Dr. Vinay Prasad, the director of the Food and Drug Administration’s vaccine division, sent a memo to staff that linked children’s deaths to the COVID-19 vaccine, but did not provide data to back the claim.
The memo said that a review “found that at least 10 children have died after and because of receiving COVID-19 vaccination,” according to multiple sources familiar with the email. The memo was first reported by the New York Times.
Prasad suggested that the deaths were related to myocarditis, or the inflammation of the heart muscle. Prasad did not share any data used in the review, including the children’s ages, whether they had existing health conditions, or how the FDA determined there was a link between their death and the vaccine. The findings were not published in a peer-reviewed medical journal.
The risk of myocarditis appears to be higher when vaccine doses are given closer together, as was the case when the vaccines first hit the market. Now, most people receive each dose of the vaccine about a year apart. If someone receives the primary series before age 5, the risk virtually disappears.
Pfizer and Moderna COVID-19 vaccines carry warnings about the risk of myocarditis or pericarditis, a condition where the membrane surrounding the heart becomes inflamed. The warnings were expanded in April 2025 to apply to males aged 16 to 25. The rate of myocarditis and pericarditis was around 8 cases per million doses for children and adults under 65 years old after use of that season’s vaccines, the FDA said at the time.
COVID-19 vaccines, developed during the first Trump administration, have become a target of the second. Top FDA officials selected by the administration under Health and Human Services Secretary Robert F. Kennedy Jr. overrode career staff to limit the approvals of COVID-19 shots from Novavax and Moderna, according to records released by the FDA. A Centers for Disease Control and Prevention official said in June that she was resigning from her role overseeing updates to the agency’s COVID-19 vaccine recommendations, following an order from Kennedy that forced an update to the agency’s guidance.
Changing COVID-19 vaccination guidance has caused confusion for many. The CDC’s vaccine advisory committee, known as the Advisory Committee on Immunization Practices, or ACIP, voted in September to change recommendations for the shot. All members of the committee have been picked by Kennedy, himself a vaccine skeptic. Several of the panel members have criticized the COVID-19 vaccine.
The updated CDC guidance recommends people make individual, informed decisions about COVID-19 vaccination, but did not specifically recommend the shots. The American Academy of Pediatrics said it was “strongly recommending” shots for children between 6 months and 2 years old, while the Infectious Diseases Society of America recommended the vaccine for everyone six months and older. State governments have also banded together, forming the West Coast Health Alliance and the Northeast Public Health Collaborative, to issue recommendations that differ from the CDC guidance.
Dr. Céline Gounder, CBS News medical contributor and editor-at-large for public health at KFF Health News, told CBS News in August that there’s “a lot of noise out there” when it comes to vaccines, but advises parents to “stick the course” and talk to your doctor about making sure children get all their necessary vaccinations, including the initial COVID vaccination series.
It’s highly infectious and definitely not a welcome Thanksgiving guest.
Pertussis, also known as whooping cough, is on the rise with outbreaks across the country, leaving some parents of infants wondering whether they should travel or visit family at all.
Pertussis is a bacterial respiratory infection characterized by the “whoop” sound made by sharp intakes of breath between coughing fits. Infected adults and kids can develop a brutal, weekslong cough. Sick infants are at risk of dying.
Vaccination offers strong protection against disease, but immunity wanes over time and Centers for Disease Control and Prevention data show fewer children are getting the vaccine. The CDC recommends adults get a Tdap booster shot every 10 years.
Infections dropped nationally during and after the COVID-19 pandemic. In 2024, cases surged. This year, infections are similarly high. As of Nov. 19, preliminary data showed more than 25,000 cases nationwide in 2025. The states of Washington, California, Florida and Oregon have been hardest hit.
Heading into the holidays, what are the symptoms to watch for, who is most at risk and who needs to get vaccinated?
Symptoms to be on the lookout for
Whooping cough symptoms progress in stages, and the disease’s severity can depend on a person’s vaccination status.
Symptoms usually appear within five to 10 days after exposure, but they can also take twice as long to develop.
During the first one to two weeks, symptoms often resemble an average cold: a mild cough, a low-grade fever and a runny nose. Although the symptoms might seem innocuous, a person is contagious during this stage.
The second, more severe stage can last up to 10 weeks. The main symptom is intense coughing fits, called paroxysms, that can lead to vomiting. The cough ends with an intake of breath that sounds like a “whoop.”
“Sometimes the coughing is so severe that ribs are cracked,” said Dr. Joseph Bocchini, a pediatric infectious disease doctor at Willis-Knighton Health. “There’s such shortness of breath that people wake up at night with a coughing spell, they feel like they’re suffocating.”
People who have never been vaccinated are likely to experience worse symptoms than their vaccinated peers, Bocchini said.
Recovery is often gradual as the cough wanes. As a person recovers, they can be more vulnerable to contracting other respiratory infections, and the cough might return.
Getting sick confers natural immunity from the disease for a time, but that protection doesn’t last long.
Infections happen year-round, but peak whooping cough season lasts from late summer through fall. Pertussis is a cyclical disease, meaning it might spread widely through a community and then disappear from that population. Infections might return to an area once that immunity has waned.
What causes the cough?
The bacteria Bordetella pertussis causes the coughing.
The bacteria enter a person’s upper respiratory tract and latch on to cilia, hair-like extensions in the airways. Cilia are essential for clearing mucus and debris from your lungs. The bacteria release a toxin that damages the cilia and causes the airway to swell. With a person’s lung-cleaning apparatus damaged, the body resorts to coughing to get the gunk out.
If one person in a household is infected, data shows about 80% of exposed family members also will get infected, if they aren’t vaccinated or immune.
Pertussis spreads through droplets when someone sneezes or coughs.
How is whooping cough treated?
Doctors use nasal swab lab tests to identify infections.
Antibiotics are the most effective treatment, especially when taken early in the illness. If taken before the coughing fits begin, antibiotics can prevent the illness from progressing or make symptoms milder.
That’s why doctors sometimes prescribe antibiotics to the infected person’s family and other contacts: to halt further spread.
Once the coughing fits have begun, antibiotics are less effective at reducing symptoms or shortening the course of the illness. The cilia have already been damaged, and the lungs need time to heal.
Antibiotics are still prescribed at that stage because a five-day course kills the bacteria, making the person no longer contagious, even if the cough persists.
To manage symptoms, the CDC advises using a cool-mist humidifier, eating small meals to prevent vomiting and drinking plenty of fluids. The agency also recommends avoiding airway irritants such as dust, smoke or chemical fumes that might trigger coughing.
Some pertussis cases require hospitalization.
Young babies are most at risk
Whooping cough is most dangerous for babies under 1 year old, especially under 3 months. The CDC reports that 1 in 3 infected babies will need hospital treatment. About 1% of infected babies die from complications, such as pneumonia, damage in the brain or difficulty breathing.
Infants with pertussis sometimes don’t cough at all, but have dangerous pauses in breathing called apnea. Babies may turn blue as they struggle to breathe.
Older people, people who are immunocompromised and people with moderate to severe asthma also could be at higher risk of complications.
DTaP and Tdap vaccines can protect against illness
Scientists first developed a pertussis vaccine in 1914. In the 1940s, it became part of a combination vaccine that also protects against diphtheria and tetanus. It’s still combined with those today.
Two vaccines protect against whooping cough: DTaP, given to young children, and Tdap, given to adolescents, adults and pregnant women.
Vaccination doesn’t stop the bacteria from entering a person’s body, but it helps stop an infection from developing. Among the minority of vaccinated people who do get sick, vaccination decreases the illness’ severity.
The CDC’s childhood vaccine schedule recommends that babies get their first dose of the DTaP vaccine at 2 months old. The vaccine is delivered in four more doses at 4 months, 6 months, between 15 and 18 months and between 4 and 6 years.
“Just like we practice baseball or piano with many games of catch or lessons, providing multiple doses gives our immune system additional practice,” said Dr. Lori Handy, a pediatric infectious disease specialist at Children’s Hospital of Philadelphia. “The vaccine schedule is designed to give enough practice to our system that eventually, the person is adequately protected.”
Vaccinated children are muchless likely than unvaccinated children to get sick with pertussis.
During the 2024-2025 school year, 92.1% of kindergarteners received a DTaP vaccine, down from about 95% in the decade before the pandemic.
Protection from the vaccine wanes over time, which is why we have the Tdap booster vaccine. The CDC recommended preteens get one dose, and adults get a shot every 10 years. Adults can infect children, so staying up to date is important for the little ones in your life.
The CDC also recommends pregnant women receive a Tdap booster between the 27th and 36th week of pregnancy, regardless of when they were last vaccinated. “Vaccination of pregnant moms provides immunity to newborn babies, so that they are protected at the time when they are most at risk of deadly disease,” Handy said.
How can I stay safe over the holidays?
“Far and away, the most important thing is to be vaccinated and be up to date,” Bocchini said. And if you have a small baby, make sure the people around the baby are also vaccinated and up to date.
Other strategies are basic: Wash your hands often. Use good cough etiquette. Teach these habits to your kids.
Since the bacteria spreads through coughs and sneezes, wearing a mask can help slow the spread, whether you are infected or around someone who is.
If you think you might have been exposed, you can ask your doctor to test you. In its initial stage, whooping cough is hard to distinguish from other respiratory infections, Bocchini advised patients to ask themselves how they might have been exposed: Have I been around someone with a persistent cough that happens in fits? Although it may be hard, it’s safest to stay home when you are sick.
California could see an early start to the annual flu season, as a combination of low vaccination rates and late mutations to the virus may leave the state particularly exposed to transmission, health experts say.
Already, there are warning signs. Los Angeles County recently reported its first flu death of the season, and other nations are reporting record-breaking or powerful, earlier-than-expected flu seasons.
Typically, flu picks up right after Christmas and into the New Year, but Dr. Elizabeth Hudson, regional physician chief of infectious diseases at Kaiser Permanente Southern California, said she expects increases in viral activity perhaps over the next two to three weeks.
“We’re expecting an early and likely sharp start to the flu season,” Hudson said.
Last year’s flu season was the worst California had seen in years, and it’s not usual for there to be back-to-back bad flu seasons. But a combination of a decline in flu vaccination rates and a “souped-up mutant” is particularly concerning this year, according to Dr. Peter Chin-Hong, an infectious diseases expert at UC San Francisco.
“That may translate into more people getting infected. And as more people get infected, a proportion of them will go to the hospital,” Chin-Hong said.
The timing of this new flu subvariant — called H3N2 subclade K — is particularly problematic. It emerged toward the end of the summer, long after health officials had already determined how to formulate this fall’s flu vaccine, a decision that had to be made in February.
H3N2 subclade K seems to be starting to dominate in Japan and Britain, Hudson said.
“It looks like a bit of a mismatch between the seasonal flu vaccine strains” and the new subvariant, Hudson said.
It remains unclear whether subclade K will reduce the effectiveness of this year’s flu shot.
In California and the rest of the U.S., “things are quiet, but I think it’s just a calm before the storm,” Chin-Hong said. “From what we see in the U.K. and Japan, a lot more people are getting flu earlier.”
Chin-Hong noted that subclade K is not that much different than the strains this year’s flu vaccines were designed against. And he noted data recently released in Britain that showed this season’s vaccines were still effective against hospitalization.
According to the British government, vaccinated children were 70% to 75% less likely to need hospital care, and adults were 30% to 40% less likely. Flu vaccine effectiveness is typically between 30% to 60%, and tends to be more effective in younger people, the British government said.
Even if there is some degree of mismatch between the vaccine and circulating strains, “the flu vaccine still provides protection against severe illness, including hospitalizations,” according to the Los Angeles County Department of Public Health.
“Public Health strongly encourages everyone who has not received the flu vaccine yet this year to receive it now, especially before gathering with loved ones during the holidays,” the department said in a statement.
