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Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015.
Vaccine. 2016 12 07; 34(50):6330-6334.V

Abstract

BACKGROUND

The 13-valent pneumococcal conjugate vaccine (PCV13) was first recommended for use in adults aged ⩾19years with immunocompromising conditions in June 2012. On August 2014, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 among adults aged ⩾65years.

METHODS

We assessed adverse events (AEs) reports following PCV13 in adults aged ⩾19years reported to the Vaccine Adverse Event Reporting System (VAERS) from June 2012 to December 2015. VAERS is a national spontaneous reporting system for monitoring AEs following vaccination. Our assessment included automated data analysis, clinical review of all serious reports and reports of special interest. We conducted empirical Bayesian data mining to assess for disproportionate reporting.

RESULTS

VAERS received 2976 US PCV13 adult reports; 2103 (71%) of these reports were from PCV13 administered alone. Fourteen percent were in persons aged 19-64years and 86% were in persons aged ⩾65years. Injection site erythema (28%), injection site pain (24%) and fever (22%) were the most frequent AEs among persons aged 19-64years; injection site erythema (30%), erythema (20%) and injection site swelling (18%) were the most frequent among persons aged ⩾65years who were given the vaccine alone. The most frequently reported AEs among non-death serious reports were injection site reactions and general malaise among persons 19-64years old; injection site reactions, general malaise and Guillain-Barré syndrome among those ⩾65years (Table 2). Data mining did not detect disproportional reporting for any unexpected AE.

CONCLUSIONS

The results of this study were consistent with safety data from pre-licensure studies of PCV13. We did not detect any new or unexpected AEs.

Authors+Show Affiliations

Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, United States. Electronic address: PHaber@cdc.gov.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, United States.National Center for Immunization and Respiratory Diseases (NCIRD), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, United States.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, United States.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, United States.Immunization Safety Office, Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and Prevention (CDC), 1600 Clifton Rd NE, Atlanta, GA 30329, United States.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27836437

Citation

Haber, Penina, et al. "Post-licensure Surveillance of 13-valent Pneumococcal Conjugate Vaccine (PCV13) in Adults Aged ⩾19years Old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015." Vaccine, vol. 34, no. 50, 2016, pp. 6330-6334.
Haber P, Arana J, Pilishvili T, et al. Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015. Vaccine. 2016;34(50):6330-6334.
Haber, P., Arana, J., Pilishvili, T., Lewis, P., Moro, P. L., & Cano, M. (2016). Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015. Vaccine, 34(50), 6330-6334. https://doi.org/10.1016/j.vaccine.2016.10.052
Haber P, et al. Post-licensure Surveillance of 13-valent Pneumococcal Conjugate Vaccine (PCV13) in Adults Aged ⩾19years Old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015. Vaccine. 2016 12 7;34(50):6330-6334. PubMed PMID: 27836437.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-licensure surveillance of 13-valent pneumococcal conjugate vaccine (PCV13) in adults aged ⩾19years old in the United States, Vaccine Adverse Event Reporting System (VAERS), June 1, 2012-December 31, 2015. AU - Haber,Penina, AU - Arana,Jorge, AU - Pilishvili,Tamara, AU - Lewis,Paige, AU - Moro,Pedro L, AU - Cano,Maria, Y1 - 2016/11/09/ PY - 2016/07/14/received PY - 2016/10/17/revised PY - 2016/10/19/accepted PY - 2016/11/12/pubmed PY - 2017/12/16/medline PY - 2016/11/13/entrez KW - 13-Valent pneumococcal conjugate vaccine (PCV13) KW - Post-licensure surveillance KW - Vaccine safety SP - 6330 EP - 6334 JF - Vaccine JO - Vaccine VL - 34 IS - 50 N2 - BACKGROUND: The 13-valent pneumococcal conjugate vaccine (PCV13) was first recommended for use in adults aged ⩾19years with immunocompromising conditions in June 2012. On August 2014, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of PCV13 among adults aged ⩾65years. METHODS: We assessed adverse events (AEs) reports following PCV13 in adults aged ⩾19years reported to the Vaccine Adverse Event Reporting System (VAERS) from June 2012 to December 2015. VAERS is a national spontaneous reporting system for monitoring AEs following vaccination. Our assessment included automated data analysis, clinical review of all serious reports and reports of special interest. We conducted empirical Bayesian data mining to assess for disproportionate reporting. RESULTS: VAERS received 2976 US PCV13 adult reports; 2103 (71%) of these reports were from PCV13 administered alone. Fourteen percent were in persons aged 19-64years and 86% were in persons aged ⩾65years. Injection site erythema (28%), injection site pain (24%) and fever (22%) were the most frequent AEs among persons aged 19-64years; injection site erythema (30%), erythema (20%) and injection site swelling (18%) were the most frequent among persons aged ⩾65years who were given the vaccine alone. The most frequently reported AEs among non-death serious reports were injection site reactions and general malaise among persons 19-64years old; injection site reactions, general malaise and Guillain-Barré syndrome among those ⩾65years (Table 2). Data mining did not detect disproportional reporting for any unexpected AE. CONCLUSIONS: The results of this study were consistent with safety data from pre-licensure studies of PCV13. We did not detect any new or unexpected AEs. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/27836437/Post_licensure_surveillance_of_13_valent_pneumococcal_conjugate_vaccine__PCV13__in_adults_aged_⩾19years_old_in_the_United_States_Vaccine_Adverse_Event_Reporting_System__VAERS__June_1_2012_December_31_2015_ DB - PRIME DP - Unbound Medicine ER -