VaxGen and BD to Jointly Evaluate Novel Dermal Injection Technology for Delivery of VaxGen's Anthrax Vaccine
The joint program is designed to determine if dermal administration of VaxGen's anthrax vaccine with the patented BD Micro Injection technology can enhance the immune response generated by the vaccine, versus standard intra-muscular injection, and/or reduce the required amount of vaccine to produce immunity. If the use of BD's technology in combination with VaxGen's anthrax vaccine proves safe and effective, and is approved by the U.S. Food and Drug Administration (FDA), it may be considered for use in future generations of VaxGen's recombinant anthrax vaccine as well as other vaccines. The evaluation being performed with BD will have no effect on VaxGen's existing contract to deliver 75 million doses of its anthrax vaccine to the U.S. government for civilian biodefense.
The collaboration will include a Phase I clinical trial to evaluate the use of BD's Micro Injection technology, featuring a microneedle technology, for vaccination with VaxGen's anthrax vaccine. The objectives of the study are to compare the safety and effectiveness of dermal injection versus traditional intramuscular administration of VaxGen's anthrax vaccine.
Under the agreement, VaxGen will be responsible for providing vaccine, conducting clinical studies and regulatory submissions. BD will be responsible for providing devices incorporating the BD Micro Injection technology and for associated regulatory filings. BD will reimburse VaxGen for certain expenses associated with conducting the clinical studies and for serological assays associated with the study.
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