RFK Jr. calls for ‘new’ vaccines to undergo placebo-controlled trials
(ER Productions Limited/Getty Images)
(WASHINGTON) — Health and Human Services Secretary Robert F. Kennedy Jr. will require new vaccines to undergo placebo testing, marking what a department spokesperson called “a radical departure from past practices.”
The policy change would force vaccines, in order to be approved for human use, to undergo studies in which half of individuals in a study receive a placebo – typically a saline shot – to compare results against the vaccine.
Placebo-controlled trials are already used to test new drugs or vaccines for safety and efficacy, but some experts consider it unethical to conduct such trials when a vaccine or treatment is already considered safe and efficacious. For example, they say, giving half of the kids in a trial a placebo for the measles vaccine when an already proven vaccine exists would put those participants unnecessarily at risk for the virus.
It remains unclear what HHS considers a “new” vaccine and whether that includes the flu and COVID vaccines, which are updated on an annual basis to better protect against currently circulating strains.
“FDA Commissioner Dr. Marty Makary has indicated that significant updates to existing vaccines—such as those addressing seasonal strain changes or antigenic drift—may be considered ‘new products’ requiring additional clinical evaluation,” the department spokesperson told ABC News.
But the spokesperson indicated the yearly flu vaccine might not be affected by the policy, calling it “tried and tested for more than 80 years.”
It appears, instead, that the policy could impact the rollout of future COVID vaccines, which are updated annually.
When asked to elaborate on what the department considers a “new” vaccine, the spokesperson said that federal health agencies would follow the “Gold Standard of Science”.
Kennedy has long questioned the safety of vaccines and argued that placebo-based trials are needed to ensure vaccines aren’t doing more harm than good.
Even as thousands were dying during the COVID-19 public health emergency, COVID vaccines still underwent placebo-controlled studies with more than 100,000 volunteers from diverse populations. Experts say the practice is necessary to determine if a vaccine is not only effective, but also safe.
Many childhood vaccines were originally tested with placebo trials. Others have been available for decades, providing data from millions of people showing those vaccines are overwhelmingly safe and effective.
Once a vaccine for a disease is approved safe and effective, future versions of the shot are tested in clinical trials against the already approved shot. Clinical trials test whether the updated vaccines generate an immune response that’s comparable to or better than previous versions of the vaccine.
Even after vaccines are made available to the public, scientists continue to monitor them for safety. They also review any reports of side effects or reactions and share these facts with the public.
(WASHINGTON) — The Advisory Committee on Immunization Practices (ACIP), made up of members recently hand-selected by Health and Human Services Secretary Robert F. Kennedy Jr., voted 5-1 on Thursday to recommend against flu vaccines containing the preservative thimerosal.
One committee member, Vicky Pebsworth, abstained on each vote.
A few moments before, the CDC’s vaccine advisory committee voted 6-0 to recommend all Americans aged 6 months and older receive an annual influenza vaccine.
This is a developing story. Please check back for updates.
Alyssa Pointer for The Washington Post via Getty Images
(WASHINGTON) — The Advisory Committee on Immunization Practices (ACIP), made up of members recently hand-selected by Health and Human Services Secretary Robert F. Kennedy Jr., voted 5-1 on Thursday to recommend against flu vaccines containing the preservative thimerosal.
A few moments before, the Centers for Disease Control and Prevention’s vaccine advisory committee voted 6-0 to recommend all Americans aged 6 months and older receive an annual influenza vaccine.
One committee member, Vicky Pebsworth, abstained on each vote.
Thimerosal is a mercury-based preservative, which is used to prevent microbial contamination of vaccines. Most flu vaccines currently used in the United States contain little to no thimerosal, but both the Food and Drug Administration and the CDC say there is no evidence low doses of thimerosal in vaccines cause harm other than minor reactions at the injection site, such as redness or swelling.
Additionally, a 2010 CDC study found exposure to vaccines and immunoglobulins that contain thimerosal, in prenatal or infant stages, does not increase risk for autism spectrum disorder.
