The Monday announcement by President Donald Trump was not just limited to the link between Tylenol, a popular pain medicine and autism, but also an attack on vaccines. Health and Me has previously covered how the vaccine policies have changed ever since RFK Jr. has been appointed as the Health Secretary. Trump's announcement further seconded the same. He went as far as saying that children should not get their first hepatitis B vaccines until they are 12 years old.

Also Read: How Has RFK Jr Changed The Vaccine Policies In The US?

Here Are All The Claims Trump Made About Vaccines, And Why They Don't Hold Scientific Value, According To Doctors

Hepatitis B

Trump said children should not receive the hepatitis B vaccine until they are 12 years old, contradicting long-standing recommendations to vaccinate newborns. He said, "Hepatitis B is sexually transmitted. There’s no reason to give a baby that’s almost just born hepatitis B. So I would, say, wait till the baby is 12 years-old and formed.”

Experts have pointed out that his claim ignores decades of medical evidence. The CDC’s Advisory Committee on Immunization Practices has recommended hepatitis B vaccination for newborns since 1991, as it prevents chronic liver infections and serious long-term damage.

Doctors stress that if a mother has hepatitis B, giving the newborn both the vaccine and immune globulin immediately after birth is crucial to prevent transmission.

Read: What Is Leucovorin - The Drug Trump Suggests As A Treatment For Autism?

MMR Vaccines And Number Of Vaccines Given To Children

He also declared that MMR vaccines, used against measles, mumps, and rubella must be administered separately "based on what I feel".

Trump’s suggestion to split the MMR vaccine “based on what I feel” was dismissed by health experts as lacking scientific basis.

His claim that babies are “loaded up” with as many as 80 vaccines. He said, "They pump so much stuff into babies, it is a disgrace". However, the claim is false. Experts criticized this statement as misleading and dangerous, likely to stoke unnecessary fear.

Read: Tylenol And Autism: Trump Announces Link Between The Two, Science Does Not Back Him

Covid-19 Vaccinations

Trump, during his first administration has been highlight critical of the Covid-19 vaccination. He in fact, suggested scientists to study the injection of bleach into the human body as a way to fight COVID. He also floated the idea of using UV light exposure inside the body to treat COVID patients.

Not only trump, but the now serving Health and Human Services Secretary, RFK Jr. is also a known conspiracy theorist and vaccine skeptic. He had been criticized for his radical views and for his contentious overhaul of the CDC.

Dan Jernigan, Director of the National Center for Emerging and Zoonotic Infectious Disease in fact condemned his actions and said, "What he is doing is not scientifically sound."

Another health expert Craig Spencer, MD, wrote on X that this was the "worst" health press conference he has ever witnessed. He wrote: "I'm absolutely speechless. Like, wow. This is the worst 'health' press conference I maybe have ever seen, and I watched every one during Covid. How are we doing this again???"

US President Donald Trump held a press conference to announce the connection between the use of Tylenol, a popular pain and fever relief medicine during pregnancy and autism. Trump in the press conference also suggested Leucovorin, as a potential treatment for autism symptom.

Read: Tylenol And Autism: Trump Announces Link Between The Two, Science Does Not Back Him

What Is Leucovorin?

It is known as folinic acid, a form of folate, also an essential B vitamin or B9, which has been approved by the US Food and Drug Administration (FDA) for counteracting the toxic effects of certain cancer drugs. It can counteract methotrexate that blocks body's use of folate.

The drug is also used to enhance the effects of chemotherapy drugs and to treat specific types of anemia.

How Is Leucovorin Administered? Who Makes Leucovorin?

The drug can be administered orally or intravenously. While it is manufactured by dozens of companies, notes US FDA, on Monday itself, FDA published a notice to the Federal Register ahead of Trump's press conference to approve a version of Leucovorin manufactured by GlaxoSmithKline or GSK.

GSK had previously withdrawn from FDA's consideration when it stopped making the drug. However, as per the FDA notice, "The FDA is working with GSK, the innovator of Wellcovorin (leucovorin calcium), on a process to include the essential scientific information needed for the safe and effective use of these drug products for adults and pediatric patients with CFD (cerebral folate deficiency)."

Is Leucovorin Effective For Autism?

As per the FDA notice, leucovorin calcium, branded as Wellcovorin by GSK is sent for approval for patients with cerebral folate deficiency, which is a neurological condition that affects folate, an essential vitamin for brain health, transport into the brain.

The FDA notice mentions that individuals with CFD have been "observed to have developmental delays with autistic features".

FDA Commissioner Marty Makary, MF, MPH said that in over two decades, the US has "witnessed a tragic four-fold increase in autism". He further noted: "Children are suffering and deserve access to potential treatments that have shown promise. We are using gold standard science and common sense to deliver for the American people.”

George Tidmarsh, MD, PhD, Director of the FDA's Center for Drug Evaluation and Research said that FDA is collaborating with GSK to broaden the existing Wellcovorin label and is committed to "finding and treating the root causes of autism".

