EU regulators okay new swine flu vaccines

European regulators recommended yesterday that two new vaccines to fight a swine flu pandemic be granted a marketing licence across Europe amid growing fears of a deadly second wave of the virus.
"The European Medicines Agency has recommended to the European Commission that two vaccines against influenza A(H1N1) be granted a marketing authorisation," the London-based EMEA said in a statement.
The assessment of the two vaccines -- Pandemrix and Focetria -- was pushed through by EMEA amid mounting concern about the upcoming winter influenza season and an upturn in British cases of swine flu.
A decision from the European Commission would be due "shortly" on their use across the 27-nation European Union, the EMEA added.
The British Department of Health said that the news was a "step forward" in tackling swine flu, adding that vaccinations were scheduled to begin next month in Britain, which is the hardest-hit country in Europe by the virus.
"This is a welcome step forward in our plans for tackling swine flu -- but we are still dependant on production and delivery of sufficient vaccine to start protecting people," a spokesman said.
"We plan to start vaccination in October, subject to vaccine being licensed and manufacturers' delivery schedules.
"This is not the Department of Health's schedule -- it is led by the manufacturers."
The new development comes as the number of new swine flu cases in Britain almost doubled in a week, in the second weekly increase following a summer lull, according to official British date released this week.
The Pandemrix vaccine was produced by British pharmaceutical group GlaxoSmithKline, while Focetria has been developed by Swiss peer Novartis.
A third vaccine, Celvapan, manufactured by drugs firm Baxter, is still being considered by the EMEA.
"Decisions on the granting of European Union-wide marketing authorisations for the vaccines by the European Commission are expected shortly," the EMEA added in its statement.
Further data from ongoing clinical studies would be received in the coming months on the two drugs, it added.
"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 EMEA said.
"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 expedited its assessment."
Experts have warned of a second wave of flu as the northern hemisphere winter nears.
On Thursday, the World Health Organization said that pharmaceutical firms can produce only three billion doses of swine flu vaccines a year, covering less than half of the global population.
However, tests on the vaccine show that just one jab would offer sufficient protection against the A(H1N1) virus and that the vaccine is as safe as seasonal flu vaccines, the UN agency added.
At least 3,486 people have died from the A(H1N1) virus since it was uncovered in April, according to the WHO's weekly bulletin issued on September 18. There have been 2,625 fatalities in the Americas region.