Cadila Healthcare (Zydus Cadila) on December 24 said the company is planning to initiate Phase III clinical trial of its COVID-19 vaccine ZyCoV-D in around 30,000 volunteers upon receiving necessary approvals.
The company said its vaccine was found to be well tolerated and immunogenic in the Phase I/II clinical trials.
In the Phase II study of the vaccine ZyCoV-D had been tested in over 1,000 healthy adult volunteers.
"The vaccine was found to be safe and immunogenic. The trial has been reviewed by an independent Data Safety Monitoring Board (DSMB) and reports have been submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome," Zydus Cadila said in a statement.
"ZyCoV-D has now completed Phase II clinical trials and the vaccine has been found to be safe and immunogenic. We are optimistic of Phase III clinical trial outcomes as well and that we would be able to start the production of the novel vaccine on its successful completion," said Pankaj Patel, Chairman, Zydus Cadila.
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.
Zydus Cadila has taken a novel approach to its potential COVID-19 vaccine. Called plasmid DNA, the vaccine consists of genetic material of SARS-CoV-2 protein that instructs 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. Zydus Cadila initiated Phase–1 and 2 trials in July.
ZyCoV-D vaccine can be stored at 2-8 degrees temperature, making it a good fit for the existing cold chain infrastructure. The vaccine is delivered through the intradermal (injected into the epidermis) route, which is much easier to administer compared to intramuscular injection, which requires training of healthcare workers.The company has said it expects to have final data of phase III by March-April 2021. If everything goes well, the launch of the vaccine is expected in the first half of 2021.