Zydus Cadila seeks approval for vaccine, says it works against Delta strain

Cadila Healthcare has sought approval from India’s drugs regulator for its Covid-19 vaccine called ZyCoV-D, saying the shot demonstrated 66.6 percent efficacy against symptomatic RT-PCR positive cases in interim analysis.

Phase 3 trial for the vaccine had more than 28,000 volunteers—the largest such exercise in India, said the Ahmedabad-based company in a statement to the BSE. The company, which is also known as Zydus Cadila, said the trial was carried out in more than 50 clinical sites across India. During the peak of the second wave of Covid-19, it had shown against the new mutant strains, especially the Delta variant.

If the Drug Controller General of India (DCGI) approves it, ZyCoV-D would be the first DNA-plasmid vaccine in the world. Conventional active vaccines are made of a killed or weakened form of the infectious agent. DNA plasmid vaccine is a relatively new approach where a piece of DNA containing the genes for the antigens is injected.

“ZyCoV-D already exhibited a robust immunogenicity tolerability safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB),” said the company.

“As the first ever plasmid DNA vaccine for human use, ZyCoV-D has proven its safety efficacy profile in our fight against COVID-19. The vaccine when approved will help not only adults but also adolescents in the 12 to 18 years age group,” said Sharvil Patel, Managing Director, Cadila Healthcare.

Separately, the company evaluated a two-dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit 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, it said.

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