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For all those waiting to take the needle-free, plasmid DNA vaccine recently approved by the Indian regulator, there is some good news. The three-dose Covid-19 vaccine will be available by September-end, the top management of Zydus Cadila, the maker of the vaccine, said on Saturday.
A day after the intradermal needle-less vaccine, touted as world’s first, was approved locally for adolescents and adults, Sharvil Patel, Managing Director, Cadila Healthcare (Zydus Cadila), said: “We currently have about 30-50 lakh doses ready. It has to go through a testing process, taking about 14-days, and drug product filling process. We will have some clarity on pricing in the next couple of weeks. So, if all goes by the plan, we can see initial doses delivery by the end of September.”
The Ahmedabad-based drug major had produced the vaccine (ZyCoV-D), at risk, on a small scale even as it awaited an Emergency Use Authorisation (EUA) from the regulator, which came on Friday. The vaccine is also the country’s first approved jab for adolescents between 12 and 18 years.
Production timelines
Outlining details on production timelines, completion of advanced clinical trials and pricing, Patel said: “We will try to make it affordable. The pricing depends on technology, delivery device and the quantity being procured. There is a current benchmark of pricing, and we believe that there is not going to be much difference between the two.”
Zydus expects to achieve production of one crore doses from October. “Due to Covid-19 second wave, the commissioning of the new plant got delayed by about 45 days,” Patel said, adding that the earlier projections of 5 crore doses by December may not be achieved. “But we are hopeful that we should be able to supply 4-5 crore doses by end of January 2022,” he said. The new plant, with the capacity to make 10-12 crore doses annually, is commissioned and awaiting regulatory approval.
Further, he said, the advanced clinical trials would be completed in about four months, after which data will be published. Local approvals were given on interim analysis of Phase III trials, he clarified.
The vaccine with 66.6 per cent efficacy and is given in the interval of 0-28-56-days using an applicator for intradermal administration. The needle-free applicator is currently imported from US-based PharmaJet, but will be produced locally soon, he added. Zydus is engaging with contract manufacturers to scale up production and initial due diligence has been completed for 2-3 manufacturers in India, he said. They are also getting overseas queries, he added, and are looking at technology transfer. The DNA Plasmid platform requires minimal bio safety requirements, at BSL-1 levels.
On the logistics and last mile connectivity, he said, the network was in place. The vaccine is integrated into the CoWin App and its roll-out would be finalised after discussions with the Central government, he added.
Also see: Zydus Cadila’s needle-free, plasmid DNA Covid vaccine gets DCGI nod
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