Top US Vaccine Official Resigns Citing RFK ‘Misinformation' Push
The Food and Drug Administration 's top vaccine regulator abruptly resigned Friday, citing what he called Health and Human Services Secretary Robert F. Kennedy Jr.'s efforts to spread misinformation about the safety of immunizations, according to a letter obtained by Bloomberg.
Peter Marks, who was a key figure in Operation Warp Speed, stepped down from his position as the director of the FDA's Center for Biologics Evaluation and Research, which is responsible for the safety and effectiveness of vaccines, along with gene therapies and blood products.
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Time Magazine
26 minutes ago
- Time Magazine
Trump's First Surgeon General: RFK Jr. Purging the CDC Advisory Committee Will Put Lives at Risk
When Secretary Robert F. Kennedy Jr. began his tenure as Health and Human Services Secretary, he pledged, 'We won't take away anyone's vaccines.' However, recent policy changes under his leadership—coupled with the unprecedented dismissal of all 17 members of the CDC's Advisory Committee on Immunization Practices (ACIP) on June 9—have proven that statement false, raising grave concerns for our nation's COVID-19 response and broader vaccine policies. These shifts not only jeopardize public health but also threaten to erode trust in our health institutions at a critical time. In May 2025, the Food and Drug Administration (FDA) introduced a new COVID-19 vaccine framework, limiting access to updated vaccines for Americans aged 65 and older or those with specific risk factors. Furthermore, Secretary Kennedy announced that the Centers for Disease Control and Prevention (CDC) would no longer recommend COVID-19 vaccines for 'healthy' children or pregnant women—bypassing the standard ACIP review process. Compounding these changes, the abrupt removal of ACIP's entire panel of independent experts, who have guided evidence-based vaccine policy for decades, risks destabilizing a cornerstone of public health. These actions collectively restrict access to a vital tool for saving lives and undermine confidence in our health systems. During my tenure as Surgeon General under the first Trump administration, we faced significant public health challenges, from addressing the opioid epidemic by increasing access to Naloxone to launching Operation Warp Speed for the COVID-19 vaccine development effort. The vaccines developed under Trump's first term have proven to be one of our most effective defenses against COVID-19; yet, the current administration's new policies limit their availability, potentially leaving millions vulnerable. The dismissal of ACIP's experts—without a clear plan for replacing them with qualified scientists—further jeopardizes trust in the institutions tasked with protecting Americans. The major flaw in the new vaccine framework is its narrow assessment of risk. Although the immediate dangers of COVID-19 have lessened, it remains a leading cause of death and hospitalization, claiming nearly 50,000 lives in the U.S. in 2024—more than breast cancer or car accidents. The fact is, 75% of Americans have risk factors, such as obesity or diabetes, that increase their vulnerability to severe COVID outcomes. However, the burden is now placed on individuals to self-identify as high risk, creating confusion and inconsistency in access. Unlike other countries with centralized systems for identifying at-risk individuals, the U.S. expects patients—many of whom lack easy access to healthcare—to navigate eligibility alone. Risk assessment should also consider individual circumstances beyond underlying health conditions. A 58-year-old bus driver or healthcare worker faces significantly greater exposure than someone working remotely. By limiting vaccines to specific groups based solely on preexisting health status, the policy overlooks these critical contextual differences. Secretary Kennedy's team argues that there is insufficient evidence to support updated COVID-19 vaccines for healthy Americans under 65, but this claim is flatly unfounded. Years of real-world data demonstrate that vaccines save lives and reduce hospitalizations across all age groups. During the 2023 to 2024 fall and winter season, 95% of those hospitalized for COVID had not received an updated vaccine. While the administration cites other countries' more restrictive vaccine policies, such comparisons ignore the unique health landscape in the U.S., which includes higher obesity rates, worse maternal health outcomes, and uneven healthcare access. The policy also neglects the issue of Long COVID, which affects millions with debilitating symptoms lasting months or years. Though older adults are at higher risk for severe acute infections, Long COVID disproportionately impacts adults aged 35 to 49—and children are also affected. Vaccination reduces the risk of developing Long COVID, an essential reason many healthy individuals choose to stay up-to-date with their vaccines. Particularly concerning is the decision to end COVID vaccine recommendations for 'healthy' pregnant women, which contradicts the FDA's own guidance. Pregnant women face heightened risks of severe COVID outcomes, including death, pre-eclampsia, and miscarriage. Vaccination during pregnancy is crucial—not just for maternal health but also for protecting infants under six months, who cannot be vaccinated and rely on maternal antibodies for protection. Decades of research confirm that vaccines, including COVID vaccines, safely transfer antibodies