2009 (H1N1) influenza pandemic

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The Agency played a key role in the authorisation of medicines and vaccines for use during the 2009 (H1N1) influenza pandemic.

The start of the pandemic was announced by the World Health Organization (WHO) in June 2009. It was caused by the emergence of a new strain of flu virus named A/H1N1, which was first identified in Mexico in April 2009. The pandemic lasted until August 2010, when the WHO announced that the world had passed into the post-pandemic period.

The Agency gave recommendations on the use of medicines during the pandemic, supporting the authorisation of five vaccines and the use of two antiviral medicines against the pandemic flu virus.

Before the pandemic started

As soon as the novel flu virus strain had been identified, the WHO elevated the pandemic alert level from 3 to 4, indicating an increased risk of an imminent pandemic.

Following this announcement, the Agency began preparing for the authorisation of pandemic-influenza vaccines, liaising closely with the manufacturers of vaccines and antiviral medicines, and increasing its information exchange with partner organisations, such as the European Centre for Disease Prevention and Control (ECDC), the European Directorate for the Quality of Medicines and Healthcare (EDQM) and the WHO.

Prior to the official declaration of the start of the pandemic on 11 June 2009, the Agency's Committee for Medicinal Products for Human Use (CHMP) recommended an extension to the shelf life of the antiviral medicine Tamiflu (oseltamivir) and also gave recommendations on its use in pregnant and breastfeeding women and in young children.

During the pandemic

Once the pandemic had started, the Agency began implementing its pandemic-influenza crisis management plan, facilitating the availability of vaccines and antiviral medicines for use during the pandemic:

This led to the authorisation of five pandemic-influenza vaccines and regular updates to the product information for vaccines and antiviral medicines in response to data being supplied by their manufacturers. The Agency also recommended the compassionate use of injected formulations of antiviral medicines in critically ill patients.

By April 2010, the information supplied on the safety and effectiveness of three of the pandemic-influenza vaccines was considered complete enough for the CHMP to recommend their use outside a pandemic situation. On the basis of this recommendation, the European Commission approved the authorisation of these vaccines for use outside the pandemic two days after the WHO announced the end of the pandemic on 10 August 2010.

The H1N1 virus that caused the pandemic is still in circulation, but is now behaving like a seasonal flu virus. For this reason, the WHO recommended that this virus strain be included in the seasonal flu vaccines for the 2010/2011 season:

Safety reports

Between December 2009 and August 2010, the Agency published regular pandemic influenza pharmacovigilance reports.

These reports provided information on the adverse reactions reported after the use of centrally authorised pandemic-influenza vaccines and antiviral medicines in the European Union (EU), as well as information on the evolution of the H1N1 pandemic, the number of doses of vaccines and antiviral medicines used in Europe and the medicines' benefits and risks.

Pandemic report and lessons learned

In April 2011, the Agency published a report summarising the key activities that took place at the Agency before and during the H1N1 pandemic. The report explains the lessons that the Agency learned during the pandemic, and makes recommendations for improvements based on these findings:

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