Pharma firms to conduct H1N1 vaccine human trials in India
An indigenous swine flu vaccine is far from ready but India has given the green signal to two foreign pharmaceutical giants to begin human trials of their vaccine in the country.
"GlaxoSmithKline (GSK) and Baxter have received approval from the drug controller of India to carry out human trials in India. The bridge study with volunteers will tell us whether their medicine is safe for us or not," V.M. Katoch, secretary, department of health research in the health ministry, said.
According to the health ministry, India has already placed orders for more than one million doses of swine flu vaccines from GSK and Novartis. But before that is administered, the government wants to ensure that the vaccines are absolutely safe.
"Through the above two bridge studies, we are trying to ascertain the safety factor. Whether they are toxic, paralysing or have any other side effect," Katoch said, adding that these human trials would be conducted in several cities.
"They have their own centres in several places of India. The trial will be conducted by these companies on volunteers," the secretary said.
Since India reported its first swine flu case in May, the country has lost over 627 lives to the contagious virus. Over 20,000 people from across the country have already been infected by Influenza A (H1N1). With over 230 deaths, Maharashtra is the worst affected state in terms of mortality and Delhi is the worst in terms of people being infected by swine flu.
The national capital has so far reported nearly 6,000 cases, but fortunately less than 30 people of them have succumbed to H1N1.
When asked about the current status of indigenous swine flu vaccine, Katoch said: "We believe they will be ready by April."
And would it be of any use then?
"Swine flu is here to stay for some more time. The surge will continue for more than one and half years from now. We can not take it lightly.
"Generally pandemics have more a life of more than two and half years. Some people develop resistance but the threat factor to common people is quite big," Katoch said, allying fears that the homegrown vaccine may arrive too late to be of any value.
Three pharma companies - Serum Institute of India (Pune), Bharat Biotech (Hyderabad) and Panacea Biotech (New Delhi) - are working on developing the vaccine. The Pune based company is leading in the race to roll it out first.
Authorities said while all imported vaccines would take care of the high risk groups, the general public may get their share of vaccination once the ingenious vaccine rolls out after April next year. Earlier, the health ministry has said the indigenous vaccine would be available by the end of 2009 or early January.