to newborns, lowering their risk of severe illness. The dismissal of ACIP's members amplifies these concerns. ACIP has been a trusted, science-driven body that ensures vaccines are safe and effective, saving countless lives through its transparent recommendations. Its members, rigorously vetted for expertise and conflicts of interest, provide independent guidance critical to public health. Removing them without clear evidence of misconduct risks replacing qualified scientists with less experienced voices. This move fuels vaccine hesitancy and skepticism about public health decisions, particularly when paired with the bypassing of ACIP's review process for the new COVID vaccine policies. These changes create uncertainty about who can access vaccines. Without clear CDC recommendations, insurance companies may impose their own coverage criteria, potentially increasing costs for a vaccine that was previously free for most Americans. Healthcare providers, lacking federal guidance and ACIP's expertise, may struggle to advise patients, leading to a confusing and inequitable system that limits choice—hardly the 'medical freedom' Secretary Kennedy claims to champion. Ultimately, these actions threaten to erode trust in public health. FDA officials argue the new framework enhances transparency, yet bypassing ACIP's review and dismissing its members undermines that aim. Extensive data demonstrate that updated vaccines lower hospitalization and death rates, yet this evidence was sidelined. Such actions breed skepticism, making it harder to unite Americans around shared health goals. The stakes are high, but a better path is possible. Restoring trust requires transparent, evidence-based policymaking that prioritizes access to life-saving tools. I urge Secretary Kennedy and the administration to reconsider this framework, reinstate ACIP's role in vaccine policy, and ensure any new appointees are qualified, independent experts. If concerns about ACIP exist, they should be addressed through reform, not dissolution. Healthcare providers and community leaders must also educate patients about vaccination benefits, particularly for vulnerable groups like pregnant women and those with high exposure. Individuals can take action by staying informed, discussing vaccination with their doctors, and advocating for clear, equitable access to vaccines. By working together—government, providers, and citizens—we can protect lives, reduce the burden of Long COVID, and rebuild confidence in our public health system. We must seize this opportunity to unite around science and ensure a healthier, safer, and prosperous future for all Americans.
Yahoo
2 hours ago
- Yahoo
Get Ready to Hear a Lot More About Your Mitochondria
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. Robert F. Kennedy Jr.'s warning about mitochondria slipped in between the anti-vaccine junk science and the excoriation of pharmaceutical drugs as 'the No. 3 killer in our country.' He was speaking in 2023 to Joe Rogan, elaborating on the dangers of Wi-Fi—which no high-quality scientific evidence has shown to harm anyone's health—and arguing that it causes disease by somehow opening the blood-brain barrier, and by degrading victims' mitochondria. The mention of mitochondria—the tiny structures that generate energy within our cells—was brief. Two years later, mitochondrial health is poised to become a pillar of the MAHA movement, already showing up in marketing for supplements and on podcasts across the 'manosphere.' Casey Means, President Donald Trump's newest nominee for surgeon general, has singled out the organelle as the main casualty of the modern American health crisis. According to Means (who has an M.D. but no active medical license), most of America's chronic ailments can be traced to mitochondrial dysfunction. Should she be confirmed to the post of surgeon general, the American public can expect to hear a lot more about mitochondria. Among scientists, interest and investment in mitochondria have risen notably in the past five years, Kay Macleod, a University of Chicago researcher who studies mitochondria's role in cancer, told me. Mitochondria, after all, perform a variety of crucial functions in the human body. Beyond powering cells, they can affect gene expression, help certain enzymes function, and modulate cell death, Macleod said. When mitochondria are defective, people do indeed suffer. Vamsi Mootha, a mitochondrial biologist based at Massachusetts General Hospital and the Broad Institute, told me that rare genetic defects (appearing in about one in 4,300 people) can cause the organelles to malfunction, leading to muscle weakness, heart abnormalities, cognitive disability, and liver and kidney problems. Evidence also suggests that defects in mitochondria directly contribute to symptoms of Parkinson's disease, and could be both a cause and an effect of type 2 diabetes. Other conditions' links to mitochondria are blurrier. Researchers see aberrant mitochondria in postmortem biopsies of patients with illnesses such as Alzheimer's, cancer, and fatty-liver disease, Mootha said; whether those damaged mitochondria cause or result from such conditions is not yet clear. But according to Good Energy, the book Means published last year with a top MAHA adviser—her brother, Calley—mitochondrial dysfunction is a veritable plague upon the United States, responsible for both serious illness and everyday malaise. In their view, modern Western diets and lifestyles wreck countless Americans' metabolic health: Every time you