Several COVID-19 vaccines are expected to be authorised over the coming months. During the subsequent vaccination of very large numbers of people, the safety of the new vaccines will need to be monitored closely so that Swissmedic can then take measures promptly if evidence emerges of previously unknown or inadequately described risks.
As part of this monitoring process, it is particularly important for healthcare professionals to report to Swissmedic the occurrence of any side effects, or suspected side effects, to the COVID-19 vaccines. This applies especially to serious side effects or those that are not listed in the Information for healthcare professionals. The online tool ElViS (Electronic Vigilance reporting System) is available for healthcare professionals to report side effects. After initial registration, ElViS can be used to send reports via a secure electronic method so that they can be recorded and assessed promptly by Swissmedic and the cooperating regional pharmacovigilance centres.
To ensure that the sensitive medical data is transmitted securely in side effect reports, two-factor authentication is needed for ElViS. This means that the registration process will take a few minutes and involve two codes that will be sent to you by e-mail or as a text message.
Once you are registered with ElViS, this procedure will save time: your contact details will already be stored for any future reports, and you can send reports at the touch of a button after entering the required medical information. You will also be able to send laboratory reports or hospital discharge reports, for example, as attachments to the report. ElViS is currently being modified in order to further simplify the submission of reports relating to COVID-19 vaccines.
Early registration recommended: Once the vaccination campaign against COVID-19 has started in Switzerland, healthcare professionals and everyone else involved can expect to be confronted with a high workload. To ensure that the important recording of suspected side effects from the new vaccines can proceed as quickly as possible in this situation, Swissmedic urges all healthcare professionals to register now for the online reporting tool ElViS via the following link: