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Review

Monitoring the safety of annual and pandemic influenza vaccines: lessons from the US experience

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Pages 75-82 | Published online: 09 Jan 2014

References

  • Fiore AE, Shay DK, Haber P et al. Prevention and control of influenza: recommendations of the Advisory Committee on Immunization Practices (ACIP) 2007. MMWR Morb. Mortal. Wkly Rep.56(RR-6), 1–60 (2007).
  • US Department of Health and Human Services. Pandemic Influenza Preparedness and Response Plan. Annex 11: lessons learned from 1976 Swine Influenza Program. (2004).
  • Fauci AS. Race against time. Nature435(7041), 423–424 (2005).
  • Wood JM, Robertson JS. From lethal virus to life-saving vaccine: developing inactivated vaccines for pandemic influenza. Nat. Rev. Microbiol.2(10), 842–847 (2004).
  • Sheets R, Petricciani J. Vaccine cell substrates 2004. Expert Rev. Vaccines3(6), 633–638 (2004).
  • Ellenberg SS, Chen RT. The complicated task of monitoring vaccine safety. Public Health Rep.112(1), 10–20; discussion 21 (1997).
  • Enserink M. Avian influenza. ‘Pandemic vaccine’ appears to protect only at high doses. Science309(5737), 996 (2005).
  • Fritzell B. Detection of adverse events: what are the current sensitivity limits during clinical development. Vaccine20, S47–S48 (2002).
  • Bohlke K, Davis RL, Marcy SM et al. Risk of anaphylaxis after vaccination of children and adolescents. Pediatrics112(4), 815–20 (2003).
  • Haber P, DeStefano F, Angulo F et al. Guillain–Barré syndrome following influenza vaccination. JAMA292(20), 2478–2481 (2004).
  • Lasky T, Terracciano GJ, Magder L et al. The Guillain–Barré syndrome and the 1992–1993 and 1993–1994 influenza vaccines. N. Engl. J. Med.339, 1797–1802 (1998).
  • Arness MK, Eckart RE, Love SS et al. Myopericarditis following smallpox vaccination. Am. J. Epidemiol.160(7), 642–651 (2004).
  • Halsey N. The science of evaluation of adverse events associated with vaccination. Semin. Pediatr. Infect. Dis.13, 205–214 (2002).
  • Bureau of Infectious Diseases. Oculo-respiratory syndrome in association with the influenza vaccine: Canada, October–November 2000. Can. Commun. Dis. Rep.26(23), 1–2 (2000).
  • Khromova A, Pool V, Chen R. Oculo-respiratory syndrome (ORS) following influenza vaccine – United States, 1990–2002: new or previously unrecognized? Presented at: 2003 Epidemic Intelligence Service Conference. Atlanta, GA, USA, 22–26 April 2003.
  • Schonberger LB, Bregman DJ, Sullivan-Bolyai JZ. Guillain-Barré syndrome following vaccination in the National Influenza Immunization Program, United States, 1976–1977. Am. J. Epidemiol.110(2), 105–123 (1979).
  • Iskander J, Haber P, Herrera G. Monitoring vaccine safety during an influenza pandemic. Yale J. Biol. Med.78(5), 265–275 (2005).
  • Izurieta HS, Haber P, Wise et al. Adverse events reported following live cold-adapted, intranasal influenza vaccine. JAMA294(21), 2720–2725 (2005).
  • Belshe R, Edwards KM, Vesikari T et al. Live attenuated versus inactivated influenza vaccine in infants and young children. N. Engl. J. Med.685–696 (2007).
  • Bergen R, Black S, Lewin E et al. Safety of cold-adapted live attenuated influenza vaccine in a large cohort of children and adolescents. Pediar. Infect. Dis. J.23, 138–144 (2004).
  • Varricchio F, Iskander J, Destefano F et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr. Infect. Dis. J.23, 287–294 (2004).
  • CDC. Intussusception among recipients of rotavirus vaccine – United States, 1998–1999. MMWR Morb. Mortal. Wkly Rep.48, 577–581 (1999).
  • Rosenthal S, Chen RT. Reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am. J. Public Health85, 1706–1709 (1995).
  • Verstraeten T, Baughman AL, Cadwell B et al. Enhancing vaccine safety surveillance: a capture-recapture analysis of intussusception after rotavirus vaccination. Am. J. Epidemiol.154(11), 1006–1012 (2001).
  • Kohl KS, Gidudu J, Bonhoeffer J et al. The development of standardized case definitions and guidelines for adverse events following immunization. Vaccine25(31), 5671–5674 (2007).
  • Zhou W, Pool V, Iskander J et al. Surveillance for safety after immunization: Vaccine Adverse Event Reporting System (VAERS) – United States, 1991–2001. In: CDC surveillance summaries (January 24). MMWR Morb. Mortal. Wkly Rep.52(No. SS-1) (2003).