But “while mismatched vaccines may still provide protection, enhanced genetic, antigenic and epidemiological … monitoring are warranted to inform risk assessment and response,” according to scientists writing in the Journal of the Assn. of Medical Microbiology and Infectious Diseases Canada.
Because the vaccine is not a perfect match for the latest mutated flu strain, Chin-Hong said getting antiviral medication like Tamiflu to infected patients may be especially important this year, even for those who are vaccinated. That’s especially true for the most vulnerable, which include the very young and very old.
“But that means you need to get diagnosed earlier,” Chin-Hong said. Drugs like Tamiflu work best when started within one to two days after flu symptoms begin, the U.S. Centers for Disease Control and Prevention says.
There are now at-home flu testing kits that are widely available for sale for people who are showing signs of illness.
Also worrying is how the flu has surged in other countries.
Australia’s flu season came earlier this year and was more severe than usual. The Royal Australian College of General Practitioners said that nation saw a record flu season, with more than 410,000 lab-confirmed cases, up from the prior all-time high of 365,000 that were reported last year.
“This is not a record we want to be breaking,” Dr. Michael Wright, president of the physician’s group, said.
Hudson noted Australia’s flu season was “particularly hard on children” this year.
L.A. County health officials cautioned that Australia’s experience isn’t a solid predictor of what happens locally.
“It is difficult to predict what will happen in the United States and Los Angeles, as the severity of the flu season depends on multiple factors including circulating strains, pre-existing immunity, vaccine uptake, and the overall health of the population,” the L.A. County Department of Public Health said.
The new strain has also thrown a wrench in things. As Australia’s flu season was ending, “this new mutation came up, which kind of ignited flu in Japan and the U.K., and other parts of Europe and Asia,” Chin-Hong said.
On Friday, Japan reportedly issued a national alert with flu cases surging and hospitalizations increasing, especially among children and the elderly, accompanied by a sharp rise in school and class closures. The Japanese newspaper Asahi Shimbun said children ages 1 through 9 and adults 80 and up were among the hardest-hit groups.
Taiwanese health officials warned of the possibility of a second peak in flu this year, according to the Central News Agency. There was already a peak in late September and early October — a month earlier than normal — and officials are warning about an uptick in flu cases starting in December and then peaking around the Lunar New Year on Feb. 17.
Taiwanese officials said 95% of patients with severe flu symptoms had not been recently vaccinated.
British health officials this month issued a “flu jab SOS,” as an early wave struck the nation. Flu cases are “already triple what they were this time last year,” Public Health Minister Ashley Dalton said in a statement.
In England, outside of pandemic years, this fall marked the earliest start to the flu season since 2003-04, scientists said in the journal Eurosurveillance.
“We have to brace ourselves for another year of more cases of flu,” Chin-Hong said.
One major concern has been declining flu vaccination rates — a trend seen in both Australia and the United States.
In Australia, only 25.7% of children age 6 months to 5 years were vaccinated against flu in 2025, the lowest rate since 2021. Among seniors age 65 and up, 60.5% were vaccinated, the lowest rate since 2020.
Australian health officials are promoting free flu vaccinations for children that don’t require an injection, but are administered by nasal spray.
“We must boost vaccination rates,” Wright said.
In the U.S., officials recommend the annual flu vaccine for everyone age 6 months and up. Those age 65 and up are eligible for a higher-dose version, and kids and adults between age 2 and age 49 are eligible to get vaccinated via the FluMist nasal spray, rather than a needle injection.
Officials this year began allowing people to order FluMist to be mailed to them at home.
Besides getting vaccinated, other ways to protect yourself against the flu include washing your hands frequently, avoiding sick people and wearing a mask in higher-risk indoor settings, such as while in the airport and on a plane.
Healthy high-risk people, such as older individuals, can be prescribed antiviral drugs like Tamiflu if another household member has the flu, Chin-Hong said.
Doctors are especially concerned about babies, toddlers and young children up to age 5.
“Those are the kids that are the most vulnerable if they get any kind of a respiratory illness. It can really go badly for them, and they can end up extraordinarily ill,” Hudson said.
In the United States, just 49.2% of children had gotten a flu shot as of late April, lower than the 53.4% who had done so at the same point the previous season, according to preliminary national survey results. Both figures are well below the final flu vaccination rate for eligible children during the 2019-20 season, which was 63.7%.
Among adults, 46.7% had gotten their flu shot as of late April, slightly down from the 47.4% at the same point last season, according to the preliminary survey results, which are the most recent data available.
“Before the COVID-19 pandemic, flu vaccination coverage had been slowly increasing; downturns in coverage occurred during and after the pandemic. Flu vaccination levels have not rebounded to pre-pandemic levels,” according to the CDC.
The disparaging of vaccinations by federal health officials, led by the vaccine-skeptic secretary of the U.S. Department of Health and Human Services, Robert F. Kennedy Jr., has not helped improve immunization rates, health experts say. Kennedy told the New York Times on Thursday that he personally directed the CDC to change its website to abandon its position that vaccines do not cause autism.
Mainstream health experts and former CDC officials denounced the change. “Extensive scientific evidence shows vaccines do not cause autism,” wrote Daniel Jernigan, Demetre Daskalakis and Debra Houry, all former top officials at the CDC, in an op-ed to MS NOW.
“CDC has been updated to cause chaos without scientific basis. Do not trust this agency,” Daskalakis, former director of the CDC’s National Center for Immunization and Respiratory Diseases, added on social media. “This is a national embarrassment.”
State health officials from California, Washington, Oregon and Hawaii on Friday called the new claims on the CDC website inaccurate and said there are decades of “high quality evidence that vaccines are not linked to autism.”
“Over 40 high-quality studies involving more than 5.6 million children have found no link between any routine childhood vaccine and autism,” the L.A. County Department of Public Health said Friday. “The increase in autism diagnoses reflects improved screening, broader diagnostic criteria, and greater awareness, not a link to vaccines.”
Hudson said it’s important to get evidence-based information on the flu vaccines.
“Vaccines save lives. The flu vaccine in particular saves lives,” Hudson said.
As the federal government prepares for the next meeting of its Advisory Committee on Immunization Practices, Health and Human Services Secretary Robert F. Kennedy Jr. has intensified his attacks on aluminum vaccine components used in many shots to boost the body’s immune response.
Kennedy, a longtime anti-vaccine activist before seeking public office, claims that aluminum adjuvants are neurotoxic and tied to autism, asthma, autoimmune disease, and food allergies.
But science and medicine advances a different view. Strong recommendations that parents introduce peanut-containing foods to infants early, for instance, have led to a drop in the incidence rate of peanut allergies.
Since taking office, Kennedy has ordered reviews of vaccine ingredients, citing aluminum as a top concern. A discussion of “adjuvants and contaminants” is on the vaccine advisory panel’s draft agenda.
A Centers for Disease Control and Prevention webpage that for years has assured the public vaccines do not cause autism was updated Nov. 19 with new language stating that studies have not definitively ruled out a link between vaccines and autism.
He has also targeted scientists who have published studies showing aluminum adjuvants are safe. In August, Kennedy denounced a large Danish study finding no link between aluminum in vaccines and childhood disease, calling it a “deceitful propaganda stunt” and demanding its retraction. The Annals of Internal Medicine rejected the claim and refused to retract the study.
And, regarding the upcoming advisory panel meeting, HHS spokesperson Emily HIlliard said ACIP “is independently reviewing the full body of evidence on adjuvants and other vaccine components to ensure the highest safety standards.”
The stakes are high because Kennedy’s push to cast doubt on aluminum isn’t just about the ingredient itself. It’s part of a broader strategy to foster uncertainty about vaccine safety and lay the groundwork to challenge the National Vaccine Injury Compensation Program, which drug manufacturers say is essential to ensure a stable market for shots.
But researchers across infectious diseases, immunology, pediatrics, and epidemiology say the data is clear: Aluminum adjuvants are safe.
“Aluminum is the third most common element on the Earth’s surface,” said Dr. Paul Offit, a pediatrician and director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “So we’re all exposed to aluminum all the time. The water that we drink has aluminum in it. The food that we eat has aluminum in it.”
Vaccines add only a tiny amount of aluminum to the body — a combined total of about 8 milligrams — after the schedule of childhood vaccines is complete. Offit said that over the first 18 years of life, people naturally take in about 400 milligrams of aluminum from everyday sources.
“I don’t know why there is so much concern,” said Dr. Rajesh Gupta, a former FDA vaccine scientist. “Aluminum gets distributed in the body everywhere. It is ultimately excreted by the kidneys in the urine. So, it is not that aluminum stays in the body.”
How they work
The aluminum in vaccines isn’t foil or metal. It’s a compound of aluminum salts, such as aluminum hydroxide or aluminum phosphate, that help the vaccine work better.
It’s a bit like zinc in cold tablets: Patients don’t swallow chunks of metal, instead ingesting a zinc salt that dissolves safely in the body.
In vaccines, these aluminum salts give the immune system an extra nudge so it learns to recognize the target germ more effectively.
When injected, the vaccine stays near the injection site and causes mild, short-lived inflammation that summons immune cells. Those cells pick up the vaccine antigen, a harmless piece of a virus or bacterium, and carry it to nearby lymph nodes. There, the adjuvants show it around like a wanted poster so the body can identify and destroy the germ quickly.
Dr. Harm HogenEsch, a professor of immunopathology at the Purdue University College of Veterinary Medicine, said that aluminum adjuvants work only when they’re injected in the same spot as the vaccine ingredient they’re meant to boost, to help nearby immune cells learn to recognize the germ. If the two shots are given in different places, he said, “you don’t see that effect.”
In response to Kennedy’s claims, scientists say that anything that acts as an adjuvant can, in principle, also boost an allergic response. But that doesn’t mean aluminum-adjuvanted vaccines are turning children into food-allergic time bombs. Antigens in vaccines such as the hepatitis B surface antigen or HPV proteins are not allergens, and no food proteins are put into vaccines.
Animal experiments
Animal studies form the basis of Kennedy’s claim that aluminum adjuvants in vaccines can create allergies. In these experiments, scientists deliberately sensitize rats or mice by injecting them with a food protein mixed with aluminum. The aluminum strengthens the immune response, but it does not cause an allergy by itself.
“That’s the basis for a lot of the experimental mouse models, where you inject a food allergen with an aluminum adjuvant to sensitize the mice,” HogenEsch said. “I’m not aware of any food antigen being included in vaccines, and so I don’t really see a way by which this could happen.”
Dr. Ross Kedl, a professor of immunology and microbiology at the University of Colorado Anschutz School of Medicine, went further, noting that there is no plausible route for vaccines to create a peanut allergy out of thin air. “Someone would have had to mix peanut proteins in with the actual vaccine prior to injection.”
Dr. Stefan H. E. Kaufmann, director emeritus at the Max Planck Institute for Infection Biology in Berlin, said results from mice often don’t match what happens in people, because “mice are much easier to push into allergic reactions than humans.” In other words, what looks dramatic in a rodent study doesn’t automatically apply to human immune systems.
And in this case, it’s “important to distinguish between how aluminum behaves in lab animals versus people,” Kaufmann said.
Human studies
Beyond animal models and theoretical scenarios, scientists have looked hard for signals of harm in large human datasets.
In 2023, a study by the Vaccine Safety Datalink, a collaboration coordinated by the CDC, reported a slight increase in asthma among children with higher aluminum exposure before age 2, but the association disappeared in further analyses.
“That paper was roundly criticized,” Offit said. “When they controlled for breastfeeding, the association between asthma and receipt of aluminum-adjuvant-containing vaccines disappeared.”
“It should have never been published,” he said.
Dr. Kathy Edwards, professor emerita of pediatrics at Vanderbilt University, said that false signals are common when large databases are mined for dozens of outcomes.
