Health Secretary Robert F. Kennedy Jr. has unveiled a proposal that mandates placebo-controlled trials for all new vaccines, surprising some specialists who pointed out that these studies are typically conducted.
Andrew Nixon, a representative for the Department of Health and Human Services, stated that “all new vaccines will undergo safety testing in placebo-controlled trials” prior to approval, labeling the initiative a “significant shift” from current practices.
While modern studies commonly use placebos, there has been an exception with the Covid booster shots, which were approved without human trials to address emerging viral strains. It remains uncertain how this new announcement will impact the availability of Covid vaccines anticipated for the fall.
Kennedy also presented an initiative on Thursday for the National Institutes of Health to accelerate the creation of new vaccines for Covid, bird flu, and seasonal flu.
The proposed vaccine development strategy will utilize methods other than the mRNA technology currently employed for existing Covid vaccines, as stated by the Department of Health and Human Services. The mRNA vaccines have faced numerous conspiracy theories, and Mr. Kennedy has been a vocal critic of them.
These developments indicate that Mr. Kennedy plans to delve deeply into the specifics of vaccine development, likely informed by his long-standing role as a prominent critic of vaccine regulations.
While some scientists affirm that understanding the potential unforeseen effects of vaccines is important, they caution that delaying the approval of essential vaccines could endanger public health.
In recent years, Mr. Kennedy has actively petitioned the Food and Drug Administration to remove the Covid vaccine from the market in 2021, during a critical phase of the pandemic, and has also urged the F.D.A. not to authorize Covid vaccines for children.
When inquired about the impact of the new testing policy on Covid booster shots, Mr. Nixon indicated that new trials might be necessary. Although the vaccines approved by the F.D.A. were initially studied in large placebo-controlled trials, Mr. Kennedy and others have criticized the lack of clinical trials for booster shots.
“As we’ve mentioned before, trials from four years ago involving individuals without natural immunity are no longer adequate,” Mr. Nixon stated. “A four-year-old trial does not give a free pass for new vaccines each year without clinical trial data, unlike the flu shot, which has been rigorously tested for over 80 years. The public deserves transparency and top-notch scientific practices — especially with continuously evolving products.”
Pfizer and Moderna, the producers of the mRNA Covid vaccines, have not yet responded to requests for comment. The Washington Post was the first to report on this change in policy.
Dr. Ofer Levy, a vaccine researcher from Harvard and a member of the F.D.A.’s vaccine advisory committee, expressed that investigating potential unexpected vaccine effects would be a worthwhile endeavor. However, he emphasized that officials must ensure this does not leave vulnerable populations, like the elderly and immunocompromised, unprotected from Covid.
He added that exposing a group taking the placebo to Covid raises significant ethical concerns that must be carefully examined. Delaying authorization for updated Covid vaccines would be “unacceptable,” he emphasized.
“Without protection against Covid, tens of thousands of people could die,” stated Dr. Levy, who co-founded a company developing an opioid vaccine.
The Centers for Disease Control and Prevention has reported around 23,000 Covid-related deaths since September, with as many as 1,000 per week during that time in January. Meanwhile, the uptake of Covid boosters has been low; only about 23% of adults received the updated Covid shot introduced in the fall, according to the C.D.C.
Mr. Kennedy’s insights on the matter are partially rooted in his examination of vaccine approvals from decades past, including those for the polio and measles, mumps, and rubella vaccines. He has also represented plaintiffs in lawsuits against manufacturers.
Along with the organization he founded and once led, Children’s Health Defense, he has often argued that vaccines are not adequately tested against placebos during their development. The organization has pointed to vaccines for polio, hepatitis, and meningitis, all of which were introduced many years ago.
“Every other medication undergoes testing against a placebo,” Mr. Kennedy mentioned in a podcast in January 2020, asserting that vaccines are exempt from this requirement.
However, this statement is not entirely accurate. Cancer medications and other drugs authorized through the F.D.A.’s accelerated approval program often receive approval after trials that do not include a placebo. Additionally, new vaccines, including Covid vaccines, were indeed tested against placebos — inactive substances like saline or, in certain cases, against vaccines for other illnesses.
However, newer formulations of already approved vaccines are tested against existing vaccines as part of clinical trials, as withholding effective vaccines from patients (including infants) would be deemed unethical.
“We’ve mandated placebo-controlled studies for most vaccines, using either an inert placebo or sometimes an unrelated vaccine for comparison,” noted Dr. Peter Marks, who previously held a significant role at the Food and Drug Administration until his departure in March. “The assertion that randomized trials for pediatric vaccines, aside from Covid, have not been conducted is incorrect.”
Mr. Kennedy has previously expressed concerns regarding testing a vaccine against what many consider a standard placebo — the same formulation devoid of immune-activating ingredients. He has pointed out that this practice introduces uncertainty about whether the components in the formulation might be harmful.
The announcement regarding the National Institutes of Health’s initiative to develop advanced technology for flu and coronavirus vaccines is likely aimed at replacing the mRNA technology, which has faced criticism, particularly from the health secretary.
This “next-generation vaccine platform” is described as being “entirely government-owned,” according to the department’s announcement. The N.I.H. was involved in developing the mRNA platform, and Moderna has compensated the government hundreds of millions of dollars to license a critical patent, although there was later a dispute regarding patent rights.
The mRNA framework utilizes fragments of genetic material, which have fueled online rumors and conspiracy theories about microchips being implanted in vaccine recipients. In contrast, the new platform will employ a more conventional approach to vaccine development using inactivated viruses to elicit an immune response.
According to the department, this new platform will incorporate beta-Propilactone, which is a component of vaccine development but is regarded by the Environmental Protection Agency as hazardous when encountered in large doses.
