In a significant shift, the Centers for Disease Control and Prevention (CDC) is reducing the number of vaccines routinely recommended for all children, from 17 to 11. This change affects vaccines for conditions such as rotavirus, hepatitis A and B, meningitis, and seasonal flu, which are now only recommended for high-risk individuals or through “shared decision-making” with healthcare providers.

The administration, led by Health Secretary Robert F. Kennedy Jr., who has long questioned vaccine safety and effectiveness, initiated this overhaul after a presidential memorandum directed the Department of Health and Human Services (HHS) and the CDC to compare the U.S. vaccine schedule to those of other developed countries. The assessment, conducted by HHS officials, concluded that the U.S. schedule should be aligned with “international consensus.”

The changes were made without formal public input or input from vaccine manufacturers, a move criticized as “radical and dangerous” by experts, who warn it will sow doubt and confusion among parents, potentially putting children’s lives at risk. HHS officials cited declining vaccine uptake, including for measles, as evidence of waning public trust, and stated the changes aim to restore confidence.

While no vaccines were removed from the schedule, their recommended status was altered. HHS also announced plans for long-term, placebo-controlled trials to study vaccine timing and effects, though details on the cost and timeline were not provided.

This significant policy shift, undertaken without standard stakeholder input, has raised concerns about its potential impact on public health and vaccine acceptance.

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The post CDC Slashes Number of Vaccines Recommended for Kids first appeared on FDA Learning Cache.

The Centers for Disease Control and Prevention (CDC) has updated the language on its webpage regarding the link between vaccines and autism. The new language suggests that the possibility of a link between infant vaccines and autism has not been ruled out, and that the Department of Health and Human Services (HHS) has launched a “comprehensive assessment” to examine the causes of autism.

This change in message has been criticized by pediatricians, vaccine experts, and the Autism Science Foundation, who argue that autism is one of the most studied childhood conditions and that no credible research has ever suggested a link between it and vaccines. The Autism Science Foundation has described the change as “anti-vaccine rhetoric and outright lies about vaccines and autism,” and has expressed concern that it will cause fear in parents and lead to them withholding vaccines, putting their children at risk of contracting and potentially dying from vaccine-preventable diseases.

It remains unclear who made the changes to the CDC webpage and from where the new information originated. The HHS has stated that the website had been updated “to reflect gold standard, evidence-based science,” but has not provided a clear definition of what it considers to be such science.

The change in message on the CDC webpage is concerning, as it could potentially undermine public confidence in the safety and efficacy of vaccines, which are a critical tool in protecting public health.

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The post Without Evidence, CDC Changes Messaging on Vaccines and Autism first appeared on FDA Learning Cache.

The head of the FDA’s drug center, Dr. George Tidmarsh, abruptly resigned on Sunday after federal officials began reviewing “serious concerns about his personal conduct.” Tidmarsh, who was appointed to the position in July, was placed on leave on Friday after the Department of Health and Human Services’ Office of General Counsel was notified of the issues.

Tidmarsh’s departure came the same day that a drugmaker, Aurinia Pharmaceuticals, filed a lawsuit alleging that he made “false and defamatory statements” about the company during his time at the FDA. The lawsuit claims Tidmarsh used his position to pursue a “longstanding personal vendetta” against the chair of Aurinia’s board, Kevin Tang, who had previously been involved in Tidmarsh’s ouster from other companies.

Tidmarsh, who had a long career in the pharmaceutical and biotech industries, was recruited to join the FDA over the summer. His resignation is the latest in a series of leadership changes at the agency, which has faced firings, departures, and controversial decisions in recent months. The FDA’s drug center, which Tidmarsh oversaw, has also lost over 1,000 staffers in the past year.

The lawsuit against Tidmarsh alleges that he made unusual public comments about one of Aurinia’s products, causing a significant drop in the company’s stock price. It also claims he used his FDA position to target a thyroid drug made by another company where Tang serves as board chair.

Overall, Tidmarsh’s abrupt resignation and the allegations against him highlight the ongoing turmoil and leadership challenges facing the FDA.

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The post FDA CDER Director Resigns After Officials probe ‘Serious Concerns’ About His Conduct first appeared on FDA Learning Cache.

During a press conference, President Trump made several inaccurate claims about Tylenol, autism, and vaccines. Trump claimed that Tylenol use during pregnancy is linked to increased autism risk, contradicting medical evidence. He also falsely stated that Amish children do not get autism because they do not get vaccines, when in fact autism has been diagnosed in Amish communities.

Trump further claimed that children receive 80 “horse-sized” vaccine doses, when in reality the recommended vaccine schedule is around 30 doses. He suggested Tylenol causes autism in young children, but studies have found no such link. Trump also wrongly claimed there is “no reason” to vaccinate newborns against hepatitis B, even though this vaccine protects infants from a serious, contagious disease.

