India’s drug regulator has granted emergency use authorisation to ZyCov-D, a three-dose coronavirus vaccine, developed by pharmaceutical company Zydus Cadila, said the Union Ministry of Science and Technology on Friday.
This is the world’s first DNA vaccine against the coronavirus disease. 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, according to the Ahmedabad-headquartered company. Spike proteins are small bumps on the viruses of the coronavirus family that assist in the infection.
The vaccine can be administered to all children and adults aged 12 and above, the ministry said in a statement. It is also the first Covid-19 vaccine that can be administered to children above the said age limit. Earlier in July, the company had said that the shot is “needle-free” and “safe for children”.
The interim results of the phase 3 trials of the vaccine showed an efficacy of 66.6% against symptomatic cases and 100% against moderate infection. The trial was conducted on 28,000 volunteers, the statement said.
“This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier,” the ministry said. “Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board.”
ZyCov-D is the second indigenously developed Covid-19 vaccine and the sixth one to be granted approval for emergency use in India. The other five are Bharat Biotech’s Covaxin, Serum Institute of India’s Covishield, Russia-made Sputnik V and shots developed by United States-based Moderna and Johnson & Johnson.
“We are extremely happy that our efforts to put out a safe, well-tolerated and efficacious vaccine to fight Covid-19 has become a reality with ZyCoV-D,” Zydus Cadila group chairperson Pankaj R Patel said. To create the world’s first DNA vaccine at such a crucial juncture and despite all the challenges, is a tribute to the Indian research scientists and their spirit of innovation.”
In July, the company had said that 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 company expects to produce 120 million, or 12 crore, doses of the shot annually. The vaccine was developed with the support of the Department of Biotechnology and the Indian Council of Medical Research.