Health
F.D.A. Blocked Publication of Research Finding Covid and Shingles Vaccines Were Safe
Officials at the Food and Drug Administration have blocked publication of several studies supporting the safety of widely used vaccines against Covid-19 and shingles in recent months, a spokesman for the Department of Health and Human Services confirmed.
The studies, which cost millions of dollars in public funds, were conducted by scientists at the agency, who worked with data firms to analyze millions of patient records. They found serious side effects to be very rare.
In October, the scientists were directed to withdraw two Covid-19 vaccine studies that had been accepted for publication in medical journals. In February, top F.D.A. officials did not sign off on submitting abstracts about studies of Shingrix, a shingles vaccine, to a major drug safety conference.
The withdrawal of the studies is the latest step by the administration to try to limit access to vaccines. It has sharply cut research funding for vaccine development, released unvetted information casting doubt on vaccines, and blocked other information supporting their safety, most recently a paper on Covid vaccine effectiveness by career scientists from the Centers for Disease Control and Prevention.
Asked about the withdrawal of the Covid vaccine safety studies, Andrew Nixon, a spokesman for the Department of Health and Human Services, said in an email: “The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data. The F.D.A. acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards.”
Of the shingles study that found the vaccine to be effective, he said, “The design of that study fell outside the agency’s purview.” He did not address a question about the Shingrix safety study, which found the vaccine to be safe.
A senior administration official said the decisions about the research had not reached Dr. Marty Makary, the F.D.A. commissioner, or Health Secretary Robert F. Kennedy Jr. Dr. Vinay Prasad was the head of the F.D.A. vaccine office at the time. Dr. Prasad, who recently left the agency, did not respond to a request for comment.
Last June, Mr. Kennedy’s office asked career C.D.C. staff members to delete from the agency’s website a 17-page summary supporting the safety of thimerosal, an additive largely removed from vaccines 25 years ago. Career scientists were later called into Health and Human Services legal offices and grilled about how the summary had been posted in the first place, they previously told The New York Times.
In posts on a website and on social media in August, Mr. Kennedy called for a prominent journal to “immediately retract” a large Danish study concluding that the vaccine additive aluminum salts was safe. Dr. Christine Laine, the editor in chief of the journal, Annals of Internal Medicine, said Mr. Kennedy did not directly contact the journal seeking a retraction. The study was not retracted.
In recent weeks, Dr. Jay Bhattacharya, who was serving as interim leader of the C.D.C., canceled the publication of a report concluding that the Covid vaccine sharply cut the odds of hospitalizations and emergency room visits last winter, saying the study had limitations.
“At a moment when public trust in institutions like the C.D.C. is fragile, we cannot afford to lower our standards,” Dr. Bhattacharya wrote in an editorial about news coverage of his decision.
Dr. Aaron S. Kesselheim, a Harvard University medical professor who studies F.D.A. regulation, said he had worked with the agency on a number of research papers and found its work to meet “the highest standards of scientific investigation.” He suggested that the request to pull the papers was an act of “censorship.”
He added: “At any other time in history, this would be a major scandal that would lead to congressional hearings and resignations of leadership, and I hope that’s what happens next.”
The withdrawn F.D.A. studies examined the safety of the Covid vaccines used in 2023 and 2024. The agency’s scientists worked with outside data firms that compile and analyze massive data sets under contracts that cost taxpayers millions of dollars each year.
Both studies saw some light of day before they were pulled from publication. One, which examined the Covid vaccine in people older than 65, was posted on a preprint server, which is a repository for studies that have not yet undergone peer review. The study reviewed the records of about 7.5 million Medicare beneficiaries who got the vaccine. The researchers focused on the period of about 21 days after they got the vaccine and compared it to the next 20 days. They were looking to see if there were more health problems in the period right after vaccination.
The study looked at 14 health outcomes potentially caused by the vaccine, including heart attacks, strokes and Guillain-Barré syndrome, an autoimmune condition sometimes associated with vaccines.
They only found a concern with one outcome, anaphylaxis, a severe allergic reaction affecting about 1 in a million people, from the Pfizer vaccine. “No other statistically significant elevations in risk were observed,” the study said.
The study was withdrawn after it had been accepted by the peer reviewed journal Drug Safety, according to people familiar with the work. Michael Stacey, a spokesman for the journal, said it deems submissions to be confidential and would not comment on them.
The Times obtained a copy of the Covid vaccine safety study of people who were 6 months to 64 years old. An abstract of the study appeared at one conference and remains online. Its withdrawal was first reported by STAT News.
That study examined the records of 4.2 million Covid vaccine recipients and examined their later experience with 17 conditions, including swelling of the brain, major blood clots, stroke and heart attacks. The study found rare cases of fever-related seizures and myocarditis, or inflammation of the heart muscle, known to be associated with Covid vaccines.