Experts firmly refuted Trump’s statements, noting there is no evidence that Tylenol causes autism, and that the childhood vaccine schedule is scientifically-based to protect kids at vulnerable stages of development. They emphasized that delaying or spacing out vaccines leaves children unprotected against dangerous illnesses. Overall, the text highlights how Trump made numerous inaccurate, medically unsupported claims about Tylenol, autism, and vaccines during the press conference.

Article Excerpt:

“Pediatricians know firsthand that children’s immune systems perform better after vaccination against serious, contagious diseases like polio, measles, whooping cough and Hepatitis B. Spacing out or delaying vaccines means children will not have immunity against these diseases at times when they are most at risk,” Dr. Susan Kressly, the president of the American Academy of Pediatrics, said in a statement.

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The post Fact-checking President Donald Trump’s Claims About Autism first appeared on FDA Learning Cache.

The Food and Drug Administration (FDA) has announced that it will be modifying the label of the drug leucovorin, or folinic acid, to make it available for children with autism. Leucovorin is a modified version of vitamin B9, or folate, which is essential for cell growth and development.

Studies suggest that some individuals with autism may have antibodies that interfere with how folate is transported in the body, leading to a condition called cerebral folate deficiency. This can result in symptoms like speech difficulties, intellectual disabilities, and seizures, typically appearing around age 2.

The FDA’s decision is based on a review of studies from 2009 to 2024, which found that leucovorin can “improve certain symptoms” of cerebral folate deficiency. One study compared 40 people on the medication to 40 on a placebo, with those taking leucovorin showing “substantial improvement” in their symptoms.

While not a cure, some children with autism who have received folinic acid have seen significant improvements in their receptive and expressive language skills, particularly those with the folate transport-blocking antibodies. However, the drug does not work for all children with autism.

Experts caution that larger, placebo-controlled studies are needed to determine who would benefit from leucovorin and at what dosage. They also warn against viewing the drug as a potential cure or preventative measure for autism, as the data is still limited.

Leucovorin is currently approved by the FDA for treating the side effects of certain chemotherapy drugs and megaloblastic anemia. Its side effects are generally minimal, as it is derived from a water-soluble vitamin.

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The post FDA To Change Leucovorin Label to Reflect Potential Benefits in Treating Autism first appeared on FDA Learning Cache.

U.S. Health Secretary Robert F. Kennedy Jr. faced intense bipartisan scrutiny at a Senate committee hearing as he defended his efforts to roll back COVID-19 vaccine recommendations and explained the turmoil he has created at federal health agencies. Kennedy claimed the fired CDC director was untrustworthy, stood by his anti-vaccine rhetoric, and disputed reports of people struggling to get COVID-19 shots.

Medical groups and Democrats called for Kennedy’s dismissal, and his exchanges with senators frequently devolved into shouting matches. Some Republican senators also expressed unease with his changes to COVID-19 policies, noting his conflicting views on the safety and use of the mRNA vaccines developed through Operation Warp Speed.

Kennedy accused CDC leaders who left the agency of deserving to be fired, criticizing the agency’s pandemic response and claiming they “failed to do anything about the disease itself.” Democrats accused him of stacking a vaccines advisory committee with “skeptics and conspiracy theorists.”

The ousted CDC director accused Kennedy of trying to weaken public health protections, though he denied making such demands. Kennedy engaged in heated exchanges with numerous senators, dismissing their questions and concerns.

Kennedy has voiced distrust of research showing the COVID-19 vaccines saved lives and said federal health policy would be based on “gold standard science,” though he admitted he wouldn’t wait for studies to be completed before taking action. Medical groups have condemned Kennedy’s policies, warning they will drive up rates of vaccine-preventable diseases.

Article Excerpt:

A number of medical groups say Kennedy can’t be counted on to make decisions based on robust medical evidence. In a statement Wednesday, the Infectious Diseases Society of America and 20 other medical and public health organizations issued a joint statement calling on him to resign.

“Our country needs leadership that will promote open, honest dialogue, not disregard decades of lifesaving science, spread misinformation, reverse medical progress and decimate programs that keep us safe,” the statement said.

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The post Kennedy Tries to Defend COVID-19 Vaccine Stance in Raucous Senate Hearing first appeared on FDA Learning Cache.

This week’s FDA update includes several significant developments. First, the director of the CDC, Susan Monarez, was fired by President Trump after refusing to resign under pressure from Health and Human Services Secretary Robert Kennedy Jr. Several other top CDC officials also resigned in response. This has led to calls for an investigation into Monarez’s firing, as well as demands for Kennedy’s own dismissal.

The FDA has accepted a proposal to develop a new biomarker for non-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), which could provide a non-invasive way to assess liver health. Additionally, the agency has extended its Chemistry, Manufacturing, and Controls (CMC) pilot program for another year, aimed at expediting the development of investigational new drugs.

