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.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
"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.