RSV Relief? FDA Approves an Injectable Drug to Protect Children

Most parents of infants and very young children know the anxiety that comes from RSV. According to the CDC, “Each year in the United States, an estimated 58,000-80,000 children younger than 5 years old are hospitalized due to RSV infection.” Until now, no vaccine or preventative treatment was available, but the approval of a a monoclonal antibody injection that can protect children up to 2 years old from respiratory syncytial virus is giving parents hope.

A Preventative Injection for Young Children

NBC News reports, “The drug, a monoclonal antibody injection called Beyfortus, can be given as a single injection to newborns and infants during their first RSV season. Children up to age 2 who are vulnerable to severe infections from the respiratory virus — such as those with congenital heart disease or premature babies with long-term breathing and lung problems — can receive a second dose during their second RSV season.”

An independent advisory committee to the FDA unanimously voted last month to recommend Beyfortus for newborns and infants. Next, The CDC’s Advisory Committee for Immunization Practices will meet to discuss recommendations about who should receive the shots. Once the CDC director, Dr. Mandy Cohen, signs off on the panel’s recommendation, the injections can be distributed to the public.  This means that parents should have a new option to protect babies from this lung-attacking virus by this fall.

In addition to this injectable prevention, CNN reports that, “The FDA is weighing whether to approve Pfizer’s vaccine for pregnant women that would also protect babies. In that case, the mom makes the antibodies, which cross the placenta to safeguard the fetus and are expected to last through an infant’s first few months of life.

That vaccine would protect babies from the moment they are born, a benefit if the infection shows up out of season. Vaccines also prompt the mom’s body to make more than one kind of antibody, which would provide broader-spectrum protection.”

Hopeful Outlooks

Doctors are excited about the prospect of these new preventative options.

“We run this gauntlet every year — RSV season,” said Dr. Frank Esper, a pediatric infectious disease specialist at the Cleveland Clinic in Ohio. “We see a lot of these infants. They come in; they can’t breathe. That’s the problem. That’s what RSV does. It causes so much swelling and secretions in their breathing tubes, called the bronchioles, that they just can’t get enough oxygen.”

Dr. Rachel Dawkins, medical director of the pediatric and adolescent medical clinics at Johns Hopkins All Children’s Hospital in St. Petersburg, Florida told CNN

“I would say any strategy that we can use to help prevent RSV and infants is a great one,” Dawkins said. “So if moms are able to be vaccinated to hopefully protect their newborns, that’s great. Or if the babies are able to be given this antibody, also great, and I think there is some evidence that they work together.”


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