CDC Tracks Adverse Events Related to Hepatitis B Vaccine

FEBRUARY 12, 2018
Kelsey Fontneau, 2018 PharmD Candidate, the University of Connecticut School of Pharmacy
According to the World Health Organization, approximately 257 million people are living with hepatitis B (HepB) virus infection. HepB is preventable with routine vaccinations. Four recombinant HepB vaccines are used in the United States. Single or multiple-antigen vaccine formulations are recommended for patients of all ages.

Researchers from the CDC assessed adverse effects (AEs) following HepB vaccinations using the Vaccine Adverse Event Reporting System (VAERS). Results from the review period of January 2005 to December 2015 were published in Vaccine in January 2018.

Dizziness/nausea and fever/injection site erythema were the most frequent AEs following single antigen and HepB-containing vaccines, respectively. Results were consistent with pre-licensure clinical trials.

Reviewers focused on reports about single HepB vaccines to assess potential safety concerns associated with the hepatitis antigen. Analysis did not detect marked safety differences between single antigen and combination vaccines.

The CDC stratified serious AEs and death reports by age; AEs and causes of death were consistent with those expected in relevant age groups. Temporal associations were observed between HepB vaccine and Sudden Infant Death Syndrome, the leading cause of death in infants. Similar associations have also been observed with other early childhood vaccines.

Early post-licensure case reports described temporal associations between HepB vaccination and Guillain-Barrè Syndrome, chronic illness, and neurological disorders. Evidence is inadequate to accept or reject a causal relationship between the vaccines and neurologic/autoimmune disorders.

Incorrect product storage was the most commonly reported vaccination error. 

VAERS is useful to detect rate of AEs and to generate hypotheses for further study. Limitations include biased reporting, over- and under-reporting, inconsistent report quality, and inability to assess causality between a vaccine and an AE.

This review did not detect new or unexpected safety concerns. Findings are consistent with other pre- and post-licensure research. Increased reports of vaccination errors indicate the need for training and education of providers.

Reference
Haber P, Moro PL, Ng C, et al. Safety of currently licensed hepatitis B surface antigen vaccines in the United States, vaccine adverse event reporting system (VAERS), 2005-2015. Vaccine. 2018 Jan 25;36(4):559-564.
 

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