"We are expecting the phase-1 and phase-2 studies to be completed in 3 months," Pankaj Patel said in an interview to Moneycontrol.
Pankaj Patel, Chairman of Zydus Cadila on July 17 said he expects the potential COVID-19 vaccine developed by the company to be ready for launch early next year. The company began human trials earlier this week.
"We are expecting the phase-1 and phase-2 studies to be completed in 3 months," Patel said in an interview to Moneycontrol.
"Typically vaccine has to complete phase-1 and phase-2 study, then phase-3 study. Thereafter if the data is convincing. The vaccine will be approved," 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.
Patel added that if the Phase-1 and Phase-2 data is compelling, and incase of a grave situation, things like emergency use apply, then we have capacities to produce.
Zydus early this week said it has begun giving its plasmid DNA vaccine candidate (ZyCoV-D) to potential coronavirus (COVID-19) vaccine to healthy volunteers in the first and second phases of human clinical trials across multiple sites.
The vaccine will be tested for safety, efficacy, will compared with placebo.
Zydus has received permission from the Drug Controller General of India (DCGI) permission to initiate Adaptive Phase I/II human clinical trials of its vaccine developed at its Vaccine Technology Centre in Ahmedabad based on encouraging pre-clinical data.
In the pre-clinical phase, the company said the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits and the antibodies produced by the vaccine were able to neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate.
It said it hasn't found any safety concerns were observed for the vaccine candidate in repeat dose.
Along with Zydus, Bharat Biotech also received approval from DCGI to initiate human testing of its COVID-19 vaccine. Bharat Biotech is developing vaccine based on SARS-CoV-2 strain shared by ICMR.Serum Institute of India, the world's largest vaccine maker by volune has tied up with British-Swedish drug maker AstraZenaca to manufacture and supply Oxford COVID-19 vaccine in India and other low and middle income countries. Serum expects too expects the launch early next year.Biological E, Indian Immunologicals, Hester Biosciences, Premas Biotech, among others are also developing vaccines.