Pandemic influenza pharmacovigilance updates
Human
Regulatory and procedural guidance
Between December 2009 and August 2010, the European Medicines Agency published regular updates on safety monitoring of vaccines and medicines used during the pandemic. The updates provided information on:
- the evolution of the A/H1N1 pandemic in the European Union (EU);
- an estimate of the number of doses of pandemic-influenza vaccines and antiviral medicines authorised by the Agency distributed or administered in the EU;
- a summary of the suspected adverse reactions reported to the Agency after use of pandemic-influenza vaccines and antiviral medicines;
- other information on the benefits and risks of pandemic-influenza vaccines and antiviral medicines.
The information in the updates was extracted from EudraVigilance, a database and management system managed by the Agency on behalf of Member States, for collecting and evaluating reports of suspected adverse reactions in the European Economic Area (EEA).
Reports were submitted to EudraVigilance by national medicines regulatory agencies and marketing authorisation holders. The updates also included some information on vaccine safety made available by Member States.