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3mo ago

HHS Mandates Placebo Trials for New Vaccines, Raising Concerns Over COVID Booster Delays

Under Secretary Robert F. Kennedy Jr., the new policy marks a major shift in vaccine approval standards, sparking fears of delays in updated COVID-19 shots and ethical challenges.

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U.S. Health Secretary Robert F. Kennedy Jr. speaks during a cabinet meeting held by U.S. President Donald Trump at the White House in Washington, D.C., U.S., April 30, 2025. REUTERS/Evelyn Hockstein
WASHINGTON, DC - APRIL 30: Health and Human Services Secretary Robert F. Kennedy Jr. attends a Cabinet meeting at the White House on April 30, 2025 in Washington, DC. Trump convened the meeting as reports released today say the U.S. economy contracted 0.3% in the first quarter of 2025, the first negative reading in three years, fueled by a massive surge in imports ahead of the administration's expected tariffs. (Photo by Andrew Harnik/Getty Images)

Overview

  • The Department of Health and Human Services (HHS) will now require placebo-controlled trials for all new vaccines, excluding flu vaccines, as part of a new policy announced on May 1.
  • Experts warn that the requirement could delay the availability of updated COVID-19 boosters by months, potentially putting vulnerable populations at greater risk during the upcoming fall season.
  • HHS has criticized current vaccine safety monitoring systems, such as VAERS and VSD, as inadequate and pledged to develop new infrastructure for more accurate risk–benefit assessments.
  • The FDA's delayed approval of Novavax's COVID-19 vaccine highlights the challenges of adapting to these new standards, with additional clinical trials now being required.
  • HHS has also announced a $500 million investment into developing a universal vaccine platform using inactivated, whole-virus technology to address pandemic-prone diseases.