03 Jun FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research

By Andy Studna, Applied Clinical Trials

As the fall approaches and preparations for this year’s COVID-19 vaccine rollout continue, a new FDA requirement is expected to cause delays and limit who is eligible for vaccination. On May 20, FDA Commissioner Vinay Prasad, MD, MPH; and FDA Vaccine Chief Martin A. Makary, MD, MPH, authored an article published in The New England Journal of Medicine (NEJM) announcing the agency’s expected requirement that any new COVID-19 vaccines will be required to undergo testing in placebo-controlled trials.¹

“Although the rapid development of multiple COVID-19 vaccines in 2020 represents a major scientific, medical, and regulatory accomplishment, the benefit of repeat dosing—particularly among low-risk persons who may have previously received multiple doses of COVID-19 vaccines, had multiple COVID-19 infections, or both—is uncertain. The American people, along with many health care providers, remain unconvinced,” Prasad and Makary wrote in the article. Read more…