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    Expect Covid vaccine human trial to be completed in 3 months: Zydus Cadila Chairman

    Synopsis

    ‘We did a detailed 28-day toxicity study in two different animal species’

    Everybody is putting their best effort to make a vaccine available.
    India has been fulfilling the world requirement of vaccines for a long time, says Pankaj Patel.

    Tell us about the vaccine that has been cleared for human trials.
    We undertook this development from the month of March and we have undertaken various animal studies. We undertook the study in four different animals: mice, rats, guinea pigs and rabbits and we found very good immunogenic responses. Also the virus neutralisation was done and we found that the serum was able to neutralise all the viruses. Based on that, we did a detailed 28-day toxicity study in two different animal species and found that the vaccine was safe and was giving a very good immunogenic response.

    So now we have applied for a clinical study. We got the approval for phase-1 to combine clinical study and the study will start very soon. Based on the animal data, we are encouraged to start this clinical study. Based on the clinical study data, we will decide and move forward. We expect the trial to be completed in about three months time from now.

    Now these will be human trials and these are for a 1,000 people initially. Can you explain how this would work and is this enough of a sample size? Do we have enough time to know correctly and accurately whether the vaccine works?
    What will happen is when we do this clinical study on these 1,000 people, they will be administered one or more doses of vaccine and the immune response will be measured. Also, the serum will be subjected to virus neutralisation assay to find out whether the immune response also is acting on the coronavirus. So that will tell us the vaccine is working and is able to neutralise the virus.

    The next step, of course, we will have to see how long this antibody remains in the body. That would decide about the long term efficacy of that. But phase-2 will clearly tell us about the safety of the vaccine and also the efficacy of the vaccine. For duration, one would need a longer clinical study.

    ICMR partnering with biotech and launching its own initial phases of clinical trials. The efficacy of those results are to be released by August 15. Meanwhile there are a number of candidates in India and across the world. I just want an overview from you on this sort of race to the vaccine which has begun and what are the most important aspects of ensuring that at the end of it, we have a vaccine which works and which is available at a reasonable price for a large population. How confident are you that India will be ahead in that race which is a global one?
    I do not think it is a race. Everybody is putting their best effort to make a vaccine available because everybody in the world is suffering today and they need something very badly. I think it is not a race but there is definitely a need to really rush for making a vaccine available. India has a large capacity and also capability of producing vaccines for a very long time and we have been fulfilling the world requirement of vaccines for a long time. Second is of course, India always has shown a cost advantage compared to any other player and that is why we are the major supplier of vaccines in the world. I am clearly seeing that whoever gets the vaccine first, that is not important but India will definitely provide a vaccine to the world as we move forward.

    What is the kind of timeline and ballpark cost that you see for the vaccine that you are working on?
    As I mentioned to you earlier, we will complete our phase 1 & 2 study which will tell us the efficacy and safety of the vaccine and also the dosage that is required. Based on that we will make a submission to the DCGI and for other regulator approvals.

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    3 Comments on this Story

    Subbu India40 days ago
    Don't know whether Bio-tech can launch the vaccine on August 15 this year. Can Zudus launch even in 3 months time from now.
    Natarajan Sundaram40 days ago
    Thank you for your efforts. wishing fir success
    Nauzal Patell41 days ago
    15th August realize date is true do it fast world needs it dont delay
    The Economic Times