Pfizer's Abrysvo Hits Key Goals in Adults at Increased RSV Risk

By Colin Kellaher

Pfizer's Abrysvo vaccine for respiratory syncytial virus, or RSV, has met the key goals of a late-stage study in adults who are at increased risk of developing severe illness related to the virus.

Pfizer on Tuesday said the Phase 3 study evaluating a single dose of Abrysvo versus placebo in adults 18 to 59 years of age who are at risk of developing severe RSV-associated lower respiratory tract disease met its co-primary immunogenicity endpoints as well as its primary safety endpoint.

Pfizer said adults with certain underlying chronic conditions, such as asthma, diabetes and chronic obstructive pulmonary disease. are at increased risk of developing and being hospitalized for RSV-associated illness.

The U.S. Food and Drug Administration last year approved Abrysvo for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older and to help protect infants at birth through six months of life from lower respiratory tract disease due to RSV by active immunization of pregnant women.

New York drugmaker Pfizer on Tuesday said it plans to submit the new study data to regulatory agencies and to request expansion of the Abrysvo age group from the current indication to include adults 18 years of age and older.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

04-09-24 0659ET