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Adverse events after tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine administered to adults 65 years of age and older reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010.
Vaccine. 2011 Nov 21; 29(50):9404-8.V

Abstract

BACKGROUND

Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine was not licensed for use in adults aged ≥65 years due to lack of sufficient efficacy and safety data.

OBJECTIVE

To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged ≥65 years who received Tdap vaccine 'off-label' to assess for potential vaccine safety concerns.

METHODS

We searched VAERS for US reports of adverse events (AEs) in subjects aged ≥65 years who received Tdap vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports coded as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening-illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after Tdap compared with Td reports in subjects aged ≥65 years.

RESULTS

VAERS received 243 reports following Tdap administered to persons aged ≥65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after Tdap compared with Td. Six of seven Tdap reports containing the term 'Cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs.

CONCLUSION

Our VAERS review of the 'off-label' use of Tdap vaccine in adults ≥65 years did not find any safety concerns that warrant further study. These data will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for Tdap in older persons are adopted.

Authors+Show Affiliations

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. psm9@cdc.govNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

21920404

Citation

Moro, Pedro L., et al. "Adverse Events After Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Administered to Adults 65 Years of Age and Older Reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010." Vaccine, vol. 29, no. 50, 2011, pp. 9404-8.
Moro PL, Yue X, Lewis P, et al. Adverse events after tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine administered to adults 65 years of age and older reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010. Vaccine. 2011;29(50):9404-8.
Moro, P. L., Yue, X., Lewis, P., Haber, P., & Broder, K. (2011). Adverse events after tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine administered to adults 65 years of age and older reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010. Vaccine, 29(50), 9404-8. https://doi.org/10.1016/j.vaccine.2011.05.100
Moro PL, et al. Adverse Events After Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Administered to Adults 65 Years of Age and Older Reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010. Vaccine. 2011 Nov 21;29(50):9404-8. PubMed PMID: 21920404.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Adverse events after tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine administered to adults 65 years of age and older reported to the Vaccine Adverse Event Reporting System (VAERS), 2005-2010. AU - Moro,Pedro L, AU - Yue,Xin, AU - Lewis,Paige, AU - Haber,Penina, AU - Broder,Karen, Y1 - 2011/09/13/ PY - 2011/05/13/received PY - 2011/05/27/revised PY - 2011/05/31/accepted PY - 2011/9/17/entrez PY - 2011/9/17/pubmed PY - 2012/4/11/medline SP - 9404 EP - 8 JF - Vaccine JO - Vaccine VL - 29 IS - 50 N2 - BACKGROUND: Tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine was not licensed for use in adults aged ≥65 years due to lack of sufficient efficacy and safety data. OBJECTIVE: To characterize reports to the Vaccine Adverse Event Reporting System (VAERS) among adults aged ≥65 years who received Tdap vaccine 'off-label' to assess for potential vaccine safety concerns. METHODS: We searched VAERS for US reports of adverse events (AEs) in subjects aged ≥65 years who received Tdap vaccine from 9/1/2005 to 9/08/2010. Medical records were requested for all reports coded as serious (death, hospitalization, prolonged hospitalization, permanent disability, life-threatening-illness). Proportional reporting ratio (PRR) was used to assess for higher proportionate reporting for AEs after Tdap compared with Td reports in subjects aged ≥65 years. RESULTS: VAERS received 243 reports following Tdap administered to persons aged ≥65 years. Eleven (4.5%) reports were serious, including two deaths. Most common AEs were local reactions in 100 (41.2%) reports. Seventy-eight (32.1%) reports contained coding terms that denoted inappropriate administration of vaccine. 'Cough' was the only term associated with disproportionately higher reporting after Tdap compared with Td. Six of seven Tdap reports containing the term 'Cough' were non-serious. Clinical review of serious reports identified no unusual patterns of AEs. CONCLUSION: Our VAERS review of the 'off-label' use of Tdap vaccine in adults ≥65 years did not find any safety concerns that warrant further study. These data will provide useful baseline information to assist CDC and FDA with monitoring efforts as permissive recommendations for Tdap in older persons are adopted. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/21920404/Adverse_events_after_tetanus_toxoid_reduced_diphtheria_toxoid_and_acellular_pertussis__Tdap__vaccine_administered_to_adults_65_years_of_age_and_older_reported_to_the_Vaccine_Adverse_Event_Reporting_System__VAERS__2005_2010_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(11)01405-8 DB - PRIME DP - Unbound Medicine ER -