The Drugs Controller-General of India (DCGI) gave a go-ahead to the Serum Institute of India (SSI) to start human clinical trials of the intra-nasal spray developed to combat the spread of the lethal swine flu. The wait for an effective vaccine to fight the H1N1 influenza may be over very soon if the results of the human trials turn out to be favourable.
The Pune based SSI has already submitted a report on toxicity and tolerance of the vaccine in animal trials.
The hunt is now on to identify 50 “completely healthy” adults who agree to undergo ‘phase- I’ human clinical trials scheduled to take place in Ahmedabad.
Results of phase-I trials are expected by February. If the SSI has complete confidence in the safety of the vaccine, it will initiate the phase-II trials.
The phase-II trials, unlike phase-I trials, are likely to be undertaken at several centres. The data of phase-II trials is likely to be tabled by the end of March or beginning of April.
If everything is found in order, the vaccine will go for commercial production. The SSI confirmed that the vaccine, to be inhaled through the nose, as opposed to being injected, can be used for children as well as adults.
The SSI took part in the global teleconferencing held by World health Organization (WHO) Director-General Margaret Chan to lay down a strategy and develop a protective swine flu vaccine.
The teleconference was held immediately after the highly contagious influenza was declared as a global pandemic.
In addition to the SSI, Panacea Biotech Limited (New Delhi) and Bharat Pharmaceuticals (Mumbai) have been assigned the job of developing the vaccine.