Scientists Urge FDA to Use Human-Specific Data to Assess Covid Vaccine Boosters

WASHINGTON, D.C.—The Physicians Committee for Responsible Medicine is urging the U.S. Food and Drug Administration to revise its authorization process for new COVID-19 boosters. The FDA recently evaluated new boosters based solely on data from mouse studies. The D.C.-based nonprofit sent a letter to the FDA’s Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research, reminding the agency of the well-known fact that mouse data often do not accurately predict human outcomes and recommending human-specific methods of evaluation instead.

The typical pipeline for medical product development involves both lab-based nonclinical tests as well as clinical trials in humans. Traditionally, nonclinical studies have relied on animal testing, but human-specific methods that can better inform human outcomes while reducing animal testing, are on the rise. Scientists have used modern technologies, such as organoids and tissue chips to test COVID products.

“The decision to rely on mouse data while skipping clinical trials is startling,” said Catharine E. Krebs, PhD, medical research specialist for the Physicians Committee. “Human-based nonclinical methods and clinical trials should be prioritized. If any testing is to be skipped, it should be the inadequate animal studies.”

Early in the pandemic, the FDA prioritized human information. As a way to expedite the development of Covid vaccines, the vaccines entered clinical trials without the extensive package of animal data. The Physicians Committee’s letter states that because the animal studies have already been run in this case, without other human-specific testing, clinical studies should be conducted to inform the decision to move forward in humans. Going forward, human-specific nonclinical methods should be used to assess product safety faster and more accurately.

To speak with Dr. Krebs or to see a copy of the letter, please contact Reina Pohl at 202-527-7326 or rpohl [at] pcrm.org (rpohl[at]pcrm[dot]org).