India Grants Emergency Use Approval To Zydus Cadila's Covid-19 Vaccine For 12 Years And Above
India's drug regulator has given emergency use authorisation to a Covid-19 vaccine candidate developed by Zydus Cadila, making it the sixth addition to the country's inoculation programme against the pandemic.
The DNA-based vaccine will be administered to all above 12 years of age, the Ministry of Science & Technology said in a media statement. This is the first vaccine shot allowed for population younger than 18 years of age.
The ZyCoV-D vaccine was developed domestically by Zydus Cadila in partnership with India's Department of Biotechnology. Interim results from the vaccine's phase-3 clinical trials, with over 28,000 volunteers, has shown an efficacy of 66.6%, Zydus Cadila had said while applying to the Drug Controller General of India.
"This has been the largest vaccine trial so far in India for COVID-19," the ministry said. "This vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier."
This marks the sixth vaccine to receive emergency use approval in the country. India's vaccination drive has been dominated by Serum Institute's Covishield, which was developed by Oxford University and AstraZeneca, and Bharat Biotech Ltd.'s Covaxin.
Russia's Sputnik V--distributed by Dr. Reddy's Laboratories--is also being administered in smaller quantities. U.S. pharmaceutical firm Moderna's Covid vaccine and Johnson & Johnson's single-shot dose have also been granted approval, but are not being administered as of now.
The ZyCov-D is an intradermal vaccine or is injected between the skin and muscles. Other Covid-19 vaccines approved in India are all administered intramuscularly—injected in the muscles.