Zydus Cadila gets EUA for ZyCoV-D vaccine for Covid-19 in India
Zydus Cadila (Cadila Healthcare) said that it has secured the emergency use authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D vaccine for Covid-19 for adults and also adolescents in the age group of 12-18 years.
According to Zydus Cadila, ZyCoV-D is the first Plasmid DNA vaccine for Covid-19 in the world. It is a three-dose vaccine, which has a gap of 28 days between the first two doses, while the third dose has to be given on the 56th day.
The ZyCoV-D vaccine was found to be safe, well tolerated, and immunogenic in its phase 1/2 trials.
The Central Drugs Standard Control Organisation (CDSCO), under which the DCGI operates, tweeted: “After evaluation of interim Phase III clinical trial results in consultation with Subject Expert Committee, CDSCO has approved DNA COVID-19 vaccine (ZyCoV-D) of M/s Cadila Healthcare for restricted use in emergency situation in India for 12 years and above.”
The needle-free vaccine has to be administered using The PharmaJet, a needle free applicator, which is claimed to give painless intradermal vaccine delivery.
Zydus Cadila revealed plans to manufacture 10-12 crore doses of ZyCoV-D vaccine annually.
The Indian pharma company said that it is for the first time that a technologically advanced vaccine has been developed successfully on the Plasmid DNA platform for human use. The platform due to its quick plug and play technology can be adapted easily for dealing with the various Covid-19 mutations.
Pankaj R. Patel — Chairman of Cadila Healthcare 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.”
Zydus Cadila said that it will pursue approval for the two dose regimen of the ZyCoV-D vaccine.
How the ZyCoV-D vaccine works in protecting against Covid-19
The company said that the Plasmid DNA vaccine produces the spike protein of the SARS -CoV-2 virus and causes an immune response mediated by the cellular and humoral arms of the immune system.
Zydus Cadila said that the ZyCoV-D vaccine has to be stored at 2-8º C but has demonstrated good stability at temperatures of 25º C for at least three months.