HHS' BARDA contract advances development of novel anthrax vaccine, antitoxin

The advanced development of a novel next-generation anthrax vaccine and a new type of anthrax antitoxin have received support through new contracts funded the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA).

Vaccines prevent illness by boosting the body's ability to make antibodies so the body recognizes and eliminates a bacteria or virus; with antitoxins, antibodies are injected directly into the body to neutralize the bacteria or virus.

The vaccine being developed under today's contract could be administered as a spray in the nose and given by non-medical personnel, making administration easier and potentially increasing the number of people who could be vaccinated against this potentially fatal infection.

Similarly, the new anthrax antitoxin medication could be administered by conventional injection, making the medication much easier and faster to administer than current anthrax antitoxins, which must be administered intravenously. This would greatly facilitate antitoxin administration in an emergency.

The vaccine development contract was awarded to Vaxin Inc. of Rockville, Md., for $14.7 million over two years and could be extended for a total of up to four years and $21.7 million. The contract for the new antitoxin was issued to Elusys Therapeutics Inc. of Pine Brook, N.J., for two years and $26.5 million, and can be extended for a total of five years and up to $68.9 million.

Under the contract, Vaxin will conduct studies and develop manufacturing processes for the vaccine, AdVAV. In part these studies will determine whether the vaccine can protect against anthrax with fewer doses than the currently licensed vaccine, which requires five doses over 18 months with annual boosters to protect against anthrax. In addition, Vaxin will optimize and validate commercial-scale manufacturing processes for the AdVAV vaccine.

Under the antitoxin contract, Elusys will conduct studies to evaluate the efficacy of its medication, Anthim, when administered before or after exposure to anthrax.

"These are promising medical countermeasure candidates. The new vaccine candidate has attractive attributes - ease of administration, the possibility of fewer doses, and technology that can be used to make vaccines for other diseases - and the new anthrax antitoxin candidate may enable a life-saving therapy to be available to more people sooner in an anthrax attack," said BARDA Director Robin Robinson, Ph.D. "Through these contracts, we are helping develop new tools to protect the public in an emergency and at the same time helping industry manage the costs of these products over their life cycle."

BARDA currently supports the advanced development of three other next-generation anthrax vaccines known as recombinant protein antigen (rPA)-based vaccines, as well as development of a new formulation of the currently licensed anthrax vaccine, Anthrax Vaccine Absorbed (AVA), that may require less antigen (the active vaccine ingredient) and fewer doses to be effective. AVA is approved by the U.S. Food and Drug Administration only for use before exposure to anthrax. BARDA is also supporting the expansion of AVA manufacturing capacity.

In addition, BARDA previously funded the development and acquisition of two anthrax antitoxin drugs that reside in the Strategic National Stockpile. These drugs could be authorized for use in an emergency. BARDA continues to support the late-stage development of these drugs toward full approval by the FDA.