Tags

Type your tag names separated by a space and hit enter

Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) in adults aged ≥65 years, Vaccine Adverse Event reporting System (VAERS), United States, September 2010-December 2018.
Vaccine. 2020 02 05; 38(6):1476-1480.V

Abstract

INTRODUCTION

The Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons ≥65 years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group.

METHODS

We searched for and analyzed U.S. VAERS reports of Tdap among individuals ≥65 years of age submitted from September 1, 2010 through December 31, 2018. We classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, we reviewed available medical records. Data mining analyses were undertaken to detect disproportionality in reporting.

RESULTS

VAERS received a total of 1,798 reports following Tdap, of which 104 (6%) were serious. The most common AEs were injection site erythema (26%; n = 468), injection site pain (19%; n = 335), injection site swelling (18%; n = 329), and erythema (18%; n = 321). We identified seven deaths; none were attributed to Tdap. Among serious non-death reports, nervous system disorders (35.1%; n = 34) and infections and infestations (n = 18.6%; n = 18) were most commonly reported. Data mining did not identify any vaccine-AE combination reported more frequently than expected.

CONCLUSIONS

We did not identify any new safety concern over nearly a decade of recommended Tdap use among adults ≥65 years of age. Findings from this post-marketing review are consistent with prior post-marketing observations and pre-licensure studies.

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, United States. Electronic address: phaber@cdc.gov.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States.Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, United States.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention, United States.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31883809

Citation

Haber, Penina, et al. "Safety Review of Tetanus Toxoid, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccines (Tdap) in Adults Aged ≥65 Years, Vaccine Adverse Event Reporting System (VAERS), United States, September 2010-December 2018." Vaccine, vol. 38, no. 6, 2020, pp. 1476-1480.
Haber P, Moro PL, Ng C, et al. Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) in adults aged ≥65 years, Vaccine Adverse Event reporting System (VAERS), United States, September 2010-December 2018. Vaccine. 2020;38(6):1476-1480.
Haber, P., Moro, P. L., Ng, C., Dores, G. M., Perez-Vilar, S., Marquez, P. L., & Cano, M. (2020). Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) in adults aged ≥65 years, Vaccine Adverse Event reporting System (VAERS), United States, September 2010-December 2018. Vaccine, 38(6), 1476-1480. https://doi.org/10.1016/j.vaccine.2019.11.074
Haber P, et al. Safety Review of Tetanus Toxoid, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccines (Tdap) in Adults Aged ≥65 Years, Vaccine Adverse Event Reporting System (VAERS), United States, September 2010-December 2018. Vaccine. 2020 02 5;38(6):1476-1480. PubMed PMID: 31883809.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Safety review of tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) in adults aged ≥65 years, Vaccine Adverse Event reporting System (VAERS), United States, September 2010-December 2018. AU - Haber,Penina, AU - Moro,Pedro L, AU - Ng,Carmen, AU - Dores,Graça M, AU - Perez-Vilar,Silvia, AU - Marquez,Paige L, AU - Cano,Maria, Y1 - 2019/12/26/ PY - 2019/08/13/received PY - 2019/11/26/revised PY - 2019/11/27/accepted PY - 2019/12/31/pubmed PY - 2021/3/9/medline PY - 2019/12/30/entrez KW - Post-licensure surveillance KW - Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccines (Tdap) KW - Vaccine Adverse Event Reporting System KW - Vaccine safety SP - 1476 EP - 1480 JF - Vaccine JO - Vaccine VL - 38 IS - 6 N2 - INTRODUCTION: The Advisory Committee on Immunization Practices (ACIP) recommends vaccination with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in persons ≥65 years of age. To date, few studies have assessed the safety of Tdap in this population. We aimed to summarize reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following receipt of Tdap in this age group. METHODS: We searched for and analyzed U.S. VAERS reports of Tdap among individuals ≥65 years of age submitted from September 1, 2010 through December 31, 2018. We classified reports according to concurrent vaccination, seriousness, and outcome (death, non-death) and determined the frequency of reported adverse events (AEs). For serious reports, we reviewed available medical records. Data mining analyses were undertaken to detect disproportionality in reporting. RESULTS: VAERS received a total of 1,798 reports following Tdap, of which 104 (6%) were serious. The most common AEs were injection site erythema (26%; n = 468), injection site pain (19%; n = 335), injection site swelling (18%; n = 329), and erythema (18%; n = 321). We identified seven deaths; none were attributed to Tdap. Among serious non-death reports, nervous system disorders (35.1%; n = 34) and infections and infestations (n = 18.6%; n = 18) were most commonly reported. Data mining did not identify any vaccine-AE combination reported more frequently than expected. CONCLUSIONS: We did not identify any new safety concern over nearly a decade of recommended Tdap use among adults ≥65 years of age. Findings from this post-marketing review are consistent with prior post-marketing observations and pre-licensure studies. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/31883809/Safety_review_of_tetanus_toxoid_reduced_diphtheria_toxoid_acellular_pertussis_vaccines__Tdap__in_adults_aged_≥65_years_Vaccine_Adverse_Event_reporting_System__VAERS__United_States_September_2010_December_2018_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(19)31628-7 DB - PRIME DP - Unbound Medicine ER -