Biological E Ltd announced that the Drugs Controller General of India (DCGI) has issued a registration certificate for BioThrax (Anthrax Vaccine Adsorbed), which enables the marketing and sale of the vaccine in India to help prevent anthrax infection.
Emergent BioSolutions has signed a marketing agreement with Biological E. Limited for the marketing of BioThrax in India. BioThrax is the only vaccine for the prevention of anthrax infection licensed by the US Food and Drug Administration (FDA).
The BioThrax market authorization for India follows the publication in July 2008 of the National Disaster Management Guidelines on Biological Disaster by the National Disaster Management Authority (NDMA), which is the government body that oversees disaster management. In that document, the government of India provided guidance with respect to the management of biological disasters and stated that there is a need to have a supply of readily available anthrax vaccines to be administered rapidly in the event of an outbreak. The report goes on to state that all first responders will be vaccinated in an impending disaster situation whether natural or man-made.
BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is licensed by the FDA as a pre-exposure prophylaxis for use in adults who are at high risk of exposure to anthrax spores. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis and contains no dead or live bacteria. Since 1998, the US government has procured nearly 33.5 million doses of BioThrax. During that time period, nearly 8.4 million doses have been administered to more than 2.1 million military personnel. BioThrax cannot cause anthrax infection.