A new requirement for vaccine studies could delay the availability of new vaccines.
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The Biden administration is set to implement a new testing requirement for upcoming vaccines, a move that could potentially postpone the release of future COVID-19 vaccines and create complications in the approval process of other vaccines.
Under the new mandate, all novel vaccines must undergo testing against a placebo before they can be authorized for use. This marks a significant shift from previous procedures, as stated by Andrew Nixon, a representative for Robert F. Kennedy Jr., the Health and Human Services secretary.
This development has raised concerns among vaccine experts, who fear that it may be part of a broader effort to undermine vaccine confidence and accessibility.
“It appears that Robert F. Kennedy Jr.’s agenda is to make vaccines more expensive, less accessible, and instill fear in the public,” remarked Dr. Paul Offit, an expert in vaccines at the University of Pennsylvania. “He is an anti-vaccine activist and a science denier who is actively working to dismantle the vaccine infrastructure in the country. Robert F. Kennedy Jr. poses a significant threat.”
The administration contends that the new requirement is essential to guarantee the safety of vaccines. However, experts in the field dispute the assertion that key vaccines have not been previously tested against placebos. They also challenge the definition of what constitutes a new vaccine, highlighting the regular updates made to vaccines like the COVID shots to align with circulating virus strains without altering the vaccines themselves, a practice common with flu vaccines.
“Secretary Kennedy’s HHS has committed to providing comprehensive transparency to the American public. This entails being truthful and direct about our knowledge and any gaps in our understanding of medical products, including vaccines,” stated Nixon.
He further claimed, “With the exception of the COVID vaccine, none of the vaccines on the CDC’s recommended childhood schedule have been tested against a placebo, leaving us with limited insight into the actual risk profiles of these products.”
Nixon also cast doubt on the reliability of current vaccine monitoring programs, which he described as “regulatory negligence.”
Implications of the new standard on future COVID shots
While the administration did not explicitly mention COVID vaccines, Nixon hinted that any modifications to the existing COVID vaccines could classify them as new vaccines subject to the new testing requirement.
“As previously stated, trials conducted four years ago on individuals lacking natural immunity are no longer sufficient. A four-year-old trial cannot serve as a substitute for new vaccines each year without clinical trial data, unlike the flu vaccine that has undergone rigorous testing for over 80 years,” Nixon explained in a statement provided to The Washington Post. “The public deserves transparency and the highest standards of scientific research, especially with evolving products.”
He referenced recent remarks by Food and Drug Administration Commissioner Marty Makary, suggesting that significant updates to existing vaccines may necessitate additional evaluation as new products.
“Makary has indicated that substantial modifications to existing vaccines—such as those addressing seasonal strain variations or antigenic drift—may be regarded as ‘new products’ requiring further clinical scrutiny,” Nixon noted. “He stressed the importance of robust data to support vaccine approvals, emphasizing, ‘Rather than allow that void to be filled with opinions, I’d like to see some good data.’ “
These developments come at a time when vaccination rates are declining, and diseases like measles are resurfacing. With COVID still claiming lives across the country, and the looming threat of another pandemic, Offit and other experts express deep concerns.
“It seems like he is launching a full-scale assault on vaccines. This is incredibly detrimental to our country and the global community,” remarked Dr. Peter Hotez, a vaccine researcher at Baylor College of Medicine in Houston. “It’s a dangerous path to take.”
Historical context of placebo-controlled vaccine trials
Offit, Hotez, and other experts challenge the assertion that testing vaccines against placebos is a radical shift and refute claims that childhood vaccines have not undergone placebo evaluations. Standard practice in the scientific community involves testing new vaccines and drugs against placebos to assess safety and efficacy.
“The blanket statement that none of the routine vaccines were ever tested against placebo is incorrect,” stated Dr. Jesse Goodman, a former FDA vaccine regulator now at Georgetown University. “Placebo trials have been conducted.”
This includes the original COVID vaccines, which underwent extensive placebo-controlled trials to assess their safety and efficacy. These trials, coupled with ongoing monitoring, have unequivocally demonstrated the safety and effectiveness of COVID vaccines, as well as other vaccines available in the market, as per Goodman and other experts.
Given the current level of immunity within the population, conducting new placebo trials for updated COVID vaccines would be logistically challenging and time-consuming, making it impractical to release the updated vaccines in time for the upcoming fall and winter seasons.
“By the time these studies are completed, the virus strain may have evolved, rendering the study obsolete,” Goodman explained. “This approach would essentially lead to the use of less effective vaccines for no valid reason.”
“It would essentially result in a state of paralysis,” Hotez added.
Furthermore, experts argue that administering placebos to individuals when an effective vaccine is available would be unethical, especially when dealing with a potentially lethal disease.
“Are they truly considering a placebo-controlled trial where a group of individuals are left unvaccinated, knowing the risks associated with the virus, which can lead to infection and severe illness in anyone? This is an ethical dilemma,” Offit emphasized.
