Cadila Healthcare (Zydus Cadila) said its COVID-19 vaccine ZyCoV-D demonstrated 66.6 percent efficacy against symptomatic RT-PCR positive cases in the interim analysis. The company has filed application with the Drug Controller General of India (DCGI) seeking emergency use authorisation (EUA) of ZyCoV-D
Zydus Cadila said the world's first Plasmid DNA vaccine for COVID-19 demonstrated safety and efficacy in the interim data of the largest vaccine trial so far in India for COVID-19.
"The primary efficacy of the three doses vaccine was at 66.6 percent for symptomatic RT-PCR positive cases in the interim analysis," the company said.
"Whereas no moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose suggesting 100 percent efficacy for moderate disease," it added.
Zydus said it has found no severe cases or deaths due to COVID-19 occurred in the vaccine arm after administration of the second dose of the vaccine.
ZyCoV-D 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 company said.
The Phase-3 clinical trials were carried out involving over 28,000 volunteers in more than 50 clinical sites spread across the country and during the peak of the second wave of COVID-19 reaffirming the vaccine’s efficacy against the new mutant strains, especially the delta variant.
The company said the study also shows that ZyCoV-D is safe for children in the age group of 12 to 18 years
The vaccine is delivered through a needle free applicator called the PharmaJet to ensure painless intradermal vaccine delivery.
Zydus Cadila said it plans to manufacture 10-12 crore doses annually.
“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," said Dr. Sharvil Patel, Managing Director, Cadila Healthcare.
Evaluating two dose regimen
Zydus said it has also evaluated a two dose regimen for ZyCoV-D
vaccine using a 3 mg dose per visit and the immunogenicity results had been found to be equivalent to the current three dose regimen.
This will further help in reducing the full course duration of vaccination while maintaining the high safety profile of the vaccine in the future.
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