Zydus ‘wrapping up Phase-III trials of three-dose vaccine’

Rutam Vora Ahmedabad | Updated on May 07, 2021

Says non-needle antidote will provide wider and longer antibody response

Zydus Cadila is optimistic that its three-dose plasmid DNA vaccine, ZyCoV-D, will offer sustained immunity with longer antibody response. The company expects to launch the antidote “very soon”, even as it completes the advanced Phase-III clinical trials and submits data to the drug regulator for review.

The Covid-19 vaccines presently in India are two-dose vaccines, and Zydus did encounter questions on the economics and logistic complexities involved in a three-dose vaccine. The company, however, stayed the course with its three-dose vaccine, and even indicated that it would be among the most affordable ones. The vaccine will be administered without a needle, intra-dermally.

Unlike most vaccines, which use a needle to inject the vaccine into the tissue, ZyCov-D will be administered without a needle, but using intra-dermal injection that will push the substance into the dermis.

Sharvil Patel, Managing Director, Zydus Cadila, said, “Currently, we are a three-dose regimen which we believe is more suitable for our vaccine and which will give a wider immune response and longer antibody response which we have seen in our data.”

Zydus is also conducting trials on a two-dose vaccine. “If the data are equally good, we will look at it,” said Patel ruling out any delay in the first project due to the trials on the two-shot vaccine.

As India’s second indigenously-developed vaccine, ZyCoV-D will be affordable, reiterates Patel.

“Currently, we are focussing on completing the Phase-III clinical trials and submitting the outcomes. We will decide the pricing of the vaccine closer to the launch,” said Patel.

In an earlier interaction with BusinessLine, Cadila Healthcare founder and pharma sector doyen, Pankaj Patel, had hinted at an affordable price for the company’s vaccine. “It is a trying time for the world. We have to ensure that we help people, more than looking at some quick bucks,” Patel had told this paper.

Ready for variants

ZyCOV-D is developed using a new technology platform that uses non-replicating and non-integrating plasmid-carrying gene of the virus SARS-CoV2. The platform, with improved vaccine stability and lower cold chain requirement, will be easy to transport to any corner of the country. It can also be modified in just a couple of weeks if the virus mutates. In January 2021, the company had received the Indian regulator’s nod to start Phase-III clinical trials for the vaccine on close to 30,000 volunteers. The vaccine was found to be safe, well-tolerated and immunogenic in the Phase I/II clinical trials conducted in 2020.

Throughout the pandemic, Zydus has ensured access to affordable treatment options. It has priced the much-in-demand Remdesivir at ₹899 for a vial, compared to others pricing it at ₹2,450-3,000.

Published on May 07, 2021

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