Reports of suspected adverse reactions to COVID-19 vaccines in Switzerland – update 22
Bern, 11.02.2022 - Up to 8 February 2022, Swissmedic evaluated 12,334 reports on suspected adverse drug reactions (ADRs). 7,649 (62%) were reported to Swissmedic as “not serious”, while 4,685 suspected cases (38%) were classified as «serious».1 The majority of the reports involved more than one reaction. In total, 39,991 reactions were reported, corresponding to an average of 3.24 reactions per report.
The Therapeutic Products Act (TPA) requires healthcare professionals to report serious adverse effects occurring in Switzerland to Swissmedic. 6,006 (47.7%) reports were submitted by healthcare professionals. Members of the public may voluntarily report suspected side effects of medicines: 6,318 reports (51.3%) were received directly from those affected, i.e. the patients, or their relatives.
Most of those affected were aged between 18 and 64 years (51.6 years on average). 22.3 % of the individuals were older than 65, while 1.2 % were 12 to 17 years old. 7,799 (63.3%) of the reports concerned women, 4,163 (33.8%) of the reports concerned men. In a few reports no age or gender was specified.
8,350 (67.7%) of the reports involve Moderna’s COVID-19 vaccine Spikevax® (with approx. 63 % of the vaccine doses administered, this is the most widely used vaccine in Switzerland) while 3,627 (29.7%) are associated with Pfizer/BioNTech’s Comirnaty® (approx. 37 % of administered vaccine doses). In some cases, the vaccine was not specified.
Reports classified as serious
Around 38 % of cases were classified by the reporters as serious. In these reports, the average age of those affected was 54. The most commonly reported reactions were fever, headache, fatigue, shivering, nausea and dizziness. These known reactions also predominated in the cases classified as not serious.
In 199 of the serious cases, a fatality was reported at differing intervals after receiving the vaccine. The average age of those who died was 79.5 years. Despite a temporal association, an in-depth analysis of the data available for these cases showed that there were other more likely causes of the reported deaths.
Booster doses
581 reports of suspected adverse reactions to the more than 3.5 million booster doses administered to date were evaluated. Apart from the reports on skin reactions (see information on individual safety aspects below), the profile for the adverse effects reported after a booster was similar to the profile for the effects reported after the first and second vaccine doses.
The reports of adverse reactions received and analysed to date do not alter the positive benefit-risk profile of the COVID-19 vaccines used in Switzerland. This largely confirms their known side effects profile. Known side effects of COVID-19 vaccines are listed in the continually updated medicinal product information texts published on www.swissmedicinfo.ch.
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Swissmedic
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Swiss Agency for Therapeutic Products
http://www.swissmedic.ch/?lang=2
