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The Safety of Acellular Pertussis Vaccine vs Whole-Cell Pertussis Vaccine:  A Postmarketing Assessment FREE

Steven Rosenthal, MD, MPH; Robert Chen, MD, MA; Stephen Hadler, MD
Arch Pediatr Adolesc Med. 1996;150(5):457-460. doi:10.1001/archpedi.1996.02170300011001.
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Objective:  To determine the impact of the introduction of acellular pertussis vaccine for the fourth and fifth doses of the diphtheria and tetanus toxoids and pertussis vaccine series in children on rates of reported vaccine-associated adverse events in the United States.

Design:  Analysis of postmarketing vaccine adverse event data from the Vaccine Adverse Event Reporting System during the years 1991 to 1993.

Population Studied:  Approximately 27 million doses of diphtheria and tetanus toxoids and pertussis vaccine and 5 million doses of diphtheria and tetanus toxoids and acellular pertussis vaccine were distributed from 1991 to 1993 to children 15 months to 7 years of age.

Main Outcome Measures:  Rates of reported fever, seizures, and hospitalizations after pertussis vaccination.

Results:  Rates of reported adverse events per 100 000 vaccinations were significantly lower after administration of diphtheria and tetanus toxoids and acellular pertussis vaccine than diphtheria and tetanus toxoids and pertussis vaccine for the following outcomes: all reports, 2.9 vs 9.8; fever, 1.9 vs 7.5; seizures, 0.5 vs 1.7; and hospitalizations, 0.2 vs 0.9.

Conclusions:  These results confirm that minor adverse events are less frequent after administration of the acellular pertussis vaccine. In addition, these data suggested that seizures and hospitalizations associated with pertussis vaccination are less frequent after administration of the acellular pertussis vaccine in age groups for which it is now recommended.(Arch Pediatr Adolesc Med. 1996;150:457-460)

REFERENCES

Centers for Disease Control and Prevention.  Food and Drug Administration approval of use of diphtheria and tetanus toxoids and acellular pertussis vaccine . MMWR Morb Mortal Wkly Rep . 1991;;40:881-882.
Centers for Disease Control and Prevention.  Pertussis vaccination: acellular pertussis vaccine for the fourth and fifth doses of the DTP series: update to supplementary ACIP statement . MMWR Morb Mortal Wkly Rep . 1992;;41 (RR-15):1-5.
Mortimer EA, Kimura M, Cherry JD, et al.  Protective efficacy of the Takeda acellular pertussis vaccine combined with diphtheria and tetanus toxoids following household exposure of Japanese children . AJDC . 1990;;144:899-904.
Marwick C.  Changes ahead in childhood immunization . JAMA . 1996;;275:582.
Adverse Effects of Pertussis and Rubella Vaccines . Washington, DC: National Academy Press; 1991;.
Centers for Disease Control and Prevention.  Pertussis vaccination: acellular pertussis vaccine for reinforcing and booster use: supplementary ACIP statement. Recommendations of the Immunization Practices Advisory Committee (ACIP) . MMWR Morb Mortal Wkly Rep . 1992;;41(RR-1):1-10.
Black S, Shinefield H, Lewis N, Ray P, Hiatt R, Fireman B.  Decreased local/systemic side effects and emergency room utilization following dPDT in toddlers and preschoolers when compared with wDTP . Pediatr Res . 1993;;33: 163A.
Chen RT.  Special methodological issues in pharmacoepidemiology studies of vaccine safety . In: Strom BL, ed. Pharmacoepidemiology . 2nd ed. Chichester, England: John Wiley & Sons Ltd; 1994;:581-594.
Chen RT, Rastogi SC, Mullen JR, et al.  The Vaccine Adverse Event Reporting System (VAERS) . Vaccine . 1994;;12:542-550.
Centers for Disease Control and Prevention. Adverse Events Following Immunization Surveillance Report No. 3, 1985-1986 . Atlanta, Ga: Centers for Disease Control and Prevention; February 1989;.
Griffin MR, Ray WA, Mortimer EA, Fenichel GM, Schaffner W.  Risk of seizures after measles-mumps-rubella immunization . Pediatrics . 1991;;88:881-885.
Pollock TM, Morris J.  A seven-year survey of disorders attributed to vaccination in North West Thames Region . Lancet . 1983;;1:753-757.
Laboratory Centre for Disease Control. Proceedings of a Workshop on the Standardization of Definitions for Post-Marketing Surveillance of Adverse Vaccine Reactions, Ottawa, Canada, October 30-31, 1991. Ottawa, Ontario: Laboratory Centre for Disease Control; 1991:1-17.
Cherry JD.  The epidemiology of pertussis and pertussis vaccine in the United Kingdom and the United States: a comparative study . Curr Probl Pediatr . 1984;; 14:1-78.
Kanai K.  Japan's experience in pertussis epidemiology and vaccination in the past thirty years . Jpn J Sci Biol . 1980;;33:107-143.
Romanus V, Jonsell R, Bergquist SO.  Pertussis in Sweden after the cessation of general immunization in 1979 . Pediatr Infect Dis J . 1987;;6:664-671.
42 US Code, Sec 300aa-28.
Kato T, Goshima T, Nakajima N, et al.  Protection against pertussis vs acellular pertussis vaccines (Takeda, Japan): household contact studies in Kawasaki City, Japan . Acta Paediatr Jpn . 1989;;31:698-701.

