The first-ever vaccine protecting babies from RSV, a respiratory virus that can cause severe symptoms among young children, is now up for federal approval, the manufacturer Pfizer said Tuesday.
The U.S. Food and Drug Administration is expected to make a decision this August after agreeing to review Pfizer’s maternal vaccine, which would be administered to pregnant patients in order to immunize their fetuses before birth, according to the announcement.
“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, a vaccine research and development executive at Pfizer.
“We look forward to progressing the review of Pfizer’s RSV maternal vaccine candidate with the FDA and other regulatory authorities, given its significant potential to positively contribute to global health in the prevention of RSV in infants.”
RSV, or respiratory syncytial virus, accounts annually for about 2.1 million outpatient visits and 58,000 hospitalizations in the U.S. among children age 5 and younger, according to Pfizer. Studies released in November showed Pfizer’s vaccine was nearly 82% effective among newborns during their first 90 days of life and nearly 70% effective during their first six months.
“The virus can affect the lungs and breathing passages of an infected individual and can be potentially life-threatening for young infants, persons with certain chronic medical conditions and older adults,” reads the drug manufacturer’s announcement.
Pfizer previously reported positive results as well in a clinical trial involving people age 60 or older.
RSV cases surged in the U.S. last fall at the same time as COVID-19 and flu infections. Most people only experience mild, cold-like symptoms from RSV, according to the CDC, but the virus is the country’s most common cause of bronchiolitis and pneumonia among babies less than a year old.
“Every year we see high levels of RSV cases among babies in the U.S. with some regions reporting hospital admission rates higher than normal [in 2022],” infectious diseases expert Eric A.F. Simões said in November after Pfizer released the clinical data for its maternal vaccine.
“A maternal vaccine with high efficacy that can help protect infants from birth could substantially reduce the burden of severe RSV among newborns through 6 months of age, and, if approved by regulatory authorities, will likely have a significant impact on disease in the U.S. and globally.”