Panacea Biotech, the only Indian vaccine manufacturer developing a recombinant Anthrax vaccine, has completed Phase II(a) human trials at two centres in India. Depending on the results of the trials, likely to be available within two months, Panacea is planning to bid for the US Health and Human Services (HHS) Department's plans to stockpile the new vaccine in huge quantities.

"We have completed the trials and are awaiting the results. Depending on it, we will soon bid to the US Government for supply. The vaccine could reach the commercialisation stage within two to three years," Rajesh Jain, joint managing director, Panacea Biotech told Pharmabiz. Three various doses were administered to about 100 volunteers each at two centres in India, he added.

Panacea's move has gained importance considering the fact that Vaxgen Inc., the only other company claimed to have developed a recombinant Anthrax vaccine, has delayed by six-to-nine months to deliver the first 25 million doses of supply as per the schedule to HHS. Currently, a controversy is brewing in the US related to this issue and a section of politicians in US are demanding an investigation into the HHS order awarding an $877.5 million contract to VaxGen Inc. to develop the company's experimental anthrax vaccine.

The US FDA also had warned the California-based VaxGen Inc. of making exaggerated claims about its new anthrax vaccine. The HHS contract to VaxGen was the first awarded under Project BioShield, a law President Bush signed in 2004 to create a $5.6 billion corpus fund to develop remedies against possible bio-weapons that could be developed and used by anti-US terrorists.

Panacea's Anthrax vaccine, developed by a team of senior scientists in Jawaharlal Nehru University, New Delhi, is the first to be tried on human volunteers in a developing country. The JNU's vaccine technology was in-licensed by Panacea and had completed pre-clinical studies by the end of 2004. Panacea Biotec also has a license agreement with Biotechnology Consortium of India (BCI) for the manufacture & marketing of anthrax vaccine developed by Jawaharlal Nehru University.

Pharmabiz earlier had reported that Panacea was planning to conduct the trials at Indian Institute of Medical Sciences (IIMS), New Delhi and KEM Hospital Mumbai. The vaccine had received the necessary approvals from Department of Biotechnology and DCGI for the trials during early 2005.