“When you look at a hundred different things, just by the law of percentages, some of those may look like there is a signal,” she said. “The whole RFK Jr. assessment is really prone to cherry-picking,” she said, adding that “there does need to be some kind of basic understanding of statistics for people to interpret this.”
Soon after the 2023 U.S. findings drew attention, scientists at the CDC contacted Dr. Anders Hviid, head of epidemiology research at the Statens Serum Institut in Copenhagen, Denmark, to see whether his team could replicate the work.
“It makes perfect sense to try to replicate findings of any kind in different data sources,” Hviid said.
Hviid’s nationwide Danish study followed 1.2 million children over two decades, using linked national health registries that record every vaccination and diagnosis.
“Our health care system is quite egalitarian. It’s free, and there’s universal access. And everyone is in these nationwide registers,” he said. Their findings: no increased risk of these conditions associated with increasing amounts of aluminum received through the vaccines.
Rare bumps
Doctors have documented one genuine reaction to aluminum adjuvants: itchy nodules at the injection site, called “pruritic granulomas.” These small bumps are so rare that most allergists and pediatricians will never see a single case.
This reaction “doesn’t lead to something bad, and it really isn’t associated with anything other than that local irritation,” Edwards said.
Researchers believe these bumps represent a localized immune response — meaning only in the area of the injection, not a body-wide allergy — that is very different from the kind of immediate allergic reaction people treat with antihistamines. These include the reactions driven by food or beestings, when histamine, the body’s own alarm signal, floods the system within minutes and causes hives, swelling, or breathing trouble. Kedl said that distinction often gets lost in public debate.
Eliminating aluminum adjuvants
For many experts, the real issue is not just whether aluminum is safe but what happens to the entire vaccine program if aluminum adjuvants are stripped out. For many modern vaccines that rely on a single purified protein — such as those for diphtheria and tetanus toxoids, hepatitis B, and HPV — adjuvants are crucial.
Edwards said that simply swapping in a different adjuvant isn’t realistic.
“They’re kind of all built on one another,” she said. Once a vaccine has been proved to work and become the standard of care, new or updated versions are generally no longer tested against a placebo in people who should be getting that vaccine. Instead, they’re tested against the existing product, which means each approval rests on the one before it.
Core childhood vaccines would probably have to be reformulated, and large clinical trials would have to be repeated to prove the new products are safe and effective. Meanwhile, production gaps and shortages would have to be managed, potentially for years, while manufacturers and regulators start over — all while diseases such as whooping cough, hepatitis B, and HPV-related cancers gain more room to spread.
“The aluminum adjuvants have sort of hit the sweet spot in terms of being effective at inducing a robust antibody response that is protective for those vaccines in which they’re being used and being very safe,” HogenEsch said. “It would be quite frankly foolish to try to eliminate them.”
A century of safe use
The DTaP, hepatitis B, and HPV vaccines all contain aluminum adjuvants and have been in use for nearly a century. Large-scale studies show no link between aluminum and systemic allergic disease.
“We have had aluminum adjuvants in vaccines for decades,” Edwards said. “I have grandchildren. My grandchildren have received all of their vaccines. And I do not worry about the safety of them.”
If aluminum is falsely cast as the villain and vaccine uptake falls, experts warn, the consequences will not be theoretical: more measles in schools, more meningitis in college dorms, and more young adults dying of cancers that HPV shots could have prevented.
In their view, the real danger isn’t the trace amounts of a metal that children already encounter every day. It’s rolling back the protection aluminum-adjuvanted vaccines have provided for generations.
That’s the trade-off Offit hopes parents will see. “A choice not to get a vaccine is not a risk-free choice,” he said. “It’s just a choice to take a different risk.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF — the independent source for health policy research, polling, and journalism.
A page of the Centers for Disease Control and Prevention’s website was changed to include a false claim about autism and vaccines. Multiple CDC officials familiar with the situation said the change was made by political appointees inside the Department of Health and Human Services without input from relevant agency staffers.
The page about vaccines and autism formerly said that “no links have been found between any vaccine ingredients and Autism spectrum disorder.” The website has now been changed to say, “‘Vaccines do not cause autism’ is not an evidence-based claim” — a statement the Autism Science Foundation calls “misinformation” that “actually contradicts the best available science.” The CDC page also falsely claims that studies supporting a link between vaccines and autism have “been ignored by health authorities.”
Previously, changes have only occurred in consultation with subject matter experts at the agency’s National Center on Birth Defects and Developmental Disabilities and its National Center for Immunization and Respiratory Diseases. The CDC sources told CBS News political appointees at HHS devised the change and instructed an employee inside the office of acting CDC Director Jim O’Neil to make it.
Autism is a developmental disability caused by differences in the brain. It presents with a wide range of symptoms that can include delays in language, learning, and social or emotional skills. The National Institutes of Health has committed hundreds of millions of dollars a year to studying the condition and trying to understand how and why it develops.
The debunked theory that the measles, mumps and rubella vaccine causes autism has its roots in a 1998 study that was found to be fraudulent and has been retracted. Since then, “independent researchers across seven countries have conducted more than 40 high-quality studies involving over 5.6 million people,” said American Academy of Pediatrics president Susan Kressly in a statement decrying the website change.
“We are at a very dangerous moment for the health of America’s children,” said Dr. Sean O’Leary, chair of the AAP’s Committee on Infectious Diseases, in a news briefing on Thursday.
Research has found no evidence of increased rates of autism among those who are vaccinated compared to those who are not. Vaccines also undergo intensive safety testing. Research shows that genetics play a role in autism diagnoses. The NIH says some possible risk factors for autism include prenatal exposure to pesticides or air pollution, extreme prematurity or low birth weight, certain maternal health conditions, or parents conceiving at an older age.
“There is overwhelming evidence that vaccines do not cause autism,” said Dr. Mandy Cohen, a former CDC director. “This change to CDC language undermines the agency’s scientific integrity, damaging its credibility on vaccines and other health recommendations. Most concerning, it risks endangering children by driving down vaccination rates and leaving kids vulnerable to preventable diseases like measles and whooping cough.”
In a statement, HHS communications director Andrew Nixon said, “This is a common-sense update that brings CDC’s website in line with our commitment to transparency and gold standard science.
“As the updated page explains, the claim that ‘vaccines do not cause autism’ is not supported by comprehensive evidence, as studies to date have not definitively ruled out potential associations. Some research suggesting possible biologic mechanisms has been ignored or dismissed by public health agencies, and HHS is committed to finding a definitive answer,” Nixon said.
Leading autism advocacy groups dispute that.
The Autism Science Foundation said in a statement it was “appalled” by the change to the CDC’s website, and highlighted the decades of research into the topic. Alison Singer, the co-founder and president of the ASF, said that while researchers “can’t do a scientific study to show that something does not cause something else,” there are a “mountain of studies that we have exonerating vaccines as a cause of autism.”
“I think the question of whether vaccines causes autism is one that science can answer, and science has answered it,” Singer said in Thursday’s news briefing.
A subhead saying that “Vaccines do not cause autism” remains on the CDC website with an asterisk next to it. The bottom of the page explains that the header remains in place because of an agreement with Louisiana Republican Sen. Bill Cassidy, a physician who is the chair of the Senate Health, Education, Labor, and Pensions Committee and backed HHS Robert F. Kennedy Jr. during his confirmation hearings. Cassidy said Sunday on “Face the Nation with Margaret Brennan” that he supported Kennedy in part because of “serious commitments” from the Trump administration, but did not specify what those were.
“I’m a doctor who has seen people die from vaccine-preventable diseases,” Cassidy wrote on social media on Thursday afternoon. “What parents need to hear right now is vaccines for measles, polio, hepatitis B and other childhood diseases are safe and effective and will not cause autism. Any statement to the contrary is wrong, irresponsible, and actively makes Americans sicker.”
Cassidy highlighted recent outbreaks of whooping cough and measles. He also called for more research into “the real causes of autism,” and criticized HHS funding cuts.
“Redirecting attention to factors we definitely know DO NOT cause autism denies families the answers they deserve,” Cassidy wrote.
Other health agency pages with information about autism and vaccines had not been changed as of early Thursday afternoon.
Health and Human Services Secretary Robert F. Kennedy Jr.
CBS News
Kennedy has previously pushed the discredited claim that routine childhood shots cause autism. President Trump has also falsely suggested vaccines could be to blame for autism rates. Both expressed concern about rising rates of autism diagnoses, which appear to be driven by a variety of factors including increased awareness and changes in how the condition is diagnosed.
O’Leary said he feared the website changes would “scare parents and further stigmatize” people with autism.
“We have been dealing with these falsehoods for many years. They are not new. We have been promoting the science, and we’re going to continue to do that, as are the other professional societies,” he said. “The problem is now it’s coming from, these falsehoods are coming for our federal government.”
Experts have previously raised concerns about Kennedy reviving debunked theories about the cause of autism. In April, Kennedy announced the CDC would conduct a “massive testing and research effort” to find out what causes the disorder, and hired David Geier, a man who repeatedly claimed a link between vaccines and autism, to lead the effort. Kennedy said the work would be completed by September, though other health officials later pushed the timeline.
Dr. Fiona Havers, an infectious disease physician and former CDC official, said that the website change showed scientists “who in the past carefully vetted scientific information have been pushed aside.”
The “CDC should be a data-driven agency based on science and not ideology, but when you take the scientists out of the process you get rhetoric that can harm families,” said former CDC chief science and medical officer Dr. Debra Houry, who lresigned from the agency earlier this year.
A page of the U.S. Centers for Disease Control and Prevention’s website was changed to include a false claim about autism and vaccines. Multiple CDC officials familiar with the situation said the change was made by political appointees inside the Department of Health and Human Services without input from relevant agency staffers. Dr. Jon LaPook has details.
The national Centers for Disease Control and Prevention have altered their website on autism and vaccines, removing unequivocal statements that immunizations don’t cause the neurodevelopmental disorder and replacing them with inaccurate and misleading information about the links between the shots and autism.
Until Wednesday, the CDC page, “Autism and Vaccines,” began: “Studies have shown that there is no link between receiving vaccines and developing autism spectrum disorder (ASD).”
This was followed, in large font, by the blunt statement: “Vaccines do not cause autism.”
The rest of the page summarized some of the CDC’s own studies into autism and vaccine ingredients, none of which found any causal links between the two.
On Wednesday, the page was altered so that it now begins: “The claim ‘vaccines do not cause autism’ is not an evidence-based claim because studies have not ruled out the possibility that infant vaccines cause autism.”
The words “Vaccines do not cause autism” still appear near the top, but with an asterisk that leads to a note at the bottom.
“The header ‘Vaccines do not cause autism’ has not been removed due to an agreement with the chair of the U.S. Senate Health, Education, Labor, and Pensions Committee that it would remain on the CDC website,” the site states.
The chair of that committee, Sen. Bill Cassidy (R-La.), cast the deciding vote to advance Robert F. Kennedy Jr.’s appointment as Health and Human Services secretary, in exchange for Kennedy’s promise that he wouldn’t erode public confidence in vaccines.
“Studies supporting a link have been ignored by health authorities,” HHS spokesman Andrew Dixon said in an email. “We are updating the CDC’s website to reflect gold standard, evidence-based science.”
The news was met with outrage by scientists and advocates.
“We are appalled to find that the content on the CDC webpage ‘Autism and Vaccines’ has been changed and distorted, and is now filled with anti-vaccine rhetoric and outright lies about vaccines and autism,” the nonprofit Autism Science Foundation said in a statement. “The CDC’s previous science and evidence-based website has been replaced with misinformation and now actually contradicts the best available science.”
The current CDC page now says the rise in autism diagnoses correlates with an increase in the number of vaccines given to infants. Multiple researchers have argued that the rise in autism spectrum disorder diagnoses is better explained by an expanding diagnostic definition of the disorder, along with better monitoring and diagnosis for more children.
