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India’s covid-19 vaccination programme, the world’s largest, will be launched by 13 January, signalling an intended speedy start to the rollout as the number of cases shot past 10 million alongside a spike in the new strain of the virus.

Health secretary Rajesh Bhushan on Tuesday said that the covid-19 vaccine will be rolled out within 10 days of receiving emergency-use authorization. “We are prepared to roll out covid-19 vaccines within 10 days of granting emergency use authorization date, based on dry run feedback. But the government will only decide the exact date of the rollout of the vaccination programme," Bhushan told a press conference.

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The drug regulator gave emergency use approval to two vaccines —Covishield and Covaxin—on 3 January.

The health ministry last week conducted a nationwide mock drill of the vaccination programme at 285 sites in a test of end-to-end operations and the mechanism to ensure a smooth process. The government has said it will use the digital platform, Co-WIN, to provide real-time information of vaccine stocks, their storage temperatures and individual tracking of those who get the shot.

The rollout plan was laid out before reporters as the tally of cases on Tuesday climbed to 10.36 million and deaths mounted to 151,057.

India, the biggest hotspot after the US, reported 16,375 new cases and 201 deaths in last 24 hours. Worryingly, the number of people infected with the virulent new strain first reported in the UK now stands at 71 in India.

Bhushan said the vaccine will be transported under refrigerated conditions and digitally tracked during transit—from the manufacturer to the primary vaccine store, state vaccine store, district vaccine store and the primary health centre.

There are four primary vaccine stores—at Karnal, Mumbai, Kolkata and Chennai—from where they will be transported in bulk to 37 state stores. All primary, state and district stores will have temperature trackers, and information on temperature will be uploaded in real-time from the store to a central server, Bhushan added.

Once the vaccine reaches the district store, beneficiaries will have to register, on the basis of which the district magistrate will allocate shots, Bhushan said. However, there is no need for healthcare and frontline workers to register as their details will be taken from a bulk database that has been loaded on to the vaccine delivery management system.

This system will also give beneficiaries permission to create a unique health ID. “After both doses, a QR code certificate will also be generated which can be stored on the government’s DigiLocker app," he said.

In case of any adverse effect, there is a provision for real-time reporting. Other features include text messages in 12 languages, 24x7 helpline and chatbot assistance. As of now, more than 90,000 users have been trained in more than 700 districts.

Meanwhile, Dr Balram Bhargava, director general at the Indian Council of Medical Research (ICMR), on Tuesday said safety, efficacy and immunogenicity data are required for approval of a vaccine only in a non-emergency situation.

“It is in our legal provision: in a pandemic situation, restricted use is considered based on safety and immunogenicity data. While phase 3 is still on, immunogenicity data generated through phase 2 clinical trial, serves as a surrogate for efficacy," said Bhargava.

“The clinical trial rule, 2019, of the Clinical Trial Registry (CTR) provides for considering phase 2 results to guide approval. The subject expert committee guides the Drug Controller General of India in the process of decision making for restricted use under an emergency situation," he said.

The ICMR, which Bhargava heads, is a co-developer of Covaxin along with Bharat Biotech International Ltd. The regulator has been criticized for approving Covaxin for emergency use in spite of incomplete phase 3 data. Bhargava said Serum Institute’s Covishield is safe and immunogenic and data shows it is not inferior to AstraZeneca’s version.

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