FDA: Modified vaccines for COVID variants would not require large clinical trials

Marisa Fernandez
·2 min read

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.

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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."

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