Baxter advances full-scale production of H1N1 vaccine
US healthcare company Baxter International has completed the 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 in May and is working to deliver a vaccine for use in July.
US healthcare company Baxter International has completed the 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 in May and is working to deliver a vaccine for use in July.
The World Health Organisation (WHO) has raised the alert level for A/H1N1 to phase 6, which indicates that the virus has reached pandemic levels.
A number of national public health authorities have pandemic agreements with Baxter that allow them to place orders for a vaccine now that WHO has declared a pandemic. These authorities are currently evaluating their needs to determine their orders for vaccine supply. Baxter is also committed to working with WHO to allocate a portion of its 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 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 vaccine for approval after completing initial manufacturing runs.
Baxter believes its Vero cell technology can be used to produce a vaccine safely and reliably in response to this global public health issue. The company says it is possible that this technology could offer advantages, in that it may allow more rapid production and delivery of pandemic vaccines.
