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influenza A (H1N1) monovalent vaccine

Available October 2009 The 2010 flu vaccine includes the 2009 H1N1 strain. Indications: 1) pregnant women - safe during pregnancy [15] 2) persons who live with or provide care for infants aged <6 months (e.g., parents, siblings, & daycare providers) 3) health-care and emergency medical services personnel, 4) persons aged 6 months-24 years 5) persons aged 25-64 years who have medical conditions that put them at higher risk for influenza-related complications Dosage: - a single dose - may be administered on same day as seasonal influenza vaccine [12] - supply of vaccine adequate, safety reassured 2009 [6] although grounds for reassurance seem to be based upon the assumption that the method of preparation is similar to that of the seasonal flu vaccine & serious adverse effects have not observed in the limited period vaccine has been available - two doses space 8-10 days may be required for children < 10 years [7] Adverse effects: - pain at the site of injection - Guillain-Barre syndrome a) excess of 1 per million b) same incidence as seasonal flu vaccine [13] - anaphylaxis [10] - adverse effects similar to those of seasonal flu vaccine [11,14] - no increase in overall risk of congenital malformations when given during pregnancy [16] - increased risk of oral cleft & limb deformities possible for exposure during the first 8 weeks of pregnancy [16] - no adverse outcomes in offspring of mothers who received 2009 H1N1 vaccine by the age 5 years [17]

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swine flu

General

influenza virus vaccine, inactivated (Fluogen, Fluzone, Fluvirin, Flushield, Fluarix, Flulaval, Agriflu, Afluria, Flublok Quadrivalent, FluCelVax, Fluad, RIV4)

References

  1. FDQ News release FDA Approves Vaccines for 2009 H1N1 Influenza Virus Approval Provides Important Tool to Fight Pandemic http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182399.htm
  2. Greenberg ME et al Response after One Dose of a Monovalent Influenza A (H1N1) 2009 Vaccine - Preliminary Report N Engl J Med. 2009 Sep 10. PMID: 19745216
  3. H1N1 Influenza Center New Engl J Med in Association with Journal Watch http://h1n1.jwatch.org/
  4. Influenza A (H1N1) 2009 Monovalent (package insert) Food and Drugn Administration (FDA) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm181950.htm - National Center for Immunization and Respiratory Diseases, CDC Use of Influenza A (H1N1) 2009 Monovalent Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009 MMWR Recommendations and Reports, August 28, 2009 / 58(RR10); 1-8 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5810a1.htm
  5. Prescriber's Letter 16(9): 2009 Recommendations from the CDC for Use of Influenza A (H1N1) 2009 Monovalent Vaccine Detail-Document#: 250911 (subscription needed) http://www.prescribersletter.com
  6. Centers for Disease Control and Prevention Press Briefing Transcripts Weekly 2009 H1N1 Flu Media Briefing October 06, 2009, 12:00 p.m. http://www.cdc.gov/media/transcripts/2009/t091006.htm
  7. National Institute of Allergy and Infectious Diseases November 2, 2009 BULLETIN: Updated Results: In Youngest Children, a Second Dose of 2009 H1N1 Influenza Vaccine Elicits Robust Immune Response
  8. FDA US Food and Drug Administration, Nov 10, 2009 Letter from the Commissioner to Nation's Doctors on H1N1 Vaccine http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm189691.htm
  9. Prescriber's Letter 16(12): 2009 2009 H1N1 Flu Vaccine: Questions and Answers Links to the Latest Government Handouts: H1N1 vaccine general info H1N1 vaccine safety Detail-Document#: 251201 (subscription needed) http://www.prescribersletter.com
  10. WHO press briefing transcript, 26 November 2009 http://www.who.int/mediacentre/vpc_transcript_26_november_09_fukuda.pdf
  11. Centers for Disease Control and Prevention (CDC) Safety of Influenza A (H1N1) 2009 Monovalent Vaccines - United States, October 1 - November 24, 2009 Morbidity & Mortality Weekly Report Vol 58, Dec 4, 2009 http://www.cdc.gov/mmwr/pdf/wk/mm58e1204.pdf
  12. 2009 H1N1 Influenza Vaccine Dose Spacing and Administration with Seasonal Influenza and Other Vaccines http://cdc.gov/h1n1flu/vaccination/vaccine_admin.html
  13. Centers for Disease Control and Prevention (CDC) Preliminary Results: Surveillance for Guillain-Barre Syndrome After Receipt of Influenza A (H1N1) 2009 Monovalent Vaccine -- United States, 2009--2010 Morbidity and Mortality Weekly Report (MMWR) June 2, 2010 / 59(Early Release);1-5 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm59e0602a1.htm
  14. Wu J et al. Safety and effectiveness of a 2009 H1N1 vaccine in Beijing. N Engl J Med 2010 Dec 16; 363:2416. PMID: 21158658
  15. Pasternak B et al. Risk of adverse fetal outcomes following administration of a pandemic influenza A(H1N1) vaccine during pregnancy. JAMA 2012 Jul 11; 308:165 PMID: 22782418
  16. Ludvigsson JF, Strom P, Lundholm C et al Risk for Congenital Malformation With H1N1 Influenza Vaccine: A Cohort Study With Sibling Analysis. Ann Intern Med. Published online 20 September 2016 PMID: 27654505 http://annals.org/article.aspx?articleid=2552986
  17. Walsh LJ, Donelle J, Dodds L et al Health outcomes of young children born to mothers who received 2009 pandemic H1N1 influenza vaccination during pregnancy: retrospective cohort study. BMJ 2019;366:l4151 PMID: 31292120 https://www.bmj.com/content/366/bmj.l4151 - Haberg SE, Wilcox AJ Flu vaccination in pregnancy. BMJ 2019;366:l4454 Not indexed in PubMed https://www.bmj.com/content/366/bmj.l4454