- Pfizer’s vaccine for respiratory syncytial virus has gained the backing of the European Medicines Agency, which on Thursday recommended approval of the shot for use during pregnancy as well as in older adults.
- The vaccine, named Abrysvo, won U.S. approval in May for adults 60 years and older, following GSK’s competing shot to market there. The EMA’s opinion now goes to the European Commission, which has the final say on the marketing authorization of medicines.
- Pfizer’s shot is still under review in the U.S. for use in pregnant people, with a decision from the Food and Drug Administration expected by August. Maternal immunization is meant to pass on protection to newborn infants, who are at particular risk from infections by respiratory syncytial virus, or RSV.
Adults over the age of 60 now have two RSV vaccines to choose from in the U.S. and Europe. A new antibody treatment is available to prevent infants from infections, too.
So far, Pfizer is the only drugmaker to reach regulators with a candidate for use in pregnant people, which could give another option for protecting newborns. GSK, which won approval of its RSV vaccine in older adults, was also testing a candidate in pregnant women up until last year, when it halted testing for a safety review.
While RSV infections are typically mild, the virus can lead to severe disease and hospitalization in older adults and infants.
Trial results for Pfizer’s maternal candidate, published in The New England Journal of Medicine, showed that vaccination protected infants from medically attended severe RSV-associated lower respiratory tract illness. However, the shot did not meet another study goal assessing how well it protected against RSV-associated illness more broadly.
There were no major safety concerns, with local side effects like headaches, muscle pain and injection site pain the most commonly reported reactions.
In May, a panel of Food and Drug Administration advisers backed Pfizer’s shot for maternal use with a 14-0 vote endorsing its effectiveness. The same group voted 10-4 in favor of the vaccine’s safety.
The FDA is set to make a decision on approval by August, while the European Commission typically makes a decision on EMA recommendations in about two months.