RSV vaccines safe and effective, Cochrane review finds
A new Cochrane review demonstrates that vaccines for respiratory syncytial virus (RSV) are both safe and effective in protecting vulnerable groups that are most at risk of serious illness, including older adults and infants.
RSV is a common virus that causes coughs and colds but can also lead to life-threatening lung infections like pneumonia. Children under the age of two are at the highest risk of severe RSV infection and death, with older adults also vulnerable.
An international group of researchers analyzed 14 clinical trials with over 100 000 participants, including older adults, pregnant women, women of childbearing age, and children. Trials were conducted across a wide range of countries, spanning all continents.
Results showed strong evidence that the RSV prefusion vaccines in older adults reduce RSV-associated lower respiratory tract (such as pneumonia and bronchitis) disease by 77% and RSV-associated acute respiratory disease (such as the cold) by 67%. Vaccination of pregnant individuals with an RSV F protein-based vaccine reduced the risk of their children needing medical care for RSV-associated lower respiratory tract disease by 54%, reduced the babies’ chance of severe RSV-related disease by 74%, and lowered the risk of hospitalization by 54%.
“From our review of clinical trials, we found high-certainty evidence that RSV vaccines protect older adults and strong evidence they benefit infants when mothers are vaccinated during pregnancy,” said Dr. KM Saif-Ur-Rahman, lead author and Senior Research Methodologist at Evidence Synthesis Ireland and Cochrane Ireland, University of Galway, Ireland. “That’s encouraging news for two of the groups most at risk.”
The review found little to no difference in serious side effects between vaccinated and unvaccinated groups across all age groups.
The findings of this review are based on clinical trial data, as real-world evidence on effectiveness and safety was not yet available at the time of publication.
“It’s important to be clear that our review is based on evidence from randomized trials, the strongest evidence available,” said Kate Olsson, author and vaccine expert from the European Centre for Disease Prevention and Control (ECDC). “Post authorization real-world studies are ongoing and data from those studies will continue to add to what we know about the safety and effectiveness of these RSV vaccines.”
The systematic review is planned to be complemented by two additional analyses on the efficacy, effectiveness, and safety of different RSV vaccines following search updates. ECDC plans to publish the first update with new data in the coming weeks.
Reference:
Saif-Ur-Rahman K, King C, Whelan SO, Blair M, Donohue S, Madden C, Kothari K, Sommer I, Harder T, Dauby N, Moustsen-Helms IR, Ruta S, Frère J, Schönfeld V, Poukka E, Lutsar I, Olsson K, Melidou A, Adel Ali K, Dwan K, Devane D. Efficacy and safety of respiratory syncytial virus vaccines. Cochrane Database of Systematic Reviews 2025, Issue 9. Art. No.: CD016131. DOI: 10.1002/14651858.CD016131.
