IngentaConnect Safety and efficacy of meningococcal group C conjugate vaccines

Authors: Rüggeberg J.; Heath P.T.

Source: Expert Opinion on Drug Safety, Volume 2, Number 1, 1 January 2003 , pp. 7-19(13)

Abstract:

The UK was the first country to implement a universal vaccination programme with conjugate polysaccharide vaccines against Neisseria meningitidis group C. This article reviews the pre- and postlicensure data on their efficacy and safety 3 years after the introduction of the programme. Local reactogenicity data compare favourably with other routine vaccinations and no specific increase in adverse reactions has been associated with their use in infant vaccination programmes. Self-limiting systemic reactions such as fever, myalgia, headaches and irritability have commonly been observed in prelicensure studies. Passive postlicensure safety monitoring of suspected adverse reactions has identified a large number of reports, generally of reactions deemed non-serious and reversible. An Expert Working Group has concluded the balance of benefits and risks to be overwhelmingly favourable. Further safety data are expected from large data-linkage studies. Present efficacy estimates, based on active surveillance of case numbers, vaccine failures and coverage rates, are approximately 90% for all age groups. A significant fall in the number of cases attributable to meningococcal group C infection has been observed in the age group of < 20 years. The annual number of fatalities from confirmed meningococcal C disease in the same population has fallen from 67 to 5 cases within a 2-year period.

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