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live attenuated influenza virus vaccine; LAIV (FluMist, FluMist Quadrivalent)

Influenza vaccine given as nasal spray. (FDA approved 2003) Indications: - prophylaxis for influenza, healthy people age 2-49 years [6] - 1st line for healthy children 2-8 years of age [12] - no longer recommended over inactivated vaccine, because observational studies failed to support superiority of live-attenuated vaccine seen in randomized trials [14] - not recommended for 2016-17 flu season [17] - as effective as inactivated influenza virus vaccine over 3 flu seasons in Canadian children [18] - laboratory-confirmed influenza in 5% of vaccine recipients - low effectiveness against influenza A H1N1 pdm09 [19] - may be reintroduced in 2018-2019 flu season [20] Contraindications: 1) immunosuppressed patients a) immunosuppressed household contacts [7] b) caregivers & health care workers who care for immunosuppessed patients 2) children or adolescents on aspirin therapy 3) egg allergy - hives only no longer a contraindication [15,16] 4) history of Guillain-Barre syndrome 5) asthma or reactive airway disease, COPD 6) diabetes mellitus 7) renal dysfunction 8) hemoglobinopathy Dosage: 1) single dose nasal spray 0.5 mL 2) previously unvaccinated children 5-8 years of age receive 2 doses 60 days apart Avoid antiviral agents for 2 weeks after administration [4] Store at -15 degrees C* (use frost-free freezer [3]) May be thawed in refrigerator 24 hours before use Shelf life: 18 weeks (2014) [13] * 2007 formulation may be refrigerated [6] * good for 8 hours at room temperature Adverse effects: 1) nasal congestion 2) rhinitis 3) headache 4) sore throat 5) cough 6) live virus is shed in nasal secretions & may be spread to unvaccinated contacts for at least 7 days [5] 7) 20% of adverse events associated with use of expired vaccine [13] Mechanism of action: 1) live virus vaccine containing 2 type A & 1 type B strains of influenza virus [2] 2) quadrivalent live virus vaccine containing 2 type A & 2 type B strains of influenza virus FDA-approved in Feb 2012 [10] 3) induces IgA, IgG & cellular immunity [2] 4) viruses attenuated by a) multiple passages through eggs b) recombination with influenza mutants 1] enhanced growth in cool nasal passages 2] systemic replication is inhibited 5) estimates of protection vary - 20-23% reduction in symptomatic influenza in adults [2] - protection for single dose 56-89% [11] - in 3 studies, live attenuated influenza virus vaccine more more effective than inactivated influenza virus vaccine in reducing culture-confirmed influenza caused by matched strains by 35-53% [11] - also more effective than inactivated influenza virus vaccine in reducing influenza-associated otitis media by 51% [11] 6) effectiveness of LAIV against influenza A(H3N2 improved by prior vaccination [21] Notes: * Cost (2003) about $46, about $20 2007 [6]

