Serum Institute starts safety studies of H1N1 influenza vaccines in India

Serum plans to launch India’s first indigenous H1N1 vaccine by early next year

Serum Institute of India has started preclinical animal studies for its indigenous H1N1 swineflu vaccines in India.

Serum Institute has begun studies to test the toxicity and safety of its experimental vaccine currently being developed before attempting to study in humans, reports said quoting Serum officials.

Serum Institute plans administer around 500 doses of the H1N1 vaccine to animals over a period of 40 to 50 days.

Serum institute will submit the toxicity and immunogenicity data generated from the studies  to the Drug Controller General of India (DCGI) for obtain permission permission to undertake first in man – Phase I – human clinical trials.

Serum Institute expects to complete animal trials by November end or December first week.

Serum Institute will begin human trials as soon as the company receives permission from DCGI.

Though the vaccine has to undergo the regular testing process, the DCGI has reportedly promised H1N1 vaccine makers that it will speed up the process according to the guidelines of the World Health Organization and the European Medicines Agency.

Serum Institute expects to finish all the clinical trials for the H1N1 vaccine by February, 2010.

Earlier, the Pune, India-based Serum Institute of India (SII), announced that, it will launch the vaccine against the H1N1 flu (swine flu ) much ahead of the March 2010 deadline.

Serum Institute is one of select companies around the world which were contacted by WHO for producing a preventive vaccine against pandemic H1N1 swine flu. WHO has supplied H1N1 seed virus for Serum Institute.

Serum Institute had developed small quantities of the H1N1 flu vaccine, needed for animal trials, within just 3 weeks of receiving the sample strains from the World Health Organization.

Apart from Serum Institute, Panacea Biotech Limited, New Delhi, and Bharat Pharmaceuticals, Hyderabad are the other two Indian pharmaceutical companies working on developing the H1N1 flu vaccine.

A month after the trials on animals, a detailed report of toxicity as well as the immunogenicity of the vaccine will be submitted to the Drugs Controller-General of India (DCGI) for carrying out human clinical trials by the end of October 2009. After getting the
permission from DCGI, the SII will start the human clinical trials in December 2009.

The pandemic H1N1 flu virus has affected people in several parts of the world and is spreading quickly in India.

DCGI has said India is planning to bring swine flu vaccines by mid December as December and January are the two months when the flu-related cases are traditionally been reported mostly in the country.

Indian government, however, is yet to to order international to influenza A HINI vaccine suppliers.Health ministry is expected to take a decision on importing vaccine soon.

The government has written informed four multi-national H1N1 influenza vaccine makers to include India as well in their global clinical trials programme to test experimental vaccines in humans.

Foreign companies should first have to complete safety protocol study in India before introducing H1N1 influenza vaccine in the country, DCGI said.

India’s insistence to conduct separate clinical studies in India to ensure safety of H1N1 influenza vaccines could further delay the availability of the preventive vaccine in the country, experts said.

Among the H1N1 vaccine makers in India only CPL Biologicals, a joint venture between Ahmedabad based Cadila Pharmaceuticals and US based vaccine maker Novavax, is planning to supply 10 million doses of swine flu vaccine (H1N1) in the first phase from January-February next year.