RSV is the Leading Cause of Hospitalization in Infants Less Than 1 Year of Age1

• Respiratory syncytial virus (RSV) is a common, seasonal virus that affects almost all children by the age of two.2, 3 While in most children RSV mimics the common cold or flu, RSV disease can be serious for premature babies, often leading to severe lung infections like pneumonia and bronchiolitis.1, 11
• Each year, severe RSV disease can lead to approximately 400 deaths in infants,7 and causes up to 125,000 infant hospitalizations.8, 9 In children less than one year of age, RSV is the leading cause of viral death,7 and is responsible for one of every 13 pediatrician visits and one of every 38 trips to the ER in children under five years of age.10
• Even babies born just a few weeks early are at an increased risk. A study of infants born between 33‐35 weeks gestational age showed that these late‐preterm infants were two times more likely to become hospitalized by RSV than full‐term infants.11
• This is because babies born prematurely have not received the full transfer of maternal antibodies to protect them against severe RSV disease.3 Additionally, premature birth interrupts the final stages of lung development, leaving preemies with only about half the lung volume of and smaller airways than their full‐term peers.4, 5, 6

The Premature Birth Rate in the U.S. is Significant

• There are more than half a million babies born prematurely in the U.S. each year.12 Across the nation, prematurity rates increased steadily between 1996‐2006.12
• RSV‐related hospitalizations increased from 1997 ‐ 2002 by approximately 25% among all infants under one year of age.8

Prematurity and RSV are Place Burdens on Public Health and Health Care Costs

• On average, preterm infants have much longer birth hospital stays compared to full‐term infants,* resulting in significantly higher hospital costs.13
• In 2003, hospital care for preemies cost $18.1 billion ‐ almost half of the total costs for all infants, despite making up only 9%* of the infant population.13 Recent data show that this cost has since increased to $26.2 billion, or $51,600 per preterm infant.14
• One of the common reasons for hospitalization in preemies is RSV disease; premature infants with RSV use significantly more hospital resources than full‐term infants infected by the virus.16
• While all children are at risk of becoming ill from RSV, high‐risk infants are much more likely to develop serious RSV disease.11, 16
• The average cost of RSV‐related hospitalization is $18,503 for late preterm infants (33‐36 weeks GA) – twice as high as for full‐term infants ($9,014).15

By urging Medicaid to appropriately protect high‐risk infants, we can help decrease RSV related hospitalizations in preterm infants and may reduce the emotional and financial tolls that hospitalization takes on their families.

References:
(1) Leader S, Kohlhase K. Recent trends in severe respiratory syncytial virus (RSV) among US infants, 1997 to 2000. Pediatr Infect Dis J. 2002;21:629‐632. (2) Holberg CJ, Wright AJ, Martinez FD, et al. Am J Epidemiol. 1991; 133:1135‐1151 (3) Glezen WP, Taber LH, Frank AL, et al. Am J Dis Child. 1986;140:543‐546. (4) Yeung CY, Hobbs JR. Serum‐gamma‐G‐globulin levels in normal premature, post‐mature and “small for dates” newborn babies. Lancet.1968;7557:11 67‐11 70. (5) Moore KL, Persaud TVN. The Developing Human: Clinically Oriented Embryology. 7th ed. Philadelphia, PA: Saunders; 2003:245‐251 (6) Langston C, Kida K, Reed M et al. Am Rev Respir Dis, 1984;129:607‐613. (7) Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza and respiratory syncytial virus in the United States. JAMA. 2003; 289:179‐186. (8) Data on File: McLaurin KK, Leader S. Growing impact of RSV hospitalizations among infants in the US, 1997‐2002 (abstract 936). Presented at Pediatric Academic Societies Annual Meeting, May 14‐17, 2005; Washington, D.C. (9) Shay DK, Holman RC, Newman RD, et al. Bronchiolitis associated hospitalizations among US children. 1980 – 1996. JAMA. 1999; 282:1440‐1446. (10) Hall CB, Weinberg, GA.,Iwane, MK, et al. The Burden of Respiratory Syncytial Virus Infection in Young Children. NEJM, 2009; 360:588‐598 (11) Boyce TG, Mellen BG, Mitchel EF Jr, Wright PF, Griffin MR. Rates of hospitalization for respiratory syncytial virus infection among children in Medicaid. J Pediatr. 2000;137:865‐870. (12) March of Dimes. National Center for Health Statistics, Final Natality Data. www.marchofdimes.com/peristats. Accessed: September 21, 2009. (13) Agency for Healthcare Research and Quality, 2003. Nationwide Inpatient Sample. Prepared by March of Dimes Perinatal Data Center, 2006. (14)Behrman RE, Butler AS, eds. Institute of Medicine. Preterm birth:causes, consequences, and prevention. Washington (DC): National Academy Press; 2006. (15) Data on File: Forbes ML, Hall CB, Jackson A, Masaquel AS & Mahadevia PJ. (2009, May). Cost and Resource Utilization of Respiratory Syncytial Virus (RSV) or Winter Unspecified Bronchiolitis or Pneumonia (UBP) Hospitalizations During the First Year of Life Among Late‐preterm and Full‐term Infants. Poster presented at the ISPOR 14th Annual International Meeting, Orlando, FL. (16) Horn SD & Smout RJ. Journal of Pediatrics. 2003; 143: S133‐S141.