  • Chen RT, Glasser JW, Rhodes PH et al. The Vaccine Safety Datalink Project: a new tool for improving vaccine safety monitoring in the United States. Pediatrics99, 765–773 (1997).
  • Kramarz P, France EK, Destefano F et al. Population-based study of rotavirus vaccination and intussusception. Pediatr. Infect. Dis. J.20(4), 410–416 (2001).
  • France EK, Glanz JM, Xu S et al. Safety of the trivalent inactivated influenza vaccine among children: a population-based study. Arch. Pediatr. Adolesc. Med.158(11), 1031–1036 (2004).
  • Davis RL, Kolczak M, Lewis E et al. Active surveillance of vaccine safety: a system to detect early signs of adverse events. Epidemiology16(3), 336–341 (2005).
  • Breiman RF, Zanca JA. Of floors and ceilings – defining, assuring, and communicating vaccine safety. Am. J. Public Health87(12), 1919–1920 (1997).
  • Kaplan JE, Katona P, Hurwitz ES et al. Guillain–Barré syndrome in the United States, 1979–1980 and 1980–1981. Lack of an association with influenza vaccination. JAMA248(6), 698–700 (1982).
  • Institute of Medicine. Immunization Safety Review: Influenza Vaccines and Neurological Complications. National Academies Press, Washington, DC, USA (2003).
  • Mutsch M, Zhou W, Rhodes P et al. Use of the inactivated intranasal influenza vaccine and the risk of Bell’s palsy in Switzerland. N. Engl. J. Med.350(9), 896–903 (2004).
  • Couch RB. Nasal vaccination, Escherichia coli enterotoxin, and Bell’s palsy. N. Engl. J. Med.350(9), 860–861 (2004).
  • Zhou W, Pool V, DeStefano F et al. A potential signal of Bell’s palsy after parenteral inactivated influenza vaccines: reports to the Vaccine Adverse Event Reporting System (VAERS) – United States, 1991–2001. Pharmacoepidemiol. Drug Saf.13(8), 505–510 (2004).
  • McMahon A, Iskander J, Haber P et al. Adverse events alter inactivated influenza vaccination among children less than 2 years of age: analysis of reports from the vaccine adverse event reporting system, 1990–2003. Pediatrics115(2), 453–460 (2005).
  • Hambridge SJ, Glanz JM, France EK et al. Safety of trivalent inactivated influenza vaccine in children 6 to 23 months old. JAMA296, 1990–1997 (2006).
  • Pool V, Iskander J. Safety of influenza vaccination during pregnancy. Am. J. Obstet. Gynecol.194, 1200 (2006).
  • CDC. Guillain-Barre syndrome among recipients of Menactra meningococcal conjugate vaccine – United States, June–July 2005. MMWR Morb. Mortal. Wkly54(40), 1023–1025 (2005).
  • Spaeder J, Najjar SS, Gerstenblith G et al. Rapid titration of carvedilol in patients with congestive heart failure: a randomized trial of automated telemedicine versus frequent outpatient clinic visits. Am. Heart J.151(4), 844.e1––844.e10 (2006).
  • Burwen DR, La Voie L, Braun MM, Houck P, Ball R. Evaluating adverse events after vaccination in the Medicare population. Pharmacoepidemiol. Drug Saf.16(7), 753–761 (2007).
  • Rubertone MV, Brundage JF. The Defense Medical Surveillance System and the Department of Defense serum repository: glimpses of the future of public health surveillance. Am. J. Public Health92(12), 1900–1904 (2002).
  • Centers for Disease Control and Prevention. Immunization Registry Progress – United States, 2002. MMWR Morb. Mortal. Wkly Rep.51, 760–762 (2002).
  • Schwarz B, Hinman A, Abramson J. Universal influenza vaccination in the United States: are we ready? Report of a meeting. J. Infect. Dis.194(Suppl. 2), S147–S154 (2006).
  • Payne DC, Franzke LH, Stehr-Green PA et al. Development of the Vaccine Analytic Unit’s research agenda for investigating potential adverse events associated with anthrax vaccine adsorbed. Pharmacoepidemiol. Drug Saf.16(1), 46–54 (2007).

Websites

  • Centers for Disease Control and Prevention: Influenza site www.cdc.gov/flu
  • Food and Drug Administration: Vaccine and Related Biologic Products Advisory Committee (VRPBAC) briefing materials from 16 May 2007 meeting www.fda.gov
  • Food and Drug Administration: VRBPAC Briefing materials from 27 February 2007 meeting www.fda.gov
  • WHO Global Action Plan www.who.int/vaccines-documents/DocsPDF06/863.pdf
  • WHO Global Advisory Committee on Vaccine Safety www.who.int/vaccine_safety/en/
  • The Vaccine Adverse Event Reporting System www.vaers.hhs.gov
  • Centers for Disease Control and Prevention: Clinical Immunization Safety Assessment Network www.cdc.gov/od/science/iso/research_activties/cisa.htm
  • ProMED posting: Vaccines and Guillain–Barré syndrome www.sld.cu/pipermail/farmepi-l/2005-October/001286.html

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