General Conclusions:
Up to 8 January 2010, a total of 2,968,880 million doses of vaccines were delivered to the
Swiss cantons (286,250 doses of Focetria®, 985,330 doses of Celtura®, and 1,697,300
doses of Pandemrix®). Up to and including 8 January 2010, a total of 489 reports were
received and which described a total of 1365 suspected adverse reactions. The majority of
cases described self-limited and non-serious reactions occurring at the injection site, as well
as generalized reactions such as headache, fever, nausea, muscle aches and joint pain.

82 reports were classified as serious and unexpected. 36/82 cases were medically important
reactions that have been evaluated and assessed as unlikely to be related to the vaccination,
due to other medical reasons and/or a temporal course that was implausible.

Swissmedic exchanges safety data of pandemic influenza vaccines with other national
authorities on a weekly and confidential basis. Swissmedic is continuing to closely monitor
the safety profile of all 3 vaccines, and in particular with close monitoring of allergic
reactions, musculoskeletal and neurological system disorders and in special vaccinated
groups including pregnant women and children. To date, the reported adverse reactions
correspond with those described in clinical trials and with the profile from postmarketing
experience with seasonal influenza vaccines. The reported adverse reactions of the
pandemic influenza vaccines correspond to those observed in other countries using the
same vaccine products.

Available mortality statistics indicate an average of 167 deaths per day in Switzerland and a background incidence rate of stillbirth of 4 per 1000 births in Western Europe. Each year, the background incidence of facial paralysis is more than 10 per 100,000 individuals and for Guillain-Barré syndrome (GBS) more than 1 per 100,000 individuals, with the natural occurrence of either condition increasing with age. A temporal relationship between a serious adverse event and vaccination can therefore be purely coincidental.

In previous years, deaths have been reported to Swissmedic following seasonal influenza vaccination in Switzerland. Each of these reports is carefully investigated. In these cases, patients had serious underlying diseases such as heart or lung disease. A causal association with seasonal influenza vaccines and these reports was not established.