logo
RFK Jr plans placebo-trial testing for 'all new vaccines'

RFK Jr plans placebo-trial testing for 'all new vaccines'

Yahoo02-05-2025

The top US health department plans to require placebo testing for all vaccines in an effort to offer "straightforward" public health information, but experts say such testing could limit availability and raise ethical concerns.
In a statement first given to the Washington Post, the Department of Health and Human Services (HHS) said this week, "All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices".
The agency did not provide details on which "new vaccines" would be included.
But officials have suggested that updated Covid-19 shots may be included, which vaccine experts say could slow down vaccine access.
Peter Lurie, a former official with the Food and Drug Administration (FDA), said "it's hard to tell exactly what is being proposed."
"But, broadly, if they mean that every modification to an existing vaccine would require a new placebo-controlled trial, they are treading in ethically dubious territory and likely to deny Americans life-saving vaccines at some point."
HHS has not offered details on the timing of the placebo plan or specify the vaccines involved.
An HHS spokesperson told the BBC in a statement that health secretary Robert F Kennedy Jr's goal of "radical transparency" means being "honest and straightforward about what we know — and what we don't know — about medical products, including vaccines".
The statement said none of the childhood vaccines recommended in the US - except the Covid shot - had undergone "inert placebo" testing, meaning "we know very little about the actual risk profiles of these products".
But public health experts say the statement is misleading, as childhood vaccinations, including ones for Hepatitis A and B, rotavirus, polio and the mumps, were all initially tested against a placebo. In fact, all new immunizations already go through the trials - a type of random testing where one test group receives the immunization, and the other gets a placebo, like a saline shot.
But newer versions of the shots may not go through the same process, because it is considered unethical to withhold a shot known to be safe from a particular group, and because the shot is only being tweaked in a minor way, vaccine experts said.
The coronavirus shot, for example, already has gone through rigorous safety testing, said Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia.
"We have a lot of information about the safety of the vaccine," he said. "All we're doing this year is using a different Omicron variant that we used last year and the year before that."
Still, FDA Commissioner Marty Makary said this week that the agency was "taking a look" at updated coronavirus shots, telling the BBC's US partner CBS News that there is a "void of data".
An HHS spokesperson told the BBC that "significant updates to existing vaccines" may be considered "new products" requiring additional clinical evaluation.
"A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years," the spokesperson said.
Requiring companies to conduct placebo tests for simple upgrades of established vaccines would be costly - and the drug makers could ultimately decide to forgo making the newer, more effective versions of the vaccine altogether, said Dr Lurie.
Before taking office - and since assuming the role as secretary - Kennedy has spread false claims about vaccine safety. His tenure has coincided with one of the worst measles outbreaks in a decade; two children have died and 660 people have been infected in Texas.
This week, he encouraged parents to "do their own research" about the measles vaccine - which has been considered safe and 97% effective for decades - and raised questions about whether the shot could cause seizures or neurological issues.
For months, he has at times endorsed the MMR shot, and at other times, called it a "personal" decision. Kennedy also promoted alternative treatments, which doctors say patients should not use without medical supervision.
Deadly measles outbreak does little to counter vaccine scepticism in Texas
Love on the Spectrum cast questions RFK Jr's comments about autistic people
RFK Jr pledges to find the cause of autism by September

Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

An Uproar at the NIH
An Uproar at the NIH

Yahoo

time35 minutes ago

  • Yahoo

An Uproar at the NIH

The Atlantic Daily, a newsletter that guides you through the biggest stories of the day, helps you discover new ideas, and recommends the best in culture. Sign up for it here. Updated at 10:26 a.m. on June 9, 2025 Since winning President Donald Trump's nomination to serve as the director of the National Institutes of Health, Jay Bhattacharya—a health economist and prominent COVID contrarian who advocated for reopening society in the early months of the pandemic—has pledged himself to a culture of dissent. 'Dissent is the very essence of science,' Bhattacharya said at his confirmation hearing in March. 'I'll foster a culture where NIH leadership will actively encourage different perspectives and create an environment where scientists, including early-career scientists and scientists that disagree with me, can express disagreement, respectfully.' Two months into his tenure at the agency, hundreds of NIH officials are taking Bhattacharya at his word. More than 300 officials, from across all of the NIH's 27 institutes and centers, have signed and sent a letter to Bhattacharya that condemns the changes that have thrown the agency into chaos in recent months—and calls on their director to reverse some of the most damaging shifts. Since January, the agency has been forced by Trump officials to fire thousands of its workers and rescind or withhold funding from thousands of research projects. Tomorrow, Bhattacharya is set to appear before a Senate appropriations subcommittee to discuss a proposed $18 billion slash to the NIH budget—about 40 percent of the agency's current allocation. The letter, titled the Bethesda Declaration (a reference to the NIH's location in Bethesda, Maryland), is modeled after the Great Barrington Declaration, an open letter published by Bhattacharya and two of his colleagues in October 2020 that criticized 'the prevailing COVID-19 policies' and argued that it was safe—even beneficial—for most people to resume life as normal. The approach that the Great Barrington Declaration laid out was, at the time, widely denounced by public-health experts, including the World Health Organization and then–NIH director Francis Collins, as dangerous and scientifically unsound. The allusion in the NIH letter, officials told me, isn't meant glibly: 'We hoped he might see himself in us as we were putting those concerns forward,' Jenna Norton, a program director at the National Institute of Diabetes and Digestive and Kidney Diseases, and one of the letter's organizers, told me. None of the NIH officials I spoke with for this story could recall another time in their agency's history when staff have spoken out so publicly against a director. But none of them could recall, either, ever seeing the NIH so aggressively jolted away from its core mission. 'It was time enough for us to speak out,' Sarah Kobrin, a branch chief at the National Cancer Institute, who has signed her name to the letter, told me. To preserve American research, government scientists—typically focused on scrutinizing and funding the projects most likely to advance the public's health—are now instead trying to persuade their agency's director to help them win a political fight with the White House. In an emailed statement, Bhattacharya said, 'The Bethesda Declaration has some fundamental misconceptions about the policy directions the NIH has taken in recent months, including the continuing support of the NIH for international collaboration. Nevertheless, respectful dissent in science is productive. We all want the NIH to succeed.' A spokesperson for HHS also defended the policies the letter critiqued, arguing that the NIH is 'working to remove ideological influence from the scientific process' and 'enhancing the transparency, rigor, and reproducibility of NIH-funded research.' The agency spends most of its nearly $48 billion budget powering science: It is the world's single-largest public funder of biomedical research. But since January, the NIH has canceled thousands of grants—originally awarded on the basis of merit—for political reasons: supporting DEI programming, having ties to universities that the administration has accused of anti-Semitism, sending resources to research initiatives in other countries, advancing scientific fields that Trump officials have deemed wasteful. Prior to 2025, grant cancellations were virtually unheard-of. But one official at the agency, who asked to remain anonymous out of fear of professional repercussions, told me that staff there now spend nearly as much time terminating grants as awarding them. And the few prominent projects that the agency has since been directed to fund appear either to be geared toward confirming the administration's biases on specific health conditions, or to benefit NIH leaders. 'We're just becoming a weapon of the state,' another official, who signed their name anonymously to the letter, told me. 