Lawmakers urge FDA to expedite COVID-19 vaccine testing, consider challenge trials

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Thirty five members of the House of Representatives have signed a letter urging FDA to adopt expedited methods of testing COVID-19 vaccine candidates, including considering challenge trials of healthy individuals who are deliberately infected with the virus.

The letter to HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn acknowledges that rapid testing and approval could carry risks and says these are justified by the urgent need for a vaccine. “We write to assure you that Congress understands that a more risk-tolerant development process is likely appropriate in the case of a COVID-19 vaccine.”

The letter, dated Monday and signed by 33 Democrats and two Republicans, was led by Reps. Bill Foster (D-Ill.) and Donna Shalala (D-Fla.). Shalala served as HHS secretary for eight years in the Clinton administration.

The lawmakers said “justifiable risks may be taken by parallel testing of multiple dose levels, advancing more rapidly from phase to phase and potentially by challenge trials that involve deliberately infecting volunteers who have received candidate vaccines or placebos to confirm the efficacy of those vaccines and are at very low risk of serious disease from the infection.”

Such steps, the letter asserts, “could accelerate the emergency use and eventual licensure of vaccines that have also shown safety in larger groups by many months.”

The letter also emphasizes the need to take risks regarding the manufacturing of vaccines before safety and efficacy is demonstrated in order to deploy them as rapidly as possible. “Congress has given you clear direction and funding to invest in multiple routes to mass production for multiple plausible vaccine candidates, in advance of their testing and approval, with the acknowledgement that much of that capacity will likely go unused when the final set of vaccines is chosen for mass deployment.”

The lawmakers asked Azar and Hahn to “inform Congress immediately if it appears that mass production capabilities for significantly promising vaccine candidates are being delayed for economic reasons.” They also stressed the need for domestic production and deployment to be “robust against potential export blockades by other countries.”

At the same time, they cautioned against “hoarding” vaccines or intellectual property and called for the U.S. to be open to importation “if a better vaccine is developed, tested, and proven elsewhere in the world.”

The Republicans signing the letter were Jim Hagedorn (Minn.) and David Schweikert (Ariz.).

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