The plans represent a remarkable exercise of Robert F. Kennedy Jr.'s authority as health secretary to make choices that are often left to Food and Drug Administration career experts.
In a move that goes deep into vaccine development and raises concerns about whether Covid boosters will be available in the fall, Health Secretary Robert F. Kennedy Jr. announced plans on Thursday to require all new vaccines to be tested against placebos and to develop new vaccines without using mRNA technology.
The mandate for placebo testing was described as "a radical departure" from current norms by a Department of Health and Human Services spokesperson. That will rely on the department's definition of "new," though, as the majority of new vaccines have already been tested against inert chemicals called placebos or, occasionally, against vaccines for other illnesses.
One of the biggest vaccine skeptics in the country, Mr. Kennedy has made no secret of his contempt for mRNA technology, which was employed to create coronavirus vaccines under the first Trump administration. "mRNA jabs don't stop infection, don't block transmission, don't block mutants, don't last, don't work at all," he once stated on social media.
During a deadly stage of the pandemic in 2021, Mr. Kennedy petitioned the Food and Drug Administration to remove the COVID-19 vaccine from the market as part of his recent advocacy. Additionally, he pushed the FDA to deny children access to COVID-19 vaccinations. Additionally, Mr. Kennedy has insisted that vaccines and autism may be related, and he has brought a discredited researcher into his organization whose work supports this theory.
Except for his ambivalent support of the measles vaccinations in reaction to the outbreak in Texas that has claimed the lives of two children and one adult, Mr. Kennedy has not made many high-profile statements regarding vaccine policy since taking office as health secretary in February. However, he and the Trump administration have intervened in other ways, blocking the licensing of another COVID-19 vaccine and directing research on vaccines and autism.
The announcements made by Mr. Kennedy on Thursday are an unusual use of his authority as secretary to make choices that are often left to F.D.A. career scientists. The actions come after he recently advised parents who are thinking about vaccinating their newborns to "do your own research."
Dr. Jesse Goodman, a former F.D.A. official and infectious diseases specialist at Georgetown University, stated that the modifications could undermine confidence in the vaccine approval process, despite Mr. Kennedy's stated intention to restore it.
"I don't mind questions," Dr. Goodman stated, "but it's concerning when they seem to be so common and persistent that they create a great deal of uncertainty — not just about one thing, but about everything."
The next round of COVID-19 booster shots, which are anticipated to be made available in the fall, may be impacted by Mr. Kennedy's action right away. As the virus has changed, both flu shots and COVID-19 boosters that target new strains have been approved without undergoing significant human testing.
The future of Covid boosters is now in question, despite Mr. Kennedy's assertion that the new regulation will not impact flu vaccines. According to department spokesman Andrew Nixon, fresh research is needed because so many people have contracted the virus and are now immune to COVID-19.
"As we previously stated, trials carried out on individuals lacking natural immunity four years ago are no longer adequate," he stated. Unlike the flu shot, which has been tried and tested for more than 80 years, a four-year-old trial is also not a blank check for new vaccines every year without clinical trial results. The public expects openness and top-notch science, particularly when it comes to changing products.
Ethical concerns are also raised by Mr. Kennedy's strategy for the placebo studies, which was initially revealed by The Washington Post. Depriving even a small number of patients of effective immunizations against dangerous infections is regarded as unethical. The entire American population would be at risk if fresh clinical research on COVID-19 delayed the approval of booster shots.
That would be "unacceptable," according to Dr. Ofer Levy, a Harvard vaccine researcher and member of the FDA's vaccine advisory council. He said officials need to "thread the needle" to ensure that the studies are conducted in a way that does not leave elderly and immunocompromised people without protection from COVID.
Dr. Levy, a co-founder of a business developing an opioid vaccine, stated that tens of thousands of individuals could perish if they were not protected against COVID-19.
About 23,000 deaths have been attributed to COVID since September, according to the Centers for Disease Control and Prevention, with up to 1,000 deaths occurring each week throughout that month and January. According to the C.D.C., only around 23% of adults received the new COVID-19 vaccine, which was made available in the fall.
