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    Emergency approval for COVID-19 vaccine in India likely by December end or early January

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    Even as the vaccine developers are working on the additional data requested last week by the government’s subject expert committee for emergency authorisation, the process wouldn’t affect vaccination timelines in the country, Dr V.K. Paul, chairperson of the National Expert Group for vaccine administration said.

    An emergency approval for a COVID-19 vaccine is expected by end December/early January. In the first phase, the government aims to vaccinate around 30 crore people including healthcare workers, frontline workers, and those from the priority groups such as those over 50 years of age, and those with co-morbidities.

    On December 9, the subject expert committee (SEC) held a meeting to examine applications seeking emergency authorisation for vaccines developed by Pfizer India, Bharat Biotech and Oxford-Serum Institute of India.

    The committee asked for additional data from Serum Institute of India and Bharat Biotech, and the companies have yet to come back to the experts with sufficient information. “The deliberations wouldn’t affect vaccination timelines,” Rajesh Bhushan, Union health secretary told the media.

    “Timelines wouldn’t be affected. The line listing of health workers for the vaccination is ready,” he said.

    He added that the time taken for the process of ensuring a safe, effective vaccine had already been factored in the planning. “Besides, this is emergency approval [not full approval]. we are looking at more than reasonable satisfaction on account of safety, immunogenicity and efficacy. we look forward to a good decision soon,” he said.

    Updating the media on the preparations for vaccine administration, Bhushan said that 36 states and UTs had concluded meetings of state steering committee as well as the state task force for vaccination, and 633 districts had completed the meetings of the district task force.

    On the subject of cold chain, Bhushan said that the guidelines for estimation of electrical and non-electrical cold chain equipment and their strengthening have been issued.

    “Guidelines for management of cold chain at last cold chain points and session sites have been issued. 29,000 cold chain points, 240 walk-in coolers, 70 walk-in freezers, 45,000 ice-lined refrigerators, 41000 deep freezers and 300 solar refrigerators would be used,” Paul said.

    An elaborate mechanism for tracking adverse events following immunization (AEFI) had been devised: detailed instructions on infection prevention and control practices, management of minor, severe, and serious AEFI had been issued, and states had been asked to identify at least one AEFI management centre in each block. “Every session site would be linked to a designated AEFI management centre,” Bhushan said.

    On the need for the elaborate mechanism, Paul said that since the vaccines that are being developed are being built on new, and multiple platforms, and they are meant for adults—as opposed to children and pregnant women as in the existing immunization program—extensive monitoring and surveillance was required.

    “This is an emergency approval, please remember that. And hence, demands even more responsible behaviour. Besides, we are vaccinating adults, that too in such a large number in such a short time in a mission mode,” Paul said.

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