Zydus Cadila will apply for Phase 3 clinical trials of its experimental COVID-19 vaccine in December, and expects to launch it by March 2021.
"If all goes well, the company expects to introduce the vaccine by March next year," a source told The Economic Times.
Moneycontrol could not independently verify the story.
Zydus Cadila will submit results of the Phase 2 trials next week, which "will ascertain the safety, dose and efficacy of the potential vaccine", a source told The Economic Times.
Initial results from the Phase 2 trials indicate that ZyCoV-D, the company's vaccine candidate, that no safety concerns were observed, the report 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.
According to the report, the company is looking to conduct Phase 3 trials of the vaccine against COVID-19 on 39,000 participants.
"The indications are safe and the trial is under control," a source told the paper.
"We could be looking at manufacturing 100 million doses to begin with, once the vaccine receives all regulatory permissions," Zydus Cadila Chairman Pankaj R Patel recently told The Economic Times.
Zydus Cadila is also exploring collaborations if required to make the vaccine more widely available, the report said.
Vaccine candidates by Pfizer-BioNTech, Oxford-AstraZenca, Moderna and Russia's Sputnik have recently reported strong efficacy in protecting people against the disease.
US drugmaker Pfizer and its German partner BioNTech said there vaccine candidate has an efficay of 95 percent, while Moderna said its potential vaccine has 94.5 percent efficacy.
British-Swedish drugmaker AstraZeneca and the University of Oxford have said there experimental vaccine on average protected 70 percent of the trials' participants against COVID-19.Russia has said its vaccine candidate Sputnik V has shown an efficacy of 95 percent.