Geneva/Brussels - The European Medicines Agency (EMA) on Friday approved two vaccines for the pandemic A(H1N1) virus, commonly known as "swine flu", after testing them on more than 6,000 subjects. The vaccines are Focetria, which is produced by Swiss pharmaceutical giant Novartis, and Pandemrix, manufactured by GlaxoSmithKline.
The Swiss company had earlier issued a statement publicising the decision by the London-based EU agency.
The EMA said the European Commission in Brussels was expected to grant the products' marketing authorization "shortly".
The London-based EU agency 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. While governments are responsible for their own national vaccination strategies, they rely on information provided by the agency.
EMA officials said they had speeded up their tests to "ensure that authorised vaccines are available before the start of the flu season in the coming autumn and winter months."
However, it stressed that its recommendations may be updated over the coming months on the basis of further data from ongoing clinical studies.
Novartis said it had developed its vaccine for swine flu using traditional influenza manufacturing processes in an egg-based formulation.
The Swiss company has already began sending the first deliveries of pandemic vaccines under quarantine to governments in Europe.
Officials in London said the vaccines recommended for authorisation contain so-called "adjuvants" - substances that enhance the immune response so that less viral material can be used in each dose of vaccine.
"They are widely used in vaccine manufacture and have a good safety record. The adjuvant in Focetria has been used in another flu vaccine since 1997 in more than 45 million doses. The adjuvant in Pandemrix has been tested in clinical trials involving several thousand subjects," the EMA said in a statement.
The agency's recommendations are based on clinical trials conducted on more than 6,000 subjects.
On Thursday, the World Health Organization said it believed the world's drugmakers could produce up to 3 billion doses of pandemic vaccine in a 12 month period.
While this would not be enough for the world's population, experts at the Geneva-based UN health agency have said not everyone will need a shot.
WHO recommends vaccinating certain sections of the health services sector, and, based on national priorities, vulnerable populations.
