Modified Recommendations for Use of Palivizumab for Prevention of Respiratory Syncytial Virus Infections

Abstract

Palivizumab was licensed in June 1998 by the US Food and Drug Administration for prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients who are at increased risk of severe disease. Safety and efficacy have been established for infants born at or before 35 weeks' gestation with or without chronic lung disease of prematurity and for infants and children with hemodynamically significant heart disease. The American Academy of Pediatrics (AAP) published a policy statement on the use of palivizumab in November 1998 (American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 1998;102[5]:1211–1216) and revised it in December 2003 (American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 2003;112[6 pt 1]:1442–1446), and an AAP technical report on palivizumab was published in 2003 (Meissner HC, Long SS; American Academy of Pediatrics, Committee on Infectious Diseases and Committee on Fetus and Newborn. Pediatrics. 2003;112[6 pt 1]:1447–1452). On the basis of the availability of additional data regarding seasonality of RSV disease as well as the limitations in available data on risk factors for identifying children who are at increased risk of serious RSV lower respiratory tract disease, AAP recommendations for immunoprophylaxis have been updated in an effort to ensure optimal balance of benefit and cost from this expensive intervention. This statement updates and replaces the 2003 AAP statement and the 2006 Red Book and is consistent with the 2009 Red Book recommendations.

National Evidence in Israel Supporting Reevaluation of Respiratory Syncytial Virus Prophylactic Guidelines

“…In addition, other gestational age comparisons were performed based on the previous and latest AAP guidelines that included infants who were born at 24⁰/ 7 -28 6 / 7 weeks of gestation (group 1) - infants who entitled to RSV prophylaxis by the new AAP guidelines [11], infants who were born at 29⁰/ 7 -34 6 / 7 weeks (group 2) - entitled to RSV prophylaxis only by the previous AAP guidelines [6], and infants who were born at 35⁰/ 7 -41 6 / 7 weeks (group 3) - who were never entitled to RSV prophylaxis by the AAP guidelines. The study was approved by the institutional review board.…”

“…These recommendations were later extended to include all premature infants born earlier then 34 6 / 7 weeks under certain criteria as well as neonates with cyanotic CHD [5,6]. …”

Novel Vaccine Regimen Elicits Strong Airway Immune Responses and Control of Respiratory Syncytial Virus in Nonhuman Primates

“…Although great efforts have been conducted to develop a safe and efficacious vaccine against RSV, no vaccine has yet been licensed (reviewed in reference 4). Only a neutralizing monoclonal antibody, Palivizumab, has been approved for prophylaxis in infants (5), but high costs and the need for repeated administration puts limitations on its widespread use (6).…”

Respiratory Syncytial Virus Infection in High-risk Infants – an Update on Palivizumab Prophylaxis

“…The American Academy of Pediatrics [10] recommends prophylaxis with palivizumabin case of preterm infants born equal or younger than 28 weeks of gestational age during the RSV season up to 12 months of chronological age and in case of preterm infants born between 29 and 31 weeks of gestational age up to 6 months of chronological age. Additionally the policy statement emphasizes that once an infant qualifies for palivizumabprophylaxis administration should be continued throughout the RSV season.…”