robert f kennedy jr

CDC vaccine panel realizes again it has no idea what it’s doing, delays big vote

anti-vaccine, CDC, health, robert f kennedy jr / Paul Patrick / December 4, 2025

Today’s meeting was chaotic and included garbage anti-vaccine presentations.

Dr. Robert Malone speaks during a meeting of the CDC Advisory Committee on Immunization Practices (ACIP) at CDC Headquarters on December 4, 2025 in Atlanta, Georgia. Credit: Getty | Elijah Nouvelage

The panel of federal vaccine advisors hand-selected by anti-vaccine Health Secretary Robert F. Kennedy Jr. has once again punted on whether to strip recommendations for hepatitis B vaccinations for newborns—a move it tried to make in September before realizing it didn’t know what it was doing. The decision to delay the vote today came abruptly this afternoon when the panel realized it still does not understand the topic or what it was voting on.

Prior to today’s 6–3 vote to delay a decision, there was a swirl of confusion over the wording of what a new recommendation would be. Panel members had gotten three different versions of the proposed recommendation in the 72 hours prior to the meeting, one panelist said. And the meeting’s data presentations this morning offered no clarity on the subject—they were delivered entirely by anti-vaccine activists who have no subject matter expertise and who made a dizzying amount of false and absurd claims.

“Completely inappropriate”

Overall, the meeting was disorganized and farcical. Kennedy’s panel has abandoned the evidence-based framework for setting vaccine policy in favor of airing unvetted presentations with misrepresentations, conspiracy theories, and cherry-picked studies. At times, there were tense exchanges, chaos, confusion, and misunderstandings.

Still, the discussion was watched closely by the medical and health community, which expects that the panel—composed of Kennedy allies who espouse anti-vaccine views—will strip the recommendation for a hepatitis B vaccine birth dose. Decisions by the committee, the Advisory Committee on Immunization Practices (ACIP) in the Centers for Disease Control and Prevention, have historically set national vaccine policy. Health insurance programs are required to cover, at no cost, vaccinations recommended by the ACIP. So rescinding a recommendation means Americans could lose coverage.

Medical and public health experts consider the birth-dose vaccination to be critical for protecting all infants from contracting the highly infectious virus that, when acquired early in life from their mother or anyone else, almost always causes chronic infections that lead to liver disease, cancer, and early death. There is no data suggesting harms from the newborn dose, nor any safety data suggesting that delaying the first dose by a month or two, as ACIP is considering, would be safer or better in any way. But studies do indicate that such a delay would lead to more hepatitis B infections in babies

These points were hard to find in today’s presentations. Abandoning standard protocol, the meeting did not include any presentations or data reviews led by CDC scientists or subject matter experts. Kennedy has also barred medical and health expert liaisons—such as the American Medical Association, the Infectious Disease Society of America, and the American Academy of Pediatrics—from participating in the ACIP working groups, which compile data and set language for proposed vaccine recommendations.

Anti-vaccine presentations

Instead, today, ACIP heard only from anti-vaccine activists. The first was Cynthia Nevison, a climate researcher and anti-vaccine activist with ties to Children’s Health Defense, Kennedy’s anti-vaccine organization. She was also a board member of an advocacy group called Safe Minds, which promotes a false link between autism and vaccines, specifically the mercury-containing vaccine preservative thimerosal, which was removed from routine childhood vaccines in the early 2000s. (Safe Minds stands for Sensible Action For Ending Mercury-Induced Neurological Disorders.) According to her academic research profile at the University of Colorado Boulder, her expertise is in “global biogeochemical cycles of carbon and nitrogen and their impact on atmospheric trace gases.”

Far from that topic, Nevison gave a presentation downplaying the transmission of hepatitis B and the benefits of vaccines. She falsely claimed that the dramatic decline in hepatitis B infections that followed vaccination efforts was not actually due to the vaccination efforts—despite irrefutable evidence that it was. And she followed that up with her own unvetted modeling claiming that CDC scientists overestimate the risk of transmission. She ended by presenting a few studies showing declines in blood antibody levels after initial vaccination, which she claimed suggests that the hepatitis B vaccine does not offer lifelong protection, an incorrect takeaway based on her lack of expertise.

The author of one of the studies just happened to be present at today’s meeting. Pediatrician Amy Middleman, who is an ACIP liaison representing the Society for Adolescent Health and Medicine (SAHM) and a professor at Case Western Reserve University School of Medicine, was the first author on a key study Nevison referenced. Middleman was quick to point out that Nevison had completely misunderstood the study, which actually showed that cell-based immune protection from the vaccine offers robust lifelong protection, even after initial antibody levels decline (called an anamnestic response).

“This is where a really experienced understanding of immunization comes into play,” Middleman said. “The entire point of our study is that for most vaccines, the anamnestic response is really their superpower. So this study showed that memory cells exist such that when they see something that looks like the hepatitis B disease, they actually attack. The presence of a robust and anamnestic response, regardless of circulating antibody years later, shows true protection.”

The next presentation was from Mark Blaxill, an anti-vaccine activist installed at the CDC in September. Blaxill gave a presentation on hepatitis B vaccine safety, despite having no background in medicine or science. He previously worked as an executive for a technology investment firm and, like Nevison, also worked for Safe Minds, where he was vice president. Blaxill has written books and many articles falsely claiming that vaccines cause a variety of harms in children. In 2004, when an Institute of Medicine analysis concluded that there were no convincing links between vaccines and autism, Blaxill publicly protested the result.

In his presentation, he attacked the quality of safety data in past hepatitis B studies. Though he stopped short of suggesting any specific harms from the vaccine, he aired unsubstantiated possibilities popular with anti-vaccine activists. He also noted a study finding that some babies had fatigue and irritability after vaccination, which he bizarrely suggested was a sign of encephalitis (inflammation of the brain).

Real-time feedback

Cody Meissner, a pediatrician and voting member of ACIP who is the most qualified and experienced member of the panel, quickly called out the suggestion as ridiculous. “That is absolutely not encephalitis,” Meissner said with frustration in his voice. “That’s not a statement that a physician would make. [Those symptoms] are not related to encephalitis, and you can’t say that.”

As in previous meetings, Jason Goldman, the ACIP liaison representing the American College of Physicians, gave the most biting response to the meeting overall, saying:

Once again, this committee fails to use the evidence to recommend framework and shows absolutely no understanding of the process or the gravity of the moment of the recommendations that you make. We need to look at all the evidence and data and not cherry-pick them… This meeting is completely inappropriate for an administration that wants to avoid fraud, waste, and abuse. You are wasting taxpayer dollars by not having scientific, rigorous discussion on issues that truly matter. The best thing you can do is adjourn the meeting and discuss vaccine issues that actually need to be taken up… As physicians, your ethical obligation is primum non nocere, first do no harm, and you are failing in that by promoting this anti-vaccine agenda without the data and evidence necessary to make those informed decisions.

