European drugs regulators recommended Baxter's Celvapan vaccine against H1N1 flu for approval and said it expected the shot to get a license from the European Commission “shortly.”
The recommendation from the European Medicines Agency (EMEA) comes after its expert committee on new drugs also gave a green light last week to the first H1N1 swine flu vaccines from GlaxoSmithKline and Novartis, called Pandemrix and Focetria.
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 Baxter vaccine, which was submitted for approval by EMEA under the fast-track “mock-up” procedure, is a non-adjuvanted vaccine, which means it does not contain adjuvants, or boosters, to enhance the immune response.
US drugs authorities have expressed a preference for vaccines without adjuvants, and the five vaccines approved for the US market do not use them.
The London-based watchdog said it was confident the new vaccines were safe, despite being rushed through the approval process. It said all three manufacturers would have to carry out safety studies in 9,000 subjects for each vaccine after launch.
The World Health Organisation (WHO) said last week that drugmakers would only be able to produce enough H1N1 vaccine each year for half the planet -- around 3 billion doses a year -- meaning governments will have to decide who should get the limited supplies.
The WHO also said a single dose should be enough to give healthy adults and older children immunity to the virus commonly known as swine flu, which was declared a pandemic in June.
But EMEA said its expert committee recommended a two-dose vaccination program over a three week period for adults, including pregnant women, and children from six months of age.
“Clinical trials in adults and in children are ongoing, and more results will become available from mid-October 2009 onwards,” it said in a statement.
British health authorities said in August they had received around 200,000 doses of Baxter's swine flu vaccine and were waiting for it to be approved by licensing bodies. (Reuters)