Cassidy’s office did not immediately respond to requests for comment Thursday.
The United States may be heading into its second severe flu season in a row, driven by a mutated strain called subclade K that’s behind early surges in the United Kingdom, Canada and Japan.Last winter’s season was extreme, too. The U.S. had its highest rates of flu hospitalizations in nearly 15 years. At least 280 children died of influenza, the highest number since pediatric death numbers were required to be shared in 2004.Now, with a new variant in the mix, experts say we’re on track for a repeat. And with flu vaccinations down and holiday travel on the way, they worry that things may look much worse in the weeks ahead.The good news: Early analysis shows that this season’s flu shots offer some protection against being hospitalized with this variant, especially for kids. The bad news is that many Americans appear to be skipping their flu vaccines this year. New data from prescription data company IQVIA shows that vaccinations are down compared to where they usually are at this point in the year.A new playerFlu activity is low but rising quickly in the United States, according to the latest FluView report from the U.S. Centers for Disease Control and Prevention.Most of the flu viruses identified this season have been an A strain called H3N2, and half of those have come from subclade K, a variant that was responsible for a rougher-than-normal flu season this summer in the Southern Hemisphere.That variant wasn’t a major player when scientists decided which strains should be in the annual flu shots, so the vaccines cover a related but slightly different group of viruses.”It’s not like we’re expecting to get complete loss of protection for the vaccine, but perhaps we might expect a little bit of a drop-off if this is the virus that sort of dominates the season, and early indications are that’s probably going to be the case,” said Dr. Richard Webby, director of the World Health Organization Collaborating Center for studies on the ecology of influenza in animals and birds at St. Jude Children’s Research Hospital.Early analysis by the U.K. Health Security Agency shows that subclade K has seven gene changes on a key segment of the virus. Those mutations change the shape of this region, making it harder for the body’s defenses to recognize.”That’s the predominant thing that our immune system targets with antibodies, and that’s also pretty much what’s in the vaccine,” said Dr. Adam Lauring, chief of the Division of Infectious Diseases at the University of Michigan Medical School.UKHSA scientists found that the current flu vaccines are still providing decent protection against subclade K viruses. Vaccination cut the odds of an emergency department visit or hospitalization for the flu by almost 75% in children. The effectiveness for adults, even those over 65, was lower, about 30% to 40% against needing to visit the hospital or ER.But the scientists offer a caveat: These results are from early in the season, before the protection from seasonal flu vaccines has had time to wane or wear off. The findings are posted in a recent preprint study, which means it was published ahead of scrutiny from outside experts.Still, some protection is better than no protection, and while subclade K is expected to dominate the season, it won’t be the only flu strain circulating. No one gets to pick what they’re exposed to. Lauring said his daughter has just recovered from the flu, but it was a B-type strain.At the same time this new variant has emerged, flu vaccinations appear to be down in the U.S. According to IQVIA, about 64% of all flu vaccinations were administered at retail pharmacies, which administered roughly 26.5 million flu shots between August and the end of October. That’s more than 2 million fewer shots than the 28.7 million given over the same time frame in 2024.”I’m not surprised,” said Dr. Jennifer Nuzzo, who directs the Pandemic Center at Brown University’s School of Public Health. Vaccine skepticism expressed by leaders of the US Department of Health and Human Services has “injected chaos into the whole vaccination system,” she said.”There’s been a lot of attention on really non-issues,” like vaccine ingredients and separating shots, that she thinks “at the best, left people confused but possibly at the worst have left people worried about getting vaccinated,” she added.Flu vaccinations have also fallen in Australia, where subclade K was the predominant virus this year. As a result, flu hit a record, with more than 443,000 cases. Flu season in the Southern Hemisphere typically runs from May to July, so infectious disease experts often look to those countries for a preview of what might be on the way to North America.”What they saw in Australia is that they had a bad season. And so it’s concerning for you and us, what’s coming,” said Dr. Earl Rubin, director of the infectious disease division at the Montreal Children’s Hospital in Canada.’This is the time we start to see the rise’It’s difficult to say whether subclade K actually makes a person sicker than other flu strains, but if it drives more cases, it will certainly drive hospitalizations too, Rubin said.”When you look at severity, the more cases you have, if the same percentage get hospitalized, obviously you’re going to have more hospitalization if you have more cases. So it sometimes will look like the severity is also worse,” he said.Lab testing data has begun to show an uptick in flu cases.”This is the time we start to see the rise,” said Dr. Allison McMullen, a clinical microbiologist at BioMerieux, which makes the BioFire test, a popular diagnostic tool for respiratory pathogens.The company anonymously compiles its test results into a syndromic surveillance tool, which can offer a glimpse of what bugs are making people sick at any given time. At the beginning of the month, less than 1% of tests were positive for type A flu. Now it’s 2.4% – still low numbers but going up briskly, which aligns with the CDC trend.”We’re going to start seeing heavy holiday travel before we know it,” McMullen added. “With the rising cases that we’re seeing the U.K. and Japan, it can definitely be a bellwether for what we’re going to see in North America.”Signals are also rising in wastewater, said Dr. Marlene Wolfe, an assistant professor of environmental health at Emory University. In October, 18% of samples in the WastewaterSCAN network — an academically led wastewater monitoring program based at Stanford University, in partnership with Emory — were positive for type A flu, Wolfe said. In November, that number had risen to 40%.”Flu is something where, when it’s not in season, we don’t detect it very frequently in wastewater,” Wolfe said. COVID, on the other hand, can be detected pretty much all the time, which makes it challenging to know if it’s going up or down, she said.The scientists can set a threshold for when they can declare that a specific area is in flu season, Wolfe says. So far, just four of the 147 sites they monitor in 40 states have reached that threshold. Those sites are in the Northeast — in Maine and Vermont — in Iowa and in Hawaii.”I am concerned, I guess, that we could have a big flu season this year based on what we’re seeing in other parts of the world, and particularly Europe and elsewhere,” Michigan’s Lauring said.”It’s not too late. Go and get your flu shot,” Lauring advised. “And be alert that it’s out there.”
The United States may be heading into its second severe flu season in a row, driven by a mutated strain called subclade K that’s behind early surges in the United Kingdom, Canada and Japan.
Last winter’s season was extreme, too.The U.S. had its highest rates of flu hospitalizations in nearly 15 years. At least 280 children died of influenza, the highest number since pediatric death numbers were required to be shared in 2004.
Now, with a new variant in the mix, experts say we’re on track for a repeat. And with flu vaccinations down and holiday travel on the way, they worry that things may look much worse in the weeks ahead.
The good news: Early analysis shows that this season’s flu shots offer some protection against being hospitalized with this variant, especially for kids. The bad news is that many Americans appear to be skipping their flu vaccines this year. New data from prescription data company IQVIA shows that vaccinations are down compared to where they usually are at this point in the year.
A new player
Flu activity is low but rising quickly in the United States, according to the latest FluView report from the U.S. Centers for Disease Control and Prevention.
Most of the flu viruses identified this season have been an A strain called H3N2, and half of those have come from subclade K, a variant that was responsible for a rougher-than-normal flu season this summer in the Southern Hemisphere.
That variant wasn’t a major player when scientists decided which strains should be in the annual flu shots, so the vaccines cover a related but slightly different group of viruses.
“It’s not like we’re expecting to get complete loss of protection for the vaccine, but perhaps we might expect a little bit of a drop-off if this is the virus that sort of dominates the season, and early indications are that’s probably going to be the case,” said Dr. Richard Webby, director of the World Health Organization Collaborating Center for studies on the ecology of influenza in animals and birds at St. Jude Children’s Research Hospital.
Early analysis by the U.K. Health Security Agency shows that subclade K has seven gene changes on a key segment of the virus. Those mutations change the shape of this region, making it harder for the body’s defenses to recognize.
“That’s thepredominant thing that our immune system targets with antibodies, and that’s also pretty much what’s in the vaccine,” said Dr. Adam Lauring, chief of the Division of Infectious Diseases at the University of Michigan Medical School.
UKHSA scientists found that the current flu vaccines are still providing decent protection against subclade K viruses. Vaccination cut the odds of an emergency department visit or hospitalizationfor the flu by almost 75% in children. The effectiveness for adults, even those over 65, was lower, about 30% to 40% against needing to visit the hospital or ER.
But the scientists offer a caveat: These results are from early in the season, before the protection from seasonal flu vaccines has had time to wane or wear off. The findings are posted in a recent preprint study, which means it was published ahead of scrutiny from outside experts.
Still, some protection is better than no protection, and while subclade K is expected to dominate the season, it won’t be the only flu strain circulating. No one gets to pick what they’re exposed to. Lauring said his daughter has just recovered from the flu, but it was a B-type strain.
At the same time this new variant has emerged, flu vaccinations appear to be down in the U.S. According to IQVIA, about 64% of all flu vaccinations were administered at retail pharmacies, which administered roughly 26.5 million flu shots betweenAugust and the end of October. That’s more than 2 million fewer shots than the 28.7 million given over the same time frame in 2024.
“I’m not surprised,” said Dr. Jennifer Nuzzo, who directs the Pandemic Center at Brown University’s School of Public Health. Vaccine skepticism expressed by leaders of the US Department of Health and Human Services has “injected chaos into the whole vaccination system,” she said.
“There’s been a lot of attention on really non-issues,” like vaccine ingredients and separating shots, that she thinks “at the best, left people confused but possibly at the worst have left people worried about getting vaccinated,” she added.
Flu vaccinations have also fallen in Australia, where subclade K was the predominant virusthis year. As a result, flu hit a record, with more than 443,000 cases. Flu season in the Southern Hemisphere typically runs from May to July, so infectious disease experts often look to those countries for a preview of what might be on the way to North America.
“What they saw in Australia is that they had a bad season. And so it’s concerning for you and us, what’s coming,” said Dr. Earl Rubin, director of the infectious disease division at the Montreal Children’s Hospital in Canada.
‘This is the time we start to see the rise’
It’s difficult to say whether subclade K actually makes a person sicker than other flu strains, but if it drives more cases, it will certainly drive hospitalizations too, Rubin said.
“When you look at severity, the more cases you have, if the same percentage get hospitalized, obviously you’re going to have more hospitalization if you have more cases. So it sometimes will look likethe severity is also worse,” he said.
Lab testing data has begun to show an uptick in flu cases.
“This is the time we start to see the rise,” said Dr. Allison McMullen, a clinical microbiologist at BioMerieux, which makes the BioFire test, a popular diagnostic tool for respiratory pathogens.
The company anonymously compiles its test results into a syndromic surveillance tool, which can offer a glimpse of what bugs are making people sick at any given time. At the beginning of the month, less than 1% of tests were positive for type A flu. Now it’s 2.4% – still low numbers but going up briskly, which aligns with the CDC trend.
“We’re going to start seeing heavy holiday travel before we know it,” McMullen added. “With the rising cases that we’re seeing the U.K. and Japan, it can definitely be a bellwether for what we’re going to see in North America.”
Signals are also rising in wastewater, said Dr. Marlene Wolfe, an assistant professor of environmental health at Emory University. In October, 18% of samples in the WastewaterSCAN network — an academically led wastewater monitoring program based at Stanford University, in partnership with Emory — were positive for type A flu, Wolfe said. In November, that number had risen to 40%.
“Flu is something where, when it’s not in season, we don’t detect it very frequently in wastewater,” Wolfe said. COVID, on the other hand, can be detected pretty much all the time, which makes it challenging to know if it’s going up or down, she said.
The scientists can set a threshold for when they can declare that a specific area is in flu season, Wolfe says. So far, just four of the 147 sites they monitor in 40 states have reached that threshold. Those sites are in the Northeast — in Maine and Vermont — in Iowa and in Hawaii.
