Zydus Cadila to seek emergency use approval for its COVID-19 vaccine in next 2 weeks

Pankaj Patel, Chairman Zydus Cadila (2)

Cadila Healthcare (Zydus Cadila) said it is planning to seek emergency use approval from DCGI for its COVID-19 vaccine ZyCoV-D in next two weeks

"We are in final stages... awaiting for events data, following which we will file next two weeks," Sharvil Patel, Managing Director, Cadila Healthcare, told analysts.

The company has indicated that the efficacy data will be based on 158 events of COVID-19 from its Phase-3 trial.

Zydus Cadila said the manufacturing plant to produce ZyCoV-D is expected to be ready for commercial production by end of June 2021.

"We have capacity to produce 1 crore doses (10 million) per month. With partnerships with other manufacturers and debottlenecking and improving on yields at our own plant, we will be able to expand capacity to 2.5-3 crore (25-30 million doses) next 4-6 months," Patel said.

"We are in talks to enter licensing agreements with at least one manufacturer," Patel said.

Patel said in the next 4-6 months, we have more orders than we can produce, and added that the company will bring ZyCoV-D at affordable price.

Patel said the company is also working on abridged two dose regimen of the ZyCoV-D vaccine. The company expects the efficacy data of 2 dose regimen to be available in next 10 days.

The vaccine has to be given in three 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.

Zydus Cadila has invested about Rs 150 - Rs 250 crore on both R&D and manufacturing of the COVID-19 vaccine.

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.