The panel will reconvene tomorrow for an all-day meeting in which the members will consider a vote on the hepatitis B vaccine for a third time. The meeting will also host other anti-vaccine presentations attacking the childhood vaccine schedule in its entirety.

Beth is Ars Technica’s Senior Health Reporter. Beth has a Ph.D. in microbiology from the University of North Carolina at Chapel Hill and attended the Science Communication program at the University of California, Santa Cruz. She specializes in covering infectious diseases, public health, and microbes.

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Meet CDC’s new lead vaccine advisor who thinks shots cause heart disease

ACIP, anti-vaccine, CDC, fda, health, Kirk Milhoan, myocarditis, robert f kennedy jr, vinay prasad / Paul Patrick / December 2, 2025

Milhoan has a history of touting unproven COVID cures while disparaging vaccines.

Kirk Milhoan, James Pagano, and Robert Malone are seen during a meeting of the CDC’s Advisory Committee on Immunization Practices on September 18, 2025 in Chamblee, Georgia. Credit: Getty | Elijah Nouvelage

When the federal vaccine committee hand-picked by anti-vaccine Health Secretary Robert F. Kennedy Jr. meets again this week, it will have yet another new chairperson to lead its ongoing work of dismantling the evidence-based vaccine recommendations set by the Centers for Disease Control and Prevention.

On Monday, the Department of Health and Human Services announced that the chairperson who has been in place since June—when Kennedy fired all 17 expert advisors on the committee and replaced them with questionably qualified allies—is moving to a senior role in the department. Biostatistician Martin Kulldorff will now be the chief science officer for the Office of the Assistant Secretary for Planning and Evaluation (ASPE), HHS said. As such, he’s stepping down from the vaccine committee, the Advisory Committee on Immunization Practices (ACIP).

Kulldorff gained prominence amid the COVID-19 pandemic, criticizing public health responses to the crisis, particularly lockdowns and COVID-19 vaccines. He was a co-author of the Great Barrington Declaration that advocated for letting the deadly virus spread unchecked through the population, which was called unethical by health experts.

As ACIP chair, Kulldorff frequently made false and misleading statements about vaccine safety and efficacy that were in line with Kennedy’s views and statements. While Kulldorff presided over the committee, it made a series of decisions that were sharply denounced by scientific and medical groups as being based on ideology rather than evidence. Those include voting for the removal of the vaccine preservative thimerosal from some flu vaccines, despite well-established data indicating it is safe, with no evidence of harms. The committee also added restrictions to a combination measles, mumps, rubella, and varicella (chickenpox) MMRV vaccine and made an unprecedented effort to prevent Americans from getting COVID-19 vaccines, though the moves were largely ineffective.

In his new role, Kulldorff will be working with ASPE to provide analyses on health policy options, coordinate research efforts, and provide policy advice.

“It’s an honor to join the team of distinguished scientists that Secretary Kennedy has assembled,” Kulldorff said in a press release announcing his new role. “I look forward to contributing to the science-based public health policies that will Make America Healthy Again.”

The new chair, Kirk Milhoan

With Kulldorff moving on, ACIP will now be chaired by Kirk Milhoan, a pediatric oncologist with a track record for spreading COVID-19 misinformation and anti-vaccine views. In August 2021, the Hawaii Medical Board filed a complaint against Milhoan after he appeared on a panel promoting ineffective COVID-19 treatments, downplaying the severity of the disease, and spreading misinformation about COVID-19 vaccines, according to the Maui News. The complaint was dropped in April 2022 after state regulators said they had insufficient evidence to prove a violation of statutes regarding the practice of medicine.

While Milhoan claimed at the time that he is “pro-vaccine,” his statement, affiliations, and prescribing practices suggest otherwise. Milhoan is a member of the Independent Medical Alliance (formerly the Front Line COVID-19 Critical Care Alliance), a group of dubious health care providers set up amid the pandemic to promote the use of the anti-malaria drug hydroxychloroquine and the de-worming drug ivermectin to treat COVID-19. Both drugs have shown to be ineffective and potentially harmful when used to treat or prevent COVID-19. The IMA also emphasizes vaccine injuries while pushing vitamins and other unproven treatments.

In 2024, Milhoan appeared on a panel set up by Rep. Marjorie Taylor Greene (R-Ga.) to discuss alleged injuries from COVID-19 vaccines alongside other prominent anti-vaccine and COVID-19 misinformation voices. In his opening statement, Milhoan suggested that COVID-19 vaccines were causing severe cardiovascular disease and death in people aged 15 to 44—an unsubstantiated claim he frequently echoes. In his bio for the IMA, he touts that he offers treatment for “vaccine-related cardiovascular toxicity due to the spike protein.”

CDC data has found that boys and young men, aged 12 to 24, have a heightened risk of myocarditis (inflammation of the heart) after COVID-19 vaccination. However, the cases are rare, relatively mild, and almost always resolve, according to CDC data. In a COVID-19 safety data presentation in June, CDC staff scientists reported that its vast vaccine safety monitoring systems indicated that in males 12–24, there are 27 myocarditis cases per million doses of COVID-19 vaccine administered (roughly one case in 37,000 doses). In cases identified during 2021, 83 percent recovered within three months, with more than 90 percent recovering within the year. The monitoring data found no instances of cardiac transplant or death from COVID-19 vaccination.

While anti-vaccine activists have seized on this minor risk from vaccination, health experts note that the risk of myocarditis and other inflammatory conditions from a COVID-19 infection is significantly greater than the risk from vaccination. Exact estimates vary, but one CDC study in 2021 found that people with COVID-19 infections had a 16-fold higher risk of myocarditis than people without the infection. Specifically, the study estimated that there were 150 myocarditis cases among 100,000 COVID-19-infected patients versus just nine myocarditis cases among 100,000 people without COVID-19 infections and who were also unvaccinated. Similar to what’s seen with vaccination, the study found that young males were most at risk of myocarditis.

Kennedy’s allies attack on COVID-19 shots

Kennedy and his allies, like Milhoan, have consistently inflated the risk of myocarditis from COVID-19 vaccination, with some claiming without evidence that they have caused sudden cardiac arrest and deaths in young males, though studies have found no such link. In 2022, Milhoan and fellow ACIP member and conspiracy theorist Robert Malone were featured in a viral social media post suggesting that 50 percent of college athletes in the Big Ten athletic conference had myocarditis linked to COVID-19 vaccines, which could lead to deaths if they played. But the two were referencing a JAMA Cardiology study that examined subclinical myocarditis in Big Ten athletes after COVID-19 infection—not vaccination. In fact, researchers confirmed for an AFP fact check that none of the athletes in the study were vaccinated. And the rate of subclinical myocarditis in the group was 2.3 percent, not 50 percent.

