FDA to Mandate Placebo-Controlled Trials for New Vaccines (1)

The US Food and Drug Administration will require all new vaccines to undergo placebo-controlled trials before approval — a policy shift that could reshape how immunizations are developed.

The change will bring “radical transparency to the American public,” said Andrew Nixon, a spokesman for the Department of Health and Human Services, in an email to Bloomberg.

Under the new policy, vaccines must go through safety trials in which some participants receive a placebo injection before the shot can be licensed. For diseases with an existing vaccine, such studies have rarely been conducted due to ethical concerns, as they involve withholding ...