Brussels, 25/09/2009 (Agence Europe) - In a press release published on Friday 25 September, the European Medicines Agency (EMEA) says it has made a recommendation to the European Commission that vaccines, Focetria (Novartis) and Pandemrix (GlaxoSmithKline), against flu virus A(H1N1) be granted marketing authorisation. The Agency is currently recommending two vaccinations, three weeks apart, for adults, including expectant mothers, and children from the age of six months. The Agency committee which assesses medicines for use with humans acknowledges that there are preliminary data suggesting that one dose may be sufficient in adults, but prefers to await further data from clinical trials over the coming months before reviewing its recommendation. The two vaccines contain “adjuvants” to enhance the immune response. The adjuvant used in Focetria has been used in other flu vaccines since 1997 in more than 45 million doses. The adjuvant in Pandemrix has been tested in clinical trials involving several thousand subjects. EMEA has, nevertheless, requested that the two laboratories implement plans to actively check for the appearance of any unusual unwanted effects once the vaccines are put on the market. The manufacturers have undertaken to carry out post-authorisation safety studies on some 9,000 people for each vaccine. Focetria and Pandemrix were authorised using the so-called “mock-up” approach. This allowed the development and authorisation of these vaccines in advance of the pandemic, based on information generated with a different virus strain that could have caused a pandemic (an H5N1 virus strain). Once the A(H1N1) virus strain was identified, the manufacturers were able to include it in the mock-up vaccines to prepare final pandemic vaccines. (O.J./transl.rt)