All new vaccines in the US are to undergo placebo testing instead of being tested only against other vaccines or drugs, under instructions from Health and Human Services Secretary Robert F. Kennedy Jr. The Washington Post has the story.
Health and Human Services Secretary Robert F. Kennedy Jr. intends to shift the way vaccines are tested, a move that the agency said will increase transparency but that medical experts fear could limit access to vaccines and undermine the public’s trust in immunisation depending on its implementation.
The potential change outlined in a statement says all new vaccines will be required to undergo placebo testing, a procedure in which some people receive the vaccine and others receive an inert substance — such as a saline shot — before the results are compared.
“All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices,” an HHS spokesperson told The Washington Post in response to questions about Kennedy’s comments on the measles vaccines and general vaccine policy.
Vaccines for new pathogens are often tested this way. But for well-researched diseases, such as measles and polio, public health experts say it makes little sense to do that and can be unethical, because the placebo group would not receive a known effective intervention.
HHS did not clarify how the change will be implemented and for which vaccines the testing would apply, nor did it define what the department meant by “new vaccine”. But the Government indicated it wouldn’t apply to the flu vaccine, which is updated year to year and which HHS stated “has been tried and tested for more than 80 years”. In response to questions about whether other vaccines previously safety tested would be newly scrutinised, the department focused on its concerns around the coronavirus vaccine but did not address other immunisations.
Kennedy has long disparaged vaccines, said they are not adequately safety tested and previously called for placebo testing for vaccines that are approved for use.
“Secretary Kennedy is not anti-vaccine — he is pro-safety, pro-transparency, and pro-accountability,” HHS said in a statement.
The HHS statement raised concerns among medical and public health experts who said the move could be a significant shift in how the country has ensured the safety of vaccines for decades, as well as cast doubt on vaccines that are safe, effective and key to public health. The potential change comes as public trust in vaccines continues to decline amid a growing measles outbreak and worries over Kennedy’s mixed messaging about immunisations.
Medical and public health experts also expressed dismay that the testing change could require coronavirus vaccines, and potentially others, to undergo costly and, in their view, unnecessary studies that would probably limit vaccine production and access — and leave more Americans at risk of preventable disease.
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