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Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015.
Vaccine. 2018 03 20; 36(13):1781-1788.V

Abstract

BACKGROUND

The Food and Drug Administration (FDA) approved quadrivalent human papillomavirus vaccine (4vHPV) for use in females and males aged 9-26 years, since 2006 and 2009 respectively. We characterized reports to the Vaccine Adverse Event Reporting System (VAERS), a US spontaneous reporting system, in females and males who received 4vHPV vaccination.

METHODS

We searched VAERS for US reports of adverse events (AEs) following 4vHPV from January 2009 through December 2015. Signs and symptoms were coded using Medical Dictionary for Regulatory Activities (MedDRA). We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reports. Clinicians reviewed available information, including medical records, and reports of selected pre-specified conditions.

FINDINGS

VAERS received 19,760 reports following 4vHPV; 60.2% in females, 17.2% in males, and in 22.6% sex was missing. Overall, 94.2% of reports were non-serious; dizziness, syncope and injection site reactions were commonly reported in both males and females. Headache, fatigue and nausea were commonly reported serious AEs. More than 60 million 4vHPV doses were distributed during the study period. Crude AE reporting rates were 327 reports per million 4vHPV doses distributed for all reports, and 19 per million for serious reports. Among 29 verified reports of death, there was no pattern of clustering of deaths by diagnosis, co-morbidities, age, or interval from vaccination to death.

INTERPRETATION

No new or unexpected safety concerns or reporting patterns of 4vHPV with clinically important AEs were detected. Safety profile of 4vHPV is consistent with data from pre-licensure trials and postmarketing safety data.

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: JArana@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.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, US 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.Division of Viral Diseases, National Center for Immunization and Respiratory 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

29477308

Citation

Arana, Jorge E., et al. "Post-licensure Safety Monitoring of Quadrivalent Human Papillomavirus Vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015." Vaccine, vol. 36, no. 13, 2018, pp. 1781-1788.
Arana JE, Harrington T, Cano M, et al. Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015. Vaccine. 2018;36(13):1781-1788.
Arana, J. E., Harrington, T., Cano, M., Lewis, P., Mba-Jonas, A., Rongxia, L., Stewart, B., Markowitz, L. E., & Shimabukuro, T. T. (2018). Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015. Vaccine, 36(13), 1781-1788. https://doi.org/10.1016/j.vaccine.2018.02.034
Arana JE, et al. Post-licensure Safety Monitoring of Quadrivalent Human Papillomavirus Vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015. Vaccine. 2018 03 20;36(13):1781-1788. PubMed PMID: 29477308.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-licensure safety monitoring of quadrivalent human papillomavirus vaccine in the Vaccine Adverse Event Reporting System (VAERS), 2009-2015. AU - Arana,Jorge E, AU - Harrington,Theresa, AU - Cano,Maria, AU - Lewis,Paige, AU - Mba-Jonas,Adamma, AU - Rongxia,Li, AU - Stewart,Brock, AU - Markowitz,Lauri E, AU - Shimabukuro,Tom T, Y1 - 2018/02/21/ PY - 2017/04/21/received PY - 2017/10/16/revised PY - 2018/02/05/accepted PY - 2018/2/27/pubmed PY - 2018/9/8/medline PY - 2018/2/26/entrez KW - Immunization KW - Quadrivalent human papillomavirus vaccine (4vHPV) KW - Vaccination KW - Vaccine Adverse Event Reporting System (VAERS) KW - Vaccine safety SP - 1781 EP - 1788 JF - Vaccine JO - Vaccine VL - 36 IS - 13 N2 - BACKGROUND: The Food and Drug Administration (FDA) approved quadrivalent human papillomavirus vaccine (4vHPV) for use in females and males aged 9-26 years, since 2006 and 2009 respectively. We characterized reports to the Vaccine Adverse Event Reporting System (VAERS), a US spontaneous reporting system, in females and males who received 4vHPV vaccination. METHODS: We searched VAERS for US reports of adverse events (AEs) following 4vHPV from January 2009 through December 2015. Signs and symptoms were coded using Medical Dictionary for Regulatory Activities (MedDRA). We calculated reporting rates and conducted empirical Bayesian data mining to identify disproportional reports. Clinicians reviewed available information, including medical records, and reports of selected pre-specified conditions. FINDINGS: VAERS received 19,760 reports following 4vHPV; 60.2% in females, 17.2% in males, and in 22.6% sex was missing. Overall, 94.2% of reports were non-serious; dizziness, syncope and injection site reactions were commonly reported in both males and females. Headache, fatigue and nausea were commonly reported serious AEs. More than 60 million 4vHPV doses were distributed during the study period. Crude AE reporting rates were 327 reports per million 4vHPV doses distributed for all reports, and 19 per million for serious reports. Among 29 verified reports of death, there was no pattern of clustering of deaths by diagnosis, co-morbidities, age, or interval from vaccination to death. INTERPRETATION: No new or unexpected safety concerns or reporting patterns of 4vHPV with clinically important AEs were detected. Safety profile of 4vHPV is consistent with data from pre-licensure trials and postmarketing safety data. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/29477308/Post_licensure_safety_monitoring_of_quadrivalent_human_papillomavirus_vaccine_in_the_Vaccine_Adverse_Event_Reporting_System__VAERS__2009_2015_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(18)30208-1 DB - PRIME DP - Unbound Medicine ER -