LONDON — European regulators on Friday recommended approval of Pfizer’s RSV vaccine, both for older adults and for use during pregnancy, which could extend protection against the common respiratory virus to newborns.
The Pfizer vaccine, called Abrysvo, has already been approved in the United States for people aged 60 and older. The Food and Drug Administration will decide next month on its use for pregnant people.
RSV is a common virus that usually only causes the common cold, but it can cause serious illness in infants and older adults and is a leading cause of hospitalizations in children. The strategy of vaccinating people during pregnancy focuses on providing so-called passive immunization to babies from birth to 6 months of age.
The positive recommendation from a committee of the European Medicines Agency now goes to the European Commission for a final decision. The committee usually follows EMA guidelines on whether or not to approve medicines and vaccines. If the vaccine is approved, Pfizer will have to negotiate pricing and reimbursement agreements with European Union member states before countries can start offering it to pregnant people and adults age 60 and older.
“If approved, our candidate RSV vaccine for pregnant individuals would help protect infants from birth through 6 months of age, when they are most at risk for serious RSV disease and complications,” Annaliesa Anderson, Pfizer’s chief scientific officer for vaccine research and development, said in a statement. “This, together with an approval for older adults, would represent a meaningful public health advancement for the prevention of RSV disease across Europe.”
The Pfizer vaccine would be the second in the European market for use in older adults. Last monththe committee approved GSK’s RSV vaccine, Arexvy also has US approval.
In Europe, RSV hospitalises more than 270,000 older adults each year and causes some 20,000 deaths.
While the vaccine would be the first available immunization designed to protect newborns, there is another option. The European Union last year approved a monoclonal antibody called Beyfortus from AstraZeneca and Sanofi to be administered via injection to babies during their first RSV season. Beyfortus Won FDA approval earlier this week.
The EMA statement Friday in support of Abrysvo’s approval does not address how the vaccine should be used given the availability of Beyfortus. An analysis conducted by the U.S. Centers for Disease Control and Prevention and University of Michigan health economists showed that there is little additional benefit to giving Beyfortus to a full-term baby whose mother received the Pfizer maternal vaccine. However, doing so may increase costs.