Read: Trump's Claim On Linking Tylenol And Autism Is Unscientific, According To Doctors

Why Leucovorin Is Considered To Treat Autism?

Doctors have been using leucovorin off-label for autism, repurposing the drug beyond its original approval, reported Reuters.

Research from SUNY Downstate Medical Center and others suggests that as many as three-quarters of children with autism may have genetic variations or autoimmune issues that interfere with folate processing in the brain.

Smaller studies have linked these problems to more severe autism symptoms and found that leucovorin treatment may help improve speech, social interaction, and irritability. Still, the Autism Science Foundation cautions that the research is in its early stages, and more evidence is needed before firm conclusions can be drawn.

Read: Trump Suggests Changes In Childhood Vaccines, Says It Is Based On What He Feels

A 2016 study published in Molecular Psychiatry, which was a randomized controlled trial suggested that this specialized form of folate can improve communication and language skills in some children with Autism Spectrum Disorder (ASD).

A June 2020 study published in the Seminars in Pediatric Neurology suggests folate (vitamin B9) plays a vital role in brain development and function, helping with DNA synthesis, methylation, and neurotransmitter production. Some children with autism struggle with folate metabolism, particularly in transporting folate into the brain, a condition known as cerebral folate deficiency.

Another 2020 study published in October in Seminars in Pediatric Neurology suggests that in many cases, the immune system produces antibodies that target the folate receptor alpha (FRα) on brain cells. These folate receptor autoantibodies (FRAA) block folate entry into the brain, resulting in low brain folate levels even when blood levels are normal. While only about 5–10% of the general population carries these antibodies, research suggests that 50–70% of children with autism may have them. This disruption is thought to significantly affect speech and cognitive development.

However, Dr. David Mandell, a professor of psychiatry and autism expert at the University of Pennsylvania, told Reuters that leucovorin might well be a possible treatment for some children with autism, "but the evidence we have supporting it... is really, really weak."

The Monday announcement by President Trump on Tylenol and its link with autism has sparked a debate among the medical field. Experts have claimed that the link suggested is unfound in science. Australia's peak body for obstetricians and gynaecologists now fear that pregnant women will not take paracetamol when they need it and suffer harm from unmanaged fever.

Trump suggested that women should "fight like hell" and not take paracetamol, which is branded as Tylenol in the US, as it heightens the risk of autism when it is used by pregnant women. He further said that if women continue to take the medicine, "that would mean you can't tough it out, so that's up to you and your doctor. I just want to say it is like it is: don't take Tylenol. Don't take it. Fight like hell not to take it."

However, as far as science and facts are concerned, the pain medicine is widely considered a safe option to treat pain and fever even during pregnancy.

As a result of this, Australia's medicine regulator, the Therapeutic Goods Administration (TGA), re-confirmed the safety of this drug use during pregnancy.

Also Read: Tylenol And Autism: Trump Announces Link Between The Two, Science Does Not Back Him

What Is The Australian Medical Body Saying About Tylenol Use?

The Royal Australian and New Zeeland College of Obstetricians and Gynaecologists (RANZCOG) warned that Trump’s comments could lead pregnant women to avoid paracetamol and suffer harm from unmanaged fever.

Dr Elisha Broom, a counsellor and spokesperson for RANZCOG, as reported by Guardian said, evidence supports the safety of paracetamol in pregnancy when used correctly. Broom further noted that unmanaged fever is a known risk to pregnancy, unlike paracetamol.

“It’s not a no-harm scenario when women are fearful to take what we know are safe medications,” said Broom.

Broom is a maternal fetal medicine sub-specialist in Queensland and said that many obstetricians are expecting questions from their patients after Trump's announcement and would welcome them.

Read: What Is Leucovorin - The Drug Trump Suggests As A Treatment For Autism?

Is There A Link Between Fever Medicines And Babies?

Broom said, "We know that actually there is a link between fever and impacts on babies – not neurodivergence – but complications in pregnancies that result from unmanaged fever."

She further noted that "It is not a no-harm scenario where women are fearful to take what we know are safe over-the-counter medications to relieve pain and fever in pregnancy."

The reason why this announcement could harm women more than protecting them is because medicines like Nurofen or ibuprofen is already not recommended because it does not have the same safety profile, suggests Broom. Thus, this leaves women without any options but to cope with pain and unmanaged fever.

The TGA also noted that "paracetamol remains Pregnancy Category A in Australia, meaning that it is considered safe for use in pregnancy”.

It said: “The TGA maintains robust post-market safety surveillance and pharmacovigilance processes for all medicines registered in Australia, including paracetamol.”

Read: Trump Suggests Changes In Childhood Vaccines, Says It Is Based On What He Feels

What Do Other Medical Boards Say About This Announcement?

Australian Medical Association (AMA) president, Danielle McMullen stressed that studies showing a “possible association” between paracetamol and autism do not prove causation. She said autism is far more likely to be driven by genetic factors.

The American College of Obstetricians and Gynecologists (ACOG) also called Trump's announcement "irresponsible" and "highly unsettling". They emphasized acetaminophen (Tylenol) remains the safest painkiller during pregnancy.