According to one C.D.C. study, the Covid boosters used in 2023 and 2024 prevented roughly 68,000 hospital visits and worked best for those who were immunocompromised or older than 65.
Reviews of decades-old vaccine approvals, such as those for the polio vaccine and the measles, mumps, and rubella vaccine, are at least partially responsible for the health secretary's expertise with vaccine studies. Additionally, Mr. Kennedy has assisted in defending plaintiffs in cases against manufacturers.
He has frequently lamented that vaccines are not compared to placebos in clinical studies during their development, as has the group he established and previously headed, Children's Health Defense. As examples, the group has pointed to vaccines against meningitis, polio, and hepatitis, all of which were developed decades ago.
In January 2020, Mr. Kennedy stated in a podcast that vaccines are not subject to the requirement that "every other medicine is tested against a placebo."
But that isn't really accurate. Drugs for cancer and other conditions approved under the FDA's rapid approval program are frequently approved following placebo-free trials. Additionally, novel vaccinations, such as the COVID-19 vaccines, were tested against placebos, which are inert substances like saline injections, or occasionally against vaccines for other illnesses.
As the chief vaccine official at the Food and Drug Administration until his forced resignation in March, Dr. Peter Marks stated, "We've required placebo-controlled trials for most vaccines, and sometimes it's an inert placebo, and sometimes it's an irrelevant vaccine." "It is untrue to say that, aside from COVID, we have not conducted randomized trials for pediatric vaccines."
Regarding testing a vaccine against what many scientists believe to be a reasonable placebo—the same formula, but without the immune-activating agents—Mr. Kennedy has previously expressed reservations. According to Mr. Kennedy, the approach raises questions about whether formula additives could be harmful.
Mr. Kennedy announced a National Institutes of Health initiative to accelerate the development of new vaccines for COVID-19, avian flu, and seasonal flu, in addition to the new placebo requirement. This effort seems to be part of a larger attack on mRNA technology, or "platform."
The F.D.A.'s evaluation of the Moderna shot for children in 2022 was deemed "dishonest, and evidence that the public health establishment has abandoned science, logic, reason, rationality, empathy, health, and medicine," according to one of Mr. Kennedy's many social media posts regarding the mRNA shots since they were developed.
Under the Trump administration, the N.I.H. has closely monitored studies about the mRNA platform. In Texas, Idaho, and Kentucky, among other Republican-controlled state legislatures, bills limiting the use of mRNA vaccines have surfaced.
Additionally, the FDA is delaying the approval of a COVID-19 vaccination that does not use mRNA technology.
On April 1, the agency was supposed to make a decision about whether to fully approve the more conventional protein-based Novavax COVID-19 vaccine, which had been administered under emergency authorization. However, the FDA postponed the decision, requesting that the business carry out more investigation.
Richard Hughes, an attorney for various vaccine manufacturers with the Epstein Becker Green law firm, said, "I wonder if this administration really plans to just obliterate the COVID-19 vaccine."
When asked if the revised mRNA COVID-19 vaccines would be ready in the US in the fall, Pfizer and Moderna, the companies that make the vaccines, did not reply.
According to a Moderna representative, the business conducted clinical trials for its booster shots both before and following their release. President Stephen Hoge stated that the company tests its vaccines against placebos during a Thursday earnings call. "We will definitely engage constructively and make sure we understand what those needs are and that we fulfill them," he added, adding that the company has not been formally informed of a policy change.
According to the agency, the new N.I.H. program would create a "next-generation vaccine platform" that would be "fully government-owned." The mRNA platform was developed with assistance from the N.I.H., and Moderna, the vaccine manufacturer, paid the government hundreds of millions of dollars to license a crucial vaccine patent, but the two parties eventually clashed over the patent rights.
Online rumors and conspiracy theories claimed that the mRNA platform, which depends on tiny pieces of genetic code, was being utilized to implant microchips inside vaccine recipients. A more conventional approach to vaccine creation, which employs inactivated viruses to elicit an immune response, would be the foundation of the new platform.
According to the department, beta-propilactone, which is already used to create vaccines but is deemed dangerous by the EPA when ingested in high concentrations, will be used to develop the new platform.
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