Emergency approval for COVID-19 vaccine in India probably before December or early January

Even when vaccine developers are working on the additional data requested last week by the government’s departmental committee on emergency authorization, the process would not affect vaccination deadlines in the country, said Dr. VK Paul, chairman of the National Expert Group on Vaccine Management . . Emergency approval for COVID-19 vaccine is expected by the end of December / early January. In the first phase, the government aims to vaccinate about 30 million people including health workers, front-line workers, and those from the priority groups such as those over 50 and those with joint diseases.

On 9 December, the Departmental Expert Committee (SEC) held a meeting to examine applications seeking emergency authorization for vaccines developed by Pfizer India, Bharat Biotech and Oxford-Serum Institute of India. The committee requested additional data from Serum Institute of India and Bharat Biotech, and the companies have not yet returned to the experts with sufficient information. “The deliberations would not affect vaccination deadlines,” Rajesh Bhushan, a union health secretary, told the media.

“Timelines won’t hit. The list of health workers for the vaccine is ready,” Paul said. He added that the time required for the process to ensure a safe and effective vaccine had already been taken into account in the planning. “It simply came to our notice then [not full approval]. we look at more than rational satisfaction for 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 36 states and UT have concluded meetings of state steering committee and also of the state task force for vaccination, and 633 districts have completed the meetings of the district task force. “Twenty-three ministries and departments in the government and the states have been identified and assigned roles for the vaccine development,” he said. Training modules also took place, and workshops for national and state officials were completed.

On the cold chain, Bhushan said the guidelines for assessment of electrical and non-electrical cold chain equipment and their reinforcement have been published.

“Guidelines for cold chain management ultimately cold chain points and seats have been published. 29,000 cold chain points, 240 inlet coolers, 70 inlets, 45,000 ice-cold refrigerators, 41,000 deep refrigerators and 300 solar refrigerators would be used,” he said.

A comprehensive mechanism for tracking adverse events after immunization (AEFI) was devised: detailed instructions on infection prevention and control practices, management of mild, severe, and serious AEFI were issued, and states were asked to identify at least one AEFI administration. center in each block. “Each meeting site would be linked to a chosen AEFI management center,” Bhushan said.

On the need for the developed mechanism, Paul said that because the developed vaccines are built on new and multiple platforms, and they are intended for adults – as opposed to children and pregnant women as in the existing immunization program – comprehensive. monitoring and surveillance were necessary. “This is urgent approval, please remember that. And therefore requires even more responsible behavior. Besides, we vaccinate adults, also in such a large number in such a short time in a mission regime, ”Paul said.