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Photo: Michael Sohn/POOL/AFP via Getty Images

Developers for COVID-19 therapeutics, vaccines and testing do not need to conduct large and lengthy clinical trials to address new coronavirus variants, new guidance from the Food and Drug Administration said Monday.

Why it matters: Mutated versions of the coronavirus threaten to prolong the pandemic, possibly for years to come — especially if current treatments are rendered less effective. The FDA's updated recommendations could greatly accelerate the emergency authorization process to address these concerns.

The state of play: The vaccines authorized by the FDA — produced by Moderna and Pfizer-BioNTech — have still been found to be effective against the new variants, but both companies have announced plans to modify their vaccines to better protect against mutations.

  • Any adjustments developers make for new variants would need small trials, like those required for annual flu vaccines.
  • The agency has identified a few coronavirus tests that are known to be impacted by emerging viral mutations, "though at this time the impact does not appear to be significant," according to the guidance.

Between the lines: The new guidance recommends that developers consider the potential impact of viral mutations during phase 2 and phase 3 clinical trials, and it asks these companies to continuously monitor genomic databases.

  • The agency has "already been communicating with individual medical product sponsors to provide information and scientific advice as they evaluate the impact of SARS-CoV-2 variants on their products," the guidance says.

What they're saying: "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," Janet Woodcock, acting commissioner of the FDA, tweeted on Monday.

  • "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."

Go deeper

Vaccine trials fail to capture representative sample of Americans

Note: Trials occurred in the U.S. between 2011 and 2020; Population reflects average U.S. Census figures for 2011 to 2018. Source: 2021 Flores LE et al. JAMA Network Open; Chart: Michelle McGhee/Axios

U.S. vaccine trials over the past decade have not included enough seniors and Hispanic and Black adults, and show a failure to report needed demographic details, according to a study published in JAMA Network Open Friday looking at a large sample of trials.

Why it matters: By not capturing a representative sample of Americans, vaccine trials cannot fully demonstrate the safety and effectiveness for all people and miss out on an opportunity to build trust within underrepresented communities — something vitally important in the COVID-19 pandemic, two experts tell Axios.

Updated Feb 22, 2021 - Health

Fauci boss gives Trump administration credit on Operation Warp Speed

National Institutes of Health director Francis Collins tells "Axios on HBO" that the Trump administration deserves credit for the "breathtaking" speed of COVID vaccine development.

The big picture: The fact that it "got done in 11 months from when we first knew about this virus is at least five years faster than it's ever been before before," Collins said.

Ina Fried, author of Login
Feb 22, 2021 - Health

Fitbit CEO: Wearables can detect COVID and more

Fitbit started out trying to make us healthier by making us take a few extra steps. Now such wearables can help detect diseases like COVID-19 and even spot signs of depression, CEO James Park told "Axios on HBO."

Why it matters: Early detection is important for a range of health conditions, but especially so with communicable diseases like the flu or COVID-19.