Need to set up 20 active sentinel sites in country on adverse events following immunisation: expert
CHAIRMAN OF the Covid-19 working group, National Technical Advisory Group on Immunisation (NTAGI), Dr NK Arora said that at least 20 active sentinel surveillance sites need to be set up in the country for any immunisation-related adverse events. “Adverse events following immunisation (AEFI) surveillance is at the core of any vaccination programme and we need to set up at least 20 active sentinel surveillance sites in the country,” Dr Arora said.
He was in Pune to participate in a panel discussion at the 23rd annual general meeting of the Developing Countries Vaccine Manufacturers Network.
“Just like polio surveillance, where there is an active search for cases of acute flaccid paralysis (AFP), we need to set up these sites one each in 20 states so that a strict watch can be kept on deaths and hospitalisations,” Dr Arora told reporters. “We need to keep an eye on any conditions and see if there are linkages following vaccination,” he added.
Routine programme AEFI surveillance particularly in developing countries is poor. Health systems are not robust enough and hence sentinel sites are important to build community trust and confidence, which is primarily driven by vaccine safety.
“Post Covid-19 pandemic, the whole scenario has changed and the time when it used to take 8 to 10 years for a vaccine is over. Now, vaccines will be brought into the community market much faster. Therefore, safety evaluation is very important. Never have so many platforms been used for making vaccines and manufacturing as it has happened in the last two and a half years. Safety, however, is a constant concern and as we move forward with vaccine development, vaccine safety surveillance becomes very important,” Dr Arora said.
When asked about adverse events among children, Dr Arora said that hospitalisations and deaths related to children post-vaccination were not associated with the Covid-19 vaccine. “We have done evaluations of hospitalisation and death related to children reported after vaccination and none of them was associated with Covid vaccines — Corbevax and Covaxin,” he said.
AEFI assessment requires clinical, epidemiological and programmatic knowledge and a synthesis of these three eventually helps understand whether the adverse event was related to a vaccine.
Dr Arora referred to a cluster of adverse events following immunisation recently in Africa and said in-country expertise was not available to investigate the cause. “Hence, hand-holding is necessary and global institutions like WHO and UNICEF can provide technical support,” he said.
Dr V G Somani, Drug Controller General of India, who participated in the session virtually gave an account of the challenges and lessons learnt during the pandemic. “Lockdown was a big challenge,” he said.
Country’s first Omicron-specific vaccine in evaluation stage
At Pune’s Gennova Biopharmaceuticals where the country’s first homegrown mRNA Covid-19 vaccine was developed, studies are now underway to test the Omicron-specific mRNA vaccine to be used as a booster dose. Dr Arora told The Indian Express that this will be India’s first Omicron specific vaccine – a bivalent one – which will be given intradermally as a booster dose. “Presently, it is being evaluated for a booster dose,” Dr Arora said. The DCGI had approved the study to evaluate the Omicron-specific mRNA vaccine to be used as a booster dose and approximately 3,500 participants are involved in the trial across 10 sites with the likelihood of the study being completed by November this year.
