the producer of highly-suspect anthrax vaccine, for years.
Emergent BioSolutions Signs Contract with BARDA/NIAID, Valued at Up to $29.7
Million, to Fund Development of AV7909 - A Next Generation Anthrax Vaccine
--AV7909 Contract is in Addition to Recently Announced $24 Million
Development Contract for Anthrax Monoclonal and Pending Proposal to Supply
HHS with Up to 25 Million Doses of a Recombinant Anthrax Vaccine
http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-newsArticle&ID=1202589
ROCKVILLE, Md.--(BUSINESS WIRE)--Sept. 12, 2008--Emergent BioSolutions Inc.
(NYSE:EBS) announced today that it has signed a contract with BARDA/NIAID, valued at
up to $29.7 million, to fund the further development of AV7909, a next generation
anthrax vaccine candidate within Emergent's portfolio of anthrax countermeasures. The
three-year contract provides up to $24.9 million of funding for manufacturing of clinical
lots, for non-clinical safety and efficacy studies, and for stability studies to further
demonstrate that the vaccine candidate does not need refrigeration during storage, a key
requirement of this vaccine development initiative. In addition, the contract provides up
to $4.8 million for a Phase I clinical trial, to be funded as an option that, if exercised,
would increase the value of the contract to $29.7 million.
Bushco was sure to toss some taxpayer dollars Emergent Biosolutions' way before he left. Would the new administration be as generous as the previous administration was?
Vaccines: Is the Boom Sustainable During the Obama Era?
http://www.windhover.com/ezine/html/ac0109-2lp.htm
The emerging Obama health team has experience in the field; they bring
preconceived approaches and tendencies to the field. Many trained in public
health roles during the initiation of the Vaccines for Children Program. Now is
the time to understand the background and to analyze how they will
approach the changes that have occurred in the vaccine industry in the
past eight years.
Take away key perspectives and guidance in the following areas:
How do vaccines fit into the developing overall health care reform effort that promises
to be a key part of the Obama economic revitalization?
What is the future for “push” incentives for vaccines: funding for research; funding for
new production capacity; support for regulatory approvals?
Is the government ready to continue and support “pull” programs: efforts to expand
vaccination populations for flu vaccines, for vaccines for adolescents, for vaccines for
the elderly?
How far will the government go to assure the public that safety fears are unfounded?
Who will be the key voices for vaccines in the new administration?
...and much more!
Join us for Vaccines: Is the Boom Sustainable during the Obama Era? on Thursday, Jan.
29, 2009 at 12 p.m. EST (9 a.m. Pacific). Listen as our experts help you understand the
future before it's begun. Grab your team, a phone and a computer with Web access (that last
one's optional). No travel required!
The answer is yes.
Potential Billion $ Contract for Emergent Biosolutions
http://www.wilx.com/localnews/headlines/Potential_Billi...
LANSING - Emergent Biosolutions is close to securing five more years of work in Lansing. On Thursday Emergent Biosolutions
announced the U.S. government intends to purchase 44.75 million doses of biothrax, the anthrax vaccine. The contract is still being
negotiated, and a final price has not been set. A dose of biothrax costs about $30, so the contract could be worth in the
neighborhood of $1.3 billion. The new contract would last for 5 years. Approximately 400 people work at the Emergent Biosolutions
plant in Lansing.
Biothrax is the only vaccine licensed by the U.S. Food and Drug Administration to protect against anthrax infection. Emergent is the
sole provider of the vaccine to the U.S. Government. Biothrax is mainly used to vaccinate soldiers, and millions of doses are
stockpiled in case of national emergency.
The US bought an enormous amount of vaccine for a situation that it was unapproved for and which was unlikely to occur.
Project BioShield, signed into law by President Bush in July 2004, would replenish the Strategic National Stockpile of vaccines in the event of a terrorist attack. It would also allow BioThrax to be used for inhalation exposure, even though the FDA only approves it to be used for cutaneous exposure.47 However, without supplementary antibiotics BioThrax was found to be ineffective against inhalation exposure in animal testing.48
A strong advocate for Project BioShield II was Jerome Hauer, who gave his assessment of Project BioShield I in December 2004, “Bioshield I was a good start; there’s no question about it. It was intended to engage the industry {and} to stimulate the industry. …But it appears to have had just the opposite effect for many of the pharmaceutical companies.”49 At the time Mr. Hauer gave that statement, he was no longer acting assistant secretary for emergency preparedness at HHS; he was working as a lobbyist for BioPort Corporation.50 He is currently on the Board of Directors for Emergent Biosolutions (formerly BioPort) along with former FEMA director Joe Allbaugh.51
In May 2005, BioPort was awarded a $123 million dollar contract to produce 5 million doses of anthrax vaccine.52 The following November, the government decided to double the amount of vaccine they would purchase, citing the possibility of an airborne anthrax attack. Skeptical about the effectiveness of the vaccine in an airborne attack, David Ozonoff, a professor at Boston University’s School of Public Health, said, “The number of doses they are amassing is wildly out of proportion to any possible threat from anthrax. What the benefits are is very unclear and there are always the {health} risks … when you vaccinate a whole lot of people.”53
In agreement with Mr. Ozonoff is Hillel W. Cohen, an epidemiologist at the Albert Einstein College of Medicine in the Bronx, who emphasizes the difficulty of executing such an attack, “The only possible benefit of a vaccine is if there’s a danger of exposure and that danger is small because of the technological hurdles of weaponizing anthrax … It’s not something you can do in your basement.”54
Indeed, the difficulty in producing high-quality anthrax puts it beyond the reach of amateurs. According to a 2002 GAO report, “…it would be very difficult for a terrorist to overcome major technical and operational challenges to effectively and successfully weaponize and deliver a biological warfare agent to cause mass casualties.”55 The report lists five steps to producing high-quality anthrax, the first being the acquisition of a virulent strain of anthrax by either isolating it in a dead animal, purchasing it from someone who already has it, or by stealing it from a lab.56
47 Maier, T. (2005, November 20). A shot in the dark? Newsday.com. Retrieved April 15, 2009 from
http://www.military-biodefensevaccines.org/documents/ar...
48 Ibid.
49 Strohm, C. (2004). Congress seeks to stimulate market for bioagent vaccines. Retrieved April 15, 2009 from
http://www.govexec.com/story_page.cfm?filepath=/dailyfe...
50 Ibid.
51 Emergent Biosolutions Inc. (2009). Board of Directors. Retrieved April 15, 2009 from
http://investors.emergentbiosolutions.com/phoenix.zhtml...
52 Maier, T. (2005, November 20). A shot in the dark? Newsday.com. Retrieved April 15, 2009 from
http://www.military-biodefensevaccines.org/documents/ar...
53 Ibid.
54 Ibid.
55 Rhodes, K. (2002). Information on U.S. domestic anthrax attacks. General Accounting Office (GAO-03-323T). Washington, D.C. p. 3.
56 Ibid.
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