CDC reverses stance on Covid-19 vaccination for healthy children amid safety concerns and policy split with FDA

The CDC has quietly expanded Covid-19 vaccine recommendations to include healthy children and young adults, reversing previous guidance and sparking debate over safety and regulatory authority amid a wider international shift towards more risk-based vaccination policies.

The Centres for Disease Control and Prevention has quietly restored a broad Covid-19 vaccine recommendation that reaches healthy babies, children and young adults, even though the Food and Drug Administration has narrowed approval for younger people to those considered at higher risk of severe illness. According to the CDC’s updated clinical guidance, published on September 23, the 2026-2027 shot is recommended for all adults aged 18 and over, and for children aged six months to 17 years through shared clinical decision-making unless they are moderately to severely immunocompromised. The agency also acknowledges that vaccinating people aged six months to 64 years who do not have at least one underlying high-risk condition is an off-label use.

The change marks a reversal from the CDC’s November 2025 approach, when it shifted to what it called individual-based decision-making. That earlier guidance said the risk-benefit balance was most favourable for people already at increased risk and least favourable for those who were not. The CDC now says the latest schedule reflects recommendations first set out in July 2025, and it attributes the continuation of those recommendations to legal uncertainties and questions surrounding the federal vaccine advisory process.

The tension between the CDC and FDA is especially stark for younger children. The FDA’s current authorisations for updated Covid shots are limited for people under 65 and, for younger adults and children, generally apply only to those with qualifying medical conditions such as cancer, heart, kidney or lung disease, diabetes, obesity, depression and other mood disorders, HIV, Down syndrome, physical inactivity, or recent pregnancy. Yet the CDC’s own schedule now points clinicians towards vaccination for healthy infants and children as well, creating a federal split between approval and recommendation. The agency also continues to provide public guidance on finding vaccine providers, including doctors, pharmacies and local health departments.

Safety concerns remain central to the dispute. In June 2025, the FDA strengthened warnings for Pfizer’s Comirnaty and Moderna’s Spikevax over myocarditis and pericarditis, saying the highest observed risk was among males aged 12 to 24 and estimating about 27 cases per million doses in that group after the 2023-2024 formulation. The agency also said follow-up imaging showed some signs of heart injury could persist for months. Later, in an internal memo reported in November 2025, then-FDA vaccine official Vinay Prasad said staff had reviewed 96 reported paediatric deaths and judged at least 10 to be related to Covid vaccination under possible, probable or likely classifications. He also said regulators lacked reliable data showing the absolute benefit of vaccination against severe disease and death in healthy children.

The policy shift also sits uneasily beside the administration’s public language about informed consent and international alignment. Robert F. Kennedy Jr. has said the government was bringing the US childhood schedule into line with international consensus while improving transparency, but much of Europe has moved towards a much narrower risk-based approach, generally reserving Covid vaccination for older people and those with higher medical risk. In the United Kingdom, Denmark, Norway, Sweden, Germany and the Netherlands, healthy children are typically not included in routine recommendations. The dispute has become increasingly political as well as medical: a September 18 open letter to Kennedy and Donald Trump, signed by more than 160 physicians, scientists, researchers, activists and public figures, said more than 50 million Americans could receive mRNA Covid shots this year, including seven million children, and called for the products to be removed from the market.