'They're using grants as a lever to punish institutions and academia, and to censor and stifle science.' NIH officials have tried to voice their concerns in other ways. At internal meetings, leaders of the agency's institutes and centers have questioned major grant-making policy shifts. Some prominent officials have resigned. Current and former NIH staffers have been holding weekly vigils in Bethesda, commemorating, in the words of the organizers, 'the lives and knowledge lost through NIH cuts.' (Attendees are encouraged to wear black.) But these efforts have done little to slow the torrent of changes at the agency. Ian Morgan, a postdoctoral fellow at the NIH and one of the letter's signers, told me that the NIH fellows union, which he is part of, has sent Bhattacharya repeated requests to engage in discussion since his first week at the NIH. 'All of those have been ignored,' Morgan said. By formalizing their objections and signing their names to them, officials told me, they hope that Bhattacharya will finally feel compelled to respond. (To add to the public pressure, Jeremy Berg, who led the NIH's National Institute of General Medical Sciences until 2011, is also organizing a public letter of support for the Bethesda Declaration, in partnership with Stand Up for Science, which has organized rallies in support of research.) Scientists elsewhere at HHS, which oversees the NIH, have become unusually public in defying political leadership, too. Last month, after Health Secretary Robert F. Kennedy Jr.—in a bizarre departure from precedent—announced on social media that he was sidestepping his own agency, the CDC, and purging COVID shots from the childhood-immunization schedule, CDC officials chose to retain the vaccines in their recommendations, under the condition of shared decision making with a health-care provider. Many signers of the Bethesda letter are hopeful that Bhattacharya, 'as a scientist, has some of the same values as us,' Benjamin Feldman, a staff scientist at the National Institute of Child Health and Human Development, told me. Perhaps, with his academic credentials and commitment to evidence, he'll be willing to aid in the pushback against the administration's overall attacks on science, and defend the agency's ability to power research. But other officials I spoke with weren't so optimistic. Many at the NIH now feel they work in a 'culture of fear,' Norton said. Since January, NIH officials have told me that they have been screamed at and bullied by HHS personnel pushing for policy changes; some of the NIH leaders who have been most outspoken against leadership have also been forcibly reassigned to irrelevant positions. At one point, Norton said, after she fought for a program focused on researcher diversity, some members of NIH leadership came to her office and cautioned her that they didn't want to see her on the next list of mass firings. (In conversations with me, all of the named officials I spoke with emphasized that they were speaking in their personal capacity, and not for the NIH.) Bhattacharya, who took over only two months ago, hasn't been the Trump appointee driving most of the decisions affecting the NIH—and therefore might not have the power to reverse or overrule them. HHS officials have pressured agency leadership to defy court orders, as I've reported; mass cullings of grants have been overseen by DOGE. And as much as Bhattacharya might welcome dissent, he so far seems unmoved by it. In early May, Berg emailed Bhattacharya to express alarm over the NIH's severe slowdown in grant making, and to remind him of his responsibilities as director to responsibly shepherd the funds Congress had appropriated to the agency. The next morning, according to the exchange shared with me by Berg, Bhattacharya replied saying that, 'contrary to the assertion you make in the letter,' his job was to ensure that the NIH's money would be spent on projects that advance American health, rather than 'on ideological boondoggles and on dangerous research.' And at a recent NIH town hall, Bhattacharya dismissed one staffer's concerns that the Trump administration was purging the identifying variable of gender from scientific research. (Years of evidence back its use.) He echoed, instead, the Trump talking point that 'sex is a very cleanly defined variable,' and argued that gender shouldn't be included as 'a routine question in order to make an ideological point.' The officials I spoke with had few clear plans for what to do if their letter goes unheeded by leadership. Inside the agency, most see few levers left to pull. At the town hall, Bhattacharya also endorsed the highly contentious notion that human research started the pandemic—and noted that NIH-funded science, specifically, might have been to blame. When dozens of staffers stood and left the auditorium in protest, prompting applause that interrupted Bhattacharya, he simply smiled. 'It's nice to have free speech,' he said, before carrying right on. Article originally published at The Atlantic

