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studies, Andrew Nixon, a spokesman for the Department of Health and Human Services, said in an email: “The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.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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Veteran New York news anchor Bill Ritter revealed Friday that he has been diagnosed with early-stage Alzheimer’s disease, bringing an end to his more than two-decade run behind the WABC-TV anchor desk.
Ritter, 76, who has anchored the station’s 6 p.m. newscast in New York City since 2001, revealed during Friday’s Eyewitness News broadcast that it would be his final night anchoring the program.
“After a series of tests, my doctors have told me I have Alzheimer’s,” Ritter said during the broadcast.
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“It’s early-stage Alzheimer’s, and they say the treatments I’m getting are keeping it at bay, for now,” he continued. “But there is no guarantee, because there’s no cure yet for Alzheimer’s.”
Veteran New York news anchor Bill Ritter announced that he has been diagnosed with early-stage Alzheimer’s disease and is stepping away from the WABC-TV anchor desk. (Linda Rosier/NY Daily News Archive via Getty Images)
“So, unless someone finds an amazing cure, and soon, tonight will be the last newscast I anchor,” he added.
According to ABC7, Ritter joined WABC-TV in 1998 after an extensive journalism career that included work at the Los Angeles Times, local television stations in California and positions with ABC News.
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He began anchoring the station’s 11 p.m. Eyewitness News broadcast in 1999 and was added to the flagship 6 p.m. newscast in 2001. He also anchored the station’s 5 p.m. broadcast for several years.
Bill Ritter has anchored WABC-TV’s 6 p.m. newscast in New York City since 2001. (Heidi Gutman/Disney via Getty Images)
ABC7 reported that Ritter will remain with the station in a new role focused in part on reporting about Alzheimer’s disease and other neurological conditions, as well as their impact on patients and families.
“For decades, Bill Ritter has covered and led New Yorkers through the stories that matter most,” WABC-TV General Manager Marilu Galvez said in a statement.
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“A defining presence at ABC7, he has done so with exceptional insight, integrity and, most of all, heart, earning the love and respect of viewers and colleagues alike,” she continued.
“While he is stepping away from daily anchoring, he will continue to be an integral part of our ABC7 family, including sharing personal updates and providing resources to help others impacted by Alzheimer’s better understand the disease and the resources available to them.”
Bill Ritter, Eyewitness News Anchor, WABC-TV, speaks onstage at the ROAR Forward Summit at Hearst Tower on November 19, 2024 in New York City. (Craig Barritt/Getty Images for Hearst)
“Bill is strong, brilliant, and resourceful, and we look forward to his continued reporting on Eyewitness News,” Galvez added.
New York City Mayor Zohran Mamdani responded to Ritter’s announcement by wishing the veteran broadcaster and his family “strength in the days ahead.”
“For decades, Bill Ritter has been a trusted presence in New Yorkers’ homes, helping us make sense of the news that shape our city,” Mamdani wrote on X. “
“His courage in sharing his Alzheimer’s diagnosis will help countless families facing the same challenge feel less alone,” he continued. “Wishing Bill, his loved ones, and everyone affected by Alzheimer’s strength in the days ahead.”
Ritter’s colleagues also reacted to his announcement.
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WABC-TV reporter Lucy Yang paid tribute to Ritter’s professionalism and dedication during his decades-long career at the station.
“For decades, I’ve reported for his show and even filled in, anchored w him,” she posted on X. “He never gave less than 110% I salute you. I thank you. And I will pray for you.”
Lee Goldberg, the station’s chief meteorologist, said Ritter’s influence would continue long after he stepped away from the anchor desk.
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“He preaches be kind, take care of each other, & we’re all in this together,” Goldberg said on X. “Now, in addition to doing these things for himself & his loving family, he’ll build on his legendary legacy by helping millions who share his battle.”
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“You’re a saint, and my hero @billritter7,” he added. “Love you.”
Ritter also noted during the broadcast that his father died of Alzheimer’s disease in 1998 after battling the illness for years.
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Divorcees and the widowed may face a higher risk of death than those who are still coupled up, a new study reveals.
Researchers in Norway analyzed long-term national health data to weigh mortality risk among those who were divorced, ended situations where they lived with a partner or became widowed.
The study, published in the journal BMJ Public Health, looked at three groups of about 20,000 people each, from 1984 to 2019, who were married or living with a partner at the time.
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During the next wave of the study, these individuals were categorized into three groups: still married or cohabiting, divorced or moved out and widowed. Death records were then checked through January 2020, according to a press release.
Divorces or breakups were consistently linked with higher mortality across all study waves compared to couples who stayed together. (iStock)
The researchers used statistical models to gauge whether this relationship loss was associated with death later.
Divorces or breakups were consistently linked with higher mortality across all groups compared to couples who stayed together. This was the case even after accounting for factors such as age, gender, health habits, self-rated health and loneliness.
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Being widowed was also linked to about a 14% higher mortality risk, though the association was strongest in the earliest period studied.
During the second study period, the link between breakup and mortality was stronger, with a statistically significant association observed only among women.
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Although this research displays an association between living alone and mortality risk, it does not define a direct cause, the team acknowledged.
The link between breakup and mortality was stronger and found to be statistically significant only among women, the second study period revealed. (iStock)
The authors commented that these findings “highlight the importance of addressing social disconnection in public health and in clinical practice to reduce preventable mortality.”
M. David Rudd, a University of Memphis professor of psychology and director of the Rudd Institute for Veteran & Military Suicide Prevention, reflected that these findings underscore what has been known for decades.
