Baxter completes production of first commercial batches of A(H1N1)
20 August 2009
Baxter International Inc. (NYSE: BAX) has announced that it completed
production of its first commercial batches of Celvapan A(H1N1) flu
vaccine in late July and is discussing plans for distribution with
national health authorities, subject to obtaining appropriate
Celvapan, the brand name for the company’s A(H1N1) pandemic influenza
vaccine, is made using Baxter’s proprietary Vero cell culture
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.
Once national vaccination programs are initiated, Baxter will also
conduct a large-scale observational study in people receiving Celvapan.
In all countries, decisions to administer the vaccine will be determined
by local public health authorities.
About Baxter's A(H1N1) flu vaccine development
Baxter received the A(H1N1) strain for testing and evaluation
from the US Centers for Disease Control and Prevention (a WHO
Collaborating Center) in early May. The company then undertook
pre-production testing and evaluation of the virus strain to assess its
growth characteristics and ability to work in the company’s proprietary
Vero cell culture.
Based on the virus’ ability to grow in Vero cell culture, Baxter
initiated commercial production on June 3, 2009. Bulk Celvapan vaccine
is produced at its large-scale commercial facility in Bohumil, Czech
Republic, and is sent to Vienna, Austria for the final formulation, fill
and finish before distribution.
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.
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