HHS to mandate placebo-controlled trials for new vaccines

The US Department of Health and Human Services has announced a sweeping change to the way new vaccines are evaluated, saying it will now require all future vaccines to undergo testing in placebo-controlled trials before being approved for use.

In a statement issued Wednesday, the department said the move represents “a radical departure from past practices” and that it will apply to all new vaccines submitted for licensure.

The decision has already raised questions about how this policy could affect seasonal updates to COVID-19 boosters, which have until now followed a streamlined process similar to that used for flu shots.