Zydus Cadila seeks emergency use approval for its plasmid DNA vaccine against Covid

Zydus Cadila seeks emergency use approval for its plasmid DNA vaccine against Covid


Cadila Healthcare’s (Zydus Cadila) COVID-19 vaccine ZyCoV-D has demonstrated 66.6 per cent efficacy against symptomatic RT-PCR corona positive cases in the interim analysis. With promising results, the company is now all set to boost its production.

The company has now filed an application with the Drug Controller General of India (DCGI) seeking emergency use authorization (EUA) of the ZyCoV-D vaccine which is the world’s first Plasmid DNA vaccine.

Sharing the robust production plans, Sharvil Patel, MD, Cadila Healthcare said, “We expect to produce 1 crore vaccine doses per month from August onwards and 5 crore doses by December this year. Our target is to produce 10 crore vaccine doses in a year.”

About the vaccine

The company informed, “The primary efficacy of the three doses vaccine was at 66.6 percent 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 percent efficacy for moderate disease,” it added.

Zydus also revealed that no severe cases or deaths due to COVID-19 occurred after the administration of the second dose of the vaccine.

The Phase-3 clinical trials were carried out on over 28,000 volunteers in more than 50 clinical sites across the country. The trials were conducted during the peak of the second wave of COVID-19 confirming that the vaccine is effective even against the new mutant strains, especially the delta variant.

As of now, the vaccine is following a three-dose regimen, however, attempts are being made to reduce it to a two-dose regimen. The company informed that the immunogenicity of the two-dose regimen 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,” said the company.

Divulging more information on the plasmid DNA vaccine, Patel informed, “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. The vaccine, when approved, will help not only adults but also adolescents in the 12 to 18 years age group.”

As per reports, the ZyCoV-D vaccine has been proved to be safe for children in the age group of 12 to 18 years. 

This vaccine will be administered through a needle-free applicator called the PharmaJet to ensure painless intradermal vaccine delivery.

Meanwhile, India has administered over 27 lakh doses today and 33,26,04,590 doses to date overtaking the USA. 


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