Covishield, the Covid-19 vaccine candidate, produced and marketed by Serum Institute of India (SII), has been recommended for emergency use authorisation (EUA) by a regulatory expert panel, sources close to the development said on Friday.
The Subject Expert Committee (SEC) on Covid-19 vaccine, which held a marathon meeting here, gave conditional approval to Covishield, while it asked Bharat Biotech, which has developed Covaxin jointly with the Indian Council of Medical Research (ICMR), to provide more data. Post SEC green signal, a final application will be submitted to the Drugs Controller General of India (DCGI), making possible the rollout.
SII has manufacturing rights for AstraZeneca’s vaccine Covishield for India and other developing countries.
Pfizer had also applied for approval, but sought more time for presenting records.
Participating in a webinar on Thursday, VG Somani, DCGI, had hinted at the possibility of one of the vaccines getting approval. “Probably we will have a happy news (for the) New Year with something in hand,” he had said at the virtual meet on the science of vaccines organised by the Biotechnology Industry Research Advisory Council.
Umesh Shaligram, head of R&D at SII, also present at the webinar, said the Pune firm has already stockpiled 75 million doses of the vaccine and will have 100 million doses ready by the first week of January. What is, however, immediately not known is whether the entire lot will be available for India use.
A national expert panel has come up with a plan to vaccinate 30 crore people in the first half of the year. According to the plan drawn up by the National Expert Group on Covid-19 Vaccine Administration (NEGVAC), this will cover about one crore healthcare workers in the public and private sectors, two crore frontline workers including police personnel, paramilitary and armed forces as well as municipal sanitation workers, and 27 crore from the general public.
Mock drill today
In anticipation of the DCGI approval for any of the three candidates — Covishield, Bharat Biotech’s Covaxin and Pfizer’s mRNA vaccine — the Centre, together with the States and Union Territories, is carrying out mock drills of vaccine administration.
While the first dry run was carried out in four States — Andhra Pradesh, Assam, Gujarat and Punjab — on Monday and Tuesday, and the next one, a more elaborate exercise covering all States, is scheduled for Saturday.