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.
Baxter’s proprietary Vero cell production technology is meeting the
company’s expectations to rapidly produce a vaccine in response to a
pandemic. CELVAPAN was developed and commercially produced using this
process within 12 weeks of receiving the A/H1N1 virus strain, which
represents an innovation in vaccine production.
“We are pleased with our company’s ability to meet its expected
timelines in developing and producing CELVAPAN,” said Joy Amundson,
corporate vice president and president of Baxter BioScience. “This is an
encouraging validation of our science, our Vero cell vaccine technology
and the teamwork at Baxter in meeting this important milestone to help
address an urgent public health issue.”
Baxter is collaborating with regulatory authorities to ensure the
company is in accordance with all requirements needed to support
approval and use of CELVAPAN. “To make CELVAPAN A/H1N1 vaccine, we
applied the same development, qualification and manufacturing processes
used in gaining European Medicines Agency (EMEA) licensure of a mock-up
pandemic vaccine,” said Hartmut J. Ehrlich, M.D., vice president of
global research and development for Baxter BioScience. “The mock-up
vaccine made with a different pandemic strain was tested in five
clinical trials worldwide in more than 1,300 people. In addition, more
than 3,500 people have been vaccinated during an ongoing phase III
study.”
Confirmatory clinical trials to evaluate safety and immunogenicity of
CELVAPAN A/H1N1 in adults, the elderly and children are scheduled to
begin in August. Baxter has initiated its license application for
CELVAPAN A/H1N1 based on the EMEA published guidelines for pandemic
vaccine marketing authorization and will supplement its application
post-approval with the appropriate safety and immunogenicity data from
the confirmatory clinical trials.
