Update on Respiratory Syncytial Virus (RSV) Prophylaxis

In late 2010, the RSV Prophylaxis Work Group of the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) was disbanded and will not be evaluating evidence and developing guidelines for immunoprophylaxis.

This decision puts the health of our neonatal patients at risk. Your signature on NANN's petition will register your concern about this important issue. You are also encouraged to contact the CDC and ask that the RSV work group be allowed to pursue the desired outcomes as presented at ACIP's October 2009 meeting. One outcome was to "develop evidence-based recommendations for RSV immunoprophylaxis," which included review of data from all three drugs (RSV-IVIG, palivizumab, and motavizumab) related to RSV. This work would prevent more premature infants from being put at risk because of being denied care altogether or being subjected to a suboptimal regimen that has not been tested in any clinical trial.

People to contact at the CDC:

Anne Schuchat, MD
Director, National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
1600 Clifton Rd
Atlanta, GA 30333
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Rima Khabbaz, MD
Deputy Director, Office of Infectious Disease
Centers for Disease Control and Prevention
1600 Clifton Rd
Atlanta, GA 30333
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Please lend your support by requesting that this important work continue.

Written Testimony by Suzanne Staebler, DNP APRN NNP-BC,
NANN Health Policy and Advocacy Committee Co-Chair,
given to the Advisory Committee on Immunization Practices,
October 28, 2010

NAPNAP letter of support

Background Information on RSV Immunoprophylaxis

NANN appreciates the guidance of the American Academy of Pediatrics Committee on Infectious Diseases (COID) to help identify infants at highest risk who are in need of RSV prevention. The COID, however, recently has published new guidelines in the 2009 AAP Red Book. The COID updated their recommendations to “ensure optimal balance of benefit and cost from this expensive intervention.” These suggestions were made with little reference to the peer-reviewed publications that report the results from randomized controlled clinical trials that were published in respected journals. The suggested changes were based on opinions generated by members of the COID and their interpretation of the evidence from reports of small, often regional, studies. The original recommendations for dosing, age cut-off, risk factors, and gestational age eligibility were based on strong evidence from more than one properly designed randomized, controlled trial. The modified recommendations had only moderate supportive evidence AND are based on evidence from opinions of respected authorities, based on their clinical experience or descriptive studies, not well-controlled randomized clinical trials. We are concerned that these suggested changes place our patients’ health at considerable risk.

Poor consistency of RSV prevention has been examined retrospectively. The palivizumab outcomes registry suggested that infants who are discharged from the hospital without palivizumab dosing typically receive their first dose approximately 30 days post-discharge. Additionally, a recently published study from 2007 shows that there was poor compliance with dosing even in those patients who were dosed by the strict 2006 AAP Red Book Guidelines.

As defined by the Centers for Disease Control (CDC), the RSV season begins with the first two consecutive weeks that laboratories report 10% positivity and ends with the last week of 10% positivity followed by two consecutive weeks of 10% positivity of RSV screening tests. The FDA-approved prescribing information is as follows: The recommended dose of palivizumab is 15mg/kg of body weight. At risk children (primarily up to 35 weeks at birth), including those who develop RSV infection, should continue to receive monthly doses throughout the RSV season.

The first dose should be administered prior to the commencement of the RSV season. The IMPACT study (which was the licensure study for palivizumab) included infants up to 35weeks and 6 days' gestation, who received 5 monthly doses. Additionally, the half-life of palivizumab has been studied and determined to be 21 days. It takes 5 half-lives to reach steady state. In addition, data on trough levels of palivizumab suggest great variability and not all infants have protective levels even after 5 doses. Inadequacy of protective levels after 3 doses (or less) has been shown to be of even greater concern.

The National Association of Neonatal Nurses (NANN) and the National Association of Neonatal Nurse Practitioners (NANNP) believe that the changes in the AAP guidelines for immunoprophylaxis (passive antibody protection) leave fragile infants vulnerable by reducing the number of doses they can receive during the RSV season. We believe that denial of full seasonal coverage based on gestational age, without consideration of other risk factors is discriminatory to a selected population of ex-premature infants and may put certain populations at even greater risk due to health disparities.

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