*Includes any diagnosis of prematurity/low birthweight
**According to most recent data available (2006)

Policy Position Current on March 10, 2010

Download RSV: RESPIRATORY SYNCYTIAL VIRUS (PDF, 118KB)

The phase 3, pivotal trial assessed the safety and RSV hospitalization in 6,635 preterm infants aged six months or younger at enrollment or children aged 24 months or younger with chronic lung disease of prematurity who received either 15 mg/kg palivizumab or motavizumab monthly.  Secondary endpoints included outpatient medically attended lower respiratory tract infections (MALRIs), RSV-specific MALRIs, otitis media, antibiotic use, development of anti-motavizumab antibodies and motavizumab serum concentrations.

In this first head-to-head trial, motavizumab demonstrated non-inferiority, but not superiority, to SynagisÒ (palivizumab), meeting the primary endpoint with a 26 percent relative reduction in RSV hospitalizations versus Synagis (p<0.01 for non-inferiority) due to RSV. Motavizumab also demonstrated superiority compared to Synagis, with a 50 percent relative reduction in RSV lower respiratory tract infections requiring outpatient management (p=0.005), which was one of the secondary endpoints of the trial. Other secondary endpoints were not statistically significant. Adverse events were similar in both groups, although, motavizumab had two percentage points more adverse events reported for the skin compared to Synagis; the majority were non-specific rashes that did not recur or affect dosing.

In November 2008, the FDA issued a complete response letter (CRL) to MedImmune seeking clarification on the motavizumab Biologic License Application (BLA).  MedImmune filed its response with the FDA in December 2009 and continues in its ongoing dialogue with the agency.

 About RSV

Each year, up to 125,000 infants in the U.S. are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in infants in the United States. RSV is the most common respiratory infection in infancy or childhood. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV.

 About Synagis

Synagis is the only monoclonal antibody approved by the FDA to help prevent an infectious disease. Synagis was approved for use in the United States in 1998, Europe in 1999, and Japan in 2002.  Synagis is currently available in 62 countries. 

Synagis® (palivizumab) is a prescription medication that is used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in infants and children at high risk. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis should not be used in patients with a history of a severe allergic reaction to Synagis or its ingredients. Cases of severe allergic reactions such as anaphylaxis and other types of hypersensitivity reactions have been reported with Synagis. These reactions may occur when any dose of Synagis is given, not just the first one. Very low platelet counts may occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.

Common side effects may include fever, cold-like symptoms (upper respiratory infection) including runny nose and ear infection, and rash. Other possible side effects include skin reactions around the area where the shot was given (like redness, swelling, warmth or discomfort). In children born with certain types of heart disease, other possible side effects include bluish color of the skin, lips or under fingernails and abnormal heart rhythms. These are not all the possible side effects of Synagis.

For full prescribing information for Synagis, see the company’s website at: www.medimmune.com/products/synagis/index.asp.

About MedImmune

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,300 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, we aim to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.

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“MedImmune is dedicated to conducting ground-breaking research on the prevention of respiratory syncytial virus (RSV) and influenza in children,” said Alexander A. Zukiwski, M.D., executive vice president and chief medical officer. “We believe the data being presented at the conference may help advance innovative healthcare solutions for these important causes of respiratory infections in children.”

