Zydus Cadila seeks emergency use nod for its COVID-19 vaccine for 12+ age
Zydus Cadila has concluded its third phase trial. The company added that it plans to produce up to 120 million doses of the jab annually
- Jul 1, 2021,
- Updated Jul 1, 2021 9:08 AM IST
Indian drugmaker Zydus Cadila announced on Thursday that it has applied for Emergency Use Authorisation (EUA) to the country's regulator for ZyCoV-D- its COVID-19 vaccine for those aged 12 years and above.
The company has concluded its third phase trial. Zydus Cadila added that it plans to produce up to 120 million doses of the jab annually.
The drugmaker has carried out the largest clinical trials for its Plasmid DNA vaccine against coronavirus in India so far in more than 50 centres.
Also Read: COVID-19: Zydus Cadila vaccine likely to be available for 12-18 years age group by Aug
It was also the first time that any COVID-19 vaccine has been tested in adolescent population in the 12-18 years age bracket in the country.
"Around 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population. 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," Zydus Cadila said in a statement.
"ZyCoV-D had already exhibited a robust immunogenicity, tolerability and safety profile in the adaptive Phase me/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 company added.
Coronavirus cases in India dropped from a devastating peak in April and May, however, experts have warned of a third wave and reiterated that widespread vaccination remains one of the best defences against the pandemic.
Also Read: 2 Covid-19 vaccines for kids undergoing trials; supply to improve soon: PM Modi
An approval for Zydus' vaccine, ZyCoV-D, would make it the fifth vaccine authorized for use in India, after Moderna, AstraZeneca and partner Serum Institute of India's Covishield, Bharat Biotech's Covaxin, and Sputnik V developed by Russia's Gamaleya Institute.
ZyCoV-D showed safety and efficacy in a late-stage trial with more than 28,000 volunteers across the country, including about 1,000 subjects in the 12-18-year age group, Zydus Cadila said.
The study was carried out "during the peak of second wave of COVID-19 (in India), reaffirming the vaccine's efficacy against the new mutant strains, especially the Delta variant," Zydus said.
Indian drugmaker Zydus Cadila announced on Thursday that it has applied for Emergency Use Authorisation (EUA) to the country's regulator for ZyCoV-D- its COVID-19 vaccine for those aged 12 years and above.
The company has concluded its third phase trial. Zydus Cadila added that it plans to produce up to 120 million doses of the jab annually.
The drugmaker has carried out the largest clinical trials for its Plasmid DNA vaccine against coronavirus in India so far in more than 50 centres.
Also Read: COVID-19: Zydus Cadila vaccine likely to be available for 12-18 years age group by Aug
It was also the first time that any COVID-19 vaccine has been tested in adolescent population in the 12-18 years age bracket in the country.
"Around 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population. 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," Zydus Cadila said in a statement.
"ZyCoV-D had already exhibited a robust immunogenicity, tolerability and safety profile in the adaptive Phase me/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 company added.
Coronavirus cases in India dropped from a devastating peak in April and May, however, experts have warned of a third wave and reiterated that widespread vaccination remains one of the best defences against the pandemic.
Also Read: 2 Covid-19 vaccines for kids undergoing trials; supply to improve soon: PM Modi
An approval for Zydus' vaccine, ZyCoV-D, would make it the fifth vaccine authorized for use in India, after Moderna, AstraZeneca and partner Serum Institute of India's Covishield, Bharat Biotech's Covaxin, and Sputnik V developed by Russia's Gamaleya Institute.
ZyCoV-D showed safety and efficacy in a late-stage trial with more than 28,000 volunteers across the country, including about 1,000 subjects in the 12-18-year age group, Zydus Cadila said.
The study was carried out "during the peak of second wave of COVID-19 (in India), reaffirming the vaccine's efficacy against the new mutant strains, especially the Delta variant," Zydus said.