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A Randomized Controlled Trial of Influenza Vaccine in the Elderly: Title and subTitle BreakScientific Scrutiny and Ethical Responsibility FREE

Peter A. Patriarca, MD
[+] Author Affiliations

Corresponding author: Peter A. Patriarca, MD, Food and Drug Administration, HFM-30, 1401 Rockville Pike, Rockville, MD 20852.


JAMA. 1994;272(21):1700-1701. doi:10.1001/jama.1994.03520210084039
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Influenza viruses have arguably caused more morbidity and mortality than any infectious agent in recorded history. Seven pandemics of influenza have occurred during the past century alone, one of which—the infamous Spanish (swine) flu—was responsible for at least 20 million deaths worldwide. Of even greater concern has been the occurrence of annual epidemics of varying severity that have resulted in more than 599 000 excess deaths in the United States during the past 40 years.1-3 Although complacency regarding influenza is widely prevalent owing to the misperception that it is simply a mild respiratory or gastrointestinal infection,2 one needs only to briefly examine accounts of recent outbreaks to appreciate the explosive potential for influenza viruses to cause life-threatening illness.4 The unusual properties of the virus' genome, including a high frequency of point mutations (which cause the hemagglutinin [HA] and neuraminidase [NA] molecules to drift

See also p 1661.

REFERENCES

Couch RB, Kasal TR, Glezen WP, et al.  Influenza: its control in persons and populations. J Infect Dis . 1986;;153:431-440.
Glezen WP.  Serious morbidity and mortality associated with influenza epidemics. Epidemiol Rev . 1982;;4:25-44.
Williams WW, Hickson MA, Kane MA, Kendal AP, Spika JS, Hinman AR.  Immunization policies and vaccine coverage among adults: the risk of missed opportunities. Ann Intern Med . 1988;;108:616-625.
Strassburg MA, Greenland S, Sorvillo FJ, Lieb LE, Habel LA.  Influenza in the elderly: report of an outbreak and a review of vaccine effectiveness reports. Vaccine . 1986;;4:38-44.
Eickhoff TC, Sherman IL, Serfling RE.  Observations on excess mortality associated with epidemic influenza. JAMA . 1961;;176:776-782.
Advisory Committee on Immunization Practices (ACIP).  Prevention and Control of influenza: part I, vaccines. MMWR Morb Mortal Wkly Rep . 1994;;43( (RR-9) ):1-13.
Dutch Health Council Committee on Vaccination Against Influenza. Vaccination Against Influenza: 1991-1992 Season . The Hague, the Netherlands: Dutch Health Council; 1991;:15.
Monto AS.  Influenza vaccines for the elderly. N Engl J Med . 1994;;331:807-808.
Govaert ThME, Thijs CTMCN, Masurel N, Sprenger MJW, Dinant GJ, Knottnerus JA.  The efficacy of influenza vaccination in elderly individuals: a randomized double-blind placebo-controlled trial. JAMA . 1994;;272:1661-1665.
Barker WH, Mullooly JP.  Effectiveness of inactivated influenza vaccine among non-institutionalized elderly persons.  In: Kendal AP, Patriarca PA, eds. Options for the Control of Influenza . New York, NY: Alan R Liss Inc; 1986;:169-182.
Patriarca PA, Weber JA, Parker RA, et al.  Efficacy of influenza vaccine in nursing homes: reduction in illness and complications during an influenza A (H3N2) epidemic. JAMA . 1985;;253:1136-1139.
Saah AJ, Neufield R, Rodstein M, et al.  Influenza vaccine and pneumonia mortality in a nursing home population. Arch Intern Med . 1986;;146:2353-2357.
Gross PA, Quinnan GV, Rodstein M, et al.  Association of influenza immunization with reduction in mortality in an elderly population. Arch Intern Med . 1988;;148:562-565.
Couch RB.  Advances in influenza virus vaccine research. Ann N Y Acad Sci . 1993;;685:803-812.
Couch RB, Kasal JA.  Immunity to influenza in man. Annu Rev Microbiol . 1983;; 37:529-549.
Gross PA, Hermogenes A, Sacks HS, Levandowski RA.  The protective efficacy of influenza vaccine in the elderly: a meta-analysis.  In: Abstracts of the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy (October 7, 1994; Orlando, Fla) . Washington, DC: American Society for Microbiology; 1994;:265.
Nichol KL, Margolis KL, Wuorenma J, Von Sternberg T.  The efficacy and cost-effectiveness of vaccination against influenza among elderly persons living in the community. N Engl J Med . 1994;;331:778-784.
Mullooly JP, Bennett MD, Hornbrook MC, et al.  Cost-effectiveness of influenza programs for the elderly in a health maintenance organization. Ann Intern Med . In press.
Office of Technology Assessment. Cost-effectiveness of Influenza Vaccination . Washington, DC: Office of Technology Assessment; 1981;.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

