Health officials in the United States are moving to limit access to a highly effective vaccine against respiratory syncytial virus (RSV) for infants, a decision that directly contradicts mounting evidence of the jab's dramatic success in preventing severe illness.
Policy Shift Defies Clinical Data
Last week, the Trump administration, led by Health Secretary Robert F Kennedy Jr., announced new restrictions covering one-third of all routine childhood immunisations. This includes recommending the RSV shot only for babies deemed high-risk, rather than for all infants. This policy shift comes as four separate studies published in the Journal of the American Medical Association (JAMA) confirm the vaccine's significant impact.
The research shows the monoclonal antibody shot given to newborns is 81% effective at preventing RSV-related hospitalisation. A separate study found the maternal vaccine given during pregnancy is 70% effective. Prior to the shots' approval in 2023, between 2% and 3% of all US infants were hospitalised with RSV each year.
"It's easy to see in real life. We can really tell that hospitalisations are down," said Professor Richard Rupp of the University of Texas Medical Branch, who was involved in the vaccine trials. "It's made a big difference." He described RSV as "a horrible disease" that can rapidly turn a mild cold into a life-threatening struggle for breath.
Universal Healthcare Gap Fuels US Decision
The administration's rationale cites policies in the UK, Australia, and Denmark, which also recommend the shot only for high-risk newborns. However, experts point to a critical difference: those nations all recommend and provide the RSV vaccine during pregnancy through their universal healthcare systems.
In the fragmented US healthcare landscape, only about one-third of pregnant people receive the maternal shot, according to the Centers for Disease Control and Prevention (CDC). This low uptake leaves a vast majority of newborns unprotected without the infant shot.
Kevin Ault, an obstetrician-gynecologist and former member of the CDC's RSV working group, criticised the new restriction. "The vast majority, 81%, of babies hospitalised with RSV have no underlying conditions," he said. Targeting only children with existing health issues will "miss a large majority of the potential cases".
Safety Concerns and Access Fears
The decision appears rooted in claims from Tracy Beth Høeg, the new top drugs regulator at the US Food and Drug Administration (FDA). She suggested a higher death rate in clinical trials, while acknowledging the finding was not statistically significant. The FDA has launched a safety investigation.
Dr. Ault dismissed these concerns, explaining the three deaths in trials occurred "months and months after the vaccine, and they were due to things like dehydration". The shots have since been given to millions of infants with no known safety issues.
Experts now fear the restrictions will create confusion and erode access. More than half of US children receive vaccines through the federal Vaccines for Children programme. While officials say the RSV shot will remain covered for high-risk infants, doctors worry coverage could change abruptly.
Furthermore, the vague definition of "high-risk" is problematic. "There's no defined 'high risk'," said Dr. Ault. Both he and Professor Rupp argue that simply being an infant in the first few months of life constitutes high risk for RSV.
The policy leaves hospitals and paediatricians scrambling during the current RSV season to interpret the new rules, likely leading to a breakdown in coordination. Dr. Ault warned the decision was "made by political appointees without a scientific basis" and risks a surge in preventable hospitalisations this winter.
