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Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015.
PLoS Negl Trop Dis. 2016 07; 10(7):e0004846.PN

Abstract

BACKGROUND

In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States.

OBJECTIVE

To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system.

METHODS

We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV.

RESULTS

VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination.

CONCLUSIONS

This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies.

Authors+Show Affiliations

Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, United States of America.Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, United States of America.Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, United States of America.Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, United States of America.Poxvirus and Rabies Branch, Division of High-Consequence Pathogens and Pathology, NCZEID, CDC, Atlanta, Georgia, United States of America.Immunization Safety Office, Division of Healthcare Quality Promotion (DHQP), National Center for Zoonotic and Emerging Infectious Diseases (NCZEID), Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, United States of America.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27410239

Citation

Moro, Pedro L., et al. "Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015." PLoS Neglected Tropical Diseases, vol. 10, no. 7, 2016, pp. e0004846.
Moro PL, Woo EJ, Paul W, et al. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015. PLoS Negl Trop Dis. 2016;10(7):e0004846.
Moro, P. L., Woo, E. J., Paul, W., Lewis, P., Petersen, B. W., & Cano, M. (2016). Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015. PLoS Neglected Tropical Diseases, 10(7), e0004846. https://doi.org/10.1371/journal.pntd.0004846
Moro PL, et al. Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015. PLoS Negl Trop Dis. 2016;10(7):e0004846. PubMed PMID: 27410239.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Post-Marketing Surveillance of Human Rabies Diploid Cell Vaccine (Imovax) in the Vaccine Adverse Event Reporting System (VAERS) in the United States, 1990‒2015. AU - Moro,Pedro L, AU - Woo,Emily Jane, AU - Paul,Wendy, AU - Lewis,Paige, AU - Petersen,Brett W, AU - Cano,Maria, Y1 - 2016/07/13/ PY - 2016/03/15/received PY - 2016/06/22/accepted PY - 2016/7/14/entrez PY - 2016/7/15/pubmed PY - 2017/6/15/medline SP - e0004846 EP - e0004846 JF - PLoS neglected tropical diseases JO - PLoS Negl Trop Dis VL - 10 IS - 7 N2 - BACKGROUND: In 1980, human diploid cell vaccine (HDCV, Imovax Rabies, Sanofi Pasteur), was licensed for use in the United States. OBJECTIVE: To assess adverse events (AEs) after HDCV reported to the US Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting surveillance system. METHODS: We searched VAERS for US reports after HDCV among persons vaccinated from January 1, 1990-July 31, 2015. Medical records were requested for reports classified as serious (death, hospitalization, prolonged hospitalization, disability, life-threatening-illness), and those suggesting anaphylaxis and Guillain-Barré syndrome (GBS). Physicians reviewed available information and assigned a primary clinical category to each report using MedDRA system organ classes. Empirical Bayesian (EB) data mining was used to identify disproportional AE reporting after HDCV. RESULTS: VAERS received 1,611 reports after HDCV; 93 (5.8%) were serious. Among all reports, the three most common AEs included pyrexia (18.2%), headache (17.9%), and nausea (16.5%). Among serious reports, four deaths appeared to be unrelated to vaccination. CONCLUSIONS: This 25-year review of VAERS did not identify new or unexpected AEs after HDCV. The vast majority of AEs were non-serious. Injection site reactions, hypersensitivity reactions, and non-specific constitutional symptoms were most frequently reported, similar to findings in pre-licensure studies. SN - 1935-2735 UR - https://www.unboundmedicine.com/medline/citation/27410239/Post_Marketing_Surveillance_of_Human_Rabies_Diploid_Cell_Vaccine__Imovax__in_the_Vaccine_Adverse_Event_Reporting_System__VAERS__in_the_United_States_1990‒2015_ L2 - https://dx.plos.org/10.1371/journal.pntd.0004846 DB - PRIME DP - Unbound Medicine ER -