FDA advisory panel to consider Pfizer's maternal RSV vaccine
PHILADELPHIA (CBS) -- An FDA advisory panel is meeting Thursday night to consider a first-of-its-kind vaccine that could be given to pregnant women in an effort to help protect infants against RSV.
The vaccine could be a big benefit to families and ERs.
RSV fills hospitals with wheezing babies each fall and winter. This past season was especially bad, but doctors said, if this new vaccine is approved, it could be a big benefit.
Pfizer's experimental RSV vaccine would be given in late pregnancy so mothers can pass antibodies onto their babies to protect against the virus.
Pfizer said its research of nearly 7,400 vaccinated mothers found the shot is 82% effective at preventing severe RSV in infants in the first three months of life. That number is 69% at six months.
"RSVpreF maternal immunization demonstrated a satisfactory safety profile in mothers and their infants," said Dr. Bill Gruber, with Pfizer.
Reviewers with the FDA said the vaccine appears to be safe, but there are some questions about a slight difference in premature birth in the two study groups.
"A difference of 1% was noted in premature births, similar to the difference seen in preterm delivery, though not statistically significant," said Dr. Yugenia Hong-Nguyen, an FDA participant. "These findings may be of consideration for further safety evaluation for post-marketing studies."
RSV, which stands for respiratory syncytial virus, can be dangerous -- even deadly for some infants and young children. The CDC estimates about 58,000 to 80,000 children under the age of five are hospitalized due to RSV. Premature babies and infants under six months old are at the highest risk for severe RSV illness.
"Nothing more frightening for parents than the look of their three months old struggling to breathe," said Dr. Eric Simoes, with the University of Colorado, Denver.
The U.S. experienced an unprecedented early and severe surge in RSV cases last fall, putting a significant strain on hospitals. Pfizer predicts up to 16,000 infant hospitalizations could be prevented each year if pregnant women are vaccinated for RSV.
Earlier this month, Glaxosmith Kline's Arexvy became the first RSV vaccine approved for use in the U.S. for people age 60 and older.
