Health Secretary Robert F. Kennedy Jr. has announced plans that require a placebo-controlled study of all new vaccines. Some experts were surprised to find that such tests were already routine.
In a statement, Andrew Nixon, a spokesman for the Department of Health and Human Services, said before approval, “all new vaccines will undergo safety tests in placebo-controlled trials,” calling it a “fundamental departure” from existing standards.
Modern research uses placebos on a daily basis, with one exception being the Covid booster shot, which is permitted to target new strains of the evolved virus without human testing. It is unclear how the announcement will affect the availability of the Covid vaccine, which is expected to be updated in the fall.
Kennedy also announced efforts Thursday to turbo-claim the National Institutes of Health to develop new vaccinations for Covid, bird flu and seasonal flu.
The new vaccine development initiative includes methods other than mRNA technologies used to develop the dominant covid vaccines already in use, a statement from the Department of Health and Human Services said. mRNA shots are the subject of conspiracy theory, and Kennedy has criticized them vigorously.
Taken together, the move suggests that Kennedy will get far more into the details of vaccine development.
While some scientists say the quest to fully understand the potential for unexpected effects of vaccines is valuable, they also warn that doing so in a way that delays approval of life-saving shots could put public health at risk.
Kennedy's recent activities included petitioning the Food and Drug Administration to separate the Covid vaccine from the market in 2021 at the deadly stage of the pandemic. He also urged the FDA not to approve Covid shots for children.
When asked about how the new testing policy will affect Covid booster shots, Nixon suggested that new exams could be requested. The vaccine, approved by the FDA, was initially studied in a large-scale trial against placebo, but Kennedy and others have criticised the lack of clinical trials for boosters.
“As I said before, the trials conducted on people who had no innate immunity four years ago are no longer sufficient,” Nixon said. “The four-year-old trial, unlike the flu shots that have been tried and tested for over 80 years, is not a check of the blanks of new vaccines each year without clinical trial data. The public deserves the science of evolving product transparency and gold standard, especially.”
Pfizer and Modanya, the makers of mRNA covid shots, did not immediately respond to requests for comment. The Washington Post first reported policy changes.
Dr. Ofer Levy, a Harvard vaccine researcher and member of the FDA's Vaccine Advisory Committee, said exploring unexpected effects from vaccines would be a valuable effort. However, he said officials must make sure that in order to “pass through the needle” it is being done in a way that does not leave older, immunocompromised people who are not protected from Covid.
He said leaving a group taking placebos vulnerable to COVID raised ethical concerns that need to be considered carefully. He said retaining permission for the updated Covid Shot is “unacceptable.”
“We're excited to be aware of this,” said Dr. Levy, who co-founded a company working on opioid vaccines.
The Centers for Disease Control and Prevention have reported approximately 23,000 deaths from Covid since September. Still, according to the CDC, Covid boosters are low intake.
His familiarity with Kennedy's issues comes at least in part from reviews of vaccine approvals from decades ago, including polio vaccines, measles, mumps and Levella vaccines. He also helped to represent the plaintiffs in lawsuits against the manufacturer.
He and Children's Health Defense, the organisation he founded and once led, have repeatedly complained that the vaccine has not been tested against placebo in clinical trials under development. The organization cites all vaccines introduced decades ago, including polio, hepatitis and meningitis vaccines.
“All other drugs are being tested against placebo,” Kennedy said in a January 2020 podcast, claiming that the vaccine is exempt from its requirements.
But that's not entirely correct. Cancer drugs and other drugs approved under the FDA's accelerated approval program are regularly permitted after placebo-free trials. New vaccines, including Covid's vaccine, have been tested against placebo – in some cases against vaccines for inactive substances such as saline injections, or other diseases.
However, new formulations of already approved vaccines will be compared to formulations of existing vaccines in clinical trials. This is because withholding effective vaccines from patients, including infants, is considered unethical.
“We've required placebo-controlled trials for most vaccines, but sometimes inactive placebos and sometimes unrelated vaccines,” said Dr. Peter Marks, a top Food and Drug Administration vaccine official, before being kicked out in March. “The claim that we are not conducting randomized trials of non-Covid pediatric vaccines is incorrect.”
Kennedy has also raised concerns in the past about testing vaccines against what many consider a reasonable placebo. It has the same formula, but no immune-activators. Kennedy notes that the practice leaves behind uncertainty about whether formula ingredients can cause harm.
The announcement that the National Institutes of Health will develop new technologies to manufacture influenza and coronavirus vaccines to prevent the pandemic appears to be aimed at banishing mRNA vaccine technology, a target for critics, including the Health Secretary.
The “next-generation vaccine platform” is “completely owned by the government,” the department said. The NIH helped develop the mRNA platform, and vaccine maker Modanya paid the government hundreds of millions of dollars and granted licenses for the vaccine's major patents, but the company and the government were later caught up in a dispute over patent rights.
The mRNA platform relies on small bits of genetic code that produced small rumors and conspiracy theories. It is used to insert microchips into vaccine recipients. In contrast, new platforms rely on more traditional vaccine development methods that use inactivated viruses to induce immune responses.
The department said the new platform will be developed using betapropylactone. This is already a component of vaccine development, but is considered a hazardous substance by the Environmental Protection Agency when people are exposed to it in large quantities.
