FDA approves new RSV antibody

OHIO – According to the National Coalition for Infant Health, respiratory syncytial disease, or RSV, is the leading cause of hospitalization for infants under the age of one.

What do you want to know

• The US Food and Drug Administration has approved a new antibody that will protect babies and infants from RSV

• The CDC reports that up to 80,000 children under the age of five are hospitalized with the virus each year

• The new Nirsevimab antibody will be sold under the brand name Beyfortus and is said to last in a child’s body for four to six months

• It serves as a passive immunity for all children, which means it will prevent the virus from affecting healthy cells

Earlier this week, the United States Food and Drug Administration approved a new antibody to protect infants from the respiratory virus.

RSV symptoms include wheezing, coughing, nasal congestion, fever, and decreased appetite. The United States Centers for Disease Control and Prevention reports up to 80,000 children under the age of five are hospitalized each year with the virus, and it often leads to infections such as bronchiolitis and pneumonia.

The new Nirsevimab antibody will be sold under the brand name Beyfortus and is expected to last in the body for four to six months, allowing babies to be protected through the fall and winter months.

The drug can be given at birth during the next RSV winter or fall season, or at a pediatrician’s office next spring or summer before the 2024 season. It will be given as a single injection.

According to the FDA’s analysis of the antibody, nirsevimab was about 70% effective in preventing an infant from needing a doctor for RSV.

Dr Shelly Senders, from Senders Pediatrics, said it would be a unique approach to help many more infants.

“It’s called passive immunity,” Senders said. “It doesn’t affect your immune system.”

Last month FDA advisers recommended a vaccine that would be given to pregnant women so babies could be born with immunity to the respiratory virus and earlier this year the FDA approved an RSV vaccine for the elderly and elderly.

While RSV is a concern for babies and infants, there is pressure for children to be vaccinated before returning to school. Ohio public health officials are encouraging all parents to have their students vaccinated before the first day of school. Because of COVID, many children are behind on their vaccinations due to hesitation and access to their health care providers, which has led to an upsurge in various viruses including measles and influenza.

According to OPH, kindergarten vaccination rates have improved from 2021 to 2022, but about 10% of kindergarten children have missed at least one vaccination dose or are not vaccinated at all.

Vaccines for polio, MMR, hepatitis B, DTaP, and chicken pox are required to attend most schools in the state. Lack of vaccinations can lead to serious illness, affecting a child’s school performance.

Dr. Sara Bode of Nationwide Children’s Hospital says it’s better to be proactive than reactive.

“We’re really emphasizing this healthy back to school,” Bode said. “We know that children who miss even two to four days, that first month of school, in fact half of them are likely to miss a total of one month of school in that school year. That early start and coming on the first day, every day of that first month of school right from the start, is just critical.

Health officials say it’s important for parents to pay attention to their child’s overall health. Dr. Bruce Vanderhoff, director of the Ohio Department of Health, recommends children practice their commute to school if they walk or ride a bike. He also encouraged parents to submit all health-related documents including allergies, medications, etc.