The much-awaited massive Covid-19 vaccination exercise in the country can get real anytime soon with a regulatory expert panel recommending restricted emergency use of another potential vaccine, Covaxin, developed by the Hyderabad-based Bharat Biotech jointly with the Indian Council of Medical Research.
On Friday, the panel had recommended for emergency use Covishield, the AstraZeneca-Oxford University vaccine being produced and marketed by the Pune-based Serum Institute of India (SII).
Both these vaccines are cleared for final approval by the Drugs Controller General of India with certain conditionalities. While SII has to meet certain ‘multiple regulatory conditionalities, Bharat Biotech has to ensure abundant precautions as Covaxin is yet to complete phase-II clinical trials. What is particularly confusing in Covaxin is the phrase “clinical trial mode”.
The Subject Expert Committee (SEC) also cleared phase-III clinical trials of ZyCoV-D vaccine developed by the Ahmedabad-based Zydus Cadila, which plans to recruit 30,000 volunteers for the efficacy trials.
Priority groups
The vaccines would be used to inoculate one crore health-care workers in public and private facilities and, subsequently, two crore frontline workers, which include Armed Forces, police and sanitation workers. Other priority groups included in the 30-crore population, identified by the National Expert Group on Covid-19 Vaccine Administration, for vaccinationby July this year are those above 50 years of age and those with co-morbidities that make them vulnerable to the Covid-19 infection.
Mock vaccination drill
In anticipation of the roll-out, States and Union Territories on Saturday carried out a mock vaccination drill to iron out glitches in vaccine delivery and administration in different parts of the country. During an interaction with the media, while visiting one of the dry run sessions in Delhi, Health Minister Harsh Vardhan said the government is yet to finalise how the 27- crore priority group beneficiaries — other than health-care workers and frontline workers — would be vaccinated. The first two groups, however, would be vaccinated free of cost, he said.
Participating in an event recently, a key SII functionary said the firm has already stockpiled 75 million doses of the vaccine, which recently received emergency use approval in the UK. How much inventory of Covaxin — a truly indigenous vaccine based on a long-tested inactivated virus platform technology — is currently available is not known as yet.