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MedSafetyWeek 2021 – Global Campaign Calls for Reporting of Suspected Vaccine Adverse Events

21 / 2021

Again this year, drug regulatory authorities around the world have partnered in the joint campaign called "MedSafetyWeek". In the light of the Corona pandemic, the Paul-Ehrlich-Institut, together with drug regulatory authorities worldwide, is calling on people to report any suspected side effect of vaccines through the regulatory reporting channels. The reporting system is an important component to further increase the safety of vaccines and currently especially of COVID-19 vaccines. All citizens should be made aware of how important it is for the authorities to record and evaluate suspected adverse reactions to vaccines. Every suspected case counts and every person can report them – for themselves and others. In Germany, the Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedicines, collects and evaluates these reports.

This year, the campaign will run this year from 1 to 7 November 2021, for the sixth consecutive year. Drug authorities from 64 countries call for adverse reactions after vaccinations, including COVID-19 vaccinations, to be reported.

Reporting suspected adverse events and vaccine complications helps make vaccines even safer and helps other patients

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The COVID-19 vaccination campaign shows how important these reports are. With the methodically new, gene-based COVID-19 vaccines, it was possible to identify very rare side effects after only a few months through consistent suspicious case reports and their careful evaluation at the Paul-Ehrlich-Institut. This made it possible to react very quickly for these side effects, which occurred in the order of one to five cases per 100,000 vaccinations. The vaccination recommendations of the Standing Committee on Vaccination (Ständige Impfkommission, STIKO) at the Robert Koch Institute could be adapted, warnings for certain groups of people could be included in the product information and the now known side effects could be included in the product information. For healthcare professionals, instructions for recognising symptoms and treating reactions could be developed and published in the Corona Dossier of the Paul-Ehrlich-Institut.

The Paul-Ehrlich-Institut informs about the results of the assessments in the periodically published safety reports on suspected cases of vaccine side effects and vaccine complications.

"The more suspicious case reports we receive, the larger the amount of data we can work with, the more precisely it is possible to assess the risk-benefit profile and identify signals even for exceptionally rare side effects," explains Professor Dr Stefan Vieths, Vice President of the Paul-Ehrlich-Institut.

Help us and use the opportunity to report suspected side effects or vaccine complications - this is the appeal from health authorities worldwide.

Updated: 01.11.2021