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“Loneliness has significant and severe consequences for individual physical health and emotional well-being,” said Rudd, who was not involved in the study. “We’re social beings, and relationships are essential to health, happiness and survival.
“These findings are particularly salient during this period of exponentially increasing isolation, secondary to the influential role of digital technologies.”
Being widowed was also linked to about a 14% higher mortality risk, though the association was strongest in the earliest period studied. (iStock)
While limitations always exist in studies of this kind, Rudd pointed out that this longitudinal research, spanning almost four decades, offers “remarkably important contributions to understanding human behavior.”
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Divorcees and those who are widowed should understand that relationships and social engagement are “critical,” Rudd said. While these relationships don’t necessarily have to be romantic, human connection is important.
“It’s really simple,” he added. “Developing, nurturing and maintaining relationships is critical to health, well-being and happiness.”
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A parasitic tapeworm known as Echinococcus multilocularis — often called the “fox tapeworm” — has been detected for the first time in West Coast wildlife.
University of Washington researchers discovered the tapeworm, which can cause a rare but potentially deadly disease in humans, in 37 out of 100 coyotes sampled near Puget Sound in Washington State. The findings were published in PLOS Neglected Tropical Diseases earlier this year.
Researchers noted that the presence of the parasite in wildlife does not mean human infections are common, and that the risk to the general public remains low.
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“The reason that [cases are] so high in coyotes is because they are regularly eating raw rodents, and that is the primary way for them to get infected,” said lead author Yasmine Hentati, who recently graduated from the UW with a doctorate in environmental and forest science, in a press release.
The study’s genetic testing showed the coyotes carried a newer, more infectious European variant that has become the predominant strain in the U.S. and Canada.
A parasitic tapeworm that causes echinococcosis — one of the most lethal human parasitic diseases — has been detected for the first time in West Coast wildlife. (iStock)
Prior to the 2010s, the parasitic tapeworm was extremely rare in North America, with cases largely confined to the remote islands in Alaska, the authors said.
Over the last 15 years, the parasite has expanded its range, with dog and human infections increasing across the Midwestern U.S. and Canada, according to past reports.
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Cases in coyotes have been spreading west from the upper Midwest for several years, and infected animals have been found on the West Coast, according to Dr. Linda Yancey, an infectious disease specialist at Memorial Hermann in the Houston area.
While Eastern Europe has some cases, the infection is very rarely seen in the U.S., Yancey noted.
University of Washington researchers discovered the tapeworm, known as Echinococcus multilocularis, in 37 out of 100 coyotes sampled near Puget Sound in Washington State. (iStock)
Most cases of echinococcosis are diagnosed in patients who immigrated from or traveled to Central and East Asia, the Middle East and North Africa.
“Worldwide, the area with the highest prevalence of human infections with the fox tapeworm is western China,” Yancey added.
How do humans get infected?
The tapeworm is transmitted among wild animals known as canids — typically cycling from foxes to rodents and back to foxes — and is often referred to as the “fox tapeworm,” Yancey told Fox News Digital.
Humans can get sick from accidentally ingesting worm eggs after handling contaminated soil or eating contaminated food. They can also get the infection by handling a pet that has the tapeworm and then touching their mouth, according to Cleveland Clinic.
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Symptoms to watch for
The hallmark of the infection is fluid-filled sacs called cysts, which contain thousands of very small, immature tapeworms that develop commonly in the liver but can spread to other parts of the body, according to Cleveland Clinic.
The infection often goes undetected for years, or even decades, because the cysts grow at a very slow rate.
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There are two main types of forms of the illness: cystic echinococcosis and alveolar echinococcosis, according to the Centers for Disease Control and Prevention.
With cystic echinococcosis, cysts often develop in the liver and lungs. The body responds by building a protective wall around them as the cysts continue to grow slowly over years.
Symptoms can include abdominal pain or increased belly size (if it infects the liver) or coughing and shortness of breath (if the lungs are infected). (iStock)
Symptoms can include abdominal pain or increased belly size (if it infects the liver) or coughing and shortness of breath (if the lungs are infected). These signs usually do not appear until the cysts grow large enough to press on healthy organs and tissues, according to the CDC.
The infection becomes dangerous when a cyst ruptures — most often due to trauma — and may even lead to death if cyst fluid is released into the body.
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Alveolar echinococcosis is a rarer, more lethal form of the infection. It grows into a tumor-like mass that invades and destroys surrounding tissue, typically in the liver, but can also spread to other parts of the body, including the brain. In severe cases, it can lead to liver failure and death, experts say.
“Symptoms of liver failure include fatigue, yellowing of the skin and eyeballs, and abdominal pain,” Yancey cautioned.
This form of the infection can mimic cancer, so it’s important to see a doctor if symptoms are noticed, she added.
Prevention tips
While the overall risk of infection is low, simple precautions can further reduce exposure.
“The most important way to protect yourself from the fox tapeworm is also the simplest: good hand hygiene,” Yancey advised.
She recommends washing your hands before eating and after you have been outside or have handled soil in areas where the tapeworm is endemic.
The tapeworm is transmitted among wild animals known as canids — typically cycling from foxes to rodents and back to foxes. (iStock)
“For dog owners, prevent your animals from eating wild rodents and make sure all your pets get routine veterinary care,” Yancey added.
The CDC also recommends avoiding contact with wild animals that can carry the tapeworm, such as foxes, coyotes and stray dogs.
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“Routine testing and treatment for worms of all kinds keeps your pups healthy and [keeps] you safe,” Yancey noted.
Fox News Digital reached out to the lead authors of the study requesting comment.
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