New Delhi: Ahmedabad-based pharmaceutical firm Zydus Cadila Thursday announced that it has applied to the country’s drug regulator for emergency use authorisation (EUA) to ZyCoV-D, the three-shot Covid-19 vaccine it is developing.
It will be the country’s second indigenously-developed vaccine against the novel coronavirus, after Bharat Biotech’s Covaxin. If ZyCoV-D gets the nod, it will be the fifth vaccine authorised for use in India after Covishield, Covaxin, Sputnik V and Moderna.
The additional advantage of the vaccine is that it will be the first Covid-19 vaccine in India that has been tested in the adolescent population in the 12-18 years age group.
The company plans to produce up to 120 million doses annually.
So far, Zydus has carried out the largest clinical trials — by recruiting over 28,000 volunteers — for its Plasmid DNA vaccine at more than 50 centres.
ZyCoV-D is a ‘DNA vaccine’ that works against the major viral membrane protein, responsible for the novel coronavirus’ entry into body cells.
It is based on plasmid DNA, a small, circular and extrachromosomal bacterial DNA, used in genetic engineering.
ThePrint had reported on 18 June that Zydus Cadila has told the Government of India that it would be ready with an emergency use authorisation application within the next 10-12 days.
“Zydus Cadila has told us that they will apply for emergency use authorisation within the next 10-12 days so we could potentially be expecting another indigenous vaccine very soon,” a senior government official told ThePrint last month.
Vaccine was found safe and tolerable: Zydus
“Around 1000 subjects were enrolled in this age group (12-18 years) and the vaccine was found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population,” the company said in the statement.
“Primary efficacy of 66.6% has been attained for symptomatic RT-PCR positive cases in the interim analysis. Whereas, no moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose suggesting 100% efficacy for moderate disease. No severe cases or deaths due to COVID-19 occurred in the vaccine arm after administration of the second dose of the vaccine,” it added.
“ZyCoV-D had already exhibited a robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB),” the statement added.
Dr Sharvil Patel, managing director of Cadila Healthcare, said: “This breakthrough marks a key milestone in scientific innovation and advancement in technology. As the first ever plasmid DNA vaccine for human use, ZyCoV-D has proven its safety and efficacy profile in our fight against COVID-19.”
He added that “the vaccine when approved will help not only adults but also adolescents in the 12 to 18 years age group”.