Europe approves two swine-flu vaccines

pharmafile | September 30, 2009 | News story | Sales and Marketing EU, GSK, Novartis, h1n1 

The European Commission has approved the use of two vaccines for the pandemic H1N1 virus, commonly known as swine flu.

Successful testing was carried out by the EMEA on vaccines Focetria, produced by Novartis, and Pandemrix, made by GlaxoSmithKline.

The jabs are to become available in all 27 European Union's member states, Iceland, Liechtenstein and Norway this week.

Officials said in a statement it should "ensure that sufficient vaccines will be available before the start of the flu season and will reduce the risks for illnesses and deaths for European citizens".

Commissioner Gunter Verheugen added: "I am very satisfied that the Commission was able to decide in the shortest possible time. I wish to thank everybody, all the people who worked day and night to make this happen."

The London-based EMEA had speeded up review of the vaccines so they would be ready before the start of the flu season in the northern hemisphere and Europe.

The agency recommends a two-dose vaccination schedule, at an interval of three weeks, for adults, including pregnant women, and children from six months of age.

While governments are responsible for their own national vaccination strategies, they rely on information provided by the agency. Both of the authorised vaccines contain substances known as "adjuvants" that enhance the immune response so that less viral material can be used in each dose of vaccine.

Trials and post-marketing surveillance

The speed at which the vaccines are produced is important, and the trial period before approval has been shortened. However, post-marketing surveillance is important in terms of safety.

The World Health Organisation has called for post-marketing surveillance of the 'highest possible quality' to ensure extensive safety evaluation of all pandemic vaccines.

GSK is currently conducting 16 clinical trials in over 9000 subjects of healthy adults, the elderly and children across Europe, Canada and the US.

All the data from this clinical development programme will be submitted to regulators as soon as it is available. It will also be posted on GSK's Clinical Study Register.

When governments commence vaccination programmes, GSK will also collect information on the safety of the vaccine while it is being used.

Novartis will follow a similar programme, and is currently conducting trials with both its cell culture and traditional egg-based vaccines in over 6,000 adults and children.


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