This preservative was previously used in some common childhood immunizations, However, in the late 1990s, federal health agencies, the American Academy of Pediatrics and vaccine manufacturers agreed to reduce or eliminate thimerosal in vaccines as a precautionary measure, which public health experts previously told ABC News gave rise to anti-vaccine groups alleging thimerosal is not safe and fueled speculation that mercury causes autism.
Kennedy, who has promoted vaccine-skeptic views that experts and decades of robust research have refuted, wrote a book in 2014 falsely claiming thimerosal is “toxic to brain tissue” and may cause autism, calling for its removal from all vaccines.
During the ACIP meeting, Lyn Redwood, a former president of Children’s Health Defense, a group that used to be chaired by Kennedy, gave a highly charged presentation as a private citizen. She claimed the preservative was toxic to the brain and refuted evidence-based claims that there has been no proven harm from thimerosal in vaccines.
Her presentation received pushback from ACIP member Dr. Cody Meissner, who was the only member to vote against the recommendation. He said there “is no scientific evidence that thimerosal has caused problems.”
“The risk for influenza is so much greater than the non-existing risk from thimerosal,” he added.
Meissner said vaccines with thimerosal are metabolized as ethylmercury, not methylmercury, which is the form of mercury found in fish and shellfish, and is known to be a neurotoxin.
“I’m not quite sure how to respond to this presentation,” he said. “This is an old issue that has been addressed in the past. Ethylmercury is excreted much more quickly from the body. It is not associated with the high neurotoxicity that methylmercury [is].”
Meissner also added that thimerosal is included in most multi-dose vaccines administered around the world because single-dose vials are more expensive, and removing thimerosal could increase the costs of vaccines.
“Thimerosal is included in most vaccines that are administered around the globe, and that is because single-dose vials are more expensive, and many countries cannot afford a single-dose vial,” Meissner said.
He went on, “I realize ACIP is focused on the United States, but the recommendations that the ACIP makes are followed among many countries around the world and removing thimerosal from all vaccines that are used in other countries, for example, is going to reduce access to these vaccines, it will increase cost.”
Multiple liaisons of medical groups in the committee also questioned in the meeting why Redwood was permitted to present given her limited scientific background and pushed back on the lack of peer-reviewed studies in her presentation.
“This committee has always prided itself on openness, transparency and data and evidence. So I am wondering if we will have an actual scientific presentation with peer-reviewed literature, strong evidence to actually discuss this issue, as many statements have been made here today, without support of science or evidence, but merely opinion,” Dr. Jason Goldman, a liaison for the American College of Physicians (ACP), said in the meeting.
A CDC review of evidence on thimerosal was previously published on the agency’s website — showing no safety risks from the ingredient — but was later taken down. A former CDC official posted a copy of the article online.
“A scientifically rigorous CDC report reviewing the safety of thimerosal was posted for public access and then abruptly removed at the direction of the Office of the Secretary. The removal of this document, which contextualized decades of evidence showing no link between thimerosal and neurotoxicity or autism, raises serious concerns about transparency and the integrity of the decision-making process,” Sean O’Leary, chair of the American Academy of Pediatrics’ Committee on Infectious Diseases, said in a statement to ABC News.
Doctors have voiced concern that no longer recommending thimerosal in some flu shots could lead to less people getting vaccinated and fuel further distrust of vaccines.
“Any decrease in the number of flu vaccines available will likely result in fewer people being vaccinated and subsequently more hospitalizations and deaths. Its removal could also signal to the general public unwarranted safety concerns,” O’Leary said.
Another heated exchange in the meeting came during the discussion of flu vaccines when ACIP member Dr. Robert Malone described the 250 flu deaths among children during the most recent flu season as a “modest number.”
“The 250 pediatric deaths, which is, let’s acknowledge, is a modest number fortunately,” Malone said.