Milhoan’s misinformation about the cardiovascular harms from COVID-19 vaccines seems particularly pertinent to the direction of Kennedy’s anti-vaccine allies. On Friday, Vinay Prasad, the Food and Drug Administration’s top vaccine regulator, sent a memo to staff claiming without evidence that COVID-19 vaccines have killed 10 children. The memo provides little information about the extraordinary claim, but it hints that the deaths were linked to myocarditis and found among reports submitted between 2021 and 2024 to the CDC’s Vaccine Adverse Event Reporting System (VAERS).

VAERS is a system by which anyone, including members of the public, can report anything they think could be linked to vaccines. The reports are considered a type of early warning system, but the vast majority of the reports submitted are not actually related to vaccines. Further, CDC scientists have thoroughly evaluated VAERS reports and ruled out deaths attributed to COVID-19 vaccines. Prasad’s memo—which experts have speculated was designed to be leaked to produce alarming headlines about child deaths—claimed that before Trump administration officials with anti-vaccine views began sifting through the data, these deaths were “ignored” by FDA and CDC scientists. Prasad also claimed that there could be many more deaths that have gone unreported, despite the fact that healthcare providers have been legally required to report any deaths that occurred after COVID-19 vaccination, regardless of cause.

This week’s ACIP meeting

In this week’s scheduled ACIP meeting on Thursday and Friday, COVID-19 vaccines don’t appear on the draft agenda. Instead, ACIP is expected to vote to remove a recommendation for a birth dose of the hepatitis B vaccine. That dose protects newborns from contracting the highly infectious virus from their mothers during birth or from other family or acquaintances shortly after birth. About half of the people infected with hepatitis B are not aware of their infections, and testing of mothers before birth is imperfect. That can leave newborns particularly vulnerable, as infections that start at or shortly after birth almost always develop into chronic infections that can lead to liver disease, liver transplant, and cancer. In a previous ACIP meeting, CDC staff scientists presented data showing that there are no significant harms of birth doses and there is no evidence that delaying the immunization offers any benefit.

The committee is also taking on the childhood vaccine schedule as a whole, though the agenda on this topic is not yet clear. In his memo, Prasad attacked the common practice of providing multiple vaccinations at once, hinting that it could be a way in which the committee will try to dismantle current childhood vaccination recommendations. On Tuesday, The Washington Post reported that the committee will examine whether the childhood vaccine schedule as a whole is causing allergies and autoimmune diseases, something Kennedy and his anti-vaccine organization have long floated despite evidence refuting a link.

Under clear attack are aluminum salt adjuvants, which are used in many vaccines to help spur protective immune responses. Aluminum salts have been used safely in vaccines for more than 70 years. The FDA notes that the most common source of aluminum exposure is from food and water, not vaccines.

Meet CDC’s new lead vaccine advisor who thinks shots cause heart disease Read More »

As shutdown ends, dubious CDC panel gets back to dismantling vaccine schedule

ACIP, american academy of pediatrics, anti-vaccine, CDC, health, hepatitis B, kennedy, robert f kennedy jr, vaccines / Tim Belzer / November 14, 2025

Nevertheless, Kennedy’s ACIP members planned to push the first dose back a month. A vote was prepared to recommend not giving a birth dose unless there was “individual based decision-making.” While at first the panel seemed poised to vote in favor of the change, the plan collapsed with basic questioning.

Voting ACIP member Joseph Hibbeln, a psychiatrist, noted: “I’m unclear if we’ve been presented with any safety or data comparing before one month to after one month,” he said. They had not.

“And,” Hibbeln continued, “I’m wondering why one month was selected as our time point and if there are data to help to inform us if there’s greater risk of adverse effects before one month or after one month at all.”

There is no data suggesting that such a move would be more or less safe.

The discussion quickly spiraled from there with an eventual vote of 11-1 to table voting on the vaccine recommendation. According to the Federal Register notice, ACIP will try to take up the topic again. They could revive the vote or attack some other aspect of vaccine recommendations.

Pediatricians fight back

Health experts have blasted Kennedy’s lineup and their attacks on childhood vaccines, including the hepatitis B vaccination schedule. The current schedule “remains the best protection against serious health problems like liver disease and cancer,” the American Academy of Pediatrics emphasized to Ars.

With ACIP’s standing tarnished under Kennedy, AAP has put forth its own evidence-based vaccine schedule for pediatricians to trust. They’ve also been a prominent opponent among medical organizations to Kennedy’s efforts. For instance, in a revised federal lawsuit, the AAP along with other medical organizations is seeking to overturn all decisions made by Kennedy’s ACIP and replace the entire panel with actual experts.

Kennedy’s appointees “lack the credentials and experience required of their role,” and all their votes should be declared “null and void,” the organization said.

AAP President Susan Kressly said that pediatricians are already seeing the effects of having an anti-vaccine activist as the US health secretary, namely “fear, decreased vaccine confidence, and barriers for families to access vaccines.”

“The nation’s children are already paying the price in avoidable illnesses and hospitalizations,” Kressly said. “We urge federal leaders to restore the science-based deliberative process that has made the United States a global leader in public health. Urgent action is needed.”

As shutdown ends, dubious CDC panel gets back to dismantling vaccine schedule Read More »

If things in America weren’t stupid enough, Texas is suing Tylenol maker

autism, health, paxton, Policy, robert f kennedy jr, texas, Trump, tylenol / Kris Guyer / October 28, 2025

While the underlying cause or causes of autism spectrum disorder remain elusive and appear likely to be a complex interplay of genetic and environmental factors, President Trump and his anti-vaccine health secretary Robert F. Kennedy Jr.—neither of whom have any scientific or medical background whatsoever—have decided to pin the blame on Tylenol, a common pain reliever and fever reducer that has no proven link to autism.

And now, Texas Attorney General Ken Paxton is suing the maker of Tylenol, Kenvue and Johnson & Johnson, who previously sold Tylenol, claiming that they have been “deceptively marketing Tylenol” knowing that it “leads to a significantly increased risk of autism and other disorders.”

To back that claim, Paxton relies on the “considerable body of evidence… recently highlighted by the Trump Administration.”

Of course, there is no “considerable” evidence for this claim, only tenuous associations and conflicting studies. Trump and Kennedy’s justification for blaming Tylenol was revealed in a rambling, incoherent press conference last month, in which Trump spoke of a “rumor” about Tylenol and his “opinion” on the matter. Still, he firmly warned against its use, saying well over a dozen times: “don’t take Tylenol.”

