Pfizer announced promising results from a Phase 3 study of its respiratory syncytial virus (RSV) vaccine, ABRYSVO. The study assessed the vaccine’s immunogenicity and safety in adults aged 18 to 59 at high risk of developing severe RSV-associated illness.
• ABRYSVO met its primary immunogenicity and safety endpoints.
• The vaccine demonstrated a robust immune response in the target population.
• The safety profile was favorable, with no significant concerns identified.
RSV is a common respiratory virus that can cause severe illness in certain individuals, including those with underlying health conditions. Currently, no RSV vaccines are approved for adults aged 18 to 59.
Pfizer plans to submit the data to regulatory agencies for expansion of the vaccine’s age indication to 18 years and older. This would address a significant unmet need for protecting vulnerable adults from RSV.
The MONeT trial (NCT05842967) randomized 681 adults aged 18 to 59 with chronic conditions to receive ABRYSVO or placebo. The study also enrolled approximately 200 immunocompromised adults who received two doses of ABRYSVO.
“These results provide evidence that ABRYSVO can help protect adults with increased risk against RSV-associated illness,” said Annaliesa Anderson, Head of Vaccine Research and Development at Pfizer. “We are excited to potentially bring this vaccine to market, providing the first and only RSV vaccine for adults 18 years and older.”
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
