Animal trials for H1N1 vaccine begin in India

In this file photo a dose of the experimental vaccine for H1N1 flu virus is being prepared at a testing facility. Around 500 doses of the H1N1 vaccine will be administered to animals over a period of 40 to 50 days and the report on toxicity and immunogenicity will be submitted to the Drug Controller General of India for permission to undertake Phase I human clinical trials. Photo: AP

India’s hope for a H1N1 vaccine has got a shot in the arm with Serum Institute beginning animal trials for the vaccine, a prelude to the much tougher human trials.

“Animal trials for the H1N1 vaccine have started,” Rajeev M. Dhere, Senior Director, Serum Institute of India, told PTI .

Around 500 doses of the H1N1 vaccine will be administered to animals over a period of 40 to 50 days and the report on toxicity and immunogenicity will be submitted to the Drug Controller General of India (DCGI) for permission to undertake Phase I human clinical trials.

“We hope to finish the animal trials by November end or December first week and begin human trials thereafter with permission from the DGCI,” Dr. Dhere said.

All clinical trials for the vaccine are expected to end by February, he said.

“If the human trials are successful, by March the vaccine should be made available. We have the technology to produce the vaccine that can be pressed into service immediately for commercial production depending upon the scale of requirement after regulatory clearances,” he said.

“Going by our animal data, so far, the results are satisfactory,” Dr. Dhere said.

The Serum Institute has roped in Pune-based Intox Toxicological Study Centre to assess the complete systemic toxicity as well as local toxicity level of the vaccine.

The study includes evaluating acute toxicity, single dose toxicity and repeated dose toxicity of the vaccine on animals.

Thereafter, the immunogenicity study is carried out to study the effectiveness of the vaccine.

The institute had got the virus strain of H1N1 flu from U.K.-based National Institute for Biological Standards and Control.

H1N1 virus which causes swine flu has claimed 374 lives in the country and there are about 11,656 confirmed cases of the disease.

Globally, 3,917 people have died of H1N1 since the outbreak of the viral disease in April, the World Health Organisation (WHO) said in a latest update.

Besides the Serum Institute, Bharat Biotech International, Hyderabad, and Panacea Biotech, New Delhi are also working to develop the H1N1 vaccine.