PHILADELPHIA, PA — GSK plc (LSE/NYSE: GSK) announced new real-world effectiveness data for its RSV vaccine, AREXVY, showing an association with reduced RSV-related hospitalizations in adults 60 and older.
AREXVY is approved for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults 60 and older and in adults 50 to 59 at increased risk.
In a U.S. retrospective cohort study of more than 2.5 million adults age 60 and older, including 520,440 vaccinated individuals matched to more than 2 million unvaccinated individuals, the vaccine was associated with 75.6% effectiveness against RSV-related hospitalization at a median follow-up of 5.6 months.
The study reported 95 RSV-related hospitalizations among vaccinated individuals compared with 1,419 among unvaccinated participants, with a 95% confidence interval of 69.8% to 80.2%.
Exploratory analyses found an association with 63.1% effectiveness against major adverse cardiovascular events, including heart attack and stroke, during RSV-related hospitalization. The study also reported associations with 74.4% effectiveness against severe COPD flare-ups and 61.6% effectiveness against severe asthma flare-ups during RSV-related hospitalization.
In a separate nationwide cohort study in Denmark of COPD patients age 60 and older, the vaccine was associated with 100% effectiveness against RSV-related hospitalization, with no hospitalizations reported among 7,448 vaccinated individuals compared with 115 among 89,376 unvaccinated individuals. The reported 95% confidence interval ranged from 71.1% to 100%.
GSK said observational studies cannot establish causation but add to evidence on potential reductions in RSV-related complications.
Deepak L. Bhatt, director of Mount Sinai Fuster Heart Hospital, said the findings suggest RSV vaccination “could help reduce the risk of certain serious RSV-related outcomes.”
Christian Felter, GSK’s global medical lead for RSV, said the data show an association with reduced RSV-related hospitalization and acute events in chronic conditions.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.