The Food and Drug Administration has accepted an application from Pfizer to review its RSV vaccine for pregnant individuals.
“If approved, RSVpreF would help protect infants at their first breath from the devastating effects of this infectious disease, which though well-known, has been particularly evident throughout this RSV season,” said Annaliesa Anderson, chief scientific officer of vaccine research and development for Pfizer.
Pfizer says a large international study found vaccinating moms-to-be was nearly 82% effective at preventing severe cases of RSV in their babies’ most vulnerable first 90 days of life. At age 6 months, the vaccine still was proving 69% effective against serious illness — and there were no signs of safety problems in mothers or babies.
There is currently no vaccine to prevent RSV, which can be serious and even life-threatening for very young children. In the U.S., about 58,000 children younger than 5 are hospitalized for RSV each year and several hundred die from the virus. The FDA is expected to make a determination by August. If approved, this would be the first vaccine for pregnant individuals to protect against RSV.
United States Latest News, United States Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
Pfizer RSV Vaccine That Protects Infants Could Receive FDA Approval This SummerThe single-dose RSV vaccine developed by Pfizer is administered to expectant mothers in the late second-to-third trimester of their pregnancy.
Read more »
Central Texas Food Bank opens new food pantry in South AustinThe food bank says they have had more visitors than usual with many who were once supporting the food bank needing support for the first time.
Read more »
1st RSV vaccine could be approved by August, pending FDA reviewThe FDA will decide whether or not to approve an RSV vaccine designed to protect newborns by August 2023.
Read more »
1st RSV vaccine could be approved by August, pending FDA reviewPfizer's vaccine would be the first RSV vaccine given to pregnant people to protect infants. The company said that there were 'no safety concerns' for vaccinated pregnant participants and their newborns during the trial.
Read more »
1st RSV vaccine could be approved by August, pending FDA reviewPfizer's vaccine would be the first RSV vaccine given to pregnant people to protect infants. The company said that there were 'no safety concerns' for vaccinated pregnant participants and their newborns during the trial.
Read more »
1st RSV vaccine could be approved this summerAfter decades of research, a first-of-its kind vaccine designed to protect newborns against RSV, or respiratory syncytial virus, could be approved by August.
Read more »