The official announcement linking Tylenol, a popular pain medicine with autism was made by President Donald Trump on Monday. In the announcement, he noted that the US Food and Drug Administration (FDA) will notify doctors that the use of Tylenol during pregnancy can be associated with a "very increased risk of autism", despite years of research and evidence that clearly point its safety.

"They are strongly recommending that women limit Tylenol use during pregnancy unless medically necessary," such as to treat fever, "if you can't tough it out," said Trump.

Read: What Is Leucovorin - The Drug Trump Suggests As A Treatment For Autism?

Tylenol, Pregnancy, And Childhood Autism

As per earlier studies, one of which is published in American Family Physician in 2014 also noted that during pregnancy most people used acetaminophen, sold under the brand name Tylenol. Acetaminophen is considered the one safe over-the-counter option for pain or fever for pregnant people. Other common pain relief options like ibuprofen or regular-dose-aspirin is available, however, they can pose serious risk in pregnancy and could lead to complications.

Is There Any Evidence That Show The Link Between Tylenol And Autism?

As per a recent 2024 study published in JAMA Network, titled Acetaminophen Use During Pregnancy and Children’s Risk of Autism, ADHD, and Intellectual Disability, there is no risk of autism for mothers who consume the medicine during pregnancy. The study notes: "Acetaminophen use during pregnancy was not associated with children’s risk of autism, ADHD, or intellectual disability in sibling control analyses."

James Cusack, chief executive of Autistica, a UK autism research and campaigning charity in London, who is autistic told Nature: "There is no definitive evidence to suggest that paracetamol use in mothers is a cause of autism, and when you see any associations, they are very, very small. At the heart of this is people trying to look for simple answers to complex solutions.”

Helen Tager-Flusberg, a psychologist who studies autism at Boston University, Massachusetts told Nature, "he better controlled studies are less likely to find even a small risk. And even then, what we're talking about is a minor association. … We do not think that taking acetaminophen is in any way contributing to actually causing autism.”

A study led by Viktor Ahlqvist, an epidemiologist at the Karolinska Institute in Stockholm (mentioned above, published in JAMA Network) is considered one of the biggest studies in this subject have also found no such link.

Ahlqvist’s team analyzed data from nearly 2.5 million children born in Sweden between 1995 and 2019, drawing from the nation’s detailed health records. These included acetaminophen prescriptions during pregnancy, self-reported use collected by midwives, and later autism diagnoses in children.

The findings showed autism in about 1.42% of children exposed to acetaminophen prenatally, compared to 1.33% among those not exposed, a difference Ahlqvist described as “very small.”

However, a previous study from 2022, published in Cureus, titled A Systematic Review of the Link Between Autism Spectrum Disorder and Acetaminophen: A Mystery to Resolve, concluded that "using acetaminophen during pregnancy was associated with attention problems and poorer executive development in children, especially with a longer duration of acetaminophen use". The studied reviewed 16 previously published studies and noted: "All 16 studies selected in our data showed a consistent association between acetaminophen and adverse neurodevelopmental outcomes."

Also Read: Tylenol And Autism: Trump, RFK Jr., And Officials To Link The Two In An Announcement Soon

What More Was Discussed In The Announcement?

At the White House, President Trump appeared alongside US Health and Human Services Secretary Robert F. Kennedy Jr., FDA Commissioner Dr. Marty Makary, NIH Director Dr. Jay Bhattacharya, and CMS Administrator Dr. Mehmet Oz. While the discussion included concerns over Tylenol use during pregnancy, Trump went further, calling for delays in childhood vaccinations, even suggesting postponing the hepatitis B shot, which has helped nearly eliminate infections in children, until age 12.

“It’s too much liquid, too many different things are going into that baby,” Trump said, offering no evidence to support his claims.

Scientific consensus remains firm: extensive research has shown no connection between vaccines and autism.

Trump praised Kennedy for bringing autism “to the forefront of American politics” and claimed, “We understood a lot more than a lot of people who studied it.” Kennedy, a longtime vaccine skeptic, has promoted theories linking vaccines to autism that experts widely dismiss.

By contrast, Kennedy and the FDA delivered more measured messages. Kennedy announced that HHS will launch a national campaign to inform families about safe Tylenol use during pregnancy. He stressed that acetaminophen should be used only when necessary, at the lowest effective dose, and for the shortest duration possible.

The FDA said it will begin revising acetaminophen safety labels and issue a letter to physicians. The agency emphasized that while some studies have noted an association, no causal link to autism has been proven, and decisions about Tylenol use remain with parents.

Tylenol’s manufacturer, Kenvue, strongly rejected any claim that acetaminophen causes autism, warning that misinformation could endanger pregnant women. “Acetaminophen is the safest pain reliever option for pregnant women throughout their entire pregnancy,” the company said, adding that untreated fever and severe pain can pose serious risks to both mother and baby.

Kenvue also urged expectant mothers to consult healthcare professionals before using any over-the-counter medication.