MedImmune abstracts to be presented at IDSA on RSV include:

• Prophylaxis Utilizing Nebulized Motavizumab, a Monoclonal Antibody Against Fusion Protein of Respiratory Syncytial Virus (RSV) Zhang J, et al. Poster Session: October 30, 2009; 12:30 – 2:00 PM; Poster Hall A / Poster # 608

BACKGROUND: Respiratory syncytial virus (RSV) infection is the primary cause of pneumonia and bronchiolitis in young children, and also causes disease in older adults. This study evaluated the prophylactic use of nebulized motavizumab, an investigational anti-RSV humanized monoclonal antibody against RSV fusion protein, in cotton rats. The findings suggest that prophylaxis with nebulized motavizumab may inhibit RSV infection and spread in the lungs and may provide an alternative to the current intramuscular antibody delivery.

MedImmune abstracts to be presented at IDSA on influenza include:

• A Postmarketing Evaluation of the Frequency of Use and Safety of Live Attenuated Influenza Vaccine Use in Unapproved Children Less Than 59 Months of Age Tennis P, et al. Poster Session: October 31, 2009; 12:30-2:00 PM; Hall A / Poster #1179

BACKGROUND: In September 2007, the approval of live attenuated influenza vaccine (LAIV) was expanded for use in children between 24 and 59 months in age. The vaccine was not approved for use in children younger than 24 months, or for use in children with asthma or recurrent wheezing, or those with altered immunocompetence. This study evaluates the usage and safety of the vaccine in those patient populations younger than 59 months of age that were not in the approved indication. The study found that healthcare providers appear to be complying with the indications for the use of LAIV in children <5 years, and no adverse safety outcomes were detected in the small number of children in unapproved groups who received the vaccine.

• Whole Genome Transcriptional Analysis of the Early Immune Responses Induced by Live Attenuated and Inactivated Influenza Vaccines in Young Children Zhu W, et al. Poster Session: October 31, 2009; 12:30-2:00 PM; Hall A / Poster #1181

BACKGROUND: This study examined the early genomic immune response to live attenuated and inactivated vaccines in previously unvaccinated children 12 to 35 months of age. Among LAIV recipients, an increase in interferon (a natural anti-viral immune protein) production was seen, which may partly explain previous clinical study observations of LAIV-induced protection against illness in the first 2 weeks after administration.

• Influenza-Associated Antibiotic Use in Children Receiving Live Attenuated Influenza Vaccine Compared With Inactivated Influenza Vaccine Belshe R, et al. Poster Session: October 31, 2009; 12:30-2:00 PM; Hall A / Poster #1180

BACKGROUND: Influenza illness in children commonly results in the unnecessary use of prescription antibiotics. This analysis evaluated the efficacy of live attenuated influenza vaccine (LAIV) and trivalent inactivated influenza vaccine (TIV) in preventing antibiotic use in children ranging from six months to 17 years in age. Overall, there was less influenza-associated antibiotic use in LAIV recipients due to a lower rate of culture-confirmed influenza with LAIV.

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Additional information about the 2009 IDSA conference can be found at http://www.idsociety.org/IDSA2009.htm.

About FluMist®

FluMist® (Influenza Vaccine Live, Intranasal) is a vaccine indicated for active immunization of individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life- threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children less than two years of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children less than five years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.

If Guillain-Barre syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.

Most common adverse reactions (occurring in 10 percent or more of individuals receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees F in children two to six years of age, and sore throat in adults.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see complete Prescribing Information for FluMist, call 1-877-FLUMIST (1-877-358-6478) or visit http://www.medimmune.com/pdf/products/flumist_pi.pdf for additional information.

About MedImmune, Inc.

MedImmune, the worldwide biologics business for AstraZeneca PLC (LSE: AZN.L, NYSE: AZN), has approximately 3,100 employees worldwide and is headquartered in Gaithersburg, Maryland. With an advancing pipeline of promising candidates, MedImmune aims to be the next revolutionary force in biotechnology by delivering life-changing products, industry-leading performance, and a tireless commitment to improving patient health. For more information, visit MedImmune’s website at www.medimmune.com.