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Govt ready to roll out Covid vaccine shots next week

The Union Health Ministry said on Tuesday that the Centre and states were prepared to roll out the mass immunisation programme against Covid-19 within 10 days of the vaccines getting approval on Jan 3. This suggests that the rollout date for the vaccine shots could be Jan 13.

However, the final decision on the date for starting India’s biggest adult vaccination drive will be taken by the central government, it said.

As many as 3 crore healthcare and frontline workers such as policemen will be inoculated in the first phase. The Union government has already uploaded data related to these recipients on the CO-WIN IT platform which will be used for the immunisation programme.

Two vaccines,  Covishield, a variant of Oxford AstraZeneca’s AZD1222 manufactured under licence by the Serum Institute of India and Covaxin developed by Bharat Biotech with Indian Council of Medical Research (ICMR) were given  regulatory approval for restricted use in emergency situation on Sunday.

Health Secretary Rajesh Bhushan said, “We conducted the dry run in 286 session sites, and examined the operationalisation of SOPs and protocols. On the basis of this exercise, we are prepared for a rollout of the Covid-19 vaccine within 10 days from the date of Emergency Use Authorisation granted by the regulator,” he said.

“The accelerated approval came on January 3. We are prepared to roll out within 10 days after the approval was given. The final decision will be taken by the government,” Bhushan said.

At the briefing, the first after the approvals were granted, the Centre responded in detail to concerns over Covaxin being cleared without phase 3 efficacy data.

ICMR DG Dr Balram Bhargava said statutory rules framed before the pandemic allow the regulator to grant restricted use approval on the basis of phase 2 data in emergency situations.

“The New Drugs and Clinical Trials Rules of March 19, 2019, say that if remarkable efficacy is observed with a defined dose in phase 2 clinical trial of a new drug for unmet medical needs of serious and life-threatening diseases, it may be considered for grant of marketing approval by the central licensing authority based on phase 2 data,” he said.

Meanwhile, Serum Institute and Bharat Biotech have also buried their differences over the approval for the latter’s vaccine. The two companies issued a joint statement pledging “a smooth rollout of the vaccines to India and the world. “

The four cities likely to receive the first lot of vaccines are Karnal, Chennai, Mumbai and Kolkata..