"The US federal government has a goal to stockpile 75 million doses of anthrax vaccines. The new facility and its capacity will help Emergent meet the governments security needs.Emergent worked with the Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response in the United States Department of Health and Human Services on the project. The facilitys value is estimated at $104 million, according to Yahoo Finance. Administration
Vaccination schedule
Vaccination with Emergent BioSolutions BioThrax AVA and BioThrax IM intramuscular injections in the deltoid is given at 0 and 4 weeks, with three vaccinations at 6, 12, and 18 months, followed by annual boosters. As of 11 December 2008, the new BioThrax IM for intramuscular injections in the deltoid was approved by the US FDA which changes the immunity initialization sequence from 6 to 5 shots given at 0 and 4 weeks and then at 6, 12, and 18 months, followed by annual boosters. This prolonged initialization sequence is required with annual booster shots, because the anthrax vaccines primary ingredient, the Anthrax Protective Antigen, can impair the life-cycle of the human immune systems memory B-Cells and memory T-cells, through inducing the production of immunoglobulin G (IgG) which sequesters furin.The loss of memory B-Cells leads to declining concentrations of IgG which can sequester APA, and therefore declining tolerance to the presence of anthrax bacteria.
Reinstatement of the AVIP (2006-2016)
On October 16, 2006, the DoD announced the reinstatement of mandatory anthrax vaccinations for more than 200,000 troops and defense contractors. (Another lawsuit was filed by the same attorneys as before, challenging the basis of the vaccines license on scientific grounds.) The reinstated policy required vaccinations for most military units and civilian contractors assigned to homeland bioterrorism defense or deployed in Iraq, Afghanistan or South Korea. A modification of previous policy allowed military personnel no longer deployed to higher threat areas to receive follow up doses and booster shots on a voluntary basis. As of June 2008, over 8 million doses of AVA had been administered to over 2 million US military personnel as part of the AVIP. In December 2008, the FDA approved the new BioThrax IM formulation for intramuscular injections thus reducing the immunization schedule from a total of 6 shots to 5 shots (see below). On February 12, 2009, Emergent BioSolutions announced that the Drugs Controller General of India (DGCI) had approved licensing of BioThrax for distribution by Biological E. of Hyderabad.In 2011, BioThrax was approved for sale in Singapore by the Singapore Health Sciences Authority. Building 55 approval (2016)
The FDA approved the companys license (officially called a supplemental Biologics License Application, or sBLA) to manufacture BioThrax in a large building in Lansing, Michigan known as "Building 55." According to Homeland Preparedness News, "The use of Building 55 to manufacture BioThrax could expand manufacturing capacity to an estimated 20 to 25 million doses annually.