID-19 variants.This week, the FDA released guidance documents for companies on how to test those products.Current vaccines appear to be effective against severe disease and deaths from COVID-19 and people should be vaccinated when it is their turn.

Key Takeaways

The FDA has been working with companies on evaluating new and updated vaccines, diagnostic tests, and treatments for COVID-19 variants.This week, the FDA released guidance documents for companies on how to test those products.Current vaccines appear to be effective against severe disease and deaths from COVID-19 and people should be vaccinated when it is their turn.

The Food and Drug Administration (FDA)issued new guidancethis week for developers of vaccines, diagnostic tests, and medications specifically aimed at coronavirus variants.

In a February 22 reporter briefing about the guidance, FDA staff said that if any vaccines with emergency use authorization are changed to better target COVID-19 variants, they will not need to repeat full-fledged clinical trial testing. In an effort to save time, only hundreds—rather than tens of thousands—of participants will be included in trials. Testing will need to compare the immune response to the modified vaccine against the immune response to the currently-authorized vaccine.

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What We Know About Vaccines and the Variants

Several variants, or variations, of COVID-19 have emerged over the last few months. Health experts worry they could elude vaccines and treatments. These include variants identified in the U.K. (B.1.1.7), South Africa (B1.351), and Brazil (P.1).

Anthony Fauci, MD, chief medical adviser to President Biden, continually stresses at thrice-weekly White House COVID-19 briefings that swift vaccination can keep variants at bay.

But tens of millions of people in the U.S. still remain unvaccinated, and the country faced weather-related delays in many states last week. So the risk of infection remains high.

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What the FDA Says

The FDA had already been in touch with individual companies about evaluating the effectiveness of products against the COVID-19 variants.

“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, MD in astatementon Monday.

“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,” she said. “We need to arm healthcare 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 guidance also offers recommendations on how to efficiently test and createmonoclonal antibody treatmentsthat better target the variants, as well as how to evaluate the impact of variants on COVID-19 tests. The FDA says it will monitor publicly-available genomic databases to stay abreast of potential variations of SARS-CoV-2—something the U.K. has excelled at.

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What This Means For YouCurrently-available COVID-19 vaccines are believed to be protective against severe disease and death from COVID-19. But they may be less effective against new COVID-19 variants. While the FDA is now helping to advise companies trying to update their products to combat the new strains, for now, health experts say you should get any available vaccine. Booster shots could be considered if experts find that additional protection against virus variants is needed.

What This Means For You

Currently-available COVID-19 vaccines are believed to be protective against severe disease and death from COVID-19. But they may be less effective against new COVID-19 variants. While the FDA is now helping to advise companies trying to update their products to combat the new strains, for now, health experts say you should get any available vaccine. Booster shots could be considered if experts find that additional protection against virus variants is needed.

The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit ourcoronavirus news page.

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