During the 2009 (H1N1) pandemic, the Agency made recommendations on the use of vaccines and antiviral medicines to be used to prevent or treat pandemic influenza.
The Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the authorisation of five vaccines against the A/H1N1 flu virus. The authorisation of these vaccines benefited from the procedures put in place by the European Commission and the Agency to allow the rapid authorisation of vaccines across the European Union (EU) after the start of a pandemic:
- three vaccines were originally authorised as mock-up vaccines and converted to pandemic-influenza vaccines once the A/H1N1 flu strain had been identified: Celvapan, Focetria and Pandemrix;
- two vaccines were authorised using the emergency procedure: Arepanrix and Humenza.
More information is available on how pandemic-influenza vaccines are assessed, approved for use and monitored in the EU.
The class of antiviral medicines called ‘neuraminidase inhibitors’ included two medicines that were active against the A/H1N1 flu virus that caused the pandemic:
- Tamiflu (oseltamivir), a centrally authorised medicine that was authorised by the European Commission on 20 June 2002 for use in all EU Member States;
- Relenza (zanamivir), a medicine that is authorised individually by all EU Member States through the mutual-recognition procedure, co-ordinated by the Medical Products Agency in Sweden. The prescribing information for Relenza has been harmonised across all of these countries, including the summary of product characteristics and the patient information leaflet.
The other class of antiviral medicines, called ‘M2 inhibitors’, were not active against the virus that caused the pandemic.
During the pandemic, the Agency increased its level of transparency regarding the assessment of centrally authorised medicines for use against the pandemic flu virus.
The Agency published assessment reports for all variations to the marketing authorisations for these medicines during the pandemic period. These reports are available in each medicine's European public assessment report.
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- European strategy for influenza A/H1N1 vaccine benefit-risk monitoring (01/10/2009)
- Explanatory note on scientific considerations regarding the licensing of pandemic A(H1N1)v vaccines (24/09/2009)
- Addendum 1 on pandemic influenza A(H1N1)v vaccines authorised via the core dossier procedure: Explanatory note on scientific considerations regarding the dosage and co-administration with seasonal vaccines recommendations update for pandemic A(H1N1)v vaccines (14/12/2009)
- Pandemic report and lessons learned: Outcome of the European Medicines Agency's activities during the 2009 (H1N1) flu pandemic (29/04/2011)