Los Angeles: Baxter International Inc said on Wednesday it completed its first commercial batches of H1N1 vaccine in late July and is discussing distribution plans with national health authorities.
The swine flu vaccine, to be sold under the brand name Celvapan, is made using Baxter’s cell culture process, which is designed to be faster than traditional vaccine production methods, where virus samples must be put into specially raised chicken eggs to grow.
Baxter has supply contracts with five countries, including the UK, Ireland and New Zealand, but not the United States, said spokeswoman Deborah Spak.
“Mainly because of our production scale,” she said, noting that the company currently has orders for 80 million doses.
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.
H1N1 swine flu, which first surfaced in Mexico in April and was declared a pandemic by the World Health Organization (WHO) in June, has infected millions and killed an unknown number.
Healthcare officials are relying on a vaccine to contain the spread of disease, providing a potential sales windfall for those companies that are able to deliver quickly and in large volume.
AstraZeneca PLC, whose MedImmune unit makes smaller amounts of a flu vaccine that is sprayed into the nose rather than injected, said it would start clinical trials in the United States around 17 August.
Baxter said it tested a “mock-up” vaccine made with a different pandemic strain in several clinical trials, clearing the way for European licensure. Confirmatory clinical trials to evaluate the safety and immunogenicity of Celvapan in adults, the elderly and children are scheduled to begin in August.
Regulators in Europe and the United States plan to fast-track approval of swine flu vaccines to ensure they are available for the start of the northern hemisphere winter.
At the moment swine flu is rated only a “moderate” pandemic by WHO standards but it could worsen as temperatures cool, making conditions better for the virus.