Pharmaceutical company Zydus Cadila said on Thursday that it has applied for emergency use authorisation of ZyCov-D, its three-dose coronavirus vaccine.
If approved by the Drug Controller General of India, this will be the world’s first DNA vaccine, as it makes use of a portion of the genetic code – deoxyribonucleic acid or ribonucleic acid – in the SARS-CoV-2 virus to stimulate an immune response against its spike protein, the Ahmedabad-headquartered company said.
Sharvil Patel, managing director of Cadila Healthcare, said the vaccine will help not only adults but also adolescents in the 12 to 18 years age group. The shot, the company said, is “needle-free” and “safe for children”.
The company expects to produce 120 million doses of the shot annually, NDTV reported. The vaccine, tested in late-stage human clinical trials involving over 28,000 volunteers across the country, is 66.6% effective against symptomatic coronavirus cases and 100% for moderate infection. Nearly 1,000 participants were in the age group of 12 to 18. However, the trial data is not peer-reviewed yet.
The drugmaker also said it was evaluating a two-dose regimen for ZyCoV-D vaccine. “The immunogenicity results had been found to be equivalent to the current three dose regimen,” it added. “This will further help in reducing the full course duration of vaccination while maintaining the high safety profile of the vaccine in the future.”
The company said its Phase 3 trials were conducted when the second wave of the pandemic hit India, showing its efficacy against new mutants, especially the Delta variant of the virus. But, it did not mention its efficacy against those strains.
The vaccine was developed using the support of the Department of Biotechnology and the Indian Council of Medical Research. This will be the fifth vaccine to be used if authorised, after Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and Moderna.