Final summary of ADR reports in Sweden with Pandemrix through October 2009 – mid April 2010
Wednesday, June 02, 2010
As of April 16, 2010 about 6.1 million adult doses of Pandemrix have been administered according to preliminary data from the county councils to the Swedish Institute for Infectious Disease Control (SMI). The Medical Products Agency (MPA) has received a total of 4380 adverse events reports (ADR) from Health Care Professionals and from consumers during the pandemic period. In view of the great number of vaccinated individuals in Sweden and the limited number of adverse drug reaction reports and their pattern, the conclusion is that the safety of the vaccine is satisfactory.
About 10 million adult doses of Pandemrix have been delivered to the public medical service until April 16, according to the manufacturer. To the same point of time, approximately 6.1 million doses of the vaccine have been administered according to the Swedish Institute for Infectious Disease Control (SMI). The data from SMI also indicates that about 700 000 doses have been used in children 6 months - 12 years of age. Preliminary data also indicates that about 421 000 children have received a second dose of the vaccine.
The MPA has from the time when vaccination was started in October 2009, continuously published summaries of adverse events reported with Pandemrix. The summaries have focused on reports relating to previously unknown or suspected serious side effects while known adverse and mild events have been reported only briefly. All individual reports from Health Care Professionals and Consumers respectively have been assessed individually at the time of receipt by the Regional Centres and by the MPA.
This final summary specifically addresses reports from Health Care Professionals on allergic reactions and neurological adverse events, musculoskeletal reactions and adverse reactions in children and in pregnant women, transplanted patients and fatal outcomes. Included is also a short summary regarding the reporting of adverse events on a European level as well as planned follow-up research studies. The reports received directly from Consumers are also briefly described and summarised.
The analysis is based on data from reports received from Health Care Professionals until April 16 2010 and from Consumers until February 4, 2010.