VaxGen Inc has been awarded a contract from the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), to develop a new anthrax vaccine and to create a feasibility plan to manufacture an emergency stockpile of 25 million doses. NIAID is expected to award a separate contract in 2003 to manufacture the stockpile.
The only anthrax vaccine currently licensed, BioThrax, requires six injections over 18 months. The goal of the new government contract is to develop a vaccine that proves to be safe in humans, efficacious in animal challenge studies and requires no more than three injections.
Under the initial phase of the NIAID contract, VaxGen will be awarded $13.6 million to advance the development of a vaccine candidate initially developed by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID). If results from the first phase are positive, VaxGen will be eligible for an additional $13.6 million in 2003 as a continuation of the current contract to support a Phase II clinical trial. A second, much larger contract to manufacture the 25-million dose stockpile will be awarded by NIAID through a competitive bid process next year.
As a major sub-contractor to VaxGen, Battelle of Columbus, Ohio, will have primary responsibility for initial manufacturing of the vaccine candidate as well as for conducting pre-clinical safety and efficacy studies in accordance with FDA guidelines. VaxGen has budgeted approximately $4.5 million for Battelle''s contributions to this urgent initiative. Battelle has substantial experience in biologics research and development, specifically including anthrax vaccines.
VaxGen will have overall responsibility for the implementation and management of the contract, including product design, regulatory compliance, design and conduct of the Phase I human clinical trial and preparation of a plan to manufacture the 25-million dose stockpile utilizing qualified manufacturing operations. The plan may be based on use of VaxGen''s South San Francisco biologics manufacturing facility, currently under development, which will also be used to manufacture up to10 million doses per year of VaxGen''s AIDS vaccine candidates, if they are licensed.
Under an agreement with the USAMRIID, VaxGen and Battelle will continue the development and testing of the recombinant Bacillus anthracis vaccine candidate known as rPA102. This investigational vaccine, developed and tested at USAMRIID, combines the safety benefits of a vaccine made through modern recombinant technology with a record of efficacy documented in animal models. It is an alum-adjuvanted, single component, recombinant protein vaccine candidate similar in composition to VaxGen''s investigational AIDS vaccines.