Baxter's H1N1 vaccine set for European licence

Baxter's swine-flu vaccine is third in line for approval in Europe, behind already approved rivals from GSK and Novartis.

Regulatory advisors have recommended Baxter's jab Celvapan for approval, which indicates the European Commission will licence it shortly.

Governments in the Northern Hemisphere have been keen to see the vaccines made available by the autumn, which is traditionally the start of the flu season.

All H1N1 vaccines have been submitted for approval by the EMEA under the fast-track "mock-up" procedure in order to meet the deadline.

Britain is expecting to use about 200,000 doses of the vaccine from Baxter, and the company also has contracts with other countries.

However, Baxter will fewer doses than its rivals due to smaller manufacturing capacity. The company's jab Celvapan is a non-adjuvanted vaccine, which means it does not contain a booster to enhance the immune response and make the doses go further.

Last month Baxter said it unclear whether or not it would be able to fulfil its vaccine orders, due to concern about poor yield. It has not yet been made clear whether its vaccine could give protection with a single dose, as competitors GSK, Sanofi and Novartis have already declared.

All manufacturers will have to carry out safety studies in 9,000 subjects for each swine-flu vaccine after launch, according to the EMEA, as part of the post-marketing surveillance necessary due to the speed at which they needed to be produced.