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US announces major overhaul of childhood vaccines

AMERICAN health officials have outlined sweeping changes to the national childhood immunisation schedule. The changes create a new framework that keeps all recommended vaccines available and fully covered while moving several vaccines into a category designed to emphasise shared decision-making between families and clinicians.

The recommendations reduce the number of vaccines recommended as routine for all children to 11 from 17, a move the New York Times called a ‘seismic shift’ in federal vaccine policy.

Mary Holland, chief executive of Children’s Health Defense, called the change ‘the most significant change in US vaccination policy in recent history’.

Robert F Kennedy Jr’s Department of Health and Human Services (HHS) said the change follows a directive from President Trump, who issued a presidential memorandum on December 5 instructing the agency and the Centers for Disease Control and Prevention (CDC) to review whether other developed nations protect children more effectively.

After what HHS described as a ‘comprehensive, evidence-based assessment’, the department concluded that the US recommends more routine childhood vaccine doses than peer countries without achieving higher vaccination rates or greater public trust.d.

RFK Jr said: ‘President Trump directed us to examine how other developed nations protect their children and to take action if they are doing better. After an exhaustive review of the evidence, we are aligning the US childhood vaccine schedule with international consensus while strengthening transparency and informed consent. This decision protects children, respects families, and rebuilds trust in public health.’

Federal health officials emphasised that no vaccine is being banned or removed, and that families will not lose access to any immunisations. Every vaccine recommended by the CDC will remain available and fully covered by insurance without cost sharing, the agency said.

The childhood schedule will now be structured into three categories:

·         Immunisations recommended for all children;

·         Immunisations recommended for certain high-risk groups;

·         Immunisations based on shared clinical decision-making.

Under the updated schedule, vaccines protecting against what HHS called the ‘most serious childhood diseases’ will remain recommended for all children. These include vaccines for measles-mumps-rubella (MMR), polio, pertussis, tetanus, diphtheria, haemophilus influenzae type B (Hib), pneumococcal disease, human papillomavirus (HPV) and varicella (chickenpox).

Recommendations for high-risk groups will remain unchanged, officials said.

The biggest change involves vaccines that fall under shared clinical decision-making. HHS said four vaccines — hepatitis A, influenza, meningococcal ACWY and rotavirus — have been added to that category, bringing the total to seven. Three vaccines were already listed in the shared clinical decision-making category: hepatitis B, Covid-19, and meningococcal B.

Shared decision-making ‘strengthens — not weakens — vaccination’, according to HHS. A spokesman said: ‘Shared clinical decision-making doesn’t leave parents on their own. It strengthens the doctor-patient relationship, respects informed consent, and allows recommendations to reflect individual risk while preserving access to every vaccine.’

The announcement cited concerns about public trust in healthcare institutions between 2020 and 2024, along with declining childhood vaccination rates and the increased risk of vaccine-preventable diseases.

From the school years 2019-2020 to 2023-2024, national coverage for the MMR vaccine dropped from 95.2 per cent to 92.7 per cent, according to HHS. Sixteen states now report MMR coverage below 90 per cent.

The agency contrasted the US policy of mandating a higher number of vaccines with policies of other developed nations, which ‘maintain high vaccination rates through public trust and education rather than mandates’, according to the press release. In 2024, the US recommended more childhood vaccines than any peer nation, and more than twice as many doses as some European nations.

‘Public health works only when people trust it,’ said US Food and Drug Commissioner Marty Makary. ‘That trust depends on transparency, rigorous science, and respect for families. This decision recommits HHS to all three.’

Senior health officials said in a call with reporters that ‘unknown risks’ of vaccination and limited safety data on vaccination informed their decision, STAT reported.

HHS pointed to gaps in ‘gold standard’ vaccine evidence, including placebo-controlled randomised trials and long-term observational studies to better characterise vaccine benefits, risks and outcomes. ‘Vaccines are effective public-health tools, but no medical intervention is risk-free,’ the agency said in a statement.

The department said the overall childhood schedule has ‘never been comprehensively evaluated as a whole’, in spite of repeated calls from the Institute of Medicine to do so.

HHS said it will fund and conduct research, including placebo-controlled randomised clinical trials and long-term observational cohort studies.

This article appeared in the Defender on January 5, 2026, and is republished by kind permission.

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