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Final Order Supported by Extensive Scientific Evidence
GAITHERSBURG, Md., Dec. 16 /PRNewswire/ -- Emergent BioSolutions Inc.
announced today that the Food and Drug Administration (FDA) has issued a Final
Order confirming that the companys anthrax vaccine, BioThrax(R), is safe and
effective for immunization against anthrax infection, regardless of the route
of exposure.
In the 73-page order, FDA writes, "After review of the comments and
finding no additional scientific evidence to alter the proposed
categorization, FDA accepts the Panels recommendation and adopts Category I
as the final category for AVA and determines AVA to be safe and effective and
not misbranded."
The order goes on to state, "FDA agrees with the reports finding that
certain studies in humans and animal models support the conclusion that AVA is
effective against B. anthracis strains that are dependent upon the anthrax
toxin as a mechanism of virulence, regardless of the route of exposure."
The decision follows the agencys comprehensive review of the extensive
materials submitted to the FDA docket, including the clinical, scientific, and
epidemiological data establishing the safety and efficacy of the vaccine. The
ruling is supported by more than 20 scientific studies in 27 peer-reviewed
journals, as well as by numerous expert panels, including the Institute of
Medicines Committee to Assess the Safety and Efficacy of the Anthrax Vaccine,
the Anthrax Vaccine Expert Committee established by the Department of Health
and Human Services, the CDCs Advisory Committee on Immunization Practices and
the Panel on Review of Bacterial Vaccines and Toxoids convened by FDA.
"We are extremely pleased that FDA has confirmed that BioThrax is safe and
effective for the prevention of anthrax infection regardless of the route of
exposure," said Robert Kramer, Chief Executive Officer of BioPort Corporation,
the Emergent subsidiary that manufactures BioThrax. "This decisive ruling
marks an important decision for members of the United States military and
appropriate at-risk populations outside the federal government. We will
continue to work closely with the Department of Defense, the Department of
Health and Human Services, and other customers to ensure the availability of
BioThrax to protect military personnel and civilians who would benefit from
the vaccine."
An additional comment in the order reads, "Military personnel involved in
the vaccines administration under the DoD vaccination program also filed
comments in support of classifying AVA into Category I, reasoning that the
vaccine is important for soldiers entering potentially dangerous areas."
In conducting its exhaustive review, the FDA also examined the adverse
event profile of the vaccine and concluded, "Based on our review, we cannot
conclude that there is a causal relationship between serious adverse events
(other than some injection site reactions and some reports of allergic
reactions) or deaths and AVA."
The agency further stated that a number of respondents who submitted
comments during the 90-day public comment period claimed that the vaccine was
not properly licensed. In the final rule, FDA wrote, "We disagree. AVA has
been legally licensed since November 1970."
BioThrax is the only FDA-licensed vaccine for protection against anthrax,
a deadly disease caused by exposure to the anthrax bacteria or anthrax spores.
BioPort has provided more than 5 million doses of the vaccine to the
Department of Defense for the protection of military personnel and is
delivering 5 million doses to the Department of Health and Human Services for
the Strategic National Stockpile, which is available to protect the civilian
population in the event of a bioterrorist attack.
To date, the vaccine has been used to immunize more than 1.3 million
soldiers, and in the wake of the October 2001 anthrax letter attacks, public
health officials offered BioThrax in combination with antibiotics to protect
postal workers, members of Congress, congressional staffers, and others who
potentially had been exposed to anthrax.
About BioThrax
Anthrax Vaccine Adsorbed (BioThrax) is the only FDA-licensed vaccine for
protection against anthrax, a deadly disease caused by exposure to the anthrax
bacteria or anthrax spores. BioThrax is a liquid suspension made from an
avirulent strain of Bacillus anthracis. It is indicated for the active
immunization of individuals between 18 and 65 years of age who are at high
risk of exposure to Bacillus anthracis. More information about BioThrax can
be found in the product insert available on the companys website
http://www.bioport.com.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is dedicated to the research, development, and
manufacture of novel products, which harness the immune system to prevent and
treat disease. These include products for prophylactic and therapeutic use
against common infectious diseases and against biological weapons. The
company currently employs more than 400 people with facilities in Gaithersburg
and Frederick, Maryland, Lansing, Michigan, Berkshire, UK, and Munich,
Germany. More information about Emergent BioSolutions and its subsidiaries
can be found at http://www.ebsi.com.
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