A US pharmaceutical manufacturer has completed its first commercial batches of the H1N1 vaccine and is discussing distribution plans with five national health authorities, including Ireland.
The new Swine Flu vaccine, which will be marketed under the brand name Celvapan, was made using a propriety cell culture process designed to be faster than traditional vaccine production methods, where virus samples must be put into specially raised chicken eggs to grow.
Baxter has tested a "mock-up" vaccine made with a different pandemic strain in several clinical trials and clinical trials of Celvapan in adults, the elderly and children will begin this month
The company has initiated its license application for the vaccine in the EU and said it will supplement its application post-approval with the appropriate safety and immunogenicity data from confirmatory clinical trials.
Regulators in the EU and the US are expected to fast-track approval of swine flu vaccines to ensure they are available for the start of the northern hemisphere winter.
Procedures to fast-track approvals of new vaccines to combat H1N1 influenza do
not reduce safety, the World Health Organisation said this morning. It said vaccines had to be available quickly and in large quantities to have the greatest impact.
"The public needs to be reassured that regulatory procedures in place for the licensing of pandemic vaccines, including procedures for expediting regulatory approval, are rigorous and do not compromise safety or quality controls," it said.
The WHO has said the current outbreak of H1N1, declared a pandemic on June 11, is the fastest ever pandemic and could eventually affect 2 billion people.
A WHO statement said concerns had been expressed about the safety of vaccines to fight H1N1 but the United Nations agency said vaccines had arrived too late in the 1957 and 1968 flu pandemics to be of much use, and flu vaccines had not yet been developed in the 1918 "Spanish flu" pandemic which killed an estimated 50 million people.
The WHO's top vaccines expert, Dr Marie-Paule Kieny, is due to give a briefing this afternoon in which she will provide an update on H1N1 vaccines.
Several other companies are using conventional methods to develop H1N1 swine flu vaccines. Novartis AG has started human testing of its vaccine candidates while Sanofi-Aventis SA, the world leader in flu shots, will commence within days, company officials said this week. GlaxoSmithKline PLC, the other "big three" flu vaccine supplier, said it would initiate clinical studies later this month.