Baxter Expects to Deliver A/H1N1 Vaccine to WHO by July

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If you trust a company that was caught red-handed shipping out vaccines containing live avian flu virus enough to take their swine flu vaccine, then good luck to you. We’ll be politely declining.

FLASHBACK: Baxter To Develop Swine Flu Vaccine Despite Bird Flu Scandal

A U.S. based pharmaceutical company that just weeks ago was involved in a scandal involving vaccines tainted with deadly avian flu virus has been chosen to head up efforts to produce a vaccine for the Mexican swine flu that has seemingly migrated into the U.S. and Europe.

FLASHBACK: ‘Accidental’ Contamination Of Vaccine With Live Avian Flu Virus Virtually Impossible

Czech newspapers are questioning if the shocking discovery of vaccines contaminated with the deadly avian flu virus which were distributed to 18 countries by the American company Baxter were part of a conspiracy to provoke a pandemic.

PHARMABIZ.COM
Wednesday, June 17, 2009 11:00 IST
Deerfield, Illinois

Baxter International Inc. has completed testing and evaluation of the A/H1N1 influenza virus and is now in full-scale production of a commercial A/H1N1 vaccine using its Vero cell culture technology. Baxter received an A/H1N1 strain from the US Centers for Disease Control and Prevention [a World Health Organization (WHO) Collaborating Center] in early May and is diligently working to deliver a pandemic vaccine for use as early as July.

WHO raised the pandemic alert level to phase-6, indicating a global influenza pandemic involving the 2009 A/H1N1 strain. Baxter is in contact with WHO and other global public health authorities regarding the pandemic. A number of national public health authorities have existing pandemic agreements with Baxter that allow them to place orders for a vaccine now that a pandemic has been declared by WHO. These public health authorities will be evaluating their needs to determine their orders for vaccine supply. Despite the company's existing obligations to supply vaccine under a pandemic phase-6 alert, Baxter is also committed to working with WHO to allocate a portion of the company's commercial production to address global public health issues deemed most urgent.

Using its Vero cell technology, Baxter has received European Medicines Agency (EMEA) approval for a mock-up pandemic vaccine called Celvapan, the brand name for the company's pandemic vaccine. The qualification, development and manufacturing processes used in gaining mock-up licensure for Celvapan apply as the company uses this new influenza A/H1N1 virus strain to produce a pandemic vaccine. The Celvapan EMEA licensure supports fast track approval of a pandemic vaccine containing the A/H1N1 virus strain. Baxter will submit the A/H1N1 vaccine for approval upon completion of initial manufacturing runs.

Baxter's research and development, manufacturing capabilities and pandemic planning expertise allow the company to efficiently develop candidate vaccines against potentially emerging influenza viruses. Baxter believes that its Vero cell technology can be used to safely and reliably produce a vaccine in response to this global public health issue. It is possible that Baxter's Vero cell technology may offer advantages, in that it may allow more rapid production and delivery of pandemic vaccines.

Baxter International through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.

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