“I am concerned, I guess, that we could have a big flu season this year based on what we’re seeing in other parts of the world, and particularly Europe and elsewhere,” Michigan’s Lauring said.
“It’s not too late. Go and get your flu shot,” Lauring advised. “And be alert that it’s out there.”
The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Donald Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very unusual for an FDA regulator to single out individual companies and products in public comments online.According to the company’s lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.
WASHINGTON —
The head of the Food and Drug Administration’s drug center abruptly resigned Sunday after federal officials began reviewing “serious concerns about his personal conduct,” according to a government spokesperson.
Dr. George Tidmarsh, who was named to the FDA post in July, was placed on leave Friday after officials in the Department of Health and Human Services’ Office of General Counsel were notified of the issues, HHS press secretary Emily Hilliard said in an email. Tidmarsh then resigned Sunday morning.
“Secretary Kennedy expects the highest ethical standards from all individuals serving under his leadership and remains committed to full transparency,” Hilliard said.
The departure came the same day that a drugmaker connected to one of Tidmarsh’s former business associates filed a lawsuit alleging that he made “false and defamatory statements,” during his time at the FDA.
The lawsuit, brought by Aurinia Pharmaceuticals, alleges that Tidmarsh used his FDA position to pursue a “longstanding personal vendetta” against the chair of the company’s board of directors, Kevin Tang.
Tang previously served as a board member of several drugmakers where Tidmarsh was an executive, including La Jolla Pharmaceutical, and was involved in his ouster from those leadership positions, according to the lawsuit.
Messages placed to Tidmarsh and his lawyer were not immediately returned late Sunday.
Tidmarsh founded and led a series of pharmaceutical companies over several decades working in California’s pharmaceutical and biotech industries. Before joining the FDA, he also served as an adjunct professor at Stanford University. He was recruited to join the agency over the summer after meeting with FDA Commissioner Marty Makary.
Tidmarsh’s ouster is the latest in a string of haphazard leadership changes at the agency, which has been rocked for months by firings, departures and controversial decisions on vaccines, fluoride and other products.
Dr. Vinay Prasad, who oversees FDA’s vaccine and biologics center, resigned in July after coming under fire from conservative activists close to President Donald Trump, only to rejoin the agency two weeks later at the behest of Health Secretary Robert F. Kennedy Jr.
The FDA’s drug center, which Tidmarsh oversaw, has lost more than 1,000 staffers over the past year to layoffs or resignations, according to agency figures. The center is the largest division of the FDA and is responsible for the review, safety and quality control of prescription and over-the-counter medicines.
In September, Tidmarsh drew public attention for a highly unusual post on LinkedIn stating that one of Aurinia Pharmaceutical’s products, a kidney drug, had “not been shown to provide a direct clinical benefit for patients.” It’s very unusual for an FDA regulator to single out individual companies and products in public comments online.
According to the company’s lawsuit, Aurinia’s stock dropped 20% shortly after the post, wiping out more than $350 million in shareholder value.
Tidmarsh later deleted the LinkedIn post and said he had posted it in his personal capacity, not as an FDA official.
Aurinia’s lawsuit also alleges, among other things, that Tidmarsh used his post at FDA to target a type of thyroid drug made by another company, American Laboratories, where Tang also serves as board chair.
The lawsuit, filed in U.S. District Court of Maryland, seeks compensatory and punitive damages and “to set the record straight,” according to the company.
Trump administration health officials plan to remove a vaccine ingredient that’s been safely in use for decades, aluminum.
The Trump administration’s Department of Health and Human Services has reduced some vaccine access. The agency scaled back COVID-19 vaccine recommendations, approved COVID-19 vaccines for fewer people and aimed to remove the preservative thimerosal from U.S. vaccines. Experts toldPolitiFactscientific research did not support its removal.
During a Sept. 22 press conference in which President Donald Trump told people not to take Tylenol during pregnancy, he also mentioned another objective: “We want no aluminum in the vaccine,” he said. The administration was already in the process of removing aluminum from vaccines, he added.
About two weeks later on Oct. 8, the U.S. Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, or ACIP, announced a new working group focused on the childhood vaccine schedule. Its discussion topics include vaccine ingredient safety and “aluminum adjuvants.”
Robert Malone, an ACIP member who has opposed COVID-19 vaccines, told Axios he expected the committee would determine there was “a lot of evidence” of “issues” with aluminum in vaccines. The committee likely would vote to recategorize vaccines containing aluminum adjuvants so that people would have to discuss with their doctor before getting them, Malone told Axios.
That could have far-reaching ramifications. Here’s what to know about aluminum in vaccines.
Q: Why is a metal such as aluminum in some vaccines?
A: Small amounts of aluminum are sometimes included in vaccines as adjuvants, or substances that boost the body’s immune response to the vaccine to ensure protection from infection.
A: Vaccines with aluminum adjuvants usually contain less than a milligram of aluminum per dose, according to the Children’s Hospital of Philadelphia.
That’s a pretty abstract number. To help make it more concrete: A milligram is one-thousandth of a gram. One gram is about the weight of a raisin or a stick of gum. Imagine cutting one of those items into 1,000 equal pieces. One of the pieces would be about 1 milligram.
Here’s another way to think about it.
People come in contact with and consume aluminum all of the time. It is one of the most abundant metal elements in the earth’s crust, according to the U.S. Geological Survey. It’s naturally occurring in soil, air and water. Food is the main way people are exposed to aluminum. The average adult eats about 7 to 9 milligrams of aluminum per day, according to the Centers for Disease Control and Prevention.
A baby in its first six months might receive a total of about 4.4 milligrams of aluminum from recommended vaccines. In the same period of time, a breastfed infant would ingest about 7 milligrams of aluminum from breastmilk and a formula-fed baby would ingest about 38 milligrams from formula.
Q: How long have vaccines contained aluminum?
A: Aluminum adjuvants have been used in vaccines for more than 70 years, the CDC said.
“Aluminum is one of our oldest adjuvants, it’s been used in vaccines since the 1920s,” said Dr. Peter Hotez, a Baylor College of Medicine professor and codirector of Texas Children’s Hospital Center for Vaccine Development.
Q: How do we know it’s safe to include small amounts of aluminum in vaccines?
A: Every vaccine’s safety and efficacy is tested in animal studies and human clinical trials before the U.S. Food and Drug Administration licenses it for public use. Every vaccine containing adjuvants has been tested and health agencies continuously monitor their safety, the CDC said.
Over several decades of use, vaccines with aluminum adjuvants have been proven safe, the FDA said.
Vaccines containing aluminum have been “given to billions of people worldwide now,” said Dr. Kawsar Talaat, a professor at Johns Hopkins’ Bloomberg School of Public Health.
A growingbodyof research has also found aluminum adjuvants don’t cause aluminum toxicity or other adverse outcomes.
Q: Do aluminum adjuvants have any risks?
A: Rarely, some people have allergic reactions to aluminum in the same way they might have allergic reactions to other substances, Talaat said.
In 2022, researchers published a retrospective, observational study on more than 325,000 children that found an association between vaccine-related aluminum exposure and persistent asthma. Association is not the same as causation, meaning the study did not prove a link between aluminum in vaccines and asthma.
Experts from the CDC and American Academy of Pediatrics encouraged more research on the subject because the backward-looking observational study didn’t prove causation and also had limitations — including that it excluded many children who developed asthma before they turned 2 years old.
A 2025 study found no increased risk of asthma associated with childhood exposure to aluminum-absorbed vaccines.
Q: Which vaccines contain aluminum adjuvants?
A: At least 25 vaccines approved for use in the U.S. have aluminum adjuvants, the CDC says. That includes vaccines that protect against HPV, hepatitis A and B and diphtheria, tetanus, and acellular pertussis (whooping cough).
Q: Which vaccines do not contain aluminum adjuvants?
The CDC’s list of vaccines without adjuvants includes vaccines against COVID-19, Ebola, meningococcal, polio and rabies. Additionally, most seasonal flu shots and the vaccine against measles, mumps and rubella do not contain aluminum adjuvants.
Q: Can we remove aluminum from vaccines?
A: Not quickly. If it could be done at all, it would take years to develop, test and license new, aluminum-free vaccines. Many of the vaccines with aluminum adjuvants don’t have aluminum-free formulas.
“A vaccine is licensed based on all of its ingredients and the exact manufacturing process,” Talaat said. “If you were to take an ingredient out of a vaccine, you would have to start all over with the clinical trials and the manufacturing, and it is highly possible that some of these vaccines wouldn’t work without the aluminum in there.”
Although other adjuvants exist, they’re newer and often more scarce than aluminum, which is abundant.
An immediate ban on aluminum in vaccines would drastically reduce people’s ability to protect themselves and others against numerous diseases.
“I think we’d see outbreaks of vaccine-preventable diseases,” Talaat said.
Q: Why do people think aluminum in vaccines is causing autism?
A: A 2011 study said vaccines with aluminum adjuvants “may be a significant” contributing factor to the rising number of autism diagnoses in kids, Nature reported.
A year later, a World Health Organization vaccine safety committee called the 2011 study “seriously flawed.” The 2011 study and another by the same authors compared vaccines’ aluminum content and autism rates in several countries, the WHO group said, but that cannot be used to establish a causal relationship.
“We studied aluminum, and have no link between aluminum and autism,” Talaat said.
A billboard near West Virginia University questions vaccine manufacturer protections, a topic in the news as Health and Human Services Secretary Robert F. Kennedy Jr. seeks to change vaccine policy.
“Vaccine makers are exempt from all liability for vaccine injury and death,” says the billboard, which was sponsored by West Virginians for Health Freedom, a group that advocates for parental choice on vaccine requirements and risks.
The billboard has advertised vaccine-skeptical perspectives for years, and passing motorists might wonder if the claim is true. So PolitiFact West Virginia took a closer look.
Dr. Alvin Moss — a WVU professor of nephrology and medicine who was referred to PolitiFact West Virginia by West Virginians For Health Freedom — pointed to an academic paper that described vaccine manufacturers’ legal immunities as “broad” and a description of a Supreme Court case that characterized the industry’s legal protections as “significant.” (He said he was speaking in his personal capacity, not on behalf of his employer.)
However, broad and significant are not synonymous with “all,” which is the word the billboard used. In practice, the laws that provide manufacturers with extensive liability protections do include exceptions and limits that allow lawsuits in some circumstances.
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Lawsuits are allowed, eventually, under the National Childhood Vaccine Injury Act
The most important law governing vaccine liability is the National Childhood Vaccine Injury Act of 1986. This law created the National Vaccine Injury Compensation Program, a no-fault system for people who believe they have been injured by routinely recommended childhood vaccines. A fund is able to pay out awards to people claiming injury; the fund is filled by revenues from a 75 cent tax per disease prevented on each vaccine dose.
Initially, this law clamps down on the ability to pursue a lawsuit. Under the act, people who receive a covered vaccine must file a claim through the compensation program before they file suit. They must then wait for 240 days after filing to see if they are presented with an acceptable offer. If the program fails to issue a decision during that period, or if the petitioner loses their case, or they are awarded compensation but the petitioner rejects the program’s offer, the person can then file a civil lawsuit against the vaccine manufacturer.
There are other limits. A 2011 decision in the Supreme Court case Bruesewitz v. Wyeth held that manufacturers cannot be sued over a claim related to design defects. Suits related to warnings are allowed only if the manufacturer failed to warn the doctor, not the patient.
Other claims, like those related to negligence and fraud, can be pursued, though they are considered harder to prove.
An earlier version of the billboard from 2023. (Bob Britten)
Not all vaccines are covered by the 1986 law
The law limits the types of vaccines that receive liability protections, said Renee Gentry, a law professor and director of the Vaccine Injury Litigation Clinic at George Washington University Law School.