'The Telegraph' Publishes Shocking Report About King Charles' Health, Claim He'll Never Move to Buckingham Palace
'The Telegraph' Publishes Shocking Report About King Charles' Health, Claim He'll Never Move to Buckingham Palace

Yahoo

time35 minutes ago

  • Yahoo

'The Telegraph' Publishes Shocking Report About King Charles' Health, Claim He'll Never Move to Buckingham Palace

The Telegraph just published a pretty shocking report about King Charles' health. The monarch has been battling cancer for over a year, and details of his health have remained under lock and key. However, the outlet reports that there's "talk" that "he may die 'with' cancer, but not 'of' cancer following a rigorous treatment programme." They also note that one "concession" to his health is that "it appears unlikely he will ever move from Clarence House to Buckingham Palace after the restoration is completed in three year's time." Apparently there's also some concern about Charles' lack of relationship with Prince Harry as he grows older, leading to "exploratory" "discussions about if or when father and son could ever be reunited"—potentially at the 2027 Invictus Games in Birmingham. And in a pretty shocking turn of events, The Telegraph reports that the palace has "carried out discrete polling to find out how many people were aware" of Prince Harry's recent BBC interview—where Harry made it clear he wants to mend fences. As a reminder, King Charles has been undergoing cancer treatment since February 2024, when the Palace released a statement saying, 'During The King's recent hospital procedure for benign prostate enlargement, a separate issue of concern was noted. Subsequent diagnostic tests have identified a form of cancer. His Majesty has today commenced a schedule of regular treatments, during which time he has been advised by doctors to postpone public-facing duties. Throughout this period, His Majesty will continue to undertake State business and official paperwork as usual.' The statement continued, 'The King is grateful to his medical team for their swift intervention, which was made possible thanks to his recent hospital procedure. He remains wholly positive about his treatment and looks forward to returning to full public duty as soon as possible. His Majesty has chosen to share his diagnosis to prevent speculation and in the hope it may assist public understanding for all those around the world who are affected by cancer.' You Might Also Like Here's What NOT to Wear to a Wedding Meet the Laziest, Easiest Acne Routine You'll Ever Try

Fungi concerns spark nationwide recall of Zicam® and Orajel™ products
Fungi concerns spark nationwide recall of Zicam® and Orajel™ products

Yahoo

time35 minutes ago

  • Yahoo

Fungi concerns spark nationwide recall of Zicam® and Orajel™ products

(WJW) – According to the U.S. Food and Drug Administration, Church & Dwight Co., Inc. is voluntarily recalling some Zicam® and Orajel™ products because fungi could be present in the items' cotton swab components. The recalled products include all lots within expiry of Zicam® Cold Remedy Nasal Swabs, Zicam® Nasal AllClear Swabs, and Orajel™ Baby Teething Swabs to the consumer level. Consumers are advised to 'immediately' stop using the recalled products. Major grocery chain slashing prices for the summer 'Swabs found to contain microbial contamination can potentially present a significant risk to the health and safety of consumers including serious and life-threatening blood infections in users whose nasal mucosa may be compromised due to inflammation and mechanical injuries,' reads the recall alert. 'The risk is highest (potentially severe or life-threatening) among children and individuals with compromised immune systems or other underlying medical conditions.' The FDA said, so far, no serious adverse events associated with the affected product have been reported. The recalled products were distributed nationwide in the United States and in Puerto Rico, said the FDA. Brain-eating amoeba: How are people infected? Here's the specific details to check for: Zicam® Cold Remedy Nasal Swabs, with UPC 732216301205, all lots: A zinc-free, homeopathic cold remedy swab designed to shorten the duration of the common cold. Zicam® Nasal AllClear Swabs, with UPC 732216301656, all lots: A nasal cleansing swab product (discontinued in December 2024). Orajel™ Baby Teething Swabs, with UPC 310310400002, all lots: Pre-moistened swabs designed to soothe teething discomfort in infants and toddlers. You can view images of the recalled products in the slideshow below: 'This recall is limited exclusively to Zicam and Orajel swab products. All other Zicam and Orajel products, including Zicam RapidMelts, are not affected by this recall,' states the FDA on its website. Consumers can CLICK HERE or call (800) 981-4710 for refund details. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into the world of global news and events? Download our app today from your preferred app store and start exploring.
app-storeplay-store