Baxter Advances to Full-Scale Production of A/H1N1 Vaccine
News Jun 15, 2009
Baxter International Inc. has announced that it 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 U.S. 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.