During its June 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) advises against use of Vaxzevria in people with history of capillary leak syndrome. The PRAC is also continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines.

The European Medicines Agency (EMA) has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in Puurs, Belgium.

During its May 2021 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) reviewed a number of safety signals related to COVID-19 vaccines. The evaluation of safety signals is a routine part of pharmacovigilance and is essential to ensuring that regulatory authorities have a comprehensive knowledge of a medicine’s benefits and risks.

On 26 May 2021, EU Regulation 2017/745 on medical devices entered into force. This new Regulation addresses the needs for innovation, security and traceability.

As is customary and with full transparency, the FAMHP publishes the figures and results for 2019 for all its services and activities. You are receiving this annual report later than you would normally expect from us, as the COVID-19 health crisis has been given priority over the past year. The annual report contains many novelties, rising and falling trends and interesting figures. 2019 was a year of progress, you can read all about it in the FAMHP digital annual report, which is available again in four languages.

Close monitoring of medicine stocks proved particularly useful during the COVID-19 pandemic. The FAMHP managed to act proactively and find solutions in time. The monitoring was done manually, but is now automated using a new Stock Monitoring Tool.

Every Thursday, the FAMHP publishes a cumulative overview of the adverse reactions reported after administration of a COVID-19 vaccine in Belgium. By being fully transparent, the FAMHP wants to increase confidence in COVID-19 vaccines.

The FPS Public Health and FAMHP would like to invite you to take part in the public consultation on a clinical trial testing the genetically modified vaccine hRVFV-4s against the Rift Valley fever virus. The public consultation will run from 30 April 2021 to 30 May 2021.