European healthcare regulators last week (25 September) recommended the approval of two swine flu vaccines, clearing the way for mass vaccination programmes to start within weeks.
The European Medicines Agency (EMEA) expert committee on new drugs gave the go-ahead for the first H1N1 swine flu vaccines from GlaxoSmithKline and Novartis, called Pandemrix and Focetria.
The shots will now go for final approval from the European Commission, a process that should take between 10 and 20 days under an accelerated regulation system for pandemic vaccines.
A third vaccine from Baxter, which had also been submitted under a fast-track procedure, was not given the green light, but the agency said it was still reviewing this and other applications.
“We are working with the company [Baxter] to get all of the information that we need so that a recommendation can be made shortly,” said a spokeswoman.
Manufacturers and governments have been scrambling for vaccines to target the new H1N1 flu strain, which was declared a pandemic in June.
The World Health Organisation (WHO) said on Thursday that drug makers will only be able to produce enough H1N1 vaccine each year for half the planet – around three billion doses per year – meaning governments will have to decide who should get the limited supplies.
The WHO added that a single dose should be enough to give immunity to healthy adults and older children from the virus commonly known as swine flu. The EMEA, however, said it was currently recommending two doses be given, at an interval of three weeks, although it acknowledged preliminary data suggested one dose might suffice and this recommendation could be updated as new data comes in.
The London-based watchdog said it was confident the new vaccines were safe, despite being rushed through the approval process, adding manufacturers would have to carry out safety studies on 9,000 subjects for each vaccine after launch.
“Decades of experience with seasonal influenza vaccines indicate that insertion of a new strain in a vaccine should not substantially affect the safety or level of protection offered,” the agency said in a statement.
European health ministers will meet in Brussels on 12 October to discuss cooperation in combating the novel flu virus, with vaccine sharing expected to be on the agenda.
(EURACTIV with Reuters.)