EMEA backs flu vaccines from GlaxoSmithKline and Novartis

The European Medicines Agency (EMEA) has recommended to the European Commission that two vaccines against influenza A(H1N1) be granted a marketing authorization. Vaccines are one of the most important tools in the management of an influenza pandemic, helping to reduce illness and deaths by building up immune protection against the pandemic flu virus

The vaccines concerned are Focetria from Swiss pharmaceutical major Novartis and Pandemrix, made by UK drug giant GlaxoSmithKline. Decisions on the granting of European Union-wide marketing authorizations for the vaccines by the European Commission are expected shortly. Vaccination strategies are decided by the government in each EU Member State, taking into account the information provided by the Agency for each vaccine.

To ensure that authorised vaccines are available before the start of the flu season in the coming autumn and winter months, the Agency's Committee for Medicinal Products for Human Use (CHMP) expedited its assessment.

The Committee is currently recommending 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 and these recommendations may be updated.

Focetria and Pandemrix were authorized using the so-called 'mock-up' approach, which allows development and authorization in advance of the pandemic, based on information generated with a different virus strain that could have caused a pandemic (an H5N1 influenza virus strain). Once the A(H1N1)v virus strain causing the pandemic was identified by the World Health Organization, the manufacturers were able to include it in the mock-up vaccines to prepare final pandemic vaccines.