The CHMP has recommended marketing authorisations for two vaccines against influenza H1N1.
The Committee conducted a quick assessment of the vaccines Focetria (Novartis) and Pandemrix (GlaxoSmithKline) to ensure that they are available before the start of the flu season in the coming autumn and winter months.
Decisions from the European Commission are expected shortly.
The Committee has recommended a two-dose vaccination schedule, at an interval of three weeks, for adults including pregnant women, and children from six months of age.
The Committee acknowledged that there are preliminary data suggesting that one dose may be sufficient in adults. The Agency is expecting further data from ongoing clinical studies over the coming months, so these recommendations may be updated.
Focetria and Pandemrix were authorised using the ‘mock-up’ approach, where trials are performed with a different virus strain that could have caused a pandemic (an H5N1 influenza virus strain). Once the H1N1 virus strain was identified by the WHO, the manufacturers were able to include it in the mock-up vaccines to prepare final pandemic vaccines.
The Committee’s recommendation is based on information about the vaccines’ quality, safety and immunogenicity, including information on clinical trials in more than 6,000 subjects. These data were generated at the time of the authorisation of the mock-up vaccines, as well as on information relating to the change in strain from H5N1 to H1N1.
Further clinical trials in adults and in children are ongoing and the companies have announced that more results will become available from October/November 2009 onwards.