Pharmaceutical Business review

India approves EUA for Zydus Cadila’s ZyCoV-D Covid-19 vaccine

ZyCoV-D Covid-19 vaccine will be administered in three doses. Credit: Zydus Cadila.

The Drugs Controller General of India (DCGI) has granted emergency use authorisation (EUA) for Zydus Cadila’s ZyCoV-D Covid-19 vaccine for adolescents aged 12 years and above.

ZyCoV-D, an intradermal vaccine, is claimed to be World’s first Plasmid DNA vaccine and India’s first Covid-19 vaccine to be approved for this age group, apart from adults.

The vaccine will be administered in three doses using The PharmaJet a needle free applicator Tropis, which can also significantly reduce any kind of side effects.

The first dose will be administered on zero day, second on 28th day and the third dose on 56th day.

Using rapid plug and play technology, the Plasmid DNA platform can be easily adapted to deal with mutations in the virus.

Zydus Cadila stated that the ZyCoV-D Covid-19 vaccine can remain stable in room temperatures for three months. This helps in easy transportation and storage of the vaccine.

Cadila Healthcare chairman Pankaj Patel said: “This is a historic milestone with ZyCoV-D, a product of Indian innovation becoming the world’s first DNA vaccine being offered for human use and supporting the world’s largest immunization drive.

“We are particularly happy that our vaccine will contribute to this fight against COVID-19 and enable the country to vaccinate a larger population especially in the age group of 12-18 years.

“I would like to thank all the researchers, clinical trial investigators, volunteers and the regulators who have supported this endeavour.”

The company is planning to manufacture 100 million  to 120 million ZyCoV-D vaccine doses per year and also seek approval for the two-dose regimen of the vaccine.