The sources said the SEC’s recommendations come with certain conditions, such as that each vaccine recipient will be given a vaccine fact sheet prior to vaccination. The company can also be asked to report adverse events every 15 days. The SEC has recommended the USA to administer 2 full doses of Covishield with an interval of 4-6 weeks. Final marketing approval by the Comptroller General of Drugs of India is still awaited.
“DCGI’s approval will take another day or two,” said a source. The approval is on the cards and the first injections are expected to be given in 7-10 days.
This will mark the start of a massive effort to inoculate the “priority population” of around 30 million people by July.
Prime Minister Modi had said on Thursday that efforts were being made to ensure vaccines reach those who need them quickly and that 2021 came with the hope that the cure for Covid was at hand. In addition to the marketing authorization, DCGI will approve the label on the vaccine vials. Once the label with the required conditions or details is approved and printed, they will be attached to the vials prior to shipment. “There are some processes before the launch,” said an official.
A nationwide test is scheduled for January 2 to assess field readiness for the vaccination process. This will be held in all state capitals at at least three session sites. Some states will also include districts that are located 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 the details of the supply schedule and locations,” the official said. So far, IBS has accumulated a reserve of 50 million doses destined for use in India. In the first few months, the government will purchase the vaccine and supervise the inoculation process.
The first order is likely to be for Rs 10 million doses to be financed through PM Cares. “SII has offered a price of Rs 225-250 per dose for the first tranche, while Bharat Biotech has offered Rs 350. For the next batch, prices may vary,” said a source. The Bharat Biotech and Pfizer applications are still being evaluated by the SEC, which is made up of independent experts.
As TOI previously reported, around 96,000 vaccinators have been trained so far for the Covid vaccination program. The Center has asked all states to be ready with their list of healthcare workers who will be vaccinated with the first tranche of supplies. The “priority population” of Rs 30 crore includes health care and frontline workers, people over 50 and those under 50 but with severe comorbidities. Once supply improves, the government will simultaneously start inoculating other categories.
The UK Medicines and Health Products Regulatory Authority approved Covishield for emergency use on December 30.
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