drink unfiltered water or a soda, or feel the stress of mounting phone notifications, you hurt your mitochondria, they say, triggering an immune response that in turn triggers inflammation. (Damaged mitochondria really can cause inflammation, Macleod said.) This chain of events, the Meanses claim, can be blamed for virtually every common chronic health condition: migraines, depression, infertility, heart disease, obesity, cancer, and more. (Casey Means did not respond to requests for comment; reached by email, Calley did not respond to my questions about mitochondria, but noted, 'There is significant scientific evidence that healthy food, exercise and sleep have a significant impact on reversing chronic disease.') Good Energy follows a typical wellness playbook: using a mixture of valid and dubious research to pin a slew of common health problems on one overlooked element of health—and advertising a cure. Among the culprits for our mitochondrial ravaging, according to the Meanses, are poor sleep, medications, ultraprocessed foods, seed oils, too many calories, and too few vitamins, as well as chronically staying in comfortable ambient temperatures. The Means siblings therefore recommend eschewing refined sugar in favor of leafy greens, avoiding nicotine and alcohol, frequenting saunas and cold plunges, getting seven to eight hours of uninterrupted sleep a night, and cleansing your life of environmental toxins. Some studies indeed suggest that mitochondrial function is linked with sleep and temperature, but they've all been conducted on cell cultures, organoids, or mice. According to Macleod, evidence suggests that diet, too, is likely important. But only one lifestyle intervention—exercise—has been definitively shown to improve mitochondrial health in humans. The Meanses are riding a wave of interest in mitochondrial health in the wellness world. Earlier this year, the longevity influencer Bryan Johnson and the ivermectin enthusiast Mel Gibson both endorsed the dye methylene blue for its power to improve mitochondrial respiration; Kennedy was filmed slipping something that looks a lot like methylene blue into his drink. (Kennedy did not respond to a request for comment; the FDA has approved methylene blue, but only as a treatment for the blood disease methemoglobinemia.) AG1, formerly known as Athletic Greens, formulates its drinkable vitamins for mitochondrial health. Even one laser-light skin treatment promises to 'recharge failing mitochondria.' The enzyme CoQ10 is popular right now as a supplement for mitochondrial function, as is NAD, a molecule involved in mitochondria's production of energy. NAD IV drips are especially beloved by celebrities such as Gwyneth Paltrow, Kendall Jenner, and the Biebers. These supplements are generally thought to be safe, and some preliminary research shows that NAD supplementation could help patients with Parkinson's or other neurodegenerative diseases, and that CoQ10 could benefit people with mitochondrial disorders. Patients whose symptoms are clearly caused or made worse by deficiencies in a specific vitamin, such as thiamine, can benefit from supplementing those vitamins, Mootha said. But little research explores how these supplements might affect healthy adults. [Read: The MAHA takeover is complete] In Good Energy, as well as on her website and in podcast appearances, Casey Means promotes a number of supplements for mitochondrial health. She also recommends that people wear continuous glucose monitors—available from her company, Levels Health, for $184 a month—to help prevent overwhelming their mitochondria with too much glucose. (According to Macleod, glucose levels are only 'a very indirect measure' of mitochondrial activity.) As with so many problems that wellness influencers harp on, the supposed solution to this one involves buying products from those exact same people. At best, all of this attention to mitochondria could lead Americans to healthier habits. Much of the advice in Good Energy echoes health recommendations we've all heard for decades; getting regular exercise and plenty of fiber is good guidance, regardless of anyone's reasons for doing so. Switching out unhealthy habits for healthy ones will likely even improve your mitochondrial health, Jaya Ganesh, a mitochondrial-disease expert at Icahn School of Medicine at Mount Sinai, told me. After all, 'if you consistently beat your body up with unhealthy habits, everything is going to fall sick,' Ganesh said. But the mitochondrial approach to wellness carries risks, too. For patients with genetically caused mitochondrial disease, lifestyle changes might marginally improve some symptoms, Ganesh said, but attempting to cure such conditions with supplements and a healthy diet alone could be dangerous. Means also calls out medications—including antibiotics, chemotherapy, antiretrovirals, statins, and high-blood-pressure drugs—for interfering with mitochondria. Macleod told me that statins really do affect mitochondria, as do some antibiotics. (The latter makes sense: Mitochondria are thought to have evolved from bacteria more than a billion years ago.) That's no reason, though, to avoid any of these medications if a doctor has determined that you need them. [Read: America can't break its wellness habit] And yet, a whole chapter of Good Energy is dedicated to the idea that readers should mistrust the motives of their doctors, who the authors say profit by keeping Americans sick. The book is less critical of the ways the wellness industry preys on people's fears. Zooming in on mitochondria might offer a reassuringly specific and seemingly scientific explanation of the many real ills of the U.S. population, but ultimately, Means and MAHA are only helping obscure the big picture. Article originally published at The Atlantic
