Real-world data spotlights vaccine impact amid US policy rollback

A maternal RSV immunisation program has cut the risk of severe RSV-related hospitalisation among Australian infants by nearly half, according to newly published real-world data that provides evidence of the program’s public health impact.

The findings from the STREETON study, a Pfizer-sponsored real-world effectiveness study, included more than 1,000 infants aged six months or younger across nine Australian hospitals during the country’s year-round maternal RSV immunisation program.

The study revealed that maternal RSV immunisation from 28 weeks’ gestation was associated with 77.8% effectiveness against RSV lower respiratory tract disease (LRTD) hospitalisation in infants up to six months of age. Effectiveness rose to 86.3% against RSV-LRTD hospitalisation among infants up to two months of age.

The findings also pointed to a difference in disease severity among hospitalised infants. Of infants admitted with acute respiratory illness, 32% born to RSV-unvaccinated mothers had severe LRTD, compared with 17% of those born to RSV-vaccinated mothers.

Dr Krishan Thiru, Pfizer ANZ Medical Director, said the findings provided important Australian evidence of the role maternal immunisation can play in protecting infants during one of the most vulnerable stages of early life.

“The first few months of life represent the period of highest risk for severe RSV disease,” Dr Thiru said. “These Australian real-world findings add to growing evidence that maternal RSV immunisation can play an important role in helping reduce RSV-related hospitalisation in young infants.”

The STREETON study results build on evidence from the Phase 3 MATISSE clinical trial, adding to the growing body of data supporting maternal immunisation as a strategy for helping protect infants from serious RSV disease during their first months of life.

The findings emerge, however, against a backdrop of intensifying international debate over childhood vaccination.

In the United States, President Donald Trump has recently signed an Executive Order on Gold Standard Childhood Vaccine Recommendations, which is intended to “maximise parental choice”. Under the Order, RSV vaccines are no longer universally recommended for all children, alongside changes affecting recommendations for vaccines against hepatitis A, hepatitis B, rotavirus, meningococcal disease, influenza and COVID-19.

The repercussions of the increasingly polarised vaccine debate extend beyond the US, with Australia also facing declining vaccine uptake and growing concern that confidence in immunisation is being eroded. The challenge is not limited to practical barriers to accessing vaccines. Questions over the credibility of health officials and the extent to which official recommendations continue to command public trust are increasingly becoming part of the vaccination policy landscape.

The latest survey from the National Centre for Immunisation Research and Surveillance (NCIRS) suggests that acceptance barriers have overtaken practical access issues as the leading reason children are missing or delaying vaccinations.

“Healthcare professionals remain one of the most trusted sources of information for pregnant women. Providing clear, evidence-based information helps women make informed decisions about protecting themselves and their babies,” said Associate Professor Angela Brown, Midwifery Program Director at the Adelaide University.

“Many parents have never heard of RSV until their baby is hospitalised. Awareness of RSV and understanding the risk it can pose to young infants are essential to supporting informed conversations during pregnancy,” she added.

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