“When we undertake a universal immunization program, we see some adverse effects in children and pregnant women after vaccination,” said Health Secretary Rajesh Bhushan. “So, we cannot deny the possibility of an adverse event when the Covid-19 vaccination begins. In countries where immunization has already started, especially in the UK, adverse events have occurred on the first day. Therefore, it is essential that states and TUs prepare for this as well, ”he said.
Each vaccination session site will be linked to a designated Post Immunization Adverse Event Management Center (AEFI) to ensure that all of these events are efficiently addressed and reported, authorities said. The Ministry of Health has also issued guidelines for monitoring adverse events.
The authorization process for the emergency use of Covid vaccines will not affect the timing for the launch of the vaccine, as the government has already taken into account the scientific processes necessary to ensure that the approved jabs are safe, aligned with the standards global and effective, said Dr. VK Paul, NITI Aayog member and head of the national group of experts on vaccine administration.
“We have taken into account the time it will take. We hope for a good decision soon, ”said Paul.
Underlining that the vaccination campaign will involve a large group of beneficiaries in a short period of time and is different from regular immunization, the government emphasized that monitoring for adverse events in cases of the Covid-19 vaccine would also require additional efforts. .
“This is an adult vaccine, while our existing AEFI is aimed at monitoring children and women. Second, these Covid vaccines are developed on new platforms, even on multiple platforms, which makes for a complicated situation. We have to be very responsible. Vaccines are being scrutinized on a scientific basis and regulators will seek more than reasonable satisfaction to give approval, ”Paul said.
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Bhushan said that states and territories in the Union should prepare for adverse events as part of the vaccination program.
The drug regulator is currently examining three applications from Pfizer, Serum Institute of India (SII) and Bharat Biotech for the authorization of emergency use of their respective vaccines.
The government has also issued detailed guidelines for states to estimate electrical and non-electrical cold chain requirements. In the 29,000 points of the cold chain, 240 cold rooms, 70 cold rooms, 45,000 ice-lined refrigerators, 41,000 freezers and 300 solar refrigerators will be used, according to the Ministry of Health.
The government has also identified 23 ministries and departments at the central and state levels and has assigned roles for planning, implementation, social mobilization, and awareness raising for the launch of the vaccine.
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