“Don’t take Tylenol. There’s no downside. Don’t take it. You’ll be uncomfortable. It won’t be as easy maybe, but don’t take it if you’re pregnant. Don’t take Tylenol and don’t give it to the baby after the baby is born,” he said.

“Scientifically unfounded”

As Ars has reported previously, there are some studies that have found an association between use of Tylenol (aka acetaminophen or paracetamol) and a higher risk of autism. But, many of the studies finding such an association have significant flaws. Other studies have found no link. That includes a highly regarded Swedish study that compared autism risk among siblings with different acetaminophen exposures during pregnancy, but otherwise similar genetic and environmental risks. Acetaminophen didn’t make a difference, suggesting other genetic and/or environmental factors might explain any associations. Further, even if there is a real association (aka a correlation) between acetaminophen use and autism risk, that does not mean the pain reliever is the cause of autism.

If things in America weren’t stupid enough, Texas is suing Tylenol maker Read More »

An NIH director joins MAHA, gets replaced by JD Vance’s close friend

cancer, cellphones, fluoride, health, NIEHS, NIH, NTP, robert f kennedy jr, Science, trump administration / Paul Patrick / October 23, 2025

The director of a federal health institute that has arguably produced two of the most controversial government studies in recent years has accepted a new federal role to advance the goals of the Make America Healthy Again movement. Meanwhile, the person replacing him as director is a close friend of Vice President JD Vance and was installed in a process that experts describe as completely outside standard hiring practices.

The series of events—revealed in an email to staff last week from the National Institutes of Health Director Jay Bhattacharya—is only exacerbating the spiraling fears that science is being deeply corrupted by politics under the Trump administration.

Richard Woychik, a molecular geneticist, is the outgoing director of the NIH’s National Institute of Environmental Health Sciences (NIEHS), which is located in Research Triangle Park, North Carolina. He has been director since 2020 and was recently appointed to a second five-year term, according to Science magazine. Woychik was hired at the institute in 2010, when he joined as deputy director, and was appointed acting director in 2019.

As the director of NIEHS, Woychik was also the director of the National Toxicology Program (NTP). This is an interagency program that has produced two highly controversial scientific reports during Woychik’s time in NIEHS’s upper leadership. One, initially released in 2016, claimed that cellphone radiation causes cancer based on findings from rats, though only male rats. The final reports were published in 2018. Another controversial study, finalized this year, suggested that high levels of fluoride lower the IQ of children. Both the cellphone radiation and fluoride studies have been roundly criticized for flaws in their methodology and analysis, and the scientific community has largely dismissed them.

However, the studies align with—and bolster—the conspiracy theories and misinformation spread by the MAHA movement, which is led by ardent anti-vaccine activist and current US health secretary Robert F. Kennedy Jr. As health secretary, Kennedy has pledged to remove fluoride from municipal water, which, over decades, has proven safe and highly effective at preventing tooth decay in children. He has also, at various times, suggested 5G cell phone radiation causes cancer, a variety of other health conditions, changes to DNA, and is used as mass surveillance.

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Layoffs, a “coding error,” chaos: Trump admin ravages the health dept.

CDC, health, health department, HHS, layoffs, robert f kennedy jr, Trump / Paul Patrick / October 13, 2025

Federal health agencies are reeling from mass layoffs on Friday that appear to have particularly devastated the Centers for Disease Control and Prevention, despite some terminations being rescinded on Saturday.

Numbers are still sketchy, but reports from Friday indicate that more than 4,000 federal workers overall were initially targeted for layoffs. The Trump administration linked the firings to the ongoing government shutdown, which legal experts have suggested is illegal. Unions representing federal workers have already filed a lawsuit challenging the move.

Of the reported 4,000 terminations, about 1,100 to 1,200 were among employees in the Department of Health and Human Services (HHS). HHS is a massive department that houses critical federal agencies, including the Centers for Disease Control and Prevention, the National Institutes of Health, the Food and Drug Administration, and the Centers for Medicare & Medicaid Services, among others. Before Trump’s second term, the HHS workforce was about 82,000, but that was slashed to about 62,000 earlier this year amid initial cuts and efforts to push civil servants out.

While it’s unclear where all the new cuts occurred, reports from anonymous and external sources describe a major gutting of the CDC, an agency that has already been severely wounded, losing significant numbers this year. Its former leaders have accused the Trump administration of censoring its scientific work. It suffered a dramatic ousting of its Senate-confirmed director in August. And it was the target of a gunman weeks earlier, who shot over 500 rounds at its employees, killing a local police officer.

As terminations went out Friday, reports indicated that the terminations hit staff who produce the CDC’s esteemed journal Morbidity and Mortality Weekly Report, employees responding to the measles outbreaks in the US, others responding to the Ebola outbreak in the Democratic Republic of the Congo, workers in the Global Health Center, and disease detectives in the Epidemic Intelligence Service.

Layoffs, a “coding error,” chaos: Trump admin ravages the health dept. Read More »

RFK Jr. drags feet on COVID-19 vaccine recommendations, delaying shots for kids

ACIP, CDC, COVID-19 vaccines, health, robert f kennedy jr, vaccines / Mike M. / October 2, 2025

Previously, the FDA narrowed the shots’ labels to include only people age 65 and older, and those 6 months and older at higher risk. But the ACIP recommended that all people age 6 months and older could get the shot based on shared decision-making with a health care provider. Although the shared decision-making adds a new requirement for getting the vaccine, that decision-making does not require a prescription and can be done not only with doctors, but also with nurses and pharmacists. Most people in the US get their seasonal COVID-19 vaccines at their local pharmacy.

Ars Technica reached out to the HHS on Thursday about whether there was a determination on the COVID-19 vaccine recommendations and, if not, when that is expected to happen and why there is a delay. The HHS responded, confirming that no determination had been made yet, but did not answer any of the other questions and did not provide a comment for the record.

In past years, ACIP recommendations and CDC sign-offs have happened earlier in the year to provide adequate time for a rollout. In 2024, ACIP voted on COVID-19 vaccinations in June, for instance, and then-CDC Director Mandy Cohen signed off that day. Now that we’re into October, it remains unclear when or even if the CDC will sign off on the recommendation and then, if the recommendation is adopted by the CDC, how much longer after that it would take for states to roll out the vaccines to children in the VFC program.

“Children who depend on this program, including children with chronic conditions, are still waiting unprotected. The delay in adopting COVID-19 vaccine recommendations puts their health at risk, reduces access and choice for families, and puts a strain on providers who want to deliver the best care for their youngest patients,” Susan Kansagra, the chief medical officer of the Association of State and Territorial Health Officials, said in a statement to Stat.

For now, children and adults with private insurance have access to the shots without the final sign-off, and health insurance companies have said that they will continue to maintain coverage for the vaccines without the final federal approval.

