Two University of Pennsylvania vaccine authorities strongly criticized the U.S. Department of Health and Human Services’ (HHS) recent announcement of a change in vaccine policy requiring all new vaccines to undergo placebo-controlled trials before receiving a license.
Speaking at a virtual seminar titled “New Rules for Vaccine Approval,” organized by Penn’s Leonard Davis Institute of Health Economics (LDI) and the nonprofit news organization Tradeoffs, Paul Offit, MD, and Alison Buttenheim, PhD, MBA, questioned the accuracy of the HHS statements, expressed confusion about the meaning of certain wording, and warned that switching to such a system poses serious ethical and logistical problems that could directly affect the availability of crucial vaccines and the health of large numbers of Americans.