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February 7, 2011

Effects of Adverse Events on the Projected Population Benefits and Cost-effectiveness of Using Live Attenuated Influenza Vaccine in Children Aged 6 Months to 4 Years

Author Affiliations

Author Affiliations: Child Health Evaluation and Research Unit, Division of Pediatrics, University of Michigan Health System, Ann Arbor (Dr Prosser); Center for Child Health Care Studies, Department of Population Medicine (Drs Prosser and Lieu and Ms Hinrichsen), Harvard Medical School and Harvard Pilgrim Health Care, Boston, Massachusetts; and Division of Emerging Infections and Surveillance Services, National Center for Preparedness Detection and Control of Infectious Diseases, and Coordinating Center for Infectious Diseases (Dr Meltzer), and Influenza Division (Drs Fiore and Bridges and Mr Epperson), Centers for Disease Control and Prevention, Atlanta, Georgia.

Arch Pediatr Adolesc Med. 2011;165(2):112-118. doi:10.1001/archpediatrics.2010.182

Live attenuated influenza vaccine (LAIV) is approved for children 2 years or older without a history of wheezing or asthma.1-3 A recent randomized controlled trial among children younger than 5 years of age found that intranasal LAIV was more effective in preventing laboratory-confirmed influenza compared with inactivated influenza vaccine (IIV), yet these data also suggested an increase in adverse events, such as wheezing, in children younger than 5 years of age who receive LAIV compared with IIV.1 Given that a possible increase in adverse events was of potential concern to providers and parents, we sought to evaluate the effect of these events on cost-effectiveness results. The objective of this study was to evaluate the cost-effectiveness of LAIV using new data on adverse events.

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    1 Comment for this article
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    Live Attenuated Influenza Vaccine and the Incidence of Wheezing Postvaccination
    Christopher S. Ambrose, MD | MedImmune, LLC,
    In their recent article, Prosser et al. examined the impact of vaccine-associated adverse events, particularly postvaccination wheezing, on the cost-effectiveness of vaccinating young children with live attenuated influenza vaccine (LAIV).1 The authors included LAIV- associated wheezing risks of 1.21, 0.37, and 0.16 per 100 vaccinated children aged 6-23 months, 24-35 months, and 36-59 months, respectively. LAIV is not approved for use in children 6-23 months of age because a small increase in postvaccination wheezing was observed between days 7 and 28 following the first vaccination in a large, randomized, controlled trial.2 However, the rationale for the authors' inclusion of LAIV- associated wheezing risks for children 24-35 and 36-59 months of age is not clearly addressed in the article. Although not explicitly stated, we believe that the LAIV-associated wheezing rates for recipients 24-35 and 36-59 months of age were included as hypothetical scenarios; if so, we agree that inclusion of these rates is appropriate to address the public health question raised. However, for the benefit of readers, the available data do not support an association between LAIV and an increased risk of wheezing postvaccination among children 24 months of age and older. In fact, in the overall cohort of children 24-59 months of age in the study by Belshe et al., 2.1% of LAIV recipients versus 2.5% of trivalent inactivated virus (TIV) recipients experienced medically significant wheezing through 42 days following vaccination.1, 3, 4 We realize that the authors demonstrated that the presence of a small increased risk of wheezing has little impact on LAIV cost-effectiveness. However, the presence or absence of a wheezing risk is relevant for parents and pediatric healthcare providers when evaluating influenza vaccine options.
    Additionally, it is worth noting that Luce et al also evaluated the cost-effectiveness of LAIV and TIV among children 24-59 months of age using data from the randomized trial by Belshe et al. and identified net cost savings with LAIV compared with TIV.5
    References
    1. Prosser LA, Meltzer MI, Fiore A, et al. Effects of Adverse Events on the Projected Population Benefits and Cost-effectiveness of Using Live Attenuated Influenza Vaccine in Children Aged 6 Months to 4 Years. Arch Pediatr Adolesc Med. October 4 2010:archpediatrics.2010.2182.
    2. Belshe RB, Edwards KM, Vesikari T, et al. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. Feb 15 2007;356(7):685-696.
    3. Belshe RB, Ambrose C, Yi T. Safety and efficacy of live attenuated influenza vaccine in children 2-7 years of age. Vaccine. 2008;26S:D10-16.
    4. FluMist®. Influenza Virus Vaccine Live, Intranasal, Full prescribing information. 2010.
    5. Luce BR, Nichol KL, Belshe RB, et al. Cost-effectiveness of live attenuated influenza vaccine versus inactivated influenza vaccine among children aged 24-59 months in the United States. Vaccine. Jun 2 2008;26(23):2841-2848.

    Conflict of Interest: Dr. Ambrose is an employee of MedImmune, LLC. Dr. Belshe has served as a consultant and/or member of a speaker's bureau for MedImmune, GlaxoSmithKline, and Novartis.
    CONFLICT OF INTEREST: None Reported
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