EU regulator backs Pfizer’s RSV vaccine for infants, older adults

(Reuters) -The European Union’s health regulator on Friday backed authorization of Pfizer (NYSE:)’s vaccine for respiratory syncytial virus (RSV) for use in babies and older adults.

If the European Commission authorizes its use, the shot, called Abrysvo, could become the bloc’s first to protect infants up to six months of age from the virus when given to pregnant women.

The commission last month approved the region’s first RSV vaccine, branded Arexvy, from rival GSK for older people.

RSV typically causes mild, cold-like symptoms, but is a leading cause of pneumonia in toddlers and the elderly, causing thousands of hospitalizations and deaths each year.

Pfizer and GSK’s shots are already approved in the United States for protection against RSV in older adults, making them the frontrunners in a market estimated to cross $10 billion by 2030. The U.S. health regulator is expected to decide on the use of Pfizer’s vaccine in pregnant women by August.

Data from Pfizer’s late-stage study for maternal use of the vaccine had shown the shot was 82% effective in preventing severe infections in infants when given to expecting mothers in the second half of their pregnancy.

The vaccine was nearly 67% effective for those aged 60 and older with two or more symptoms of RSV, and 85.7% against severe illness defined by three or more symptoms in a late-stage trial.

The European Medicines Agency’s recommendations are usually taken into consideration by the European Commission for its final decision on drug or vaccine approvals.

Sanofi (NASDAQ:) and partner AstraZeneca (NASDAQ:)’s long-acting therapy against RSV infections was approved last year by the European Commission for use in infants.