“Given the available evidence, F.D.A. continues to conclude the benefits of vaccination outweigh the risks,” the study said.
Angela Rasmussen, an editor in chief of the journal Vaccine, said the paper had been withdrawn by the authors.
Dr. Caleb Alexander, a drug safety and methodology expert at Johns Hopkins University, reviewed both studies at the request of The Times and said that “no study answers every question” but “there is nothing inherently problematic regarding these reports.”
“It’s too bad that these haven’t seen the full light of day,” Dr. Alexander said in an email. “They provide useful information regarding the most commonly used COVID-19 vaccines.”
Jeffrey Morris, director of the University of Pennsylvania biostatistics division, who also reviewed the study drafts at the request of The Times, said the studies were generally well done.
“I think if there’s any critique,” he said, “it’s that they don’t do enough of these studies with the resources they have.”
Dr. Jeanne Marrazzo, a former high-ranking National Institutes of Health official and chief executive of the Infectious Diseases Society of America, said that F.D.A. leaders withdrawing papers from publication is a “pretty active act of sabotage.”
“This black box of decision making around data suppression should be having people very alarmed and very worried,” said Dr. Marrazzo. She filed a whistle-blower complaint against the N.I.H., was fired by Mr. Kennedy and has since sued the agency, claiming that she was ousted for objecting to its policies.
By contrast, Mr. Kennedy’s team has had lower standards for releasing information critical of vaccines. A memo by Dr. Prasad, the former head of the F.D.A.’s vaccine division, drew widespread news coverage by claiming that the Covid vaccine had been linked to the deaths of 10 children, a conclusion the agency has not backed up or explained.
In February, agency officials did not sign off in time for staff to submit abstracts on two studies of the Shingrix vaccine to a drug safety conference, according to two people familiar with the decision. A senior administration official said the studies were not moving forward at the agency.
One study found the efficacy to be in line with findings from the clinical trials done before agency approval. A safety study also aligned with what was known, finding an elevated but low risk for Guillain-Barré syndrome, an autoimmune disease already noted in the vaccine’s label.
Dr. Helen Chu, an infectious disease doctor who was among 17 scientists fired from an influential vaccine advisory body at the C.D.C. last summer, said large studies by health agencies are closely watched by doctors and professional societies. They are important, she said, because they can examine the effect of a vaccine on millions of people, far more than the thousands that were tracked in clinical trials.
“You really do need these studies for us to truly be safe and to make sure that vaccines continue to be safe,” she said. “These types of studies have to be done and the results have to be published.”
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An investigational dementia drug may also ease alcohol withdrawal by calming the brain inflammation linked to addiction and relapse.
That’s according to researchers at the University of Kentucky, who studied an experimental medication called MW150 that targets a brain inflammation pathway known as p38α MAPK.
The drug, which has not yet been approved, is designed to treat mild to moderate Alzheimer’s disease.
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Scientists believe neuroinflammation may contribute to relapse risk and long-term neurological damage in people with alcohol use disorder.
In laboratory and animal-model experiments, MW150 was found to reduce certain inflammatory markers during alcohol withdrawal.
An investigational dementia drug may also ease alcohol withdrawal by calming the brain inflammation linked to addiction and relapse. (iStock)
The work, which was published in the journal Alcohol, came from the University of Kentucky’s Sanders-Brown Center on Aging, led by neuroinflammation researcher Linda Van Eldik.
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Caleb Bailey, Ph.D., co-author of the study and a researcher in Van Eldik’s lab, said the study provides “biological plausibility” that MW150 could mitigate neuroinflammation arising from alcohol withdrawal.
Alcohol use disorder is difficult to treat because of high relapse rates, especially during withdrawal, according to Bailey.
Alcohol use disorder is difficult to treat because of high relapse rates, especially during withdrawal, according to the researchers. (iStock)
“If follow-up experiments reveal similar anti-inflammatory effects of MW150 in animal models of alcohol use disorder, it would provide a strong rationale for development of MW150 as a treatment for those struggling with chronic alcohol relapse due to alcohol withdrawal,” he told Fox News Digital.
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Along with a related drug called Neflamapimod, MW150 is already being investigated in clinical trials as a potential therapy for dementia and other neurodegenerative conditions, the researchers noted.
“That gives this work added significance,” Bailey said. “Because these compounds are already further along in development for other neurological diseases, it raises the possibility that they could someday be repurposed more efficiently for alcohol-related conditions if future studies continue to show promise.”
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There were some important caveats to the research, including that it was conducted in cell culture and animal models.
“Because they are ‘dish’-based models, they provide limited information regarding what happens in the full organism – or even the full brain for that matter,” Bailey said.
