HHS modifies approach to supporting second generation anthrax vaccine

HHS modifies approach to supporting second generation anthrax vaccine

The HHS Biomedical Research and Development Authority (BARDA) will cancel its request for proposal (RFP) for “Recombinant Protective Antigen Anthrax Vaccine for the Strategic National Stockpile” (RFP-BARDA-08-15). BARDA took this action after a technical evaluation panel determined that none of the vaccine developers submitting proposals could meet the Project BioShield statutory requirements of having a product ready for licensure within 8 years. In response to this development, BARDA will modify its approach to the advanced development of a next-generation anthrax vaccine.

Instead of re-issuing an RFP, BARDA will request that vaccine developers submit product development plans under special instructions to an existing broad agency announcement (BAA-BARDA-09-34) that supports the development of medical countermeasures for chemical, biological, radiological, and nuclear threats. Studies funded through this program can help potential vaccines advance far enough to enable meeting Project BioShield requirements in the future.

HHS is committed to a modernized countermeasure production process that promotes promising discoveries, more advanced development, more robust manufacturing, better stockpiling, and more advanced distribution practices. Aligning the funds and authorities with the product development programs is of paramount importance to ensure success for BARDA’s end-to-end, comprehensive strategy of product development.

“Following a thorough evaluation of proposals, we determined that awarding Project BioShield acquisition contracts at this time would have placed undue risk of failure on potential contractors and the federal government,” said BARDA Director Dr. Robin Robinson. “However, we believe the broad agency announcement and the flexibilities it provides are well adapted to the further development of these products. Anthrax preparedness remains one of our highest priorities so we will continue to address this threat using all of the authorities and resources at our disposal.”

BARDA supports development of chemical, biological, radiological and nuclear medical countermeasures using both Project BioShield special reserve funding and annual appropriations for advanced research and development.

Additional information on BAA-BARDA-09-34 can be found through www.medicalcountermeasures.gov or on Fed Biz Opps, https://www.fbo.gov/download/e69/e69e84ba1aa7a515d21f91d15f8d6570/Rolling_BAA.pdf.

BARDA, part of the HHS Office of the Assistant Secretary for Preparedness and Response helps protect the American people from natural and man-made public health threats by developing and acquiring safe and effective vaccines, drugs, and diagnostics. To learn more about BARDA including Project BioShield and advanced development programs, visit www.hhs.gov/aspr/barda.

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HHS modifies approach to supporting second generation anthrax vaccine