RFK Jr. will order placebo testing for new vaccines, alarming health experts
The potential change outlined in a statement would require all new vaccines to undergo placebo testing, sparking concerns among medical experts.
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“… 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 scrutinized, the department focused on its concerns around the coronavirus vaccine but did not address other immunizations.
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. …”
“…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.
“You are watching the gradual dissolution of the vaccine infrastructure in this country,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “The goal is to make vaccines less available and less affordable.”
… Vaccine and public health experts said the statement from HHS is a combination of misinformation and exaggeration or misrepresentation of scientific studies.
“To make a blanket statement like that, I think that would go against the science,” said Sean O’Leary, a pediatric-infectious-diseases physician and chair of the American Academy of Pediatrics’ committee on infectious diseases.
… Since Kennedy became HHS secretary, the department has appointed a
vaccine skeptic to investigate the debunked link between vaccination and autism. Peter Marks, the nation’s top vaccine regulator,
resigned under pressure. And Kennedy has
not spoken as forcefully for
vaccination amid an ongoing measles outbreak as the first Trump administration did.
… And while HHS said the trials would be for “new vaccines,” if Kennedy tries to test vaccines that have already been approved, such as the measles vaccine, against a placebo, that would mean in practice some children would not get vaccinated against the infectious disease while their neighbors did — a quandary that physicians say leaves them susceptible to diseases when there is a vaccine that works.
Stanley Plotkin, a pioneer in the field who developed the rubella vaccine, said that when scientists test vaccines against a new disease, they typically look for evidence that the vaccinated individuals do not get a disease, compared with those who received a placebo.
This is how the coronavirus vaccines were tested, in 30,000-person trials in which half of the participants received saline shots.
But when a disease is already well understood, scientists can look for evidence that vaccines induce a biological response that has been scientifically shown to protect against the disease — what scientists call “a correlate of protection.”
In the case of diseases that cause serious illness and can even be fatal, if there are existing interventions, the use of placebos is often not considered ethical.
“Ethics must be taken into account when you set up a study,” Plotkin said.
“Can I ethically agree to having people acquire the disease because they receive a placebo?” …”