The FDA has also published a study finding that common use of cannabidiol (CBD) products may lead to elevated liver enzymes in healthy adults. Meanwhile, the agency has withdrawn its approval for Amylyx Pharmaceuticals’ Relyvrio drug to treat amyotrophic lateral sclerosis (ALS) at the company’s request.

In the medical device space, the FDA has issued warnings about the risks associated with hyperbaric oxygen therapy devices, and initiated several Class I recalls for infusion systems and ventilators due to potential safety issues.

The text also covers upcoming FDA events, including a workshop on patient-focused drug development and a hearing on the Trump administration’s healthcare agenda featuring HHS Secretary Kennedy.

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The post This Week at FDA: CDC Director Fired, FDA Advances New MASH Tool, CMC Pilot Extended first appeared on FDA Learning Cache.

The Trump administration is urging West Virginia to offer religious exemptions from school vaccine mandates, alarming public health advocates. West Virginia is one of five states that do not allow any nonmedical exemptions. The U.S. Department of Health and Human Services (HHS) has sent a letter to West Virginia officials warning that the state may be violating civil rights laws by not offering religious exemptions.

HHS Secretary Robert F. Kennedy Jr., a critic of vaccine mandates, has voiced support for the governor’s efforts to allow religious exemptions. Anti-vaccine organizations have praised HHS’s involvement, seeing it as a sign that the federal government may target other states with strict vaccine mandates next.

Public health experts argue that the administration’s approach is unprecedented and could undermine effective immunization strategies. They warn that the expansion of vaccine mandate exemptions would have dire consequences, leading to an increase in vaccine-preventable illnesses.

The HHS letter was meant to remind West Virginia of its obligations for participating in a federal vaccine program, but some see it as political posturing. The federal agency denies that it is trying to weaken school immunization requirements, claiming it is about protecting conscience and religious freedom rights.

The battle over vaccine exemptions in West Virginia is ongoing, with the GOP-controlled state House rejecting a bill that would have made religious exemptions part of state law, and the state Board of Education unanimously maintaining that it will not offer such exemptions.

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The post RFK Jr. Targets West Virginia School Vaccine Mandate Laws first appeared on FDA Learning Cache.

The FDA has approved new coronavirus vaccines from Pfizer, Moderna, and Novavax, but has limited their use to “higher risk” individuals, rather than providing them routinely to all Americans as in previous years. This decision has sparked uncertainty, as it’s unclear who exactly will be considered high-risk and able to access the shots.

The vaccines will begin shipping in the coming days and weeks, with Moderna and Pfizer’s mRNA vaccines available first, followed by Novavax’s non-mRNA option in the early fall. However, public health experts say the narrowed approval creates questions around insurance coverage and access at local pharmacies for those not deemed high-risk.

Past administrations had recommended vaccines for all Americans 6 months and older, but the current administration is taking a more targeted approach, citing insufficient data to justify sweeping recommendations. This shift means doctors and pharmacists may be hesitant to provide the shots off-label to those not explicitly approved.

The CDC’s advisory committee is expected to meet in mid-September to discuss the coronavirus vaccine, but its membership has been overhauled, raising further uncertainty. Major medical associations, including the AAP and ACOG, have criticized the FDA’s decision, arguing it creates dangerous vulnerabilities, especially for children and pregnant women.

Overall, the narrowed approval injects significant uncertainty around who will be able to access the updated coronavirus vaccines and whether they will be covered by insurance, potentially leaving many Americans without the protection.

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The post FDA Limits Approval for New Coronavirus Vaccines to High-Risk People first appeared on FDA Learning Cache.

The White House has fired Susan Monarez as the director of the Centers for Disease Control and Prevention (CDC) after she refused to resign amid pressure to change vaccine policy. Monarez’s lawyers accused the Health and Human Services (HHS) Secretary, Robert F. Kennedy Jr., of “weaponizing public health for political gain” and “putting millions of American lives at risk” by purging health officials from the government.

The firing comes after Monarez declined to support rescinding certain approvals for coronavirus vaccines, as demanded by Kennedy, who has a long history of anti-vaccine advocacy. Monarez refused to commit to changing vaccine policy without consulting her advisers, which prompted Kennedy to urge her to resign.

The leadership disruption at the CDC follows months of chaos, including budget cuts, the termination of hundreds of employees, and an attack on its Atlanta headquarters. After news of efforts to oust Monarez, at least three top CDC officials announced their resignations, citing lost funding, the political climate, and a broader attack on public health.

Public health advocates had hoped Monarez would be a check on Kennedy and block him from limiting access to vaccines. However, the White House has now formally fired Monarez, accusing her of not being aligned with the President’s “Making America Healthy Again” agenda.

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The post White House Fires CDC Director Who Says RFK Jr. is ‘weaponizing public health’ first appeared on FDA Learning Cache.