Emergent Bio submits anthrax vacc plan to FDA

Emergent BioSolutions says it has submitted a development plan for the company's recombinant Protective Antigen (rPA) anthrax vaccine candidate  to the US Food and Drug Administration. Emergent submitted the plan  ahead of the June 15 deadline in response to the Department of Health  and Human Services' amendment to its request for proposal to develop and  deliver up to 25 million doses of an rPA vaccine for the strategic  national stockpile. The amendment requested that all bidders deemed to  be in the competitive range submit to FDA a comprehensive plan outlining  the regulatory strategy for their rPA vaccine.

"We are pleased to successfully meet this HHS requirement ahead of  schedule and look forward to receiving comments and guidance from the  FDA," said Daniel Abdun-Nabi, president of Emergent BioSolutions. "As  the premier supplier of medical counter-measures to the US government,  we are fully committed to moving our rPA program forward and remain  optimistic of our competitiveness to receive any award granted by HHS to  develop and supply the Strategic National Stockpile with an rPA  vaccine," he added.