Yahoo
2 hours ago
- Yahoo
HHS justifies decision to stop recommending Covid shots during pregnancy with studies supporting the shots' safety
The Department of Health and Human Services is circulating a document on Capitol Hill to explain its decision to remove the Covid-19 vaccine recommendation for pregnant women — citing studies that largely found the shot is safe. The document, which HHS sent to lawmakers days before Secretary Robert F. Kennedy Jr. announced his plan to fire the panel that advises the CDC on immunizations, says that studies have shown that women who got the vaccine during pregnancy had higher rates of various complications. And it claims that "a number of studies in pregnant women showed higher rates of fetal loss if vaccination was received before 20 weeks of pregnancy,' footnoting a research paper on vaccination during pregnancy. But Dr. Maria P. Velez of McGill University, the lead author of one of the studies, told POLITICO in an email that 'the results of our manuscript were misinterpreted.' The 2023 study shows a slightly higher rate of miscarriages among women who were immunized against Covid-19 during their pregnancies. But, Velez said, that after adjusting for 'variables that can confound a crude association,' like 'age, rurality, neighbourhood income quintile, immigration status, comorbidity' and other factors that could affect the outcome, Canadian researchers found 'no association between SARS-CoV-2 vaccination and an increased risk of miscarriage.' Raw numbers don't account for significant differences among the groups being compared — such as underlying conditions and when during pregnancy the people were vaccinated, said Katelyn Jetelina, an epidemiologist who's consulted for the Centers for Disease Control and Prevention. Scientists, including the Canadian researchers, use statistical methods to adjust for those factors, she said, which is how they determined the vaccine wasn't associated with miscarriage. In a statement, HHS spokesperson Andrew Nixon pointed to the raw study data, which showed a slightly higher rate of miscarriage in the first half of pregnancy for women who were vaccinated against Covid compared with those who weren't. "The underlying data speaks for itself — and it raises legitimate safety concerns," he said. "HHS will not ignore that evidence or downplay early pregnancy loss." Nixon added that HHS and the CDC encourage people to talk to their providers "about any personal medical decision." Vaccine researchers and obstetricians criticized the decision to remove the recommendation for pregnant women, and researchers cited in the HHS document largely dismissed any connection between Covid vaccination and miscarriages. 'Given that COVID-19 infection during pregnancy is associated with serious maternal and neonatal morbidity, the current study can inform healthcare providers, pregnant women and those considering a pregnancy about the safety of SARS-CoV-2 vaccination in relation to miscarriage risk,' Velez and her co-authors wrote in the study. That research was based on health-system data from Ontario, Canada, and aligned with similar population studies in the U.S., Scotland and Norway. Similarly, HHS cited an April 2022 study in its document concerning mRNA vaccination in people undergoing in-vitro fertilization, which also found no adverse effects on conception rates or on early pregnancy outcomes. 'Administration of COVID-19 mRNA vaccines was not associated with an adverse effect on stimulation or early pregnancy outcomes after IVF,' the New York City-based researchers at the Icahn School of Medicine at Mount Sinai and Mount Sinai West hospital wrote in the study. 'Our findings contribute to the growing body of evidence regarding the safety of COVID-19 vaccination in women who are trying to conceive.' The HHS document also includes an incorrect link for that study, instead leading to a different study — also cited in HHS' document — by Israeli researchers that found the vaccine 'appears to be safe during pregnancy,' with no increase in preterm labor or in newborns with low birth weight. That February 2022 study did note a possible increase in preterm birth rates for women vaccinated during the second trimester, and the authors suggested future investigations of outcomes based on the timing of immunization. HHS' assertion about significant risks to pregnant women 'contradicts the bulk of published studies,' said Dr. Paul Offit, an expert who has served as an outside adviser on vaccines to the FDA and the CDC. HHS deviated from past practice when it changed the Covid vaccine guidance last month, announcing the decision without the endorsement of an existing outside panel of expert advisers. Dr. Steven Fleischman, president of the American College of Obstetricians and Gynecologists, told POLITICO at the time that he was disappointed by HHS' decision, and pointed to data showing that newborns can benefit from maternal antibodies from the vaccine for protection from Covid. 'In fact, growing evidence shows just how much vaccination during pregnancy protects the infant after birth, with the vast majority of hospitalized infants less than 6 months of age — those who are not yet eligible for vaccination — born to unvaccinated mothers,' Fleischman said.
