The Poonawalla group owned Serum Institute of India, Pune is in mission mode. At the present pace, the company is most likely to become the first Indian player to launch the swine flu vaccine in its commercial form, in most likelihood by the middle of next year. Although Panacea Biotech and Bharat Biotech are also working towards developing the vaccine, Serum Institute has an edge over the other two firms as it has already been working on the H5N1 vaccine for two and half years and it is also the only company that is working on both the ?live? as well as ?killed? version of the vaccine. The institute?s executive director Suresh S Jadhav spoke to FE?s Soma Das over phone. Excerpts:
Could you specify the timeline by which you can launch the vaccine commercially?
We should be able to start the animal trials by September this year. If we are successful, we should be able to start the phase-I human clinical trials by December-January. This would be followed up by phase-II and phase-III trials. After the human clinical trials, we would have to follow it up with all regulatory approvals. If all goes well, the commercial launch of the vaccine should happen by the middle of next year.
Have you finalised on the sites for clinical trials yet?
One of the sites for the trials would definitely be Pune. Our medical division is in talks to finalise other sites, which could be Delhi, and a site possibly somewhere in the southern part of the country.
Yours is the only company that is working on both the ?live? and ?killed? version. Which one is likely to translate into commercial vaccine first? What is it that has enabled your company to compress the time frame of vaccine and how long would it have taken to develop the vaccine in normal course of time?
The ?killed version? is the one that would most likely hit the market first. It is the vaccine-based on the ?killed? version for which the September animal trials are scheduled. The fact that we have been closely working with WHO for the last two and half years on developing the seasonal influenza vaccine for strain H5N1 gave us the capability to develop the vaccine in such a short span of time. The number of years we have invested in developing the H5N1 vaccine could give you some indication on how long it would have taken in normal course of time to develop the swine flu vaccine.
What is the status on H5N1 or the avian flu vaccine?
On the status of H5N1 vaccine, we have already tested the vaccine on animal but for now we have put the project on backburner and are channelising all our capacities and energies into developing the swine flu vaccine.
We have learnt that the vaccine once developed, could cost somewhere between Rs 80 to Rs100 (single dose), do you validate this and what are your plans of manufacturing the vaccine?
It is difficult to comment on the price now. It would depend on various factors. As per the manufacturing plans, our owner Poonawalla has already constructed a building that would be used for the purpose. Depending on the yield, demand and final technology other plans would also be finalised.
You are also working on a nasal drop for the swine flu. What?s the status on that?
That will take time. There is no standardised procedure to expedite the process on that account. The strain is there in the country and we are working on it.
