New Delhi: Ahmedabad-based drug and vaccine maker Zydus Cadila is all set to roll out the Phase III trial of its Covid-19 vaccine, ZYCoV-D, at over 60 clinical trial sites with 30,000 participants.
The clinical trial is expected to start this month. The company expects the results of its indigenously-developed vaccine to be out by the end of March or early April.
On Sunday, the Drugs Controller General of India (DCGI) granted “conditional approval” to two vaccine candidates — Oxford-AstraZeneca’s Covid vaccine Covishield, manufactured in India by the Pune-based Serum Institute of India, and Hyderabad-based Bharat Biotech’s Covaxin.
Zydus vaccine was the third candidate in India to get the nod to conduct Phase III clinical trials.
“At around 60 plus sites, we are targeting to administer doses to 30,000 volunteers, and we believe that we can accomplish this in the next 2-3 months so by the first quarter or by the end of March, we could potentially have the efficacy results coming out,” Pankaj Patel, chairman of Zydus Cadila, told ThePrint in an exclusive interview.
A maker of hydroxychloroquine and remdesivir, which registered a turnover of over Rs 14,253 crore in 2019-20, Zydus Cadila claims that its vaccine is easy to store, transport and inject. It can also be produced in large quantities, in an exclusive ten-dose vial format, which will help in manufacturing large quantities quickly.
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‘Easy to store, inject and produce’
According to Patel, the Zydus vaccine is very stable at 2 to 8 degrees and can be stored in a normal refrigeration temperature. “Our vaccine is also very thermostable (not readily deactivated by heat) at 25 degrees,” he said.
“We already have three to four months data where we are seeing good stability of vaccine at temperatures of around 25 degrees, so we believe that this will be a thermostable vaccine which can be very comfortably transported and you will not face the issues of vaccine going bad because of fluctuations in temperature because we have very thermostable product,” he said.
Explaining the uniqueness of its vaccine platform, he said, “Another good aspect of the vaccine is that it is only intradermal injection and is used with a new applicator. It is a very easy way to administer which can also lead to a significant reduction in any kind of major side effects.”
Under intradermal route, the dose is injected in the skin and not the muscle, leading to lesser pain.
“It is in a ten-dose vial format so we can produce in very large quantities and make it available. It will have a device attached to it which will make it much easier for administering at different centres across the country,” he said.
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‘Very good’ results of Phase II trial
Patel said the company has noticed “very good” response in its Phase II data in terms of “strong immune response”.
“The platform we are using is the third generation of a new vaccine platform where the DNA, the antigenic material of the virus, the active part of the virus is injected into the DNA plasmid,” he said, adding that “we believe that this will lead to a very strong adaptive immunity in the people”.
The company has administered three doses to volunteers and tracked the study for more than three months. “We have seen very good geometric mean titres where we have seen 20-80 fold rise in the antibody levels, so we believe that we have very good data in terms of antibody response or the T-cell response as well,” said Patel.
Speaking on the safety aspect, he said: It has also been established that across DNA platforms are non-replicating in nature and they don’t have any vector based immunity, so the platform is extremely safe and we have been able to demonstrate that in our Phase II data.”
Under Phase III, the company’s first primary objective analysis will be based on 158 cases of Covid.
“So once the vaccination cycle is completed, one needs to wait for getting in the 158 number of cases who test positive for Covid-19 as this is a double-blind, randomised, placebo controlled trial,” he said.
“Once this efficacy analysis number comes in, the trials’ primary objective would be complete and we can expect the results to be out by end March or early April 2021.”
Will late launch affect takers?
While two players have already got the approval to become a part of the country’s immunisation drive, Patel said it doesn’t matter even if ZYCoV-D enters the market and vaccination programmes a little later.
“The priority at this point is to provide access to a vaccine that is safe, efficacious and affordable and I think there is a huge population in India for this vaccination programme,” he said.
“Our aim would be to first cater to the population in India and then look at partnering with collaborators to manufacture the vaccine in other markets… But yes, we have been receiving enquiries from other markets,” he said, responding to a query regarding the company’s plans to export the vaccine.
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All very good. However, approval for Phases 1 & 2 trials of the vaccine was given at end of June ’20, along with for Covaxin. Phase 3 trials could have been started in Oct ’20 end if the regulators and Company were proactive in this emergency. Hopefully, they will be more proactive now, increase the number of sites if reqd, carry out testing in other countries to establish safety and efficacy across different ethnicities etc, for export and preliminary results will come in by March – April.
All very fine, but why so much delay in starting Phase 3 trials? Approval for Phase 1 & 2 trials was given in End June ’20, same as for Covaxin. In this emergency situation, Phase 3 could have been started by Beginning of November, at the latest and the regulators should have proactively seen Phase 1 & 2 results on a weekly basis to determine safety and efficacy. Hope that sufficient number of volunteers come forth. If reqd, more number of centres may be opened and trials carried out in foreign countries also, to assure buyers that vaccine is suitable for all age groups, ethnicity etc. Hope that EUA is got by May ’21 at the latest and all the world is benefited.