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Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013.
Vaccine. 2016 05 27; 34(25):2841-6.V

Abstract

BACKGROUND

23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted.

OBJECTIVE

To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile.

METHODS

We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting.

RESULTS

During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining.

CONCLUSIONS

We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies.

Authors+Show Affiliations

Immunization Safety Office, Centers for Disease Control and Prevention, United States. Electronic address: EMiller@cdc.gov.Immunization Safety Office, Centers for Disease Control and Prevention, United States.Immunization Safety Office, Centers for Disease Control and Prevention, United States.Immunization Safety Office, Centers for Disease Control and Prevention, United States.Center for Biologics Evaluation and Research, US Food and Drug Administration, United States.Immunization Safety Office, Centers for Disease Control and Prevention, United States.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27087150

Citation

Miller, Elaine R., et al. "Post-licensure Safety Surveillance of 23-valent Pneumococcal Polysaccharide Vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013." Vaccine, vol. 34, no. 25, 2016, pp. 2841-6.
Miller ER, Moro PL, Cano M, et al. Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013. Vaccine. 2016;34(25):2841-6.
Miller, E. R., Moro, P. L., Cano, M., Lewis, P., Bryant-Genevier, M., & Shimabukuro, T. T. (2016). Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013. Vaccine, 34(25), 2841-6. https://doi.org/10.1016/j.vaccine.2016.04.021
Miller ER, et al. Post-licensure Safety Surveillance of 23-valent Pneumococcal Polysaccharide Vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013. Vaccine. 2016 05 27;34(25):2841-6. PubMed PMID: 27087150.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-licensure safety surveillance of 23-valent pneumococcal polysaccharide vaccine in the Vaccine Adverse Event Reporting System (VAERS), 1990-2013. AU - Miller,Elaine R, AU - Moro,Pedro L, AU - Cano,Maria, AU - Lewis,Paige, AU - Bryant-Genevier,Marthe, AU - Shimabukuro,Tom T, Y1 - 2016/04/15/ PY - 2015/11/25/received PY - 2016/04/06/revised PY - 2016/04/07/accepted PY - 2016/4/19/entrez PY - 2016/4/19/pubmed PY - 2017/10/17/medline KW - 23-Valent pneumococcal polysaccharide vaccine KW - Immunizations KW - Surveillance KW - Vaccine Adverse Event Reporting System (VAERS) KW - Vaccine safety KW - Vaccines SP - 2841 EP - 6 JF - Vaccine JO - Vaccine VL - 34 IS - 25 N2 - BACKGROUND: 23-Valent pneumococcal polysaccharide vaccine, trade name Pneumovax(®)23 (PPSV23), has been used for decades in the Unites States and has an extensive clinical record. However, limited post-licensure safety assessment has been conducted. OBJECTIVE: To analyze reports submitted to the Vaccine Adverse Event Reporting System (VAERS) following PPSV23 from 1990 to 2013 in order to characterize its safety profile. METHODS: We searched the VAERS database for US reports following PPSV23 for persons vaccinated from 1990 to 2013. We assessed safety through: automated analysis of VAERS data, crude adverse event (AE) reporting rates based on PPSV23 doses distributed in the US market, clinical review of death reports and reports involving vaccine administered to pregnant women, and empirical Bayesian data mining to assess for disproportional reporting. RESULTS: During the study period, VAERS received 25,168 PPSV23 reports; 92% were non-serious, 67% were in females and 86% were in adults aged ≥19 years. When PPSV23 was administered alone, fever (43%), injection site erythema (28%) and injection site pain (25%) were the most commonly reported non-serious AEs in children. Injection site erythema (32%), injection site pain (27%) and injection site swelling (23%) were the most commonly reported non-serious AEs in adults. Of serious reports (2129, 8% of total), fever was most commonly reported in both children (69%) and adults (39%). There were 66 reports of death, four in children and 62 in adults. Clinical review of death reports did not reveal any concerning patterns that would suggest a causal association with PPSV23. No disproportional reporting of unexpected AEs was observed in empirical Bayesian data mining. CONCLUSIONS: We did not identify any new or unexpected safety concerns for PPSV23. The VAERS data are consistent with safety data from pre-licensure clinical trials and other post-licensure studies. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/27087150/Post_licensure_safety_surveillance_of_23_valent_pneumococcal_polysaccharide_vaccine_in_the_Vaccine_Adverse_Event_Reporting_System__VAERS__1990_2013_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(16)30150-5 DB - PRIME DP - Unbound Medicine ER -