Govt expects no delay in covid immunization despite SEC move

The Centre does not expect the timelines of the covid-19 immunization programme to be impacted despite a subject expert committee (SEC) deferring its decision on recommending emergency licensure for the vaccines developed by Bharat Biotech International and Serum Institute of India.

“We have to be more than reasonably satisfied about safety, immunogenicity, and effectiveness (when we give an emergency use authorization). It has all been factored in and it will come to a decision soon,” NITI Aayog member-health V.K. Paul said at a press conference on Tuesday.

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Serum Institute’s Covishield shots, which is the frontrunner for launch next month, along with Bharat Biotech, had applied for an emergency use authorization for the vaccine to the Drugs Controller General of India (DGCI) V.G. Somani earlier this month. However, both companies were asked by an independent SEC last week to furnish more data on the trails.

From Serum Institute, the SEC sought updated data on the safety of the vaccine, immunogenicity data from the clinical trial in the UK and India, and the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA), to grant emergency use authorization (EUA) to the original candidate. The Covidshield vaccine was developed by the University of Oxford and AstraZeneca Plc, and the British researchers have applied to MHRA for EUA, which is being considered by the UK regulator.

Bharat Biotech was asked to submit data from its phase 3 trial as well, along with phase 1 and 2 data. The company started its 26,000-participant phase 3 trial last month and was banking on its phase 1 and 2 data for safety and immunogenicity last month.

Pfizer had also placed an application before the DCGI for an emergency licensure and a waiver on local clinical trials. However, during the SEC meeting it “sought more time for making a presentation before the committee”.

The government is preparing for the launch of vaccines and issued its operating guidelines earlier this week, detailing plans for the country’s largest single-vaccine immunisation drive. In the first phase, the government plans to inoculate healthcare workers and other frontline workers such as security personnel and municipal workers, as well as the elderly and comorbid by August. This will target 300 million beneficiaries and may require around 600 million vaccine doses. Following vaccination, the beneficiaries will be given a digital certificate as a proof of vaccination.

The government is creating a list of doctors and other healthcare officials for the vaccination drive. So far, a database of about 5 million doctors has been added to the government’s Co-WIN software, meant to work as a centralized end-to-end database for the covid-19 immunization programme, a senior health ministry official said on Tuesday.

For the pan-India programme, the government expects to use 29,000 cold-chain points, 240 walk-in coolers, 70 walk-in freezers, 45,000 ice-lined freezers, 41,000 deep freezers, and 300 solar refrigerators, health secretary Rajesh Bhushan said. The cold storage equipment has so far been used for the universal immunization programme but will now be primarily used for covid vaccines.

“All the equipment is already there with states and more equipment is also being supplied to them,” Bhushan said.