The law covers routine childhood vaccines and does not address adult-only vaccines such as those for shingles or pneumonia. Manufacturers of these vaccines may be, and have been, sued.
COVID-19 vaccines fall under the Public Readiness and Emergency Preparedness Act. This law offers broader liability protection, effectively shielding manufacturers from litigation.
So while manufacturers are protected from lawsuits for some of the vaccines they make, these legal protections aren’t across-the-board, said Dorit Reiss, a law professor who specializes in vaccine liability. For instance, Reiss said, more than 200 cases have been brought against Merck related to its Gardasil vaccine, which aims to protect against HPV. Some of that litigation is ongoing.
Moss, the doctor who was referred to PolitiFact West Virginia by West Virginians For Health Freedom, downplayed the protections for adult vaccines, saying that “childhood vaccines constitute a very high percentage of vaccines given.”
Data from the federal Health Resources and Services Administration shows that childhood vaccinations are more numerous than adult vaccines, but adult vaccines still account for a large number of vaccines given. The influenza vaccine, which is mostly given to adults, had more than 2.5 billion doses distributed between Jan. 1, 2006, and Dec. 31, 2023.
Our ruling
On its billboard, West Virginians For Health Freedom said, “Vaccine makers are exempt from all liability for vaccine injury and death.”
Under federal law, vaccine manufacturers do benefit from significant lawsuit protections, including being shielded against suits about design defects. These protections are paired with a fund that is empowered to make compensation payments to injured parties in lieu of filing a lawsuit.
However, vaccine makers’ liability protections are not — as the billboard says — unlimited. Companies may be sued if the injured party rejects the compensation fund’s offer; if negligence and fraud are alleged; and when a company’s vaccines are intended for adult use.
Dakota County in Minnesota is reporting three new measles cases, bringing the state’s total number this year to 20.
The Minnesota Department of Health says each of the new cases involves unvaccinated children who likely caught measles from an unvaccinated adult.
When you look at Minnesota’s overall cases, most are unvaccinated children who have not traveled, but have been in close contact with an adult family member who had. Eighteen out of the 20 measles cases are children, the health department reports.
“Twenty cases is more than we would like to see in Minnesota,” said Jessica Hancock-Allen, director of infectious disease for the health department.
“We are very, very concerned about measles. We have been working closely with our public health providers, our school providers,” said Hancock-Allen.
Minnesota health officials say measles starts out like any other viral infection, with a fever, cough, runny nose and watery eyes. About two or three days after those symptoms, people typically get a skin rash. And for children, it can be serious. About one in five kids are hospitalized when they have measles. In rare cases, it can be fatal.
“It can cause encephalitis or brain swelling. And it’s very, very uncomfortable,” said Hancock-Allen.
Just like the cold and flu, measles are passed through the air. But unlike those viruses, it can hang out for hours after an infected person leaves the room. Hancock-Allen says the best prevention is the measles, mumps, and rubella (MMR) vaccine.
“It is an extremely effective vaccine, so about 93% on the first dose and 97% effective on the second dose,” she said.
Cases fluctuate. Last year, there were 70 in Minnesota, but the year before, none were reported. For health officials, the goal is to keep that number as low as possible.
“It can make people very sick. Rarely, but it can have serious consequences. Very preventable by a highly, highly impactful vaccine,” said Hancock-Allen.
The CDC says nearly half of all measles cases in the U.S. this year were reported in Texas, three of which were fatal.
WCCO spoke last month with Stacene Maroushek, pediatric infectious disease specialist with Hennepin Healthcare, who blames the outbreaks of the disease — once thought to be eliminated more than two decades ago — on misinformation spread online, namely, that vaccines can cause autism.
“I think we as physicians need to do a better job of promoting all of the stuff that we actually know from a scientific standpoint, and good data, to a level that people can readily access and understand,” said Maroushek.
The significance of calls to split up the MMR vaccine into separate shots – CBS News
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Acting CDC Director Jim O’Neill is calling for the measles, mumps and rubella vaccine to be split into three separate shots. It comes as the CDC approves new guidelines for updated COVID vaccines. Dr. Celine Gounder explains.
From inoculations against polio and smallpox to protections from measles and tetanus, vaccines are critical health care tools that have saved more than 150 million lives in the past 50 years.
Rarely, they can also have side effects.
This week on 60 Minutes, correspondent Jon Wertheim reports on vaccine court, a little-known legal forum that has, for almost four decades, been compensating Americans who say they were injured by vaccines. Whether a person developed chronic arthritis after receiving an MMR vaccine or a shoulder injury resulting from a misplaced tetanus shot, the vaccine court is intended to provide an efficient way to compensate claimants without overwhelming vaccine makers with legal fees.
But for the more than 14,000 people who say they were injured after receiving a COVID vaccine, finding compensation is currently a little more complicated.
History of the VICP
In the 1980s, there was a public health scare over the DTP vaccine, an older version of today’s DTaP. At that time, families who said their children had been injured by the vaccine successfully sued the drug manufacturers in civil court. This caused all but one of those drug companies to stop production of the DTP vaccine.
Members of Congress and public health officials were concerned that if vaccine manufacturers weren’t given some form of legal protection, they might stop other vaccine production, putting the public health at risk. In response, Congress passed a bipartisan bill establishing the Vaccine Injury Compensation Program (VICP). The program acknowledged both that vaccines could cause injury while also partially shielding drug manufacturers from liability so they would continue to produce vaccines.
Vaccine court is part of that program. It allows people who claim vaccine-related injuries to seek compensation through a simplified legal process. There’s no jury in vaccine court. Instead, cases are decided by one of eight judges called special masters. The court is no-fault, which means that petitioners who bring claims don’t have to prove negligence. They just prove that more likely than not, their injury was caused by the vaccine.
The money for this program comes from a 75-cent tax added to every dose of recommended childhood vaccinations. Since the Vaccine Injury Compensation Program began, some 12,000 Americans have received almost $5 billion in payouts.
This program is structured around the Vaccine Injury Table, listing vaccines and eligible injuries. When the VICP began, it included six vaccinations. Today, that table has expanded to 16 immunizations, including the seasonal flu vaccine and those that inoculate against HPV.
Vaccine injuries remain very rare, but when they do occur, they can range from a physical injury in the shoulder because the needle is misplaced, to rare, severe cases in which a vaccine triggers a neurological condition.
Where COVID sits today
The vaccines that protect against COVID-19 are not among those included on the Vaccine Injury Table. That is because, to date, they are still included in a separate program for emergency measures.
In 2005, Congress established the Public Readiness and Emergency Preparedness Act (PREP Act) to ensure public health during emergencies. The legislation partially shields manufacturers and health care workers from most lawsuits related to the use of certain medical treatments during public health emergencies, including vaccines.
People who do experience serious harm or death due to these medical measures may be eligible for compensation through the Countermeasures Injury Compensation Program (CICP). This program only covers severe injuries or fatalities caused by approved emergency treatments.
Unlike VICP, the CICP is an administrative program. It has a one-year statute of limitations and is more restrictive than the vaccine court program, which is a judicial program with a three-year statute of limitations for vaccine injuries. In vaccine court, claimants can also be compensated for pain and suffering.
Around 14,000 claims have been brought to the countermeasures program regarding the COVID vaccinations. About 5,000 of those claims have been denied, and fewer than 100 have been compensated. The most common injuries compensated have been cases of myocarditis.
The COVID vaccines are considered safe and effective by public health organizations, including the CDC, which notes the rigorous clinical trials they underwent. As of May, more than 676 million doses of the COVID vaccines had been administered in the U.S.
Adding COVID vaccines to the VICP
Today, many legal experts say the COVID vaccines should be added to the VICP.
“Those people went out and did exactly what was asked of them to protect themselves, their communities, and their families. And they’re basically being hung out to dry in the countermeasures program without any real compensation,” said Renée Gentry, a top vaccine injury litigator and head of the Vaccine Injury Litigation Clinic at the George Washington University Law School.
For the COVID vaccines to be rolled into the VICP, three things would need to happen. First, the vaccine would again need to become a recommended childhood vaccine. Earlier this year, the Centers for Disease Control and Prevention’s vaccine advisory committee voted to change recommendations for the COVID-19 vaccine. The CDC now says parents of children over 6 months should speak with a health care provider about the COVID vaccination.
Next, Congress would need to pass an excise tax on the COVID vaccination so that the vaccine court would have the money to cover claims.
Finally, Secretary of Health and Human Services Robert F. Kennedy, Jr. would have to put the COVID vaccine on the Vaccine Injury Table.
In an email to 60 Minutes, Kennedy said the CDC makes the underlying decision, and he “will accept their recommendations, including as to COVID vaccines.”
If the PREP Act Declaration for COVID is terminated before the vaccines protecting against it are added to the vaccine court, COVID vaccine manufacturers would lose their shield from legal liability. The Department of Health and Human Services late last year extended certain elements of the PREP Act for COVID, keeping liability protections for certain countermeasures — including vaccine manufacturers and distributors — through 2029.
“Crushing” to add the COVID vaccine
The concern with adding COVID to the vaccine court is a matter of backlog, given the thousands of Americans who believe that they were injured by the COVID vaccine who have already brought claims to the countermeasures program. The number of special masters who adjudicate such claims has stayed at eight since the late 1980s, even though the number of cases in the court has multiplied.
“Without any improved infrastructure, without any additional special masters, it’s going to be crushing,” Gentry told 60 Minutes. “Because we know there are 10,000 unresolved cases in COVID in the countermeasures program still that haven’t been addressed. If just those cases came over, it would be a massive impact on the court. But we know that there are tens of thousands of other potential cases that are out there.”
The vaccine court’s chief special master agrees. He addressed the possibility of adding COVID vaccines to the court in a letter to Congress last year, writing, “The court’s ability to resolve vaccine injury claims efficiently will be crippled in the event we are not permitted to add more judicial officers…”
Still, those with knowledge about the subject say the COVID vaccine should be added.
“It is a medical intervention that we administered to otherwise healthy people that can cause side effects, and the fact that by having them vaccinated means that people who can’t be vaccinated are protected. That herd immunity, if you will,” said retired special master Denise Vowell.
Vowell and another former special master, George Hastings, addressed the possibility that, were the COVID vaccines added to the vaccine court, it might dissuade people from receiving the vaccine, an outcome that would be at odds with the court’s founding purpose.
“That’s always been a concern going back for the whole life of the Vaccine Injury Compensation Program, that the fact that you even had this system might worry people that vaccines can cause injuries,” Hastings said. “But the overall benefit is to have a program that, if there are rare instances where there are some adverse reactions, you compensate them without forcing people into a litigation system that would take forever. And then you’ll keep the vaccines flowing into people’s arms.”
Vowell was more pointed, noting that, while many public health interventions have side effects, the benefits outweigh them — especially when it comes to children’s health.
“Overall, the vaccine process has saved lives,” Vowell said. “If you go to an old cemetery and you look at headstones and you see the number of children who died at six months or three years of age, and then you go to a more modern cemetery today, you don’t see that number of children. Why? Because vaccine preventable illnesses have not been conquered, but they have been put in check.”
The video above was produced by Denise Schrier Cetta, Brit McCandless Farmer, Elizabeth Germino, and Jane Greeley. It was edited by Scott Rosann.
Brit McCandless Farmer is a digital producer for 60 Minutes, where her work has been recognized by the Webby, Gracie and Telly Awards. Previously, Brit worked at the CBS Weekend News, CBS Mornings, CNN and ABC News.
At his six-month check up, Jacob Thompson received a combination shot that included the recommended childhood vaccinations against diphtheria, tetanus and pertussis, or DTaP, all deemed safe and effective in clinical trials. Later that day, Jacob began to seize.
