The best American health service plans to require placebo tests for all vaccines in order to offer “simple” public health information, but experts say that such tests could limit availability and raise ethical concerns.
In a statement given for the first time to the Washington Post, the Ministry of Health and Social Services (HHS) said this week: “All new vaccines will undergo security tests in placebo tests before the license to make a license – a radical difference in past practices”.
The agency has not provided details on “new vaccines”.
But officials suggested that the updated COVVI-19 plans could be included, which, according to vaccine experts, could slow down access to vaccines.
Peter Lurie, a former official of Food and Drug Administration (FDA), said: “It is difficult to say exactly what is proposed”.
“But, largely, if they mean that each modification of an existing vaccine would require a new placebo controlled trial, they walk on an ethically doubtful territory likely to refuse Americans vital vaccines at a given time.”
HHS did not offer details on the calendar of the placebo plan or specified the vaccines involved.
An HHS spokesman told the BBC in a statement that the Secretary of Health, Robert F Kennedy Jr, the objective of “radical transparency” means to be “honest and direct on what we know – and what we do not know – about medical products, including vaccines”.
The press release indicates that none of the infant vaccines recommended in the United States – with the exception of cocovated shooting – had undergone “placebo inert” tests, which means “we know very little the real risk profiles of these products”.
But public health experts say that the declaration is misleading, because infant vaccinations, including those of hepatitis A and B, rotavirus, polio and mumps, were all initially tested against a placebo. In fact, all new immunizations are already going through tests – one type of random tests where a test group receives vaccination, and the other obtains a placebo, like a saline solution.
But the new versions of the shots may not go through the same process, because it is considered contrary to the ethics of refusing a photo known to be sheltered from a particular group, and because the plan is only minorly changed, have said vaccine experts.
Coronavirus stroke, for example, has already undergone rigorous security tests, said Paul Offer, director of the Vaccine Education Center at the Philadelphia children’s hospital.
“We have a lot of information on the security of the vaccine,” he said. “All we are doing this year is to use a different omicron variant that we used last year and the previous year.”
However, the FDA commissioner, Marty Makary, said this week that the agency “glanced” at the Coronavirus shots updated, telling the American partner of the BBC CBS News that there is a “vacuum”.
An HHS spokesperson told the BBC that “important updates of existing vaccines” could be considered “new products” requiring additional clinical assessment.
“A four-year trial is not a white verification for new vaccines each year without clinical trial data, unlike the flu vaccine that has been judged and tested for more than 80 years,” said the spokesperson.
Obligning businesses to perform placebo tests for simple upgrades of established vaccines would be expensive – and drug manufacturers could finally decide to give up the most effective versions of the vaccine, said Dr. Lurie.
Before taking office – and since assuming the role of secretary – Kennedy has disseminated false complaints on vaccine safety. His mandate coincided with one of the worst measles epidemics in a decade; Two children died and 660 people were infected with Texas.
This week, he encouraged parents to “do their own research” on the measles vaccine – which has been considered safe and 97% effective for decades – and raised questions about whether the shot could cause convulsions or neurological problems.
For months, he sometimes approved the ROR shot and, at other times, called this a “personal” decision. Kennedy has also promoted alternative treatments, which doctors say that patients should not use without medical supervision.
