The U.S. FDA has approved Pfizer’s bivalent RSV vaccine, Abrysvo, for the prevention of lower respiratory tract disease in individuals aged 60 years and older.
The vaccine’s approval hinged on data from the phase 3 trial RENOIR, a global, randomized, double-blind, placebo-controlled study that enrolled approximately 37,000 patients. Trial data demonstrated that the jab was effective in preventing RSV-related respiratory illnesses, showing efficacy rates of 66.7% and 85.7% for cases with different symptom severities.It also demonstrated a 62.1% efficacy in preventing RSV-associated acute respiratory illness with adverse events and serious adverse events were reported at comparable rates in both groups.
The agency’s decision comes just a few weeks after one of its advisory committees voted to back the vaccine's use by maternal patients to protect infants younger than 6 months.
Abrysvo is now the second RSV jab to be approved in the United States. In one of the most anticipated regulatory decisions of the year, last month, the FDA gave the OK to GSK’s Arexvy in individuals 60 years of age and older, marking the first-ever RSV vaccine for older adults to be approved globally.