Postlicensure Safety Surveillance for Varicella Vaccine

Abstract

Most of the reported adverse events associated with varicella vaccine are minor, and serious risks appear to be rare. We could not confirm a vaccine etiology for most of the reported serious events; several will require further study to clarify whether varicella vaccine plays a role. Education is needed to ensure appropriate use of varicella serologic assays and to eliminate confusion between varicella vaccine and varicella zoster immunoglobulin. JAMA. 2000;284:1271-1279

Trends in varicella mortality in the United States: Data from vital statistics and the national surveillance system

“…20 However, severe breakthrough varicella has been described. 11,14,15,20,21 Since 1996, CDC received reports of 5 varicella-related deaths among children and adolescents who previously received 1 dose of varicella vaccine. Four of these 5 deaths ( Table 4, Patients A-D) have been previously reported in the literature.…”

“…Four of these 5 deaths ( Table 4, Patients A-D) have been previously reported in the literature. [11][12][13][14][15] All patients, with the exception of one, were on high-dose steroids or had an underlying immunocompromising condition. No additional fatal breakthrough cases (among 1 or 2-dose vaccinees) have been reported in the literature.…”

“…This case was also reported to CDC through the national death surveillance but included in our analysis as an unvaccinated individual. In a review of Merck's safety database, Galea et al reported 3 deaths in vaccinated persons, 11 the one described above with uncertain vaccination status, one described in earlier publications, 14,15 and a 3rd one that was also reported through national surveillance ( Table 4, Patient B) (S. Galea, personal communication).…”

“…Five deaths reported to CDC occurred among persons who had received varicella vaccine, all were in children [11][12][13][14][15] (age range 4-15 years) [ Table 4]. All had received 1 dose of vaccine >42 d before rash onset (fatal breakthrough varicella) [ Table 4].…”

Varicella Zoster Virus: A Common Cause of Stroke in Children and Adults

“…Importantly, Varivax vaccine contains live attenuated virus that becomes latent and can reactivate to cause zoster and other neurological disorders, including stroke. Several reports have described zoster meningitis in vaccinated individuals (45)(46)(47)(48). Multifocal large artery vasculopathy in a 6-year-old boy immunocompromised by DOCK8 deficiency who received the Varivax vaccine was found to be due to vaccine strain VZV based on sequence analysis of PCR-amplified VZV DNA in his CSF (41).…”