General

live virus vaccine

References

  1. Prescriber's Letter 10(7):37 2003
  2. Journal Watch 23(18):147, 2003 http://www.fda.gov/cber/label/infimed061703lb.pdf http://www.fda.gov/bbs/topic/NEWS/2003/NEW00913.html
  3. Prescriber's Letter 10(10):56 2003
  4. Prescriber's Letter 11(1):1 2004
  5. Prescriber's Letter 11(9): 2004
  6. Prescriber's Letter 14(9): 2007 Immunization Update 2007 Detail-Document#: 230923 (subscription needed) http://www.prescribersletter.com
  7. Prescriber's Letter 14(10): 2007 Selected Issues in the Effective and Safe Use of Live Virus Vaccines. Detail-Document#: 231009 (subscription needed) http://www.prescribersletter.com
  8. US Food and Drug Administration (FDA). FDA News. FDA approves nasal influenza vaccine for use in younger children. 2007, Sept 19 http://www.fda.gov/bbs/topics/NEWS/2007/NEW01705.html
  9. Prescriber's Letter 15(10): 2008 CHART: Stability of Refrigerated and Frozen Drugs TECHNICIAN TRAINING TUTORIAL: Handling Refrigerated Drugs and Vaccines Detail-Document#: 241001 (subscription needed) http://www.prescribersletter.com
  10. FDA News Release: Feb. 29, 2012 FDA approves first quadrivalent vaccine to prevent seasonal influenza http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm294057.htm
  11. Ambrose CS et al Current Status of Live Attenuated Influenza Vaccine in the United States for Seasonal and Pandemic Influenza. Influenza Resp Viruses. 2008;2(6):193-202. on Medscape http://www.medscape.com/viewarticle/588302_2
  12. Kelley KJ. Sofair A and Chavey WE (editors) CDC Panel Recommends Nasal Flu Vaccine Over Shot for Kids Physician's First Watch, June 27 2014 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
  13. Haber P et al. Centers for Disease Control and Prevention (CDC) Notes from the Field: Reports of Expired Live Attenuated Influenza Vaccine Being Administered - United States, 2007- 2014. MMWR. Weekly. September 5, 2014 / 63(35);773-773 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6335a3.htm
  14. Grohskopf LA et al Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 Influenza Season. MMWR. August 7, 2015 / 64(30);818-825 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6430a3.htm
  15. Turner PJ et al Safety of live attenuated influenza vaccine in young people with egg allergy: multicentre prospective cohort study. BMJ 2015;351:h6291 PMID: 26645895 http://www.bmj.com/content/351/bmj.h6291 - Greenhawt M. Live attenuated influenza vaccine for children with egg allergy. BMJ 2015 Dec 9; 351:h6656. PMID: 26657778 http://www.bmj.com/content/351/bmj.h6656
  16. Centers for Disease Control and Prevention (CDC) VACCINE INFORMATION STATEMENT. Influenza (Flu) Vaccine (Live, Intranasal): What You Need to Know. Information Fact Sheet. Feb. 2016 http://www.cdc.gov/vaccines/hcp/vis/vis-statements/flulive.pdf
  17. Centers for Disease Control and Prevention (CDC) ACIP votes down use of LAIV for 2016-2017 flu season. http://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html - American Academy of Pediatrics AAP Supports ACIP Recommendation for Use of Inactivated Flu Vaccine. https://www.aap.org/en-us/about-the-aap/aap-press-room/pages/AAP-Supports-ACIP-Recommendation-for-Use-of-Inactivated-Flu-Vaccine.aspx - COMMITTEE ON INFECTIOUS DISEASES Recommendations for Prevention and Control of Influenza in Children, 2016-2017 Pediatrics Sep 2016, e20162527 PMID: 27600320
  18. Loeb M, Russell ML, Manning V Live Attenuated Versus Inactivated Influenza Vaccine in Hutterite Children: A Cluster Randomized Blinded Trial. Ann Intern Med. Published online 16 August 2016 PMID: 27538259 http://annals.org/article.aspx?articleid=2543271
  19. Kim DK, Riley LE, Harrima KH et al Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, 2017. Ann Intern Med. 2017;166(3):209-219 PMID: 28166560 http://annals.org/aim/article/2601209/recommended-immunization-schedule-adults-aged-19-years-older-united-states
  20. NEJM JWatch Editors Live Attenuated Flu Vaccine Coming Back in 2018-19. Physician's First Watch, Feb 22, 2018 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org - Fox M FluMist nasal flu vaccine can come back, vaccine advisers say. NBC News. Feb 22, 2018 https://www.nbcnews.com/health/health-news/flumist-nasal-flu-vaccine-can-come-back-vaccine-advisers-say-n849986 - Walker M ACIP Reinstates FluMist for 2018-2019 Flu Season Committee persuaded by new efficacy analyses. MedPage Today. February 21, 2018 https://www.medpagetoday.com/meetingcoverage/acip/71298
  21. McLean HQ, Caspard H, Griffin MR et al Association of Prior Vaccination With Influenza Vaccine Effectiveness in Children Receiving Live Attenuated or Inactivated Vaccine. JAMA Netw Open. 2018;1(6):e183742 Not indexed in PubMed https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2709714 - Cobey S Repeated Vaccination May Protect Children From Influenza Infection. JAMA Netw Open. 2018;1(6):e183730 Not indexed in PubMed https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2709711

Component-of

influenza virus vaccine/live attenuated influenza virus vaccine