PHOENIX — Federal health officials have opened a safety review of two injectable drugs used to protect babies and toddlers from RSV, a respiratory virus that routinely impacts pediatric wards across the Valley each winter.
A family nurse practitioner at Banner Health recently told KTAR News 92.3 FM that health care providers across metro Phoenix are bracing for another busy flu season, with RSV, COVID and the flu expected to rise as families gather indoors during the holidays.
The two injectable RSV drugs being reviewed are Enflonsia and Beyfortus. They aren’t the only medications approved for babies that are under federal scrutiny.
Last week, U.S. Health Secretary Robert F. Kennedy Jr.’s committee voted to end a longstanding recommendation that all U.S. babies get the hepatitis B vaccine on the day they’re born.
In response, an Arizona health official urged parents across the state to still vaccinate their newborns against the virus, despite the change in the federal recommendation.
More details about the injectable RSV drugs under a safety review
Enflonsia and Beyfortus are essentially laboratory-made versions of natural antibodies that help the immune system fight off RSV.
The FDA has cleared RSV vaccines for older adults and pregnant women, but not for infants or young children. That makes antibody injections the main option to protect babies from the seasonal virus.
Merck, which makes the drug Enflonsia, told The Associated Press that company officials met with the FDA last week and that it values transparency and the agency’s rigorous review of its clinical data.
Merck’s injection is approved to shield babies before or during their first RSV season, which usually lasts about five months. Sanofi, maker of Beyfortus, said it regularly shares any potential safety concerns with regulators and has not seen new issues in more than 50 studies, according to The Associated Press.
The company added that no safety problems have been identified in clinical trials or in post‑marketing use, with more than 6 million babies immunized worldwide.
How does RSV impact babies and toddlers?
RSV is a common seasonal respiratory virus that usually causes mild, cold-like symptoms in adults, but it can be dangerous for babies.
Those with the greatest risk for severe illness include premature infants 6 months and younger, children with chronic lung and heart disease and children with weakened immune systems.
Symptoms include a runny nose, decrease in appetite or a cough that may progress to wheezing. Young children with severe RSV infection may experience dehydration, trouble breathing and difficulty feeding. They may need to be hospitalized to receive oxygen therapy, intubation or mechanical ventilation to help them breathe better.
Earlier this year, an Arizona nurse practitioner told KTAR News that the flu season as of February was worse than last year’s, leaving some people sick for as long as a whole week. Her comments came after the Centers for Disease Control and Prevention posted data showing that the U.S. winter virus season was the worst it had been in 15 years.
The Associated Press contributed to this report.
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