Pfizer grabs another breakthrough tag for RSV shot in older adults

Pfizer’s respiratory syncytial virus (RSV) program is piling on the wins. After gaining a breakthrough tag for its maternal vax program earlier this month, the New York pharma has added the same designation for prevention of the virus in older adults.

PF-06482077, or RSVpreF, snagged the FDA tag Thursday to prevent lower respiratory tract infections from RSV in adults aged 60 and over. The designation comes thanks to phase 2a data Pfizer presented on the shot’s safety, immunogenicity and efficacy after a single shot in healthy adults aged 18 to 50.

The company launched a phase 3 clinical trial called RENOIR for the vaccine in September 2021 to look at the same measures in adults over 60.

Breakthrough tags expedite development and review of new drugs or vaccines intended to treat or prevent serious conditions when clinical studies show the candidate marks a substantial improvement over available treatments.

Previously, RSVpreF won the breakthrough tag to prevent lower respiratory tract illness in infants from birth to up to six months via immunization of pregnant women.

The latest regulatory milestone is another leap for Pfizer, which had been competing neck and neck with GlaxoSmithKline, at least until the beginning of this year. But the U.K. rival’s maternal RSV program was put on hold in late February after a potential safety problem cropped up in testing.

AstraZeneca and Sanofi also have a joint candidate, and Johnson & Johnson and Moderna each have RSV vaccines in the works.

The latter recently announced a triple vaccine that would protect against SARS-CoV-2 virus, influenza virus and RSV. The famed biotech also has a phase 1 study underway in children, younger adults, older adults and women of child-bearing age for its RSV-only candidate, mRNA-1345, and a late-stage trial for that RSV shot in adults under 60, according to a Thursday vaccine R&D day presentation.