New Delhi: Ahmedabad-based pharmaceutical firm Zydus Cadila has said that its indigenously-developed vaccine against the novel coronavirus could be launched early next year.
“Depending on the trial outcomes, we see the possibility for our vaccine ZYCoV-D to be ready for launch, early next year,” Panjak R Patel, chairman of Zydus Cadila, told ThePrint in an exclusive interview.
ZyCoV-D, a plasmid DNA vaccine, is being developed at the company’s Vaccine Technology Centre (VTC) in Ahmedabad.
The firm had, on 15 February, made an announcement about its vaccine development programme for Covid-19.
“The vaccine candidate has successfully completed its pre-clinical animal testing phase and was approved by the Drug Controller General of India, Review Committee on Genetic Manipulation (RCGM) and Central Drugs Laboratory (CDL) in Kasauli for phase 1 and 2 trials in humans,” Patel said, adding that the company “is enrolling over 1,000 human subjects across multiple clinical study sites in India”.
The company has already manufactured clinical batches of the vaccine candidate for the phase 1 and 2 trials. “The adaptive phase I and II clinical trials are likely to be completed in three months,” said Patel.
Zydus will present the outcomes of these trials to regulators before starting on phase 3.
Apart from Zydus’ ZyCoV-D, the ICMR-backed Covaxin by Bharat Biotech is another indigenously-developed vaccine candidate. Covaxin’s trials are being fast-tracked on ICMR’s directions with an aim to launch it on 15 August.
When asked for a comment on this, Patel only said, “We would not like to comment on this.”
How ZyCoV-D works
Zydus Cadila has developed a ‘DNA vaccine’ against the major viral membrane protein that is responsible for the novel coronavirus’ entry into cells.
“The plasmid DNA is introduced into the host cells, where it is translated into the viral protein and elicits a strong immune response mediated by the cellular and humoral arms of the human immune system. This plays a vital role in protection from disease as well as viral clearance,” explained Patel.
The plasmid DNA “is a bacterial smaller, circular and extrachromosomal DNA”, which is used in genetic engineering.
It has the unique property of self-replication due to which it can be used in “different molecular genetic research such as gene therapy, gene transfer and recombinant DNA technology”.
Zydus claims to be the first company in India to develop and indigenously manufacture a vaccine against the swine flu in 2010. It also claims to be the first Indian company to indigenously-develop and commercialise the tetravalent seasonal influenza vaccine.
“The company also has a strong pipeline of other vaccines like Measles-Mumps-Rubella-Varicella (MMRV), Human papillomavirus vaccine, Hepatitis A, Hepatitis E vaccines which are at various stages of development,” Patel detailed.
‘ZyCoV-D uses latest technology’
Patel also said its Covid-19 vaccine candidate, ZyCoV-D, has been developed using the latest technology.
“Ours is the latest technology for vaccine development based on DNA platform. The DNA-based vaccine does not need a Covid strain, unlike the inactivated vaccines that require viruses in killed or inactivated forms,” said Patel.
In the absence of any infectious agent in the vaccine, it can be manufactured with ease, under minimal biosafety requirements (BSL-1), the company has claimed.
“The platform (technology) is also known to show much improved vaccine stability and lower cold chain requirements, making it easy for transportation to remote regions of the country,” Patel explained.
He also said the technology used by them can be “used to modify the vaccine in a couple of weeks in case the virus mutates to ensure it still elicits protection”.
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