[Safety of meningococcal A and C vaccine. Data from the Spanish drug surveillance system. Meningococcal Vaccine Research Group of the Spanish System of Drug Surveillance]

Gac Sanit. 1999 Nov-Dec;13(6):462-7. doi: 10.1016/s0213-9111(99)71407-x.
[Article in Spanish]

Abstract

Objective: Data on meningococcal vaccines safety are scanty. In 1997 several vaccination campaign took place in Spain. Thus, this situation was used to improve our knowledge about the safety profile of this vaccine.

Methods: An inquiry was carried out to the Regional Centers of the Spanish Pharmacovigilance System to know the number of vaccinated people and the type and number of suspected cases of adverse reactions.

Results: There were 133 identified cases of suspected adverse reactions associated with meningococcal A and C vaccine until June 1st, 1998. Most of them affected the skin (25,3%) or nervous system (similar proportion). Those of allergic reactions accounted for 35,2%. Two cases were considered as severe, although they were resolved without secuelae.

Conclusions: Serious risks were not detected. The Spanish Pharmacosurveillance System as an epidemiological surveillance resource has been useful to know the safety problems associated with antimeningococcal vaccine in the community.

Publication types

  • Comparative Study

MeSH terms

  • Adolescent
  • Adult
  • Age Factors
  • Bacterial Vaccines / adverse effects*
  • Child
  • Child, Preschool
  • Data Interpretation, Statistical
  • Female
  • Humans
  • Infant
  • Male
  • Meningococcal Vaccines
  • Neisseria meningitidis / immunology*
  • Product Surveillance, Postmarketing
  • Spain

Substances

  • Bacterial Vaccines
  • Meningococcal Vaccines