Europe – Euro Roundup

The number of authorized product suspected adverse reactions sent to EudraVigilance jumped 93% last year because of a surge in reports related to COVID-19 vaccines. Almost half of the record 3.5 million individual case safety reports (ICSRs) uploaded to the database related to vaccines against the pathogen.

With member states seeking to quickly vaccinate hundreds of millions of people with newly authorized products, the European Medicines Agency (EMA) was braced for a rise in adverse event reports in 2021. The 2021 annual report on EudraVigilance, the system EMA uses for managing and analyzing information on suspected adverse reactions, shows the expected jump in ICSRs came to pass.

In 2020, EMA processed 1.8 million adverse event reports in total. Last year, EMA processed 1.7 million adverse event reports related to COVID-19 vaccines. The ICSRs for COVID-19 vaccines, which accounted for 48% of all adverse event reports last year, drove the total up 93% year on year to 3.5 million…