The European Medicines Agency (EMA) is responsible for reviewing data on pandemic influenza vaccines and antiviral medicines eligible for authorisation in the European Union (EU) via the centralised procedure. It also provides scientific and regulatory support to EU Member States in taking the necessary public health decisions during an influenza pandemic.
Pandemic influenza occurs when a new strain of influenza (flu) virus emerges that can spread easily from person to person. It is different from the normal 'seasonal' flu, because the strain is new, and because people have no protection or 'immunity' against it. Because of the lack of immunity, the virus can spread widely across the world.
The consequences of a flu pandemic can be serious, in terms of both public health and economic costs. Four pandemics have occurred since the beginning of the 20th century:
- 'Spanish influenza' in 1918;
- 'Asian influenza' in 1957;
- 'Hong Kong influenza' in 1968;
- 2009 (H1N1) pandemic in 2009-10.
There are two types of medicine used in the prevention and treatment of pandemic influenza:
- vaccines, which are one of the most effective means for preventing people contracting flu;
- antiviral medicines, which can be used either to prevent people contracting flu or to treat them once they have contracted it.
Influenza pandemics are announced officially by the World Health Organization (WHO) or the European Commission, on the basis of information on the activity of flu virus around the world.
EMA has developed a health threat management plan, which describes how it works during an emerging health threat, including an influenza pandemic. The plan allows the Agency to respond rapidly and efficiently to the challenges of an outbreak of influenza even before a pandemic is declared:
- EMA plan for emerging health threats
- Annex to EMA plan for emerging health threats: health threat plan map
When a pandemic is declared, EMA implements level four of the plan, which indicates a public health crisis. For more information, see Public health threats.
EMA's main activities during an influenza pandemic include:
- fast-track review of data for the authorisation of pandemic influenza vaccines for use in all EU Member States;
- continuous monitoring the safety of centrally authorised pandemic influenza vaccines and antiviral medicines;
- recommending changes to the use or authorisation status of these medicines where necessary;
- liaising with European partners, including the European Commission, regulatory authorities in EU Member States, agencies such as the European Centre for Disease Prevention and Control (ECDC), and international partners, such as the World Health Organization (WHO) and regulatory bodies of non-EU countries, to ensure timely exchange of information and coordination of activities relating to the pandemic;
- communicating relevant information about its activities to the public, healthcare professionals and the media.