If approved, vaccine would be the first in U.S. to protect babies against leading cause of hospitalization
Advisers to the U.S. Food and Drug Administration voted Thursday in favor of Pfizer’s PFE respiratory syncytial virus vaccine for pregnant people, following extensive debate about its safety.
FDA advisory-committee votes are not binding, but the agency often follows their recommendations. If the FDA ultimately approves the vaccine, called Abrysvo, it would be the first in the U.S. to protect babies against RSV, which is the leading cause of hospitalization for infants under a year old. Pfizer is among several pharmaceutical giants that have been racing to develop RSV vaccines. Earlier this month, the FDA approved GSK’s GSK Arexvy for prevention of RSV in people 60 and older, making it the first RSV vaccine approved for use in the U.S. Pfizer is also working on a RSV vaccine for older adults, with an FDA approval decision expected later this month.
The committee voted unanimously that there was enough data to show that the vaccine is effective. But members were split on a second question about safety, with four of the 14 voting members saying there wasn’t adequate data to support the safety of vaccination with Abrysvo during pregnancy.
South Africa Latest News, South Africa Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA advisers vote in favor of Pfizer maternal RSV vaccineAdvisers to the U.S. Food and Drug Administration voted Thursday in favor of Pfizer’s respiratory syncytial virus vaccine for pregnant people. FDA advisory...
Read more »
Pfizer RSV Vaccine for Infants Has ‘Generally Favorable' Safety Data, FDA Staff SayThe FDA is slated to make a decision on whether to approve Pfizer’s shot in August before respiratory syncytial virus season in the fall.
Read more »
RSV Vaccine: Here’s What To Know As FDA Advisors Consider Approving Pfizer’s ShotFDA analysts have flagged concerns over the risk of preterm birth for the shot, which is given to pregnant people to protect infants from RSV in their first months of life.
Read more »
FDA advisors recommend Pfizer’s RSV vaccine for infants but raise safety concernsThe FDA is slated to make a decision on whether to approve Pfizer's shot in August before respiratory syncytial virus season in the fall.
Read more »
FDA panel to vote on the first RSV vaccine for infants, given to pregnant mothersAn independent advisory committee to the FDA will decide on Thursday whether to recommend an RSV vaccine for infants. If approved, the shot, which is administered to pregnant mothers, would be the first of its kind.
Read more »
FDA panel to vote on the first RSV vaccine for infants, administered to pregnant mothersIf eventually approved, the shot, which is made by Pfizer and administered to pregnant mothers, would be the first RSV vaccine for infants in the U.S.
Read more »