The
Centre is looking forward to a “good decision” on the
Covid-19 vaccine soon and has asked states to identify at least one adverse event management centre in each block to monitor the safety and efficacy aspects of the jabs.
“When we undertake a
universal immunisation programme, some adverse effects are seen in children and pregnant women after vaccination,” health secretary Rajesh Bhushan said. “So, we can’t deny chances of an adverse event when Covid-19 vaccination begins. In countries where immunisation has already begun, especially in the UK, adverse events have taken place on the very first day. So, it is essential that states and UTs prepare for this too,” he said.
Every vaccination session site will be linked to a designated Adverse Event Following Immunisation (AEFI) management centre to ensure all such events are tackled and reported efficiently, officials said. The health ministry has also issued guidelines for monitoring adverse events.
The process of emergency use authorisation of Covid vaccines will not impact timelines for vaccine rollout since the government has already factored the scientific processes needed to ensure that the jabs approved are safe, aligned to global standards and are effective, said Dr
V K Paul,
NITI Aayog member and head of national expert group on vaccines administration.
“We have factored in the time it will take. We are looking forward to a good decision soon,” Paul said.
Underlining that the vaccination drive will involve a large beneficiary pool in a short period of time and is different from regular immunisation, the government stressed adverse event monitoring in cases of Covid-19 vaccine would also require extra efforts.
“This is an adult vaccine whereas our existing AEFI is targeted to monitor children and women. Secondly, these Covid vaccines are developed on new platforms, even on multiple platforms, that makes it a complicated situation. We have to be very responsible. Vaccines are being examined on a scientific basis and regulators will look for more than reasonable satisfaction to give an approval,” Paul said.
Bhushan said states and Union Territories must prepare for adverse events as part of the vaccination programme.
Currently, the drug regulator is examining three applications from
Pfizer, Serum Institute of India (SII) and
Bharat Biotech for emergency use authorisation of their respective vaccines.
The government has also issued detailed guidelines to the states to estimate the electrical and non-electrical cold chain requirements. In all 29,000 cold chain points, 240 walk-in coolers, 70 walk-in freezers, 45,000 ice-lined refrigerators, 41,000 deep freezers and 300 solar refrigerators are to be used, according to the health ministry.
The government has also identified 23 ministries and departments at the Centre and state level and assigned roles for planning, implementation, social mobilisation and awareness generation for the vaccine rollout.