The AAP now recommends that Synagis be administered only to infants born prematurely at 29 weeks or less and to babies considered “high-risk.”
The American Academy of Pediatrics (AAP) has released new guidelines that could affect the way severe lower respiratory tract disease from respiratory syncytial virus (RSV) is prevented. RSV is the most common cause of bronchiolitis and pneumonia in children younger than 1 year of age in the United States.
Palivizumab prophylaxis, commonly known as Synagis, is a monoclonal antibody that has been shown to effectively prevent RSV. The AAP is now recommending that Synagis be administered only to infants born prematurely at 29 weeks’ gestation or less and to babies considered “high risk.” However, some doctors worry that the new guidance is putting infants at risk for unnecessary illness and hospitalization due to RSV.
“The recent recommendation to limit the use of Synagis to 29-week preemies and high-risk infants means 75 percent of babies who would have been eligible for the life-saving medication are no longer eligible. This means every year, over 140,000 babies will be affected by this change,” says Mitchell Goldstein, a neonatologist in West Covina, California.
Since Synagis was approved in 1998, the AAP has revised its recommendations for its use five times. Each update has narrowed the group recommended to receive the series of monthly preventative shots. During the recent review, the AAP’s Committee on Infectious Diseases and Bronchiolitis Guideline Committee judged the quality of the available data, as well as the impact of Synagis, and reached a unanimous consensus. The infectious diseases panel said that cost was considered during deliberations, but that the final guidance was driven by the limited clinical benefit Synagis provides.
The new guidance by the American Academy of Pediatrics on Synagis says:
During the first year of life
Palivizumab prophylaxis is recommended during RSV season for the following infants:
- Preterm infants born at or before 29 weeks’ gestation
- Preterm infants with chronic lung disease (CLD) born at 32 weeks’ gestation who required 21 percent oxygen therapy during the first 28 days of life
- Infants with hemodynamically significant congenital heart disease
- Children with anatomic abnormalities or neuromuscular disorders
During the second year of life
Palivizumab prophylaxis is recommended only for preterm infants with CLD who require continued medical support in the second year of life. Doctors should:
- Administer a maximum of five monthly doses.
- Discontinue monthly prophylaxis if a breakthrough RSV infection occurs during prophylaxis.
Also, prophylaxis is not indicated for children with Down syndrome or for immunocompromised children. And the AAP says children with cystic fibrosis should not routinely receive prophylaxis; palivizumab may be indicated based on the degree of lung disease in the first two years of life.
“The new guidance on Synagis is an effective measure since there is just not enough medical data over the past 15 years to show the drug’s effectiveness for infants outside of the high-risk category,” says Ian Holzman, chief of newborn medicine at the Kravis Children’s Hospital at Mount Sinai in New York City.
Holzman stresses that by no means will the recent change in the guidelines cause unnecessary illness to infants outside high-risk categories. It’s also important to note that these AAP guidelines are just that—guidelines—and not written law. Synagis is still readily available for doctors to administer to any child who will medically benefit from it. It’s up to the parents to discuss coverage with their insurance company.
Vanessa Moore, a mother of three, learned firsthand how AAP guidelines on Synagis can affect an infant’s care when her third child, born at 34 weeks, was hospitalized repeatedly for RSV. After her daughter’s second hospitalization in the NICU, the pediatrician recommended Synagis as a preventive measure. But because of the guidelines in effect at the time, Vanessa was told by her insurance company that she would have to pay the full cost for the expensive series of shots. Her family could not afford the shots, and her daughter was hospitalized two more times with complications from RSV. Today, at 6 years old, her daughter suffers from asthma, which may have been caused by the repeated bouts with RSV.