The expected number of background disease events during mass immunization in China

PLoS One. 2013 Aug 20;8(8):e71818. doi: 10.1371/journal.pone.0071818. eCollection 2013.

Abstract

It is critical to distinguish events that are temporarily associated with, but not caused by, vaccination from those caused by vaccination during mass immunization. We performed a literature search in China National Knowledge Infrastructure and Pubmed databases. The number of coincident events was calculated based on its incidence rate and periods after receipt of a dose of hypothesized vaccine. We included background incidences of Guillain-Barré syndrome, anaphylaxis, seizure, sudden adult death syndrome, sudden cardiac death, spontaneous abortion, and preterm labour or delivery. In a cohort of 10 million individuals, 7.71 cases of Guillain-Barré syndrome would be expected to occur within six weeks of vaccination as coincident background cases. Even for rare events, a large number of events can be expected in a short period because of the large population targeted for immunization. These findings may encourage health authorities to screen the safety of vaccines against unpredictable pathogens.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abortion, Spontaneous / epidemiology
  • Abortion, Spontaneous / immunology
  • Adolescent
  • Adult
  • Anaphylaxis / epidemiology
  • Anaphylaxis / immunology
  • Child
  • Child, Preschool
  • China / epidemiology
  • Death, Sudden, Cardiac / epidemiology
  • Death, Sudden, Cardiac / etiology
  • Female
  • Guillain-Barre Syndrome / epidemiology*
  • Guillain-Barre Syndrome / immunology
  • Humans
  • Incidence
  • Infant
  • Influenza A Virus, H1N1 Subtype / immunology*
  • Influenza Vaccines / adverse effects*
  • Influenza, Human / immunology
  • Influenza, Human / prevention & control*
  • Influenza, Human / virology
  • Male
  • Mass Vaccination*
  • Obstetric Labor, Premature / epidemiology
  • Obstetric Labor, Premature / etiology
  • Pandemics / prevention & control*
  • Pregnancy
  • Seizures / epidemiology
  • Seizures / etiology
  • Young Adult

Substances

  • Influenza Vaccines

Grants and funding

The study was funded by the Chinese Government Major Grants administrated under the 5-year Plan (2012BAI37B03, 2009ZX10004-903, 2008ZX100-01-003), National Natural Science Foundation of China (81001281), Importation and Development of High-Calibre Talents Project of Beijing Municipal Institutions, and the Grant of the Municipal Key Laboratory of Clinical Epidemiology, Beijing China (2012LCLB03). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.