Cadila Healthcare (Zydus Cadila), which is developing COVID-19 vaccine ZyCoV-D, said it has far more orders from various countries for the jabs than the capacity it has committed.
"We have always believed that this (DNA) platform offers the most safe and efficacious way of handling such a large pandemic and we are very happy to see the strong response we are getting from different countries," Sharvil Patel, Managing Director, Cadila Healthcare, told analysts.
"In terms of our opportunity size, we have orders far more than what we can make ... I have to work on prioritisation of supplies and manufacturing," Patel said.
Patel added that while many countries are ready to accept Phase 2 data and approve marketing authorisation, in some countries local clinical trials would be conducted if necessary.
Zydus Cadila is setting up a manufacturing plant to produce 120 million doses of ZyCoV-D vaccine. Patel said the plant is expected to be ready for commercial production by the first quarter of FY22. In addition, the company is also looking at possible tie-ups with partners to add another 60-70 million doses, with a target production capacity of 200 million doses.
Zydus Cadila had completed Phase–1 and 2 trials, and began the Phase-3 trial last month, for which it plans to recruit around 30,000 volunteers across 60 clinical trial sites. The vaccine has to be given in three doses. The company expects to complete the first dosing of the vaccine in Phase-3, by the end of February, and anticipates a clinical trial readout in the first quarter of FY22. This will be based on 158 events of COVID-19.
Patel said Zydus Cadila has invested about Rs 150 - Rs 250 crore on both R&D and manufacturing of the COVID-19 vaccine.
Novel approach
Zydus Cadila has taken a novel approach for its potential COVID-19 vaccine. Called plasmid DNA, the vaccine consists of genetic material of SARS-CoV-2 proteins that instruct human cells to make SARS-CoV2 antigen, eliciting an immune response. The company says that this approach is easily replicable and scalable, requiring just Biosafety Level (BSL)-1. The vaccine can be stored at 2-8 degrees temperature, making it conducive for Indian cold chain conditions.
If it gets emergency approval in India, ZyCoV-D will be competing against Serum Institute of India's Covishield (developed by AstraZeneca-Oxford University) and Bharat Biotech's Covaxin. Dr Reddy's is also planning to launch the Sputnik V vaccine in March.
Thee Indian government has allocated Rs 30,000 crore for COVID-19 vaccination with the aim of inoculating at least 50 crore people in FY22. The government plans to vaccinate three crore healthcare and frontline workers in the initial phase of the COVID-19 vaccination drive. So far it has managed to vaccinate 5.8 million people with the first dose of SII's and Bharat Biotech's vaccines.
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