New Delhi, Aug 20: Zydus Cadila’s indigenously developed needle-free COVID-19 vaccine ZyCoV-D was granted the Emergency Use Authorisation (EUA) by the drug regulator on Friday, making it the first vaccine to be administered to beneficiaries in the age group of 12-18 years in the country, the Department of Biotechnology (DBT) said.
Describing the development as a momentous feat, Prime Minister Narendra Modi said the country is fighting COVID-19 with full vigour. According to the CoWIN portal, over 57.5 crore doses of Covid vaccines have so far been administered in the country.
It is the sixth vaccine to get the emergency use authorisation in the country after Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, Russian vaccine Sputnik V and the vaccines of Moderna and Johnson and Johnson.
Of these, Covishield, Covaxin and Sputnik V are in use. These vaccines are being given to only those above 18 years of age and unlike ZyCoV-D, which has three doses, these are administered in two doses.
“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 Central Drugs Standard Control Organisation (CDSCO) wrote on Twitter.
The DBT said ZyCoV-D is the world’s first DNA-based vaccine against the coronavirus and when injected, produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from the disease as well as viral clearance.
The “plug-and-play” technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring, it said.
“Zydus Cadila has received approval for Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D today i.e. 20/08/2021, the world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 to be administered in humans, including children and adults 12 years and above,” the government department said.
In another tweet, the CDSCO said the vaccine has a 66-per cent efficacy and it is to be stored in a temperature range of two to eight degrees Celsius. The vaccine is needle-free, to be administered intradermally in three doses at days 0, 28 and 56.
It is administered using PharmaJet, an applicator that ensures painless intradermal vaccine delivery, Zydus Cadila said in a statement.
The DBT said the interim results from the Phase-III clinical trials in over 28,000 volunteers showed a primary efficacy of 66.6 per cent for symptomatic RT-PCR positive cases. This has been the largest vaccine trial so far in India for COVID-19, it said.
The vaccine had already exhibited robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both Phase I/II and Phase III clinical trials were monitored by an independent data safety monitoring board, the DBT said.
Zydus Cadila said it plans to manufacture 10-12 crore doses of ZyCoV-D annually. The vaccine has been developed in partnership with the DBT under the Mission COVID Suraksha, the department said.
Speaking on the development, Zydus Group chairman Pankaj Patel said, “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.” (PTI)
