Indian central drug regulator's Subject Expert Committee (SEC) has granted Emergency Use Authorisation (EUA) to Zydus Cadila's three-dose indigenous Covid-19 vaccine ZyCoV-D, the world's first DNA-based Covid vaccine that can be administered to people aged 12 and above.

The vaccine demonstrated a 66.6% efficacy against symptomatic RT-PCR positive cases in the interim analysis. The company had filed the application with the Drug Controller General of India (DCGI) for an Emergency Use Authorisation (EUA) for ZyCoV-D on July 01.

“It is a matter of great pride that today we have the EUA for the world’s first DNA COVID-19 vaccine ZyCoV-D by Zydus Cadila developed in partnership with the Department of Biotechnology and supported through Mission COVID Suraksha. The Indian Vaccine Mission COVID Suraksha was launched under the Atma Nirbhar Bharat package 3.0 being implemented by BIRAC, is aimed at the development of safe and efficacious COVID-19 vaccines for public health,” said Dr Renu Swarup, Secretary, Department of Biotechnology, and Chairperson, Biotechnology Industry Research Assistance Council.

The company said, it 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. The SEC required additional data for the two-dose vaccine from the company, it added.

Zydus Cadila has also said that it plans to manufacture 10-12 crore doses annually. It added that the plug and play technology on which the plasmid DNA platform is based is ideally suited for dealing with Covid-19 as it can be easily adapted to deal with mutations in the virus, such as those already occurring. A three-dose vaccine, its second and third shots will be administered on the 28th and 56th days respectively.

After Hyderabad-based Bharat Biotech International Limited’s Covaxin, the Zydus Cadila coronavirus vaccine is India’s second indigenous anti-Covid shot. It also has several firsts to its name- it is India’s first Covid-19 vaccine for the 12-18 age group; it is also the first coronavirus vaccine in the world based on Plasmid DNA technology, as well as its first needle-free vaccine.

Dr Sharvil Patel, the Managing Director of the Ahmedabad-based pharmaceutical firm said that the supply of the vaccine will begin in mid-September, adding that clarity on its price will be given next week.

“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. 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,” said Pankaj R Patel, Chairperson, Zydus group.

Image source: The Financial Express