Couch RB, Kasal TR, Glezen WP, et al.  Influenza: its control in persons and populations. J Infect Dis . 1986;;153:431-440.
Glezen WP.  Serious morbidity and mortality associated with influenza epidemics. Epidemiol Rev . 1982;;4:25-44.
Williams WW, Hickson MA, Kane MA, Kendal AP, Spika JS, Hinman AR.  Immunization policies and vaccine coverage among adults: the risk of missed opportunities. Ann Intern Med . 1988;;108:616-625.
Strassburg MA, Greenland S, Sorvillo FJ, Lieb LE, Habel LA.  Influenza in the elderly: report of an outbreak and a review of vaccine effectiveness reports. Vaccine . 1986;;4:38-44.
Eickhoff TC, Sherman IL, Serfling RE.  Observations on excess mortality associated with epidemic influenza. JAMA . 1961;;176:776-782.
Advisory Committee on Immunization Practices (ACIP).  Prevention and Control of influenza: part I, vaccines. MMWR Morb Mortal Wkly Rep . 1994;;43( (RR-9) ):1-13.
Dutch Health Council Committee on Vaccination Against Influenza. Vaccination Against Influenza: 1991-1992 Season . The Hague, the Netherlands: Dutch Health Council; 1991;:15.
Monto AS.  Influenza vaccines for the elderly. N Engl J Med . 1994;;331:807-808.
Govaert ThME, Thijs CTMCN, Masurel N, Sprenger MJW, Dinant GJ, Knottnerus JA.  The efficacy of influenza vaccination in elderly individuals: a randomized double-blind placebo-controlled trial. JAMA . 1994;;272:1661-1665.
Barker WH, Mullooly JP.  Effectiveness of inactivated influenza vaccine among non-institutionalized elderly persons.  In: Kendal AP, Patriarca PA, eds. Options for the Control of Influenza . New York, NY: Alan R Liss Inc; 1986;:169-182.
Patriarca PA, Weber JA, Parker RA, et al.  Efficacy of influenza vaccine in nursing homes: reduction in illness and complications during an influenza A (H3N2) epidemic. JAMA . 1985;;253:1136-1139.
Saah AJ, Neufield R, Rodstein M, et al.  Influenza vaccine and pneumonia mortality in a nursing home population. Arch Intern Med . 1986;;146:2353-2357.
Gross PA, Quinnan GV, Rodstein M, et al.  Association of influenza immunization with reduction in mortality in an elderly population. Arch Intern Med . 1988;;148:562-565.
Couch RB.  Advances in influenza virus vaccine research. Ann N Y Acad Sci . 1993;;685:803-812.
Couch RB, Kasal JA.  Immunity to influenza in man. Annu Rev Microbiol . 1983;; 37:529-549.
Gross PA, Hermogenes A, Sacks HS, Levandowski RA.  The protective efficacy of influenza vaccine in the elderly: a meta-analysis.  In: Abstracts of the 34th Interscience Conference on Antimicrobial Agents and Chemotherapy (October 7, 1994; Orlando, Fla) . Washington, DC: American Society for Microbiology; 1994;:265.
Nichol KL, Margolis KL, Wuorenma J, Von Sternberg T.  The efficacy and cost-effectiveness of vaccination against influenza among elderly persons living in the community. N Engl J Med . 1994;;331:778-784.
Mullooly JP, Bennett MD, Hornbrook MC, et al.  Cost-effectiveness of influenza programs for the elderly in a health maintenance organization. Ann Intern Med . In press.
Office of Technology Assessment. Cost-effectiveness of Influenza Vaccination . Washington, DC: Office of Technology Assessment; 1981;.
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