Doctors hoped the seizure was a one-time reaction. It wasn’t. In the following months as the seizures continued, doctors diagnosed Jacob with a rare and severe form of epilepsy. His parents, John and Huali, became increasingly convinced that their son’s condition could be traced back to his six-month shot.
“Vaccines are great. They’ve done a lot to help people. I think that parents need to know what can happen,” John Thompson said.
Serious vaccine injuries are so rare that, while hard to quantify precisely, their have been likened to lottery odds and lightning strikes. When an injury happens, families like the Thompsons can go to vaccine court, part of the National Vaccine Injury Compensation Program. The court is not a place to prove or disprove the safety of vaccines, but rather to compensate the injured.
The Thompsons’ experience with vaccine court
Jacob’s life now is drastically different than it was before his first seizure. He was born in St. Louis on New Year’s Eve 2011, rounding out a family of four, with sister Meili and parents John and Huali.
“He would be able to jump up and down on my wife’s lap, and very alert, recognized who mom and dad was,” Jacob’s father said.
That all changed after he got his six-month vaccinations, Jacob’s parents said. By age two, Jacob could suffer up to 700 seizures in one day.
John and Jacob Thompson
60 Minutes
The Thompsons, seeking accountability, took their case to Renée Gentry, who is a leading vaccine injury litigator and director of the Vaccine Injury Litigation Clinic at George Washington University Law School.
“All of my clients are vaccinated. Most of them will start the conversation by saying, ‘I’m not anti-vax,'” Gentry said.
The Thompsons are not anti-vaxxers and are not invested in the heavily charged vaccine debate. They’re invested in their son, Jacob — an anguishing exception, harmed by what they say is otherwise a public health force of good.
In July, the Thompsons received a judgment of $2.1 million in vaccine court based on the special master’s ruling that it was more likely than not that Jacob’s six-month vaccinations aggravated an underlying genetic mutation. Jacob, now 13, also received a lifetime annuity to cover his future care.
The development of the National Vaccine Injury Compensation Program
Jacob is one of around 12,000 Americans who’ve received payments through vaccine court since it was started in the late 1980s. Almost $5 billion has been made in payouts since the program began.
The National Vaccine Injury Compensation Program was established in response to a public health scare in the 1980s. When families of injured children went to civil court and successfully sued the manufacturers of the DTP vaccine — an older version of the DTaP vaccine — it caused all but one of those drug companies to pull out of the market, resulting in vaccine shortages.
Congress crafted a bill that partially shielded drug manufacturers from liability so they would continue to develop life-saving vaccines.
“It’s bipartisan. It takes everyone’s views into account. And everybody compromises, which is a dirty word now. But that’s the goal of it,” Gentry said. “And it’s helped these people. Jacob will be taken care of for the rest of his life because of this program.”
Renée Gentry
60 Minutes
While global immunizations have saved an estimated 154 million lives worldwide, Congress acknowledged that vaccines can cause injury. As bill sponsor Sen. Ted Kennedy described, when “children are the victims of an appropriate and rational national policy, a compassionate Government will assist them in their hour of need.”
There’s no jury in vaccine court. Cases are decided by one of eight judges called special masters. The court pays lawyers by the hour. Where does money come from? There is a 75-cent tax imposed on recommended childhood vaccines which goes into a trust fund earmarked for vaccine injury compensation.
People who believe they’ve been injured by a vaccine can still sue a manufacturer, but they have to file in vaccine court first. And the burden of proof for claimants is lower in the National Vaccine Injury Compensation Program, so it’s easier for people to get compensation, Gentry said.
Drug companies are left out of the proceedings in the National Vaccine Injury Compensation Program. It’s a “no fault” court, meaning negligence does not need to be proven, just that the vaccine more likely than not caused the injury.
“There’s very clear indication that said it would be better to compensate somebody that wasn’t injured than to miss somebody who was,” Gentry said.
The program is structured around a Vaccine Injury Table listing eligible vaccines and injuries. If your child, for instance, got a rubella vaccine and developed chronic arthritis within seven to 42 days, you may be eligible for damages.
The most common compensation is for shoulder injuries suffered from a misplaced injection. You can file for an injury not on the table. Overall, about half of all claims are dismissed.
The table now has 16 vaccines listed, up from six when it was created. It includes the annual flu shot, though not the COVID vaccine. Autism is not listed among the eligible injuries.
Vaccine court and autism
The decision to leave autism off the injuries list did not come easily, retired Special Masters Denise Vowell and George Hastings said. The issue was litigated and decided in their court 15 years ago.
In the early 2000s, cases alleging vaccinations caused autism flooded the court, more than 5,000 in all. Vowell, Hastings and a third special master oversaw what was a class action of sorts that spanned almost a decade.
Denise Vowell and George Hastings
60 Minutes
Vowell said the special masters ultimately concluded the evidence wasn’t there. Vowell had hoped it would be. “Because the parents of children with autism go through so much,” she said.
But, she told 60 Minutes, she could not base her decision on sentiment.
“I had to apply the law. And the law was that if there is a preponderance of evidence of vaccine causation, I rule for them. If there isn’t, I rule against them,” Vowell said.
All three special masters concluded there was no link between vaccines and autism. On appeal, eight additional federal judges unanimously upheld the vaccine court decisions.
This has not been persuasive to Health and Human Services Secretary Robert F. Kennedy Jr.
Secretary of Health and Human Services Kennedy, whose uncle was a champion of the court, is imbued with the authority to add or redefine injuries on the vaccine table.
He declined a 60 Minutes request for an on-camera interview but said via email that he would like to “expand the table,” which he hopes will create an easier path to compensation. In particular, he wants to broaden definitions for “seizures and encephalopathy,” two neurological conditions that can be associated with autism.
Criticism of vaccine court
Kennedy told 60 Minutes that though the court’s original intent was “idealistic, compassionate, and sensible,it has become “a disaster for the families of injured children. Its effective function is delay, denial, and systematic cruelty.”
Ryan Farrell, who received a tetanus shot in 2017 after cutting his hand on some rusty metal, is very familiar with the delays in vaccine court.
He started suffering pain a few days after getting the tetanus shot.
“I felt like my back was just, like, being stabbed, like I was being like crushed,” Farrell said.
Jon Wertheim and Ryan Farrell
60 Minutes
At one point, he could see out of only one eye. His bladder shut down. He was hospitalized multiple times over the next few years. Doctors diagnosed him with a rare autoimmune disease.
“I didn’t wanna live for a long time,” Farrell said. “That’s how I felt.”
His wife, Angela, made the link between Farrell’s condition and his tetanus shot. She hadn’t heard of the National Vaccine Injury Compensation Program at the time, but stumbled upon it online and found a lawyer.
They filed a case in 2019, and only in July of this year did the special master rule that the tetanus shot more likely than not, likely led to Farrell’s illness.
“That couldn’t be further from the truth,” Farrell said.
He remains unable to work. And six years in, the court has yet to determine his damages.
The court acknowledges the delays. Citing a backlog of more than 3,000 cases, its chief special master has — in documents obtained by 60 Minutes — asked Congress for help four years running, saying, “it becomes more difficult each year to resolve the huge number of case filings in the expedient fashion they deserve.”
Yet, Congress has not acted.
Vaccination has become such a loaded, heavily politicized issue that some legislators appear to be reluctant to wade in.
“If what you care about are vaccine-injured people, and them being compensated, then you want this court to work. And you want this court to be here,” Gentry said.
If you’ve never before heard of the national vaccine court, you’re hardly alone. It sits inconspicuously, a few hundred yards from the White House; and stands as a model of effective public policy, balancing the societal good of widespread vaccination with rare individual harm. Founded in the 1980s, the court has, with little fanfare, paid out billions of dollars to Americans who have claimed injury after getting a vaccine. Today, with vaccine skepticism rising and given voice in the highest ranks of government, we wondered: can this singular court block out the noise, withstand the political winds, and stay true to its mission?
Jacob Thompson is 13 years old. He loves airplanes, swimming and Chick-fil-A. But Jacob can speak only a handful of words and needs help walking more than a few yards.
Jacob was born in St. Louis on New Year’s Eve, 2011, rounding out a family of four, with sister Meili and parents John and Huali — he, a pilot for FedEx; she, a recent immigrant from China.
John Thompson: We had this perfectly normal, happy little baby. He would be able to jump up and down on my wife’s lap, and very alert, recognized who mom and dad was.
At his six-month checkup, Jacob received a combination shot that included the recommended childhood vaccinations against diphtheria, tetanus and pertussis, or DTaP, all deemed safe and effective in clinical trials.
John and Jacob Thompson
60 Minutes
Hours later, Jacob began to seize. Doctors hoped it was a one-time reaction. It wasn’t.
John Thompson: Within I’d say six months or less, he didn’t know that we were mom and dad anymore, and he was slithering on the floor like a snake.
Jon Wertheim: Unrecognizable–
John Thompson: Un– yeah.
Jon Wertheim: –from the child you knew?
John Thompson: Yeah.
By age two, Jacob could suffer up to 700 seizures in one day. He was diagnosed with a rare and severe form of epilepsy.
The Thompsons became increasingly convinced that his condition could be traced back to his six-month vaccinations. And, they began to seek accountability. They took their case to attorney Renée Gentry.
She’s a leading vaccine injury litigator and director of the Vaccine Injury Litigation Clinic at George Washington University Law School in Washington, D.C.
Renée Gentry: I represent both vaccine-injured children and adults. All of my clients are vaccinated. Most of them will start the conversation by saying, “I’m not anti-vax.”
Jon Wertheim: Why do you think they need to tell you right off the bat they’re not anti-vax, but?
Renée Gentry: There’s a lot of public pressure when you say that you have a vaccine injury, that people think you’re some kind of a crazy person or you’re out there. And also, because most people have never heard of a vaccine injury. They’re rare.
So rare that, while hard to quantify precisely, the chances of serious vaccine injury have been likened to lottery odds, lightning strikes. Bear in mind, in total, global immunization has saved an estimated 154 million lives, six lives each minute.
But when an injury does occur, families can come to vaccine court, seen in this informational video.
Part of the National Vaccine Injury Compensation Program, the court was established in response to a public health scare in the 1980s.
When families of injured children went to civil court and successfully sued the manufacturers of the DTP vaccine, an older version of DTaP, it caused all but one of those drug companies to pull out of the market, resulting in vaccine shortages.
Congress acted, crafting a bipartisan bill that partially shielded drug manufacturers from liability so they would continue to develop life-saving vaccines.
And, at the same time, Congress acknowledged that vaccines can cause injury. As bill sponsor Sen. Ted Kennedy described, when children are, “…the victims of an appropriate and rational national policy, a compassionate Government will assist them in their hour of need.”
Renée Gentry
60 Minutes
Renée Gentry: It was hailed as such a unique accomplishment back in the day because you had these disparate groups, you had the parents of vaccine-injured children together in the room with, with the manufacturers and everybody agreed that this was the best-case scenario.
Jon Wertheim: Is that fair to the public? They think they have an injury caused by a vaccine, but they can’t sue the vaccine manufacturer directly?
Renée Gentry: You can still opt out of this program and sue a manufacturer. You have to just start in this program. But it’s a lower burden of proof in our program. So it’s an easier thing for vaccine-injured people to get compensation.
Drug companies are not only not being sued; they’re not part of the proceedings. Vaccine court is a “no fault” court, meaning in cases like Jacob Thompson’s, negligence does not need to be proven, just that the vaccine, more likely than not, caused the injury.
Vaccine court is not your typical court. There’s no jury. Cases are decided in front of one of eight judges called special masters. Since the program began in the late ’80s, 12,000 Americans have received almost $5 billion in payouts. There are no financial windfalls for lawyers — the court pays them by the hour. Where does all this money come from? A 75-cent tax, imposed on recommended childhood vaccines, goes into a trust fund earmarked for vaccine injury compensation.