RFK Jr. drags feet on COVID-19 vaccine recommendations, delaying shots for kids Read More »

Anti-vaccine groups melt down over reports RFK Jr. to link autism to Tylenol

anti-vaccine, autism, children's health defense, health, robert f kennedy jr, tylenol, vaccines / Mike M. / September 22, 2025

Results of this study indicate that the association between acetaminophen use during pregnancy and neurodevelopmental disorders is a noncausal association. Birthing parents with higher acetaminophen use differed in many aspects from those with lower use or no use. Results suggested that there was not one single “smoking gun” confounder, but rather that multiple birthing parents’ health and sociodemographic characteristics each explained at least part of the apparent association. The null results of the sibling control analyses indicate that shared familial confounders were involved, but do not identify the specific confounding factors.

Critical factors

Another factor to consider is that untreated fevers, and/or prolonged fevers during pregnancy—reasons to take Tylenol in the first place—are linked to increased risks of autism. And, as the Society for Maternal-Fetal Medicine pointed out earlier this month, untreated fever and pain during pregnancy carry other significant risks for both the mother and the pregnancy.

“Untreated fever, particularly in the first trimester, increases the risk of miscarriage, birth defects, and premature birth, and untreated pain can lead to maternal depression, anxiety, and high blood pressure,” SMFM noted.

With no clear evidence supporting a link between acetaminophen and autism, doctors highlight another fold in the issue: Acetaminophen is considered the safest pain reliever/fever-reducer during pregnancy. Nonsteroidal anti-inflammatory medications (also called NSAIDS), such as ibuprofen (Advil) and aspirin, can cause reduced blood flow, heart problems, and kidney problems in a fetus.

After The Wall Street Journal’s report of Kennedy’s plans, the American College of Obstetricians and Gynecologists (ACOG) reiterated its guidance for acetaminophen during pregnancy, writing on social media:

Acetaminophen remains a safe, trusted option for pain relief during pregnancy. Despite recent unfounded claims, there’s no clear evidence linking prudent use to issues with fetal development. ACOG’s guidance remains the same. When pain relief is needed during pregnancy, acetaminophen should be used in moderation, and after consulting your doctor.

Christopher Zahn, ACOG’s chief of clinical practice, put it more plainly, saying: “Pregnant patients should not be frightened away from the many benefits of acetaminophen, which is safe and one of the few options pregnant people have for pain relief.”

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In new level of stupid, RFK Jr.’s anti-vaccine advisors axe MMRV recommendation

ACIP, CDC, health, MMR, mmrv, robert f kennedy jr, vaccine / Tim Belzer / September 19, 2025

The vote to strip the recommendation came after a day of inept discussion.

An MMR and VAR vaccine ready for a pediatric vaccination at Kaiser Permanente East Medical offices in Denver in 2015. Credit: Getty | Joe Amon

The panel of vaccine advisors hand-selected by anti-vaccine activist Robert F. Kennedy Jr. voted on Thursday to change the federal vaccine recommendations for children, removing safe, well-established vaccine doses from current schedules and realizing Kennedy’s anti-vaccine agenda to erode federal vaccine policy and sow distrust.

Specifically, the panel—the Advisory Committee on Immunization Practices (ACIP)—voted to remove the Centers for Disease Control and Prevention’s previous recommendation for use of a measles, mumps, rubella, varicella (chickenpox) MMRV combination vaccine for children under 4 years old.

The context

In June, Kennedy fired all 17 highly qualified, highly vetted members of ACIP and quickly replaced them with seven questionable members, who largely did not have subject matter expertise. Moreover, many of them have clearly expressed anti-vaccine rhetoric and skepticism about pandemic responses and COVID-19 vaccines. At least two new members have been paid witnesses in trials against vaccine makers, a clear conflict of interest. Earlier this week, Kennedy added five additional members, who raise the same anti-vaccine concerns as the first group.

In the meeting today—the first of two all-day meetings—members made clear their inexperience and lack of expertise in evaluating vaccine policy. They asked basic questions about study data and analysis—such as asking what a “low confidence” designation means—and claimed CDC presentations lacked critical data when, in fact, a CDC scientist had just presented the exact data in question.

The first half of the day focused on the MMRV vaccine, while the second half focused on a newborn dose of the hepatitis B (hep B) vaccine. A vote was initially scheduled for that vaccine today, too, but was postponed after the panel decided to change the wording of the voting question. They meet again tomorrow to vote on the hep B recommendation as well as recommendations for this year’s COVID-19 vaccine. Ars Technica will have coverage of the second half of the meeting tomorrow, along with a report on the hepatitis B discussion today.

MMRV vaccine change

For the MMRV vaccine, the panel rehashed an issue that vaccine experts had thoroughly examined years ago. Currently, the CDC recommends children get vaccinated against measles, mumps, rubella, and varicella (chickenpox) twice—one dose at 12 to 15 months, and a second dose between the ages of 4 and 6 years.

In 2005, the Food and Drug Administration approved a combo shot for all four—the MMRV vaccine—which provided an alternative to the previous method of giving an MMR vaccine dose (against measles, mumps, and rubella) plus a separate varicella vaccine dose at the same time. (This vaccination strategy is shorthanded as MMR + V.) Thus, the MMRV combo shot meant one fewer shot for children. But, in 2008, post-market data suggested that the MMRV shot might have a slightly higher risk of causing febrile seizures (seizures associated with fevers), which is a very low risk with the MMR + V separate shots.

Febrile seizures are a somewhat common reaction in young children; this type of seizure almost entirely occurs in children under age 5 years, most often striking between 14 and 18 months. The seizures are short, usually less than a minute or two, and they can be caused by essentially anything that can cause a fever—ear infections, vaccines, the flu, etc. For parents, a febrile seizure can be very scary and lead them to bring their child to a doctor or hospital. However, febrile seizures are almost always harmless—the prognosis is “excellent,” as CDC staff experts noted. Nearly all children fully recover with no long-term problems. By age 5, up to 5 percent of all children have had a febrile seizure at some point, for some reason.

Low risks

In post-market studies of the MMRV vaccine, it was very clear that a slightly increased risk of febrile seizures was only linked to the first dose (given at 12 to 15 months, not the second, given at 4 to 6 years). In studies of over 400,000 children, data found that the risk of a febrile seizure after a first-dose MMRV vaccine was 7 to 8.5 seizure cases for every 10,000 vaccinations. That’s compared to 3.2 to 4.2 seizure cases in 10,000 vaccinations with MMR + V. In all, a first-dose MMRV vaccine had about one additional febrile seizure per 2,300 to 2,600 children vaccinated compared with MMR + V.

