Safety of pandemic influenza A(H1N1) 2009 vaccines
GACVS reviewed data on the safety of pandemic influenza A (H1N1) 2009 vaccines. Overall, safety information for the pandemic influenza vaccines continues to be reassuring. Since the Committee’s earlier report in June 2010,1 data from passive surveillance from different countries has not generated any new safety concerns other than reports of narcolepsy from Finland and Sweden in August. These reports are being investigated by independent groups in Europe. Preliminary analyses of active surveillance studies for Guillain–Barré syndrome, which have evaluated both adjuvanted and unadjuvanted vaccines, suggest that there may be a small risk associated with vaccination (1–2 cases per million doses of vaccine administered). Even if this finding is confirmed, the data suggest that the risk would be much lower than that observed following the 1976 swine influenza vaccination campaign in United States; it would be similar to the risk that has been associated in some, but not all, studies with the use of seasonal influenza vaccine (an excess risk of the order of 1–2 cases/million doses). Final analyses of active surveillance studies are expected to be completed by late 2011.
- See No. 30, 2010, pp. 285–291.