In July the Thompsons received a judgment of $2.1 million based on the special master’s ruling that it was more probable than not that Jacob’s six-month vaccinations aggravated an underlying genetic mutation. Jacob also received a lifetime annuity to cover his future care.
Jon Wertheim: Is there any doubt that the vaccine caused Jacob’s injury?
Renée Gentry: We can’t ever prove scientific certainty on it.
Jon Wertheim: Does that not mean though that some cases are being compensated when in fact the science might not support it?
Renée Gentry: Sure. Sure. And that’s what Congress intended. There’s very clear indication that said it would be better to compensate somebody that wasn’t injured than to miss somebody who was.
Jon Wertheim: How do you feel about that?
Renée Gentry: I think that’s fine. While vaccines are critically important public health tools, they’re not magic. You know, you can have an allergic reaction to aspirin. So it’s a lot of different factors come into play to have a person be injured by a vaccine. Their genetics, their immune system. That’s why the no-fault part is critical. The vaccine caused it. But there’s no bad actor in this case.
The program is structured around a Vaccine Injury Table, basically, a conversion chart of vaccines and eligible injuries — if your child, for instance, got a rubella vaccine and developed chronic arthritis within seven and 42 days, you may be eligible for damages.
The most common compensation is for shoulder injuries suffered from a misplaced injection. You can file for an injury not on the table. Overall, half of all claims have been dismissed.
Today, vaccines on the table have jumped from the original six to 16, including the annual flu shot, though, notably notCOVID. As for the eligible injuries, autismis not one of them.
That decision did not come easily, as retired special masters Denise Vowell and George Hastings explained.
Denise Vowell and George Hastings
60 Minutes
Jon Wertheim: There’s been a lot of talk lately about a possible link between vaccines and autism. This has been litigated and decided in your court 15 years ago.
George Hastings: You know, I spent many, many years of my life, almost full-time looking at that issue.
In the early 2000s, cases alleging vaccinations caused autism flooded the court. Vowell, Hastings and a third special master oversaw what was a class action of sorts, a vaccine court proceeding that spanned almost a decade, incorporating testimony from dozens of medical experts and hundreds of scientific articles.
Jon Wertheim: What did you ultimately conclude?
Denise Vowell: Ultimately concluded there simply was not the evidence. I hoped there would be.
Jon Wertheim: Why?
Denise Vowell: Because the parents of children with autism go through so much.
But Vowell said she could not decide cases based on sentiment.
Denise Vowell: I had to apply the law. And the law was that if there is a preponderance of evidence of vaccine causation, I rule for them. If there isn’t, I rule against them.
All three special masters concluded there was no link between vaccines and autism. On appeal, eight additional federal judges unanimously upheld the vaccine court decisions.
This has not been persuasive to Robert F. Kennedy, Jr.
We wanted to know RFK, Jr.’s views about vaccine court, a court his uncle championed, because today, as secretary of Health and Human Services,, he is imbued with the authority to add or redefine injuries on the vaccine table.
He declined our request for an on-camera interview but said via email that, yes, he wouldlike to “expand the table,” which he hopes will create an easier path to compensation. In particular, he wants to broaden definitions for “seizures and encephalopathy,” two neurological conditions that can be associated with autism.
Although the original intent was “idealistic, compassionate, and sensible,” the court, RFK, Jr. told us, has become “a disaster for the families of injured children. Its effective function is delay, denial, and systematic cruelty.”
Vaccine court delays are something Ryan Farrell knows only too well.
Jon Wertheim and Ryan Farrell
60 Minutes
Husband to Angela and father of three, Ryan worked as a lineman for a Boston-area power company, hanging electrical wires 100 feet high.
On the job in 2017, Ryan cut his hand on rusty metal and got a tetanus shot. A few days later, the pain started.
Ryan Farrell: I felt like my– my back was just, like, being stabbed.
Angela Farrell: He would take a shower, he was like, “I feel like there’s razor blades hitting my skin.”
Over the next few years, Ryan was hospitalized multiple times. Doctors diagnosed him with a rare autoimmune disease.
Ryan Farrell: I didn’t wanna live for a long time, you know. That’s how I felt.
Jon Wertheim: When did you make the link that “I had this vaccine. Maybe there’s some correlation here?”
Angela Farrell: I made the correlation.
Like most Americans, Angela Farrell had never heard of vaccine court, but she stumbled upon it online and found a lawyer. They filed a case in 2019. And only in July, did the special master rule: the tetanus shot more likely than not led to Ryan’s illness.
Jon Wertheim: Do you feel like you were treated with compassion?
Ryan Farrell: I mean the special master was kind to me and my family when we were in the courtroom.
Jon Wertheim: [The] court was intended to compensate people for vaccine injuries. I want to quote this, “quickly, easily, and with certainty and generosity.”
Ryan Farrell: That couldn’t be further from the truth. You know–
Jon Wertheim: What do you mean?
Ryan Farrell: I feel like they made it way too– way too long.
Ryan remains unable to work. Six years in, the court has yet to determine his damages.
The court acknowledges the delays. Citing a backlog of more than 3,000 cases, its chief special master has, in documents obtained by 60 Minutes, asked Congress for more resources four years running, saying, “… it becomes more difficult each year to resolve the huge number of case filings in the expedient fashion they deserve.” Congress has yet to act.
Our reporting suggests that this inaction is, in part, because vaccination has become such a loaded, heavily politicized issue that legislators are reluctant to wade in.
The Thompsons are not invested in the heavily-charged vaccine debate — they’re invested in their son, Jacob — an anguishing exception, harmed by what’s otherwise a public health force of good.
Jon Wertheim: I do wonder if people aren’t going to hear your story and be terrified of giving their kids vaccinations.
John Thompson: We’re definitely not anti-vaxxers. We think– and– I mean, vaccines are great. They’ve done a lot to help people. But I think that parents need to know what can happen.
Renée Gentry: If what you care about are vaccine-injured people, and them being compensated, then you want this court to work. And you want this court to be here.
Jon Wertheim: We have this program that incentivizes the manufacturing of vaccines, but also acknowledges that in some rare cases, there are injuries and damages.
Renée Gentry: Right. It’s bipartisan. It takes everyone’s views into account. And everybody compromises, which is a dirty word now. But that’s the goal of it. And it’s helped these people. Jacob will be taken care of for the rest of his life because of this program.
Produced by Denise Schrier Cetta. Associate producers, Elizabeth Germino and Arman Badrei. Broadcast associate, Mimi Lamarre. Edited by Warren Lustig.
Health Secretary Robert F. Kennedy Jr. has fired a top official with the National Institutes of Health who blew the whistle on internal clashes over vaccine research in the early months of the Trump administration.
On Wednesday, Dr. Jeanne Marrazzo received a letter from Kennedy — which CBS News reviewed — informing her that her role leading NIH’s National Institute of Allergy and Infectious Diseases, or NIAID, had been terminated. He did not cite a cause beyond his constitutional authority to do so. Last month, in an exclusive interview with CBS News, Marrazzo said she had been silenced when she and her colleagues pushed back against NIH officials appointed by President Trump who questioned the importance of childhood flu vaccines and canceled long-running clinical trials.
“My termination, unfortunately, shows that the leaders of HHS and the National Institutes of Health do not share my commitment to scientific integrity and public health,” Marrazzo wrote in a statement following her firing. “Congress must act to protect scientific research from those who would serve political interests first.”
Marrazzo had been in her role since August 2023, succeeding Dr. Anthony Fauci, who had served as NIAID director for nearly four decades. She was put on indefinite leave in March and filed a whistleblower complaint with the U.S. Office of Special Counsel in September, alleging illegal retaliation. In a statement, Marrazzo’s attorney alleged her firing is further “retaliation for her protected whistleblower activity.”
Despite following a well-established whistleblower process by filing a complaint with OSC, recourse for Marrazzo is far from certain. Mr. Trump fired the head of the independent agency in February and has since installed his top trade official Jamieson Greer to lead the agency on an acting basis.
In August, the office launched an ethics probe into Jack Smith, the former special counsel who indicted Mr. Trump before he returned to office for his actions around the January 6, 2021, attack on the U.S. Capitol, and for allegedly mishandling classified documents from his first term.
The allegations in Marrazzo’s whistleblower complaint focus on Dr. Matthew Memoli, who served as acting NIH director earlier this year before moving to the health agency’s No. 2 post.
Marrazzo claimed Memoli made statements downplaying the importance of vaccines that closely mirrored the views of Kennedy, a longtime vaccine skeptic. In a series of meetings, Memoli argued that “vaccines are unnecessary if populations are healthy,” and that the NIH “should not focus on vaccines,” Marrazzo alleged in her complaint.
Marrazzo told CBS News it was like “hearing the echo of” the vaccine skepticism often promoted by Kennedy. “It was extremely alarming,” Marrazzo said.
An HHS spokesperson defended Memoli to CBS News, writing in a statement: “He remains fully aligned with this administration’s vaccine priorities and consistently champions gold-standard evidence-based science.”
In June, Kennedy removed all 17 members of the Advisory Committee on Vaccine Practices, which makes vaccine recommendations to the Centers for Disease Control. He then handpicked their replacements, and the newly reconstituted panel recently voted to endorse splitting the measles, mumps, rubella and varicella vaccine into separate shots.
Michael Kaplan is an award-winning reporter and producer for the CBS News investigative unit. He specializes in securing scoops and crafting long-form television investigations. His work has appeared on “60 Minutes,” CNN and in The New York Times.
Three more measles cases have been reported in Minnesota in the past week.
The Minnesota Department of Health said the new cases all involved unvaccinated children, ages 5 to 17, who are all from the same family.
Health officials are working with local health departments to contact people believed to have been exposed.
These new cases bring the state’s number of identified cases this year to eight.
“Unfortunately, we still see kids die of measles and it is a vaccine-preventable disease,” said Stacene Maroushek, pediatric infectious disease specialist with Hennepin Healthcare. “Three is considered an outbreak and it is concerning because we know our vaccine rates have really dropped off since COVID.”
Measles is one of the most contagious infectious diseases, and in some cases can cause severe infections in the lungs and brain that can lead to cognitive issues, deafness or death.
The best way to prevent measles, according to health experts, is through immunization.
Officials recommend children receive two doses of the measles, mumps and rubella vaccine — the first at 12 to 15 months old and the second between 4 and 6 years old.
Maroushek blames the current outbreaks of the disease, once thought to be eliminated more than two decades ago, on misinformation spread online — namely, that vaccines can cause autism.
“I think we as physicians need to do a better job of promoting all of the stuff that we actually know from a scientific standpoint, and good data, to a level that people can readily access and understand,” Maroushek said.
Earlier this summer, state health officials announced an unvaccinated child, also from Dakota County, exposed hundreds of people to measles during a visit to Mall of America’s Nickelodeon Universe.
Stephen Swanson is a web producer at CBS News Minnesota. Stephen was a floor director for a decade before moving to the WCCO-TV newsroom in 2011, where he focuses on general assignment reporting.
BOSTON — A state appeals court has sided with a medical worker and voodoo worshipper who was fired by University of Massachusetts Medical Health Care after her request for a religious exemption to the COVID-19 vaccine was rejected.
The ruling, issued Monday by the state Court of Appeals, overturns a Superior Court ruling that rejected a lawsuit filed by Rachelle Jeune against UMass Medical over its denial of a religious exemption in October 2021 as part of her employment as a surgical technician.
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BOSTON — A state appeals court has sided with a medical worker and voodoo worshipper who was fired by University of Massachusetts Medical Health Care after her request for a religious exemption to the COVID-19 vaccine was rejected.
The ruling, issued Monday by the state Court of Appeals, overturns a Superior Court ruling that rejected a lawsuit filed by Rachelle Jeune against UMass Medical over its denial of a religious exemption in October 2021 as part of her employment as a surgical technician.
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