In 2009, CDC vaccine experts reviewed all the data and updated the vaccine recommendation. They maintained that MMRV and the MMR+V vaccinations are still both safe, effective, and recommended at both vaccination time points. But, they added the nuance that there is a preference (or a default, basically) for using the MMR + V shots for the first dose, unless a parent expressly wanted the MMRV vaccine for that first dose. This skirted the slightly increased risk of febrile seizure in young children, without entirely taking away the option if a parent prioritized fewer jabs and wanted the MMRV. For the second dose, again, both MMRV and MMR + V are options, but the CDC stated a preference for the one-shot MMRV.

Since then, about 85 percent of vaccinated children have gotten MMR + V for their first dose shots, with the other 15 percent getting the MMRV vaccine.

Inept discussion

In the discussion today, Kennedy’s members seemed to have little grasp of the issue at hand and the clinical significance of febrile seizures generally. They continued to circle back to unfounded concerns about febrile seizures and fringe theories about potential long-term effects.

Cody Meissner, a pediatric professor at Dartmouth’s Geisel School of Medicine who has served on ACIP in the past—arguably the most qualified of Kennedy’s new lineup—was bewildered at why the committee was rehashing the issue addressed years ago. “This discussion is really a déjà vu for me,” he said. Yet, while Meisner felt the issue was settled and pediatricians were well-equipped to calm parents’ fears about febrile seizures, the other members could not be swayed. They claimed, without evidence, that parents of children who have febrile seizures after a vaccine would be less likely to get future vaccines.

As the committee seemed to be leaning toward removing the recommendation for MMRV for the first dose, Jason Goldman, president of the American College of Physicians, who attended the meeting as a liaison, pushed back strongly. He pointed out that—as with the last time Kennedy’s ACIP met—they were not following the standard framework for making and changing recommendations.

“Are we going to have a thoroughly vetted evidence-to-recommend framework presentation that looks at all the harms benefits, acceptability, feasibility—with input from practicing clinicians and liaisons in order to make an informed decision?” Goldman asked. “I would argue that this recommendation is going to create more confusion among the public.”

Goldman noted that if the committee rescinds the recommendation for MMRV for children under 4, the shot would no longer be covered by the Vaccines for Children (VFC) Program, a federal program for Medicaid-eligible and under- or uninsured kids, which covers about half of American children.

“And finally, you are taking away the choice of parents to have informed consent and discussion with their physician on what they want to do for the health and benefit of their children,” Goldman said. “So, I urge this committee not to change the recommendations if they truly want to give the power to the parents to decide what is best for their child and allow them to make the choice in consultation with their physicians.”

Voting confusion

In the end, Kennedy’s panel voted 8–3 (with one abstention) to not recommend MMRV for children under age 4, meaning the MMRV vaccine could potentially no longer be available for some children under age 4. Private insurance companies are required to cover ACIP-recommended vaccines, so this move strips the recommendation and that coverage requirement.

But, anticipating such a change, AHIP, a trade organization representing insurance companies, put out a statement earlier this week suggesting that they would still cover the MMRV vaccine for children under 4, even if it’s not required.

“Health plans will continue to cover all ACIP-recommended immunizations that were recommended as of September 1, 2025, including updated formulations of the COVID-19 and influenza vaccines, with no cost-sharing for patients through the end of 2026,” the statement reads.

But, there’s more: In a second vote today, ACIP voted 8–1 (with three abstentions) against changing VFC coverage for MMRV. Therefore, the VFC program will continue to cover MMRV vaccines for children under age 4. This is a split from standard policy that is likely to spur confusion, because VFC typically goes with ACIP recommendations. Also, Medicaid’s Children’s Health Insurance Program (CHIP) has to follow the ACIP vaccine recommendation and thus will no longer cover MMRV for children under age 4 covered by CHIP.

One of the abstentions on the VFC coverage vote was Meissner, who didn’t want to strip the recommendation or the VFC coverage but was entirely confused by how this would work in practice.

In new level of stupid, RFK Jr.’s anti-vaccine advisors axe MMRV recommendation Read More »

RFK Jr. adds more anti-vaccine members to CDC vaccine advisory panel

ACIP, anti-vaccine, CDC, COVID-19 vaccines, health, hepatitis B, measles, robert f kennedy jr / Kris Guyer / September 16, 2025

Kirk Milhoan, a pediatric cardiologist who is a senior fellow at the Independent Medical Alliance (formerly Front Line COVID-19 Critical Care Alliance), which promotes misinformation about COVID-19 vaccines and touts unproven and dubious COVID-19 treatments. Those include the malaria drug hydroxychloroquine, the de-worming drug ivermectin, and various concoctions of vitamins and other drugs. Milhoan has stated that mRNA COVID-19 vaccines should be removed from the market, telling KFF in March: “We should stop it and test it more before we move forward.”

Evelyn Griffin, an obstetrician and gynecologist in Louisiana who reportedly lost her job for refusing to get a COVID-19 vaccine. In a speech at a Louisiana Health Freedom Day in May 2024, Griffin claimed that doctors “blindly believed” that mRNA COVID-19 vaccines were safe. She has also claimed that the vaccines cause “bizarre and rare conditions,” according to the Post.

Hillary Blackburn, a pharmacist in St. Louis. Reuters reports that she is the daughter-in-law of Sen. Marsha Blackburn (R-Tenn.), who has opposed vaccine mandates.

Raymond Pollak, a semi-retired transplant surgeon who filed a whistleblower lawsuit against the University of Illinois Hospital in 1999, alleging the hospital manipulated patient data to increase their chances of receiving livers. The hospital settled the suit, paying $2.5 million, while denying wrongdoing.

ACIP is scheduled to meet at the end of this week, on September 18 and September 19. According to an agenda recently posted online, the committee will vote on recommendations for a measles, mumps, rubella, and varicella (MMRV) combination vaccine, the Hepatitis B vaccine, and this year’s updated COVID-19 vaccines. Vaccine experts widely fear that the committee will rescind recommendations and restrict access to those vaccines. Such moves will likely create new, potentially insurmountable barriers for people, including children, to get vaccines.

ACIP-recommended vaccines are required to be covered by private health insurance plans and the Vaccines for Children program for Medicaid-eligible and under- or uninsured kids, which covers about half of American children. Without ACIP recommendations for a vaccine, insurance coverage would be an open question, and vulnerable children would simply lose access entirely.

RFK Jr. adds more anti-vaccine members to CDC vaccine advisory panel Read More »

Ousted CDC director to testify before Senate after RFK Jr. called her a liar

ACIP, CDC, COVID-19, health, robert f kennedy jr, Senate, vaccines / Rejus Almole / September 11, 2025

Kennedy is reportedly vetting seven additional members for ACIP, who may be added before the next meeting. They include additional anti-vaccine voices and fringe members of the medical community, such as Kirk Milhoan, who promoted the de-worming drug ivermectin to treat COVID-19, despite several clinical trials finding it is not effective. There is also Joseph Fraiman, who has repeatedly called for COVID-19 vaccines to be pulled from the market.

