The Drugs Controller General of India (DCGI) has granted authorization to Zydus Cadila's three-dose COVID-19 vaccine ZyCoV-D for emergency use in India.
Developed by an Indian multinational pharmaceutical company, Cadila Healthcare Limited, ZyCoV-D is the world's first DNA vaccine against the novel Coronavirus infection.
It becomes the fifth vaccine that has been approved for use in the country after Serum Institute's Covishield, Bharat Biotech's Covaxin, Russia's Sputnik V and the US-made Moderna and Johnson and Johnson
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO expert panel of India's central drug authority had recommended the DCGI for granting final emergency use authorisation to the vaccine.
The Ahmedabad-based pharma major had on July 1 applied for emergency use authorisation (EUA) with the DCGI for the vaccine.
Plasmid DNA-based ZyCoV-D will be administered intradermally using a needle-free injector.
In the interim analysis, the pharmaceutical major had said, the primary efficacy of the vaccine is 66.6% for symptomatic RT-PCR positive cases. The company further said that the vaccine is also “safe and very well tolerated" in the adolescent population in the 12-18 years age group.
No moderate case of covid-19 was observed in the vaccine arm post administration of the third dose, suggesting 100% efficacy for moderate disease. No severe cases or deaths due to covid-19 occurred in the vaccine arm after administration of the second dose of the vaccine, the company had said in a statement.
Zydus Cadila claimed to have conducted the largest clinical trial for its covid-19 vaccine in India so far in over 50 centers. This was also the first time that any covid-19 vaccine has been tested in adolescent population in the 12-18 years age group in India, the company had said.
(With Agency Inputs)