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References

Centers for Disease Control and Prevention.  Food and Drug Administration approval of use of diphtheria and tetanus toxoids and acellular pertussis vaccine . MMWR Morb Mortal Wkly Rep . 1991;;40:881-882.
Centers for Disease Control and Prevention.  Pertussis vaccination: acellular pertussis vaccine for the fourth and fifth doses of the DTP series: update to supplementary ACIP statement . MMWR Morb Mortal Wkly Rep . 1992;;41 (RR-15):1-5.
Mortimer EA, Kimura M, Cherry JD, et al.  Protective efficacy of the Takeda acellular pertussis vaccine combined with diphtheria and tetanus toxoids following household exposure of Japanese children . AJDC . 1990;;144:899-904.
Marwick C.  Changes ahead in childhood immunization . JAMA . 1996;;275:582.
Adverse Effects of Pertussis and Rubella Vaccines . Washington, DC: National Academy Press; 1991;.
Centers for Disease Control and Prevention.  Pertussis vaccination: acellular pertussis vaccine for reinforcing and booster use: supplementary ACIP statement. Recommendations of the Immunization Practices Advisory Committee (ACIP) . MMWR Morb Mortal Wkly Rep . 1992;;41(RR-1):1-10.
Black S, Shinefield H, Lewis N, Ray P, Hiatt R, Fireman B.  Decreased local/systemic side effects and emergency room utilization following dPDT in toddlers and preschoolers when compared with wDTP . Pediatr Res . 1993;;33: 163A.
Chen RT.  Special methodological issues in pharmacoepidemiology studies of vaccine safety . In: Strom BL, ed. Pharmacoepidemiology . 2nd ed. Chichester, England: John Wiley & Sons Ltd; 1994;:581-594.
Chen RT, Rastogi SC, Mullen JR, et al.  The Vaccine Adverse Event Reporting System (VAERS) . Vaccine . 1994;;12:542-550.
Centers for Disease Control and Prevention. Adverse Events Following Immunization Surveillance Report No. 3, 1985-1986 . Atlanta, Ga: Centers for Disease Control and Prevention; February 1989;.
Griffin MR, Ray WA, Mortimer EA, Fenichel GM, Schaffner W.  Risk of seizures after measles-mumps-rubella immunization . Pediatrics . 1991;;88:881-885.
Pollock TM, Morris J.  A seven-year survey of disorders attributed to vaccination in North West Thames Region . Lancet . 1983;;1:753-757.
Laboratory Centre for Disease Control. Proceedings of a Workshop on the Standardization of Definitions for Post-Marketing Surveillance of Adverse Vaccine Reactions, Ottawa, Canada, October 30-31, 1991. Ottawa, Ontario: Laboratory Centre for Disease Control; 1991:1-17.
Cherry JD.  The epidemiology of pertussis and pertussis vaccine in the United Kingdom and the United States: a comparative study . Curr Probl Pediatr . 1984;; 14:1-78.
Kanai K.  Japan's experience in pertussis epidemiology and vaccination in the past thirty years . Jpn J Sci Biol . 1980;;33:107-143.
Romanus V, Jonsell R, Bergquist SO.  Pertussis in Sweden after the cessation of general immunization in 1979 . Pediatr Infect Dis J . 1987;;6:664-671.
42 US Code, Sec 300aa-28.
Kato T, Goshima T, Nakajima N, et al.  Protection against pertussis vs acellular pertussis vaccines (Takeda, Japan): household contact studies in Kawasaki City, Japan . Acta Paediatr Jpn . 1989;;31:698-701.

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