MW150, along with a related drug called Neflamapimod, is already being investigated in clinical trials as a potential therapy for dementia and other neurodegenerative conditions. (iStock)
“A series of follow-up studies in living animals is required to more fully understand how future MW150 treatment in alcohol use and withdrawal affects systemic health and/or alcohol consumption.”
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Dr. Amy Swift, deputy chief medical officer at Silver Hill Hospital in Connecticut, was not involved in the study but shared her reactions to the findings.
“Although detoxification using tapering doses of medication has long been considered the evidence-based first step in treating alcohol use disorder, its impact on the long-term trajectory of a person’s drinking behavior has been limited,” she told Fox News Digital.
“Minimizing alcohol consumption … is the best strategy for staying healthy.”
“Put simply, detoxification does not treat alcohol use disorder itself; rather, it prevents the potentially fatal complications of alcohol withdrawal.”
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Adding supportive medications — especially those intended to improve overall brain health — could address an important gap in early treatment of detoxification, according to Swift.
“It is worthwhile to investigate whether reducing neuroinflammation could improve a patient’s ability to engage in treatment earlier in recovery and, in turn, meaningfully alter their long-term relationship with alcohol,” an expert said. (iStock)
“Given the profound inflammatory effects alcohol has across multiple organ systems, it is worthwhile to investigate whether reducing neuroinflammation could improve a patient’s ability to engage in treatment earlier in recovery and, in turn, meaningfully alter their long-term relationship with alcohol,” she added.
Bailey emphasized that no amount of alcohol consumption is good from a physical health standpoint.
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“We don’t currently have robust pharmacological treatments to mitigate damage caused by chronic alcohol consumption,” he said. “Minimizing alcohol consumption, therefore, is the best strategy for staying healthy.”
As the MW150 compound continues to be studied for dementia patients, Bailey saud, “information regarding the interaction between these drugs and alcohol — for better or for worse — will be important for patient outcomes.”
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For years, researchers have believed prolonged sitting could raise dementia risk — but new findings suggest the type of sitting may matter more than previously thought.
The research, which was published in the American Journal of Preventive Medicine in March, found that replacing mentally passive sedentary behavior with mentally active sedentary behavior was associated with a significant reduction in dementia risk.
Mentally active sedentary behaviors could include reading, office work and other activities that keep the brain engaged while sitting, while mentally passive behaviors may include watching television or other low-engagement screen activities.
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To gather the findings, Swedish researchers analyzed data from more than 20,000 adults between ages 35 and 64 who were tracked over a 19-year period, between 1997 and 2016, according to a press release.
Participants answered questions about their sitting habits, physical activity and other lifestyle behaviors, while dementia diagnoses were identified using Swedish health and death records.
Researchers emphasized that how people use their brains while sitting may matter more than previously understood. (iStock)
Mentally active sedentary behavior was associated with “a significant reduction in dementia risk” compared to more passive sitting activities.
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Although the study was based in Sweden, the release said the findings “are likely generalizable to a wider global population” and could help “inform public health guidelines and preventive strategies to reduce dementia.”
In a statement, lead researcher Dr. Mats Hallgren of Sweden’s Karolinska Institute said the study highlighted major distinctions between passive and mentally engaging sedentary habits when it comes to brain health.
The research tracked more than 20,000 adults over nearly two decades to examine links between sitting habits and dementia. (iStock)
“While all sitting involves minimal energy expenditure, it may be differentiated by the level of brain activity,” said Hallgren.
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“How we use our brains while we are sitting appears to be a crucial determinant of future cognitive functioning and, as we have shown, may predict dementia onset.”
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Sedentary behavior is a “ubiquitous but modifiable risk factor for many health conditions, including dementia,” according to the researcher.
“Our study adds the observation that not all sedentary behaviors are equivalent; some may increase the risk of dementia, while others may be protective,” he added. “It is important to remain physically active as we age, but also mentally active — especially when we are sitting.”
The findings suggest not all sitting behaviors are equal when it comes to protecting long-term brain health. (iStock)
The CDC projects that by 2060, nearly 14 million American adults will have Alzheimer’s disease.
One recent study published by the Alzheimer’s Association found that a person’s biological age may be tied to dementia risk.
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Researchers also recently found that a higher intake of unprocessed meat may protect against dementia in older people who have a variant of a certain gene.
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Walking is a great way to get the body moving and clear the mind — but if you’re doing it wrong, it may do more harm than good.
That’s according to Dr. Milica McDowell, author of the new book “Walk,” a guide to getting the most out of walking.
The Montana-based doctor of physical therapy, who specializes in lower extremity and orthopedics, shared in an interview with Fox News Digital how powerful walking can be.
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“Walking has incredible health benefits for your wellness today and your longevity tomorrow,” she said. “And it’s something that’s at an all-time low since the pandemic.”
