- HHS Secretary Robert F. Kennedy Jr. plans to test all new vaccines against placebos.
- Critics say that most vaccines are initially tested that way, but adjustments for new strains should not be.
- The Department of Health and Human Services announced a new platform for vaccine development.
Robert F. Kennedy Jr. has announced that all new vaccines will be tested against placebos.
But while the U.S. Secretary of Health and Human Services said the move will increase transparency, medical experts told The Washington Post the move could “limit access to vaccines and undermine the public’s trust in immunization depending on its implementation.”
Per the Post, which first reported the story, “‘All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices,’ an HHS spokesperson told The Washington Post in response to questions about Kennedy’s comments on the measles vaccines and general vaccine policy."
While it’s common to test vaccines that are designed for new pathogens that way, pitting the proposed vaccine against a substance like saline in randomized controlled trials, the Post reported that “for well-researched diseases such as measles and polio, public health experts say it makes little sense to do that and can be unethical, because the placebo group would not receive a known effective intervention” while suffering from a disease that could be very harmful.
The Hippocratic Oath, which deals with medical ethics, is undergirded by a principle of not harming patients. Critics say that giving people with a disease a placebo instead of a treatment that’s been shown to help is potentially very problematic.
“No institutional review board at any academic center would ever accept that — so he’s asking what personal injury lawyers invariably ask for, which is the impossible to be done," Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told The Guardian.
Critics have suggested that the plan was announced to further undermine confidence in vaccines. But HHS in a statement countered claims that Kennedy is anti-vaccine, saying instead that he is “pro-safety, pro-transparency and pro-accountability.”
Kennedy’s office has not defined what qualifies as a “new vaccine,” or said how the mandate would be implemented.
Tweaking vaccines as viruses mutate
As STAT explained, “For seasonal vaccines that require regular tweaks because the viruses they target keep changing, the (Food and Drug Administration) has developed a practical approach, known as the strain change rule. The viruses that flu and COVID vaccines target are updated annually, but the way the vaccines are produced remains the same. As a result, they are not treated like new vaccines and don’t need to undergo the lengthy and expensive studies required to first bring a vaccine to market."
Whether that will change is not known. STAT and other reports suggest that COVID vaccines have drawn the particular interest of HHS officials, although an HHS official indicated flu vaccines would continue to have the strain change rule applied.
Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, told STAT there are real problems with a plan to test updated shots every year. Currently, any changes are made a few months in advance to be ready for a surge in cases. Testing each change would require a surge in cases, but, “by the time they could get vaccine approved with early season studies, it would be too late … to get vaccine out. It makes no sense at all.”
Offit told the Post, “You are watching the gradual dissolution of the vaccine infrastructure in this country. The goal is to make vaccines less available and less affordable.”
Is a COVID vaccine stalled?
Per CNN, “Questions about the fate of COVID vaccines began to swirl after the FDA missed an April 1 deadline to decide whether to grant full approval to the Novavax vaccine, the only non-mRNA vaccine available to protect against the coronavirus; Novavax’s shot uses a more traditional protein-based technology. A source familiar with the situation, who wasn’t authorized to speak on behalf of the agency, told CNN that the vaccine had been on track to be approved.”
Instead, more testing, which is being billed as “a postmarketing commitment” is being asked, though the vaccine has had emergency use authorization since 2022. It’s not clear if the testing will be required before or after the vaccine receives full approval, which had been expected this spring.
The administration has indicated there is no urgency and spoken of COVID as a thing of the past, but tracking by the Centers for Disease Control and Prevention found that between September 2023 and August 2024, the last year with complete data, more than 36,000 people 65 and older died in the U.S. That was the largest age cohort impacted.
A new vaccine platform
The news came just ahead of the announcement by Kennedy’s department Thursday that it will join the National Institutes of Health to develop a “next-generation, universal vaccine platform, Generation Gold Standard, using a beta-propiolactone (BPL)-inactivated whole virus platform.”
The initiative will fund the institute’s “in-house development of universal influenza and coronavirus vaccines,” including specific candidate drugs, the press release said, with the goal of providing “broad-spectrum protection against multiple strains of pandemic-prone viruses like H5N1 avian influenza and coronaviruses including SARS-CoV-2, SARS-CoV-1, and MERS-CoV.”
The notice said the program realigns the Center for the Biomedical Advanced Research and Development Authority with its public health mission to be ready for all influenza viral threats, regardless of what’s circulating.
“Generation Gold Standard is a paradigm shift,” said NIH Director Dr. Jay Bhattacharya. “It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats — not just today’s, but tomorrow’s as well — using traditional vaccine technology brought into the 21st century.”
Per the department, the platform will be adaptable for future use against respiratory syncytial virus, metapneumovirus and parainfluenza. And it will offer protection capability against avian influenza, too.
“Clinical trials for universal influenza vaccines are scheduled to begin in 2026, with FDA approval targeted for 2029. The intranasal BPL-1357 flu vaccine, currently in advanced trials, is also on track for FDA review by 2029,” according to the announcement.