Also on the list is Catherine Stein, who, The Washington Post noted, has advocated against vaccine mandates and wrote a 2021 article arguing that people should not be afraid of contracting COVID-19 because: “Our Lord has given us a mission to share the gospel. If we live in fear of death, that weakens our testimony. Remember, the Lord Jesus did not fear lepers, and leprosy was (and continues to be) a highly contagious infectious disease.”

Leprosy, or Hansen’s disease, is, in fact, not a highly contagious disease. It does not spread easily from person to person, is not spread through casual contact, and about 95 percent of people are immune to it naturally. COVID-19, meanwhile, is estimated to have caused more than 7 million deaths worldwide since the start of the pandemic.

Regardless of whether these candidates are added to the roster, Cassidy has called for the ACIP meeting scheduled for September 18 and 19 to be postponed.

“Serious allegations have been made about the meeting agenda, membership, and lack of scientific process being followed for the now announced September ACIP meeting,” Cassidy said. “These decisions directly impact children’s health and the meeting should not occur until significant oversight has been conducted. If the meeting proceeds, any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership.”

After Monarez and Houry testify before the HELP committee, Cassidy said that Senators are planning to invite current health officials to respond in a subsequent hearing.

Ousted CDC director to testify before Senate after RFK Jr. called her a liar Read More »

Who can get a COVID vaccine—and how? It’s complicated.

ACIP, CDC, COVID-19, fda, health, mRNA, pharmacists, robert f kennedy jr, vaccines / Mike M. / September 6, 2025

We’re working with a patchwork system, and there are a lot of gray areas.

Vaccinations were available at CVS in Huntington Park, California, on August 28, 2024. Credit: Getty | Christina House

As fall approaches and COVID cases tick up, you might be thinking about getting this season’s COVID-19 vaccine. The annually updated shots have previously been easily accessible to anyone over 6 months of age. Most people could get them at no cost by simply walking into their neighborhood pharmacy—and that’s what most people did.

However, the situation is much different this year with an ardent anti-vaccine activist, Robert F. Kennedy Jr., as the country’s top health official. Since taking the role, Kennedy has worked diligently to dismantle the country’s premier vaccination infrastructure, as well as directly hinder access to lifesaving shots. That includes restricting access to COVID-19 vaccines—something he’s done by brazenly flouting all standard federal processes while providing no evidence-based reasoning for the changes.

How we got here

In late May, Kennedy unilaterally decided that all healthy children and pregnant people should no longer have access to the shots. He announced the unprecedented change not through official federal channels, but via a video posted on Elon Musk’s X platform. Top vaccine and infectious disease officials at the Centers for Disease Control and Prevention—which sets federal vaccination recommendations—said they also learned of the change via X.

Medical experts—particularly the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG)—immediately slammed the change, noting that data continues to indicate pregnant women and children under age 2 are particularly vulnerable to severe COVID-19. Both medical groups have since released their own vaccination guidance documents that uphold COVID-19 vaccine recommendations for those patient groups. (AAP here, ACOG here)

Nevertheless, in line with Kennedy, officials at the Food and Drug Administration signaled that they would take the unprecedented, unilateral step of changing the labels on the vaccines to limit who could get them—in this case, people 65 and over, and children and adults with health conditions that put them at risk of severe COVID-19. Kennedy’s FDA underlings—FDA Commissioner Martin Makary and top vaccine regulator, Vinay Prasad—laid out the plans alongside a lengthy list of health conditions in a commentary piece published in the New England Journal of Medicine. The list includes pregnancy—which is evidence-based, but odd, since it conflicts with Kennedy.

What was supposed to happen

When there isn’t a zealous anti-vaccine activist personally directing federal vaccine policy, US health agencies have a thorough, transparent protocol for approving and recommending vaccinations. Generally, it starts with the FDA, which has both its own scientists and a panel of outside expert advisors to review safety and efficacy data submitted by a vaccine’s maker. The FDA’s advisory committee—the Vaccines and Related Biological Products Advisory Committee (VRBPAC)—then holds a completely public meeting to review, analyze, and discuss the data. They make a recommendation on a potential approval and then the FDA commissioner can decide to sign off, typically in accordance with internal experts.

Resulting FDA approvals or authorizations are usually broad, basically covering people who could safely get the vaccine. The specifics of who should get the vaccine fall to the CDC.

Once the FDA approves or authorizes a vaccine, the CDC has a similar evaluation process. Internal experts review all the data for the vaccine, plus the epidemiological and public health data to assess things like disease burden, populations at risk, resource access, etc. A committee of outsides expert advisors do the same—again in a totally transparent public meeting that is livestreamed with all documents and presentations available on the CDC’s website.

That committee, the Advisory Committee on Immunization Practices (ACIP), then makes recommendations to the CDC about how the shots should be used. These recommendations can provide nuanced clinical guidance on exactly who should receive a vaccine, when, in what scenarios, and in what time series, etc. The recommendations may also be firm or soft—e.g., some people should get a vaccine, while others may get the vaccine.

The CDC director then decides whether to adopt ACIP’s recommendations (the director usually does) and updates the federal immunization schedules accordingly. Those schedules set clinical standards for immunizations, including routine childhood vaccinations, nationwide. Once a vaccine recommendation makes it to the ACIP-guided federal immunization schedules, private health insurance companies are required to cover those recommended vaccinations at no cost to members. And—a key catch for this year—19 states tie ACIP vaccine recommendations to pharmacists’ ability to independently administer vaccines.

What actually happened

Days after Kennedy’s X announcement of COVID-19 vaccine restrictions in late May, the CDC changed the federal immunization schedules. The recommendation for a COVID-19 shot during pregnancy was removed. But, for healthy children 6 months to 17 years, the CDC diverged from Kennedy slightly. The updated schedule doesn’t revoke access outright; instead, it now says that healthy children can get the shots if there is shared decision-making with the child’s doctor, that is, if the parent/child wants to get the vaccine and the doctor approves. ACIP was not involved in any of these changes.

On August 27, the FDA followed through with its plans to change the labels on COVID-19 vaccines, limiting access to people who are 65 and older and people who have an underlying condition that puts them at high risk of severe COVID-19.

FDA’s advisory committee, VRBPAC, met in late May, just a few days after FDA officials announced their plans to restrict COVID-19 vaccine access. The committee was not allowed to discuss the proposed changes. Instead, it was limited to discussing the SARS-CoV-2 strain selection for the season, and questions about the changes were called “off topic” by an FDA official.

