European healthcare regulators have recommended two swine flu vaccines for approval today – one of which is to be used in Ireland - clearing the way for mass vaccination programmes to start.
The European Medicines Agency (EMEA) expert committee on new drugs gave the go-ahead for the first H1N1 swine flu vaccines from GlaxoSmithKline called Pandemrix – which is to be used in this State - and Focetria, produced by Novartis.
The Health Service Executive plans to set up 60 and 100 mass vaccination clinics once the vaccine is licensed and delivered.
A spokeswoman for the Department of Health confirmed today the EMEA approvals meant the product was now licensed for use in this country.
She was unable to say when the vaccinations would begin, saying this was dependent on supplies of the vaccine.
Governments and manufacturers have been scrambling for vaccines to target the new H1N1 flu strain, ahead of a feared second wave of infection as the northern hemisphere heads into winter.
The EMEA said its 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 now only need final approval from European Commission, a move EMEA chief executive Thomas Lonngren said he expected to happen "very rapidly ... hopefully next week" as part of an accelerated regulation system for pandemic vaccines.
A third vaccine from Baxter, which had also been submitted under the fast-track "mock-up" procedure, did not get a green light, but the watchdog said it was still reviewing this and other applications.
The agency said it was working to get all the information needed on the Baxter shot, while a spokeswoman for the company said it expected to receive a positive opinion "within days".
The World Health Organisation (WHO) said yesterday that drugmakers will only be able to produce enough H1N1 vaccine each year for half the planet - around 3 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, which was declared a pandemic in June.
Reuters