Abstract
A vaccination campaign against pandemic influenza A (H1N1)pdm09 was held in Brazil in March 2010, using two types of monovalent split virus vaccines: an AS03-adjuvanted vaccine and a non-adjuvanted vaccine. We compared the reactogenicity of the vaccines in health professionals from a Clinical Research Institute in Rio de Janeiro, Brazil and there were no serious adverse events following immunization (AEFI) among the 494 subjects evaluated. The prevalence of any AEFI was higher in the AS03-adjuvanted vaccine at 2 h and 24 h post-vaccination [preva-lence ratio (PR): 2.05, confidence interval (CI) 95%: 1.55-2.71, PR: 3.42, CI 95%: 2.62-4.48, respectively]; however, there was no difference between the vaccines in the assessments conducted at seven and 21 days post-vaccination. The group receiving the AS03 post-adjuvanted vaccine had a higher frequency of local reactions at 2 h (PR: 3.01, CI 95%: 2.12-4.29), 24 h (PR: 4.57, CI 95%: 3.29-6.37) and seven days (PR: 6.05, CI 95%: 2.98-12.28) post-vaccination. We concluded that the two types of vaccines caused no serious AEFI in the studied population and the adjuvanted vaccine was more reactogenic, particularly in the 24 h following vaccination. This behaviour must be confirmed and better characterised by longitudinal studies in the general population.
Highlights
In April 2009, a new subtype of influenza A (H1N1) human virus of swine origin was identified in North America (CDC 2009a)
Given the safety concerns and the urgency to start using the vaccine on a large scale before the 2010 influenza season, the postmarketing surveillance of adverse events grew in importance in the case of the pandemic influenza vaccine, for the detection of rare adverse events following immunization (AEFI), such as the recently observed cases of narcolepsy that led the European Medicines Agency to recommend restricting the use of the AS03-adjuvanted vaccine in people under age 20 (EMA 2011)
To compare the safety profile of monovalent pandemic influenza vaccines used in the 2010 campaign, we analysed the active surveillance data for adverse events that accompanied the vaccinations of health professionals from the Institute of Clinical Research Evandro Chagas (IPEC) of the Fundação Oswaldo Cruz (Fiocruz) in Rio de Janeiro (RJ), Brazil
Summary
In April 2009, a new subtype of influenza A (H1N1) human virus of swine origin was identified in North America (CDC 2009a). To compare the safety profile of monovalent pandemic influenza vaccines used in the 2010 campaign, we analysed the active surveillance data for adverse events that accompanied the vaccinations of health professionals from the Institute of Clinical Research Evandro Chagas (IPEC) of the Fundação Oswaldo Cruz (Fiocruz) in Rio de Janeiro (RJ), Brazil.
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