NEW DELHI: India’s second indigenously developed Covid-19 vaccine — ZyCoV-D by Zydus Cadila — that was approved last month for the national vaccination programme is set to seek approval for a two-dose regimen, in a departure from a schedule permitted earlier.
The permission granted by DCGI in August was for a three-dose schedule, which was tested for efficacy in the Phase 3 clinical trials. Sources said that ZyCoV-D, which showed an efficacy of about 66.6% for preventing Covid-19 infection, is planning to move a fresh application to the Central Drugs Standard Control Organisation for allowing the vaccine to be administered in two doses.
Currently, the plasma DNA based vaccine has been permitted to be administered on Day 0, Day 28 and Day 56. “While the vaccine has been approved for a three-dose schedule, it will be logistically more convenient and user friendly if the vaccine can be administered in two doses,” said a source. As of now, tests are underway to check the efficacy of the vaccine in two doses and with concrete data in hand, the firm will apply to the CDSCO for a change in the dosing regimen.
ZyCoV-D is the first vaccine in India also permitted for 12-17 year olds apart from adults. It has also been touted as a needle free vaccine that can be administered with a applicator which ensures painless intra-dermal vaccine delivery.
The Ahmadabad-based firm has claimed that the platform used in the vaccine, because of its rapid plug and play technology, can be easily adapted to deal with mutations in the virus, such as those already occurring. The company is looking to launch the vaccine commercially by this month, though it is yet to announce its price for the private market. It is in negotiations with the government over the rate at which the Centre will purchase it for the national programme.
Like other Covid-19 vaccines in India, 75% of ZyCov-D manufactured every month will be picked up by the Union health ministry for supply to the states. The rest will be available for private hospitals and will be available for beneficiaries at a pre-decided rate.
Nearly 10-12 crore doses have been planned to be manufactured annually. But by year end, about 5 crore doses are likely to be supplied by the company which had stockpiled about 15-20 million doses before the vaccine was granted restricted use authorisation.