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DEERFIELD, Ill., August 5, 2009 — Baxter International Inc. (NYSE: BAX) today announced that it completed production of its first commercial batches of CELVAPAN A/H1N1 pandemic vaccine in late July and is discussing plans for distribution with national health authorities, subject to obtaining appropriate authorizations. CELVAPAN, the brand name for the company's A/H1N1 pandemic influenza vaccine, is made using Baxter's proprietary Vero cell culture technology.
Baxter plans to deliver initial quantities of CELVAPAN to national public health authorities that have pandemic agreements with the company. These health authorities placed orders for the vaccine following the World Health Organization's (WHO) elevation of the pandemic alert level to phase 6 and declaration of a pandemic.
Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the European Medicines Agency (EMEA) in 2004. This pathway allows for the development, evaluation and testing of a company's vaccine production capabilities using an available influenza strain that has the potential to cause a pandemic. Once a pandemic is declared and the influenza virus strain causing the pandemic is identified, the mock-up licensure allows for fast track approval of a pandemic vaccine containing the actual pandemic strain. Other countries may choose to evaluate the company's EMEA submission and use that information as the basis for their national health authority's authorization for use of the vaccine.
ATLANTA — The last time the government embarked on a major vaccine campaign against a new swine flu, thousands filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to head that off.
Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.
Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.
Originally posted by grapesofraft
reply to post by kiwifoot
That is great news that they will have this ready before the fall hits. It should definitely help contain the spread of the flu that it targets.