“Walking improves every system in your body – gut, musculoskeletal, mental health, your hormones – and so it has an incredible power to help optimize how you’re doing.”
“Walk,” co-authored by physical therapist Milica McDowell, explores how walking can improve longevity, mobility, mental well-being and overall fitness. (Amelia Anne Photography; Hachette Book Group/Alexander Ryabintsev)
McDowell added that walking is a “phenomenal way” to support a weight-loss journey, as it’s low-impact and low-intensity. It can also boost creativity and reduce stress.
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While the health benefits of walking are evident, McDowell warned of some mistakes that could reverse progress.
No. 1: Walking while scrolling
Escaping our phones can sometimes feel impossible, but if there’s ever a time to be on do-not-disturb, it’s during a walk, according to McDowell.
Walking while scrolling is “really dangerous,” she cautioned, as you’re less aware of your surroundings and more susceptible to accidents.
Walking while scrolling is a danger to public health, the expert says. (iStock)
“You could step in a pothole. You could get hit by a car. You could trip over something. You could bump into someone,” she said. “Walking and scrolling is actually a bit of a public health crisis.”
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Scrolling also puts the neck in a downward position, making the head heavier, which changes your posture “from the top down,” McDowell said. “That can be a problem if you’re someone who struggles with neck pain, back pain or shoulder pain.”
No. 2: Wearing the wrong shoes
McDowell recommends wearing a proper shoe designed specifically for walking to support the feet, promote healthy alignment and protect musculoskeletal health.
The shoe should be “shaped like a foot” so that the toes have room to spread within a wide toe box, she said.
Having space between each toe activates more muscles in the foot and creates a “more healthy walking gait,” according to the expert.
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More than 60% of adults wear the wrong shoe size, according to McDowell, and sizing can vary significantly between brands and manufacturers. She recommends getting measured by a professional to ensure the optimal fit.
No. 3: Not balancing your routine
Walking engages important muscles that support stability and mobility, including the glutes, which help propel the body forward with each step.
But walking shouldn’t be your only form of exercise, experts say. Incorporating strength training and other forms of movement can help prevent overuse injuries, improve balance and build overall fitness.
A well-rounded fitness routine will boost the health benefits of walking, the expert said. (iStock)
“A health stack includes drinking enough water, having healthy nutrition and sleeping adequately — and walking can be added to the other activities,” she said.
Pairing walking with activities like weightlifting, pickleball, dancing or CrossFit can help create a more balanced fitness routine, according to McDowell, and are all part of building a strong “health stack.”
“A health stack includes drinking [enough] water, having healthy nutrition, sleeping adequately — and walking can be added to the other activities,” she said.
No. 4: Not considering walking speed
The speed at which we walk may tell us more about our health than we think.
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Walking speed is the sixth vital sign of health, according to McDowell. These clinical measurements also include blood pressure, heart rate and body temperature.
If your walking speed begins to decline, this could be a marker of underlying health conditions up to seven years before they occur.
A decline in walking speed could be an early warning sign of an underlying health condition. (iStock)
While most people walk at about 90 to 100 steps per minute, translating to about three miles per hour, McDowell suggested increasing your speed to reap “higher level benefits.”
This might mean taking a brisk walk at about 120 to 130 steps per minute, or three and a half to four miles an hour.
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“That can be a place where you get higher level payoff, including more calories burned, if you’re on a weight-loss journey,” she said.
No. 5: Not staying consistent
McDowell emphasized the importance of staying consistent with your walking routine.
A daily walk will have bigger payoffs than only walking once or twice a week. The expert likened walking to basic hygiene, such as brushing your teeth.
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“Everyone is at different places on their walking journey,” she said. “Don’t set the 10,000 steps per day benchmark. That is a marketing myth … Go ahead and find a step count that works well for you, maybe between 5,500 and 7,500.”
Efficiency is everything
McDowell summed up that each walk should be efficient.
“If you are an efficient walker, you are graceful, you are not wasting energy, you are walking balanced no matter your height, your weight or your age,” she said.
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As the wellness movement has emphasized the importance of just moving, McDowell commented that walking is a “pinnacle activity” in this push.
“People are recognizing that these softer, more consistent activities can provide a lot of benefit for our physical and mental health,” she said.
McDowell encourages walking with a friend for added social benefit. (iStock)
“You don’t have to go and crush yourself in the gym. You don’t have to be dripping sweat … It’s something you can do for periods of time throughout the day, little ‘snacks’ that all add up, or you can take longer walks depending on what time is available to you.”
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Walking can also be a positive social experience done with friends and loved ones, McDowell noted. This is particularly important for seniors who can benefit from the combined physical activity and social interaction.
“Walking with an older adult can help combat loneliness,” she said. “It can also help improve balance and reaction time, and reduce fall risk.”
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