This past season saw the highest number of flu deaths among children for a non-pandemic season, and the highest number seen since the 2009 H1N1 global flu pandemic, CDC data shows.
Malone received immediate push back during the meeting. Goldman from ACP said the number of deaths “is not a small number, especially if it’s your own child dying from the vaccine preventable illness.”
Ricky Carioti/The Washington Post via Getty Images
(MORGANTOWN, WV) — The Department of Health and Human Services on Tuesday reversed the firings of more than 100 federal employees with the National Institute for Occupational Safety and Health, the federal institute that helps protect coal miners from black lung, according to Republican Sen. Shelley Moore Capito.
Roughly 200 employees of the NIOSH office in Morgantown, West Virginia, were put on administrative leave in April and informed they would be formally fired in June. Some were temporarily brought back roughly two weeks ago, but until Tuesday they were told they would still be terminated next month.
In a letter sent Tuesday, a copy of which was obtained by ABC News, HHS said, “You previously received a notice regarding the Department of Health and Human Services’ (HHS) upcoming reduction in force (RIF). That notice is hereby revoked. You will not be affected by the upcoming RIF.”
The move comes after public pressure from Capito, and follows a series of ABC News reports detailing the impact the firings would have on black lung health care programs for coal miners.
Capito, announcing the reversals on X, said, “The heath and safety of our WV workers, including our miners, is of the utmost important and I will always advocate for their wellbeing.”
Critics said the initial firings, part of President Donald Trump’s efforts to slash the size of the federal government, belied his vow to reinvigorate America’s coal industry.
NIOSH has offices in several other states covering a range of issues from vehicle safety to firefighter health care. It’s unclear if any employees in those offices were also rehired.
ABC News reached out to HHS for comment.
The announcement came just hours before a federal judge ordered HHS Secretary Robert F. Kennedy Jr. to temporarily halt its dismissal of NIOSH officials who oversee the black lung surveillance program.
“Losing the services of these experienced and dedicated employees is an aspect of the irreparable harm to the miners and the public that cannot and should not be ignored,” U.S. District Judge Irene Berger wrote in her order Tuesday.
It was not immediately clear whether the ruling had anything to do with the Trump administration’s decision to reinstate the workers earlier Tuesday.
Judge Berger’s ruling came after a veteran coal miner named Henry Wiley, in April, challenged the Trump administration’s removal of the NIOSH employees, arguing that terminations endangered him and other miners.
The judge wrote Tuesday that Wiley and a handful of NIOSH officials who testified in a hearing last week persuaded her of the importance of NIOSH’s health screening program and a waiver called Part 90, which allows miners with early-stage black lung disease to transfer to roles out of the mines.
If the NIOSH dismissals were allowed to go forward, Berger wrote, “thousands of miners will go without screening for black lung, and those with black lung will be deprived of access to the Part 90 transfer option.”
Berger referenced Kennedy directly, writing, “Does the Secretary of the Department of Health and Human Services genuinely believe that a miner diagnosed with black lung is not being injured when the program designed to confirm his condition and provide him with workplace protections to prevent its progression is rendered inaccessible? This court does not share such a belief.”
Berger ordered the Trump administration to grant “full restoration of the NIOSH Respiratory Health Division, rescission of the [reduction in force letters], and compelling continued health surveillance” through the health surveillance program and Part 90.
She gave Kennedy three weeks to report in writing when the court’s orders have been satisfied.
In a statement to ABC News, plaintiffs attorney Sam Petsonk said, “This opinion gives life to our foundational principles of judicial review, empowering ordinary citizens like these coal miners to defend their rights.”
“We’re glad to see the Administration already taking some initial steps in the direction of complying with the order. America’s coal miners deserve nothing less, and in fact they deserve a heck of a lot more,” Petsonk said.
An HHS spokesperson told ABC News that Kennedy has been working hard to maintain NIOSH’s critical functions as HHS streamlines its operations, and that the Trump administration is committed to supporting coal miners and firefighters.
