Sources said the SEC’s recommendations come with certain conditions like every recipient of the vaccine will be given a factsheet about the vaccine prior to vaccination. The company may also be asked to report adverse events every 15 days. The SEC has recommended EUA for 2 full doses of Covishield to be given with a gap of 4-6 weeks. The final marketing approval by the Drugs Controller General of India is still awaited.
“DCGI approval will take another day or two,” a source said. The approval is on the cards and the first shots are expected to be given in 7-10 days.
This will mark the start of a massive effort to innoculate “priority population” of around 30 crore people by July.
PM Modi had on Thursday said that efforts were being made to ensure the vaccines reach those who need them quickly and that 2021 was arriving with a sense of hope that a cure for Covid was at hand. Apart from marketing authorisation, DCGI will approve the label for vaccine vials. Once the label with requisite conditions or details are approved and printed, they will be stuck to the vials before dispatch. “There are some processes before the rollout,” an official said.
A nation-wide dry run to assess the preparedness on field for the vaccination process is scheduled on January 2. This will be conducted in all state capitals in at least three session sites. Some states will also include districts that are situated in difficult terrain or have poor logistical support.
“Preparations are in full swing. As soon as DCGI approves the EUA, the government will place a formal contract or supply order with the manufacturer along with details of supply schedule and locations,” the official said. So far SII has built up a stockpile of 50 million doses intended for use in India. In the initial months, the government will procure the vaccine and oversee the inoculation process.
The first order is likely to be for 10 crore doses that will be funded through PM Cares. “SII has offered a price of Rs 225-250 per dose for the first tranche, whereas Bharat Biotech has offered Rs 350. For the next lot, the prices may vary,” a source said. Bharat Biotech and Pfizer applications are still being evaluated by the SEC, which comprises independent experts.
As earlier reported by TOI, around 96,000 vaccinators have been trained so far for the Covid vaccination programme. The Centre has asked all states to be ready with their list of healthcare workers who will be inoculated with the first tranche of supplies. The 30 crore “priority population” includes healthcare and frontline workers, people above 50 years of age and those below 50 but with serious co-morbidities. Once supplies improve, the government will simultaneously start inoculating other categories.
The UK’s regulator Medicines and Health Products Regulatory Authority approved Covishield for emergency use on December 30.