Zydus Cadila has applied for Emergency Use Authorisation (EUA) to Drug Controller General of India for ZyCoV-D- its COVID-19 vaccine for those aged 12 years and above, the drugmaker said on Thursday.
Zydus Cadilla said that they completed phase 3 trial, adding that they aim to procure 120 million doses annually.
The drugmaker has carried out largest clinical trials for its Plasmid DNA vaccine against coronavirus in India so far in more than 50 centers. It is also the first candidate to conducts trials for those aged between 12-18.
“ZyCoV-D had already exhibited robust immunogenicity, tolerability, and safety profile in adaptive Phase me/II clinical trials carried out earlier.
Both the Phase I/II and Phase III clinical trials have been monitored by independent Data Safety Monitoring Board (DSMB),” the company added.
ZyCoV-D applies for DCGI approval for emergency use of its DNA vaccine
India currently has four approved vaccines, including recently approved Moderna, Russia’s Sputnik V, AstraZeneca developed Covishield, and indigenous Covaxin.
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 the second wave of COVID-19 (in India). Reaffirming the vaccine’s efficacy against the new mutant strains, especially the Delta variant,” Zydus said.
“Around 1000 subjects were enrolled in this age group and 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 was observed in vaccine arm post of third-dose suggesting 100% efficacy for moderate disease.
No severe cases or deaths due to COVID-19 occurred in vaccine arm after administration of the second dose of vaccine.”