HHS to require all “new vaccines” to be tested against placebo

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HHS Introduces Mandatory Placebo-Controlled Trials for All New Vaccines

The U.S. Department of Health and Human Services (HHS) will now require all new vaccines to be tested against an inert placebo in randomized controlled trials prior to approval, a significant shift from prior procedures where most vaccines were compared to existing vaccines or standard care1 2 3 5.
This policy is being led by HHS Secretary Robert F. Kennedy Jr., who has pledged "radical transparency" in vaccine safety and criticized previous practices, claiming they suppressed information about vaccine injuries and eroded public trust1 5.
The only exception to this new requirement is the influenza vaccine, which will remain subject to existing testing protocols due to its long history of established testing and use5.
COVID-19 vaccines initially underwent placebo-controlled trials during their emergency use authorization phase; however, annual COVID-19 boosters have not, and experts warn the new policy could delay timely updates for vaccines targeting rapidly evolving pathogens, such as influenza and COVID-191 2 5.
Public health experts, such as Dr. Paul Offit, caution that requiring placebo-controlled trials for every new vaccine could slow vaccine development, potentially leaving populations at risk longer and impacting overall vaccine availability and affordability2 5.
The policy is part of a broader HHS initiative to enhance vaccine safety monitoring systems and ensure both the risks and benefits of new vaccines are rigorously assessed and transparently reported1 4.