India is on the cusp of twin Covid-19 vaccine rollouts with the expert committee of the drug regulatory authority on Saturday recommending emergency use approval for the first indigenous candidate Covaxin.
The positive recommendation for Bharat Biotech-ICMR’s Covaxin came a day after experts suggested approval to the Oxford University-AstraZeneca-Serum Institute’s Covishield.
Drug Controller General of India VG Somani is likely to announce tomorrow official emergency use approvals for both the vaccines, besides explaining the conditions under which these would be permitted. There are now two vaccines on India’s pandemic management horizon with the government successfully conducting vaccine dry run at 259 sites in 116 districts pan India today. Around 1.14 lakh vaccinators have been trained and over 75 lakh beneficiaries (of first phase priority inoculation) registered on Co-WIN. Sources said once approved by the DCGI, the vaccine rollout could start as early as next week.
Covaxin is yet to conclude phase-3 trials with recruitment of participants underway, but the subject experts have recommended its restricted use on the basis of interim analysis of the available data. The manufacturers have been told to continue presenting additional safety data.
The two-dose Covishield has demonstrated 90 per cent efficacy in phase-3 trials when the vaccine is administered as a halved first dose and a standard second dose after a month.
The data from phase-2 Covaxin trials recently showed the vaccine was well tolerated across age groups, produced cell mediated immune response and did not show any serious adverse event. Bharat Biotech and ICMR have published results for phase-1 and phase-2 trials with the late-stage phase-3 trials progressing well, though full data was awaited.
The phase-2 trial of Covaxin was a double-blind, randomised, multi-centre clinical trial involving 380 healthy children and adults who received two vaccine formulations—3 µg and 6 µg. Two intramuscular vaccine doses were administered four weeks apart. Its developers hypothesise that the vaccine can generate antibodies that may persist for six to 12 months.