As at 21 January 2021, Swissmedic has received 42 reports of suspected adverse drug reactions (ADR) in connection with the first COVID-19 vaccinations in Switzerland. Experienced medical specialists at Swissmedic, in collaboration with the regional pharmacovigilance centres, are conducting an in-depth analysis of all the reports of suspected adverse reactions to the COVID-19 vaccines. So far this analysis has not resulted in any change in the positive benefit/risk ratio of the vaccines.
Reports to date in line with the known risk profile
Swissmedic has received a total of 42 reports of suspected adverse drug reactions (ADR) in connection with the first COVID-19 vaccinations in Switzerland as at 21 January 2021. Most of the reports were not serious (26, 62 %) and involve mild reactions that are already known from the clinical trials. 16 reports (38 %) were classified as serious and five reports were associated with a fatal outcome. The patients concerned in these five cases were aged between 84 and 92 and, according to the latest available information, died of illnesses that commonly occur at this age. Despite a chronological correlation with the vaccination, there is no concrete evidence to suggest that the vaccination was the cause of death.
As at 21 January 2021, almost 170,000 people had received a dose of a vaccine against COVID-19 in Switzerland according to the Federal Office of Public Health (FOPH). In line with the current vaccination strategy, people who are especially vulnerable and with the highest risk are being vaccinated as a priority, i.e. those aged over 75, those with chronic diseases and those who live in a retirement or care home. When such a group of exclusively vulnerable individuals is vaccinated within a short period, one would expect, for purely statistical reasons, a certain number of fatalities to occur in a temporal relationship with the COVID-19 vaccination. In Switzerland, around 2,300 people aged over 85 die over a period of 4 weeks (interval between two vaccinations).
The reports of adverse reactions received to date and subjected to careful analysis do not change the positive benefit-risk profile of the COVID-19 vaccines. Known side effects of COVID-19 vaccines are listed in the product information texts published at www.swissmedicinfo.ch.
Advice for healthcare professionals
Before administering a vaccine, healthcare professionals should take account of the health status of the person concerned in respect of the known common vaccine side effects such as fever, shivering or nausea. Suspected adverse drug reactions should be reported promptly to Swissmedic via ElViS, the electronic online reporting tool.
Consistent market surveillance (pharmacovigilance) is designed to detect new, as yet unknown and rare adverse drug reactions. Doctors and other healthcare professionals are legally obliged to report adverse drug reactions (ADR) that may be connected with the use of a medicine to Swissmedic. Each year Swissmedic receives around 14,000 such reports, which are reviewed and evaluated by pharmacovigilance specialists according to internationally defined criteria. If any new findings come to light, the necessary adaptations are made to the authorisation of the medicinal product concerned, usually in the form of an addition to the product information.