India's covid vaccine
Health Ministry informed that India’s biggest adult vaccination drive will be taken by the central government.
The Union Health Ministry said on Tuesday that companies developing indigenous vaccines against COVID19 were prepared to roll out the mass immunisation programme within 10 days of the getting approval from apex body. Health Ministry informed that India’s biggest adult vaccination drive will be taken by the central government.
Two India-developed COVID19 vaccines – Covaxin, developed by Bharat Biotech under supervision of Indian Council of Medical Research (ICMR), and Covishield of Oxford, developed by Serum Institute of India – were approved for emergency use in India on Sunday.
Dry runs of COVID Vaccine have been held in many states, testing operational feasibility of Co-WIN (software platform) in largescale use; assessing linkages between planning, implementation, and reporting mechanisms.
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”. Health Secretary added that they are prepared to roll out within 10 days after the approval was given. The final decision will be taken by the government.
Over the controversy of approval before phase 3 trial, 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. Explaining in details about approval, he continued saying, ‘In phase 3, with 25,800 participants, there have been no safety concerns after the first dose; and 5,000 have been given the second dose. Therefore, restricted use [approval] has been given in clinical trial mode; which means that they have to give consent, and there has to be regular follow-up’.
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