European Medicines Agency (EMA) 2009 Influenza Pandemic EvaluationArchived

ECDC comment

The European Medicines Agency (EMA) was key in the Europe during the 2009 pandemic concerning the authorisation and the benefit – risk assessment of the novel pandemic vaccines.

Pandemic report and lessons learned - Outcome of the European Medicines Agency's activities during the 2009 (H1N1) flu pandemic  The European Medicines Agency (EMA), London, April 2011

The European Medicines Agency (EMA) was key in the Europe during the 2009 pandemic concerning the authorisation and the benefit – risk assessment of the novel pandemic vaccines.(1) This internal report, recently published by EMA, contains a summary of the key activities overseen by the Agency during the pandemic and a listing of the lessons the Agency staff learnt. The report also makes a series of recommendations for improvement. The activities covered in this report took place between when the World Health Organization (WHO) announced the identification of the novel virus (April 2009) and March 2010.

The report note that the Agency achieved its objectives during the 2009 pandemic. It describes how the Agency, with its committees, working parties/groups and experts drawn from the European Member States facilitated the authorisation of pandemic vaccines five months after identification of the novel virus. It especially notes how this was fostered by the plans and procedures for ‘mock-up pandemic vaccines’ developed ahead of the pandemic. 

Six main achievements of the Agency and its partners during the pandemic are described:

  • The approval of pandemic vaccines within five months of the identification of the novel virus by the Agency, its committees and partners with the vaccine finally being authorised in days by the European Commission after approval by the Agency;
  • The success of authorisation by the ‘mock-up’ vaccines process whereby vaccines using a different antigen (A(H5N1)but otherwise identical to the pandemic vaccines in their components are taken through the Agency procedures. Though it was noted that this still leaves gaps in knowledge for the use of vaccines in certain groups at higher risk of severe disease: pregnant women, children and those with chronic medical conditions;
  • A strict code of conduct was maintained as was the independence of the regulatory system consistent with the Agency’s policy on conflicts of interest;
  • The establishing of an expert group (Pandemic Pharmacovigilance Rapid Response Expert Group – known as PREG) that met weekly in the pandemic to receive and assess reports of seeming adverse events following immunisation (AEFIs) from member states;
  • The public were continuously informed though the EMA web-site about all major procedural steps related to the authorisation and supervision process for pandemic vaccines and antivirals;
  • The development of a close working relationship with relevant partner organisations during the pandemic, both at the European level the national authorities of the Member States, the European Commission (EC) and the European Centre for Disease Prevention and Control (ECDC) and more internationally including through WHO.

The report indicates four main lessons that were learnt namely the needs to:

  1. Preparedness  To adjust preparedness plans and in particular the “mock-up vaccines” approach since there are areas needing improvement notably a need for more flexibility in relation to global phases, the severity of the pandemic and the groups most affected.  
  2. Working with Partners  To clarify and communicate the respective roles of the various EU partners including  the European Commission (EC), the National Competent Authorities (NCAs), ECDC and national public health agencies.
  3. Communications  The Report notes some uncertainty over whether the Agency was successful in its communication activities and providing the most up-to-date information to healthcare professionals and patients. A weakness is suggested in only providing information in English and there is a general need to make improvement in communications from the Agency to professionals and the public.
  4. Research It is noted that there is a need to have research activities in place ahead of a novel pandemic into areas such as new technologies and serology assays to measure the immune response to influenza vaccines, into the influenza disease itself and into methodologies for efficient detection of safety signals during a pandemic. A particular need is identified for establishing and funding a European infrastructure for industry-independent studies of the safety and effectiveness of vaccines.

Related diseases and public health areas

2009 influenza A (H1N1) pandemic

The 2009 influenza A(H1N1) pandemic was declared over in August 2010 by the World Health Organization. Europe has now entered a new inter-pandemic phase of seasonal influenza.

Disease / public health area

Seasonal influenza

Seasonal influenza is a preventable infectious disease with mostly respiratory symptoms. It is caused by influenza virus and is easily transmitted, predominantly via the droplet and contact routes and by indirect spread from respiratory secretions on hands etc.

Influenza vaccine safety

Risks of an adverse event following influenza vaccination are far less common than complications related to influenza itself, and the adverse events are generally localized and mild.