Home » Medical Experts Urge FDA to be Tougher on COVID-19 Vaccine Trial Monitoring
Medical Experts Urge FDA to be Tougher on COVID-19 Vaccine Trial Monitoring
October 12, 2020
Dozens of medical experts from across the nation have written a letter to FDA Commissioner Stephen Hahn, Center for Biologics Evaluation and Research (CBER) Director Peter Marks and the FDA’s vaccine advisory committee calling for stronger requirements for monitoring participants in COVID-19 vaccine trials.
The letter comes on the heels of the agency’s publication last week of guidance — despite a threatened block from the White House — that outlines more stringent Emergency Use Authorization (EUA) requirements for COVID-19 vaccines.
The 62 experts who signed the letter took issue with the guidance requiring a median of at least two months of safety observation of trial participants after vaccination, arguing it doesn’t set the bar high enough.
They implored the agency to require a minimum of two months of safety observation for all trial participants. Without that requirement, a vaccine could receive authorization before many trial participants have been monitored through the period when most adverse events are seen, the experts wrote.
“There is too much at stake. Authorization of a vaccine before a high safety bar is met would severely erode public trust and set back efforts to achieve widespread vaccination. In short, premature authorization would prolong the pandemic, with disastrous consequences,” they wrote. Signers of the letter included Gail D’Onofrio, the chair of Yale University’s Department of Emergency Medicine, Tom Inglesby, director of Johns Hopkins’ Center for Health Security, and Robert Truog, director of Harvard University’s Center for Bioethics.
Concerns abound that the FDA could cave to political pressure in its efforts to verify a COVID-19 vaccine’s safety and effectiveness, and authorize one before it has proven itself in a late-stage trial. While the White House allegedly blocked the EUA guidance because the industry took issue with it, former FDA Commissioner Scott Gottlieb said he was unaware of any industry pushback and Pfizer CEO Albert Bourla said that his company had never discussed the guidelines with the White House.