ACIP, meanwhile, has not met to discuss the use of the updated COVID-19 vaccines for the 2025–2026 season. Last year, ACIP met and set the 2024–2025 COVID-19 shot recommendations in June. But, instead, in June of this year, Kennedy fired all 17 members of ACIP, falsely claiming members were rife with conflicts of interest. He quickly repopulated ACIP with anti-vaccine allies who are largely unqualified and some of whom have been paid witnesses in lawsuits against vaccine makers, a clear conflict of interest. While Kennedy is reportedly working to pack more anti-vaccine activists onto ACIP, the committee is scheduled to meet and discuss the COVID-19 vaccine on September 18 and 19. The committee will also discuss other vaccines.

Outside medical and public health experts view ACIP as critically compromised and expect it will further restrict access to vaccines.

With this set of events, COVID-19 vaccine access is in disarray. Here’s what we do and don’t know about access.

Getting a vaccine

FDA vaccine criteria

Prior to Kennedy, COVID-19 vaccines were available to all people ages 6 months and up. But that is no longer the case. The current FDA approvals are as follows:

Pfizer’s mRNA COVID-19 vaccine (COMIRNATY) is only available to people:

65 years of age and older, or
5 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Moderna’s mRNA COVID-10 vaccine (SPIKEVAX) is only available to people:

65 years of age and older, or
6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Novavax’s protein subunit COVID-19 vaccine NUVAXOVID is only available to people:

65 years of age and older, or
12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

Who can get a COVID-19 vaccine and where now depends on a person’s age, underlying conditions, and the state they reside in.

States-based restrictions

The fact that ACIP has not set recommendations for the use of 2025–2026 COVID-19 vaccines means vaccine access is a messy patchwork across the country. As mentioned above, 19 states link pharmacists’ ability to independently provide COVID-19 vaccines to ACIP recommendations. Without those recommendations, pharmacies in those states may not be able to administer the vaccines at all, or only provide them with a doctor’s prescription—even for people who fit into the FDA’s criteria.

Last week, The New York Times reported that CVS and Walgreens, the country’s largest pharmacy chains, were either not providing vaccines or requiring prescriptions in 16 states. And the list of 16 states where CVS had those restrictions was slightly different than where Walgreens had them, likely due to ambiguities in state-specific regulations.

The National Alliance of State Pharmacy Associations (NASPA) and the American Pharmacists Association (APhA) have a state-by-state overview of pharmacist vaccination authority regulations here.

For people meeting the FDA criteria

In the 31 states that allow for broader pharmacist vaccination authority, people meeting FDA’s criteria (65 years and older, and people with underlying conditions), should be able to get the vaccine at a pharmacy like usual. And once ACIP sets recommendations later this month—assuming the committee doesn’t restrict access further—people in those groups should be able to get them at pharmacies in the remaining states, too.

Proving underlying conditions

People under 65 with underlying health conditions who want to get their COVID-19 shot at a pharmacy will likely have to do something to confirm their eligibility.

Brigid Groves, APhA’s vice president of professional affairs and the organization’s expert on vaccine policy, told Ars that the most likely scenario is that people will have to fill out forms prior to vaccination, indicating the conditions they have that make them eligible, a process known as self-attestation. This is not unusual, Groves noted. Other vaccinations require such self-attestation of conditions, and for years, this has been sufficient for pharmacists to administer vaccines and for insurance policies to cover those vaccinations, she said.

“APhA is a strong supporter of that patient self-attestation, recognizing that patients have a very good grasp of their medical conditions,” Groves said.

For people who don’t meet the FDA criteria

There are a lot of reasons why healthy children and adults outside the FDA’s criteria may still want to get vaccinated: Maybe they are under the age of 2, an age that is, in fact, still at high risk of severe COVID-19; maybe they live or work with vulnerable people, such as cancer patients, the elderly, or immunocompromised; or maybe they just want to avoid a crummy respiratory illness that they could potentially pass on to someone else.

For these people, regardless of what state they are in, getting the vaccine would mean a pharmacist or doctor would have to go “off-label” to provide it.

“It’s very gray on how a pharmacist may proceed in that scenario,” Groves told Ars. Going off-label could open pharmacists up to liability concerns, she said. And even if a patient can obtain a prescription for an off-label vaccine, that still may not be enough to allow a pharmacist to administer the vaccine.

“Pharmacists have something called ‘corresponding responsibility,’ Groves explained. “So even if a physician, or a nurse practitioner, or whomever may send a prescription over for that vaccine, that pharmacist still has that responsibility to ensure this is the right medication, for the right patient, at the right time, and that they’re indicated for it,” she said. So, it would still be going outside what they’re technically authorized to do.

Doctors, on the other hand, can administer vaccines off-label, which they might do if they choose to follow guidance from medical organizations like AAP and ACOG, or if they think it’s best for their patient. They can do this without any heightened professional liability, contrary to some suggestions Kennedy has made (doctors prescribe things off-label all the time). But, people may have to schedule an appointment with their doctor and convince them to provide the shot—a situation far less convenient than strolling into a local pharmacy. Also, since pharmacies have provided the vast majority of COVID-19 vaccines so far, some doctors’ offices may not have them on hand.

Pregnancy

It’s unclear if pregnancy still falls under the FDA’s criteria for a high-risk condition. It was included in the list that FDA officials published in May. However, the agency did not make that list official when it changed the vaccine labels last month. Some experts have suggested that, in this case, the qualifying high-risk conditions default to the CDC’s existing list of high-risk conditions, which includes pregnancy. But it’s not entirely clear.

In addition, with Kennedy’s previous unilateral change to the CDC’s immunization schedule—which dropped the COVID-19 vaccine recommendation during pregnancy—pregnant people could still face barriers to getting the vaccine in the 19 states that link pharmacist authorization to ACIP recommendations. That could change if ACIP reverses Kennedy’s restriction when the committee meets later this month, but that may be unlikely.

Insurance coverage

It’s expected that insurance companies will continue to cover the full costs of COVID-19 vaccines for people who meet the FDA criteria. For off-label use, it remains unclear.

Groves noted that in June, AHIP, the trade organization for health insurance providers, put out a statement suggesting that it would continue to cover vaccines at previous levels.

“We are committed to ongoing coverage of vaccines to ensure access and affordability for this respiratory virus season. We encourage all Americans to talk to their health care provider about vaccines,” the statement reads.

However, Groves was cautious about how to interpret that. “At the end of the day, on the claims side, we’ll see how that pans out,” she said.

Rapidly evolving access

While the outcome of the ACIP meeting on September 18 and 19 could alter things, a potentially bigger source of change could be actions by states. Already, there have been rapid responses with states changing their policies to ensure pharmacists can provide vaccines, and states making alliances with other states to provide vaccine recommendations and vaccines themselves.

Who can get a COVID vaccine—and how? It’s complicated. Read More »