EU Recommends Third Flu Vaccine for Authorisation

4 October 2009 (Last Updated October 4th, 2009 18:30)

The European Medicines Agency has recommended that Baxter's Celvapan be granted a marketing authorisation as a third vaccine against the influenza pandemic (H1N1) 2009. The recommendation for Celvapan, a non-adjuvanted vaccine, follows the authorisation of Novartis's Focetria and Glaxo

The European Medicines Agency has recommended that Baxter's Celvapan be granted a marketing authorisation as a third vaccine against the influenza pandemic (H1N1) 2009.

The recommendation for Celvapan, a non-adjuvanted vaccine, follows the authorisation of Novartis's Focetria and GlaxoSmithKline's Pandemrix in September 2009.

The recommendation will allow the manufacturer to replace the flu virus strain currently used in the 'mock-up' vaccine with the A(H1N1) virus responsible for the current pandemic.

The Committee for Medicinal Products for Human Use (CHMP) is currently recommending a two-dose vaccination schedule, every three weeks, for adults, including pregnant women, and for children from six months of age.

Clinical trials in adults and in children are currently ongoing, with more results expected from mid-October 2009 onwards. The manufacturer has also committed to carrying out post-authorisation safety studies in about 9,000 subjects.