Tracking vaccine lot lifecycles using reports to the vaccine adverse event reporting system (VAERS)

Pharmacoepidemiol Drug Saf. 2005 Oct;14(10):671-6. doi: 10.1002/pds.1070.

Abstract

Purpose: There is currently no systematically available information available on how rapidly a specific lot of vaccine is used once distributed. We used data from reports to the Vaccine Adverse Event Reporting System (VAERS) to develop a proxy means of surveillance for the lifecycle of selected vaccine lots.

Methods: A convenience sample, consisting of selected lots of: diphtheria, tetanus, and acellular pertussis (DTaP), Haemophilus influenzae type b (Hib), Hepatitis B, and varicella vaccines, was selected for lifecycle analysis. Assuming that circulation of a vaccine lot is proportional to vaccine-specific adverse event (AE) reporting for that vaccine type, we constructed Gamma distributed usage models and compared them with lot-specific VAERS reports to estimate the actual lifecycle of lots in the system.

Results: Evidence of lot circulation was detected within 1-2 months, and a peak was observed 3-4 months after the vaccine release date for most of the study vaccines. Ninety percent of the vaccine doses in each lot were estimated to be used within 5-9 months of distribution. The length of time a vaccine lot was in use ranged from 5 to 17 months from earliest vaccination date.

Conclusions: Our modeled and inferred administration of the selected lots of different vaccines were concordant. This method may be useful for spatial and temporal tracking of vaccine lot utilization.

MeSH terms

  • Models, Theoretical
  • Product Labeling
  • Product Surveillance, Postmarketing / methods*
  • Product Surveillance, Postmarketing / standards
  • Quality Control
  • Thimerosal / analysis
  • Time Factors
  • Vaccination / statistics & numerical data
  • Vaccines / analysis*
  • Vaccines / standards

Substances

  • Vaccines
  • Thimerosal