The European Medicines Agency has reaffirmed the efficacy and safety of H1N1 pandemic vaccines Celvapan, Focetria and Pandemrix.
The Agency has reviewed further data on the centrally-authorised pandemic vaccines and has reaffirmed their positive balance of benefits and risks in the context of the current H1N1 influenza pandemic.
The data on Focetria and Pandemrix indicate that a single dose is able to trigger an immune response that may be sufficient to give protection against the H1N1 pandemic influenza in some age groups.
For both vaccines, a single dose may be used in adults aged between 18 and 60 years and in children and adolescents (from the age of 9 years for Focetria, and from 10 years for Pandemrix). Pandemrix may also be used as a single dose in the elderly.
For certain groups, such as younger children and immunocompromised patients, the Agency’s recommendation remains that two doses should be given, to ensure that their immune system responds adequately to the vaccination.
Data on Celvapan are still being assessed.
The Agency also concluded that Focetria and Pandemrix can be co-administered with non-adjuvanted seasonal flu vaccines.
The Agency, together with other national authorities, is continuously monitoring the safety profile of H1N1 pandemic influenza vaccines. With vaccination campaigns ongoing in the EU, about 5 million people have been vaccinated so far.
The Agency has said that it will continue to evaluate all information that becomes available and make further recommendations as necessary.