BENGALURU: While manufacturers await approvals for vaccines against Covid-19, the Union government will initiate a nationwide surveillance network to detect and respond to possible adverse events following immunisation (AEFI), which is important for approvals given for emergency use. According to the guidelines released by the Union Ministry of Health and Family Welfare on Tuesday, post-vaccination health-watch centres must be set up in all states and Union Territories.
“The existing AEFI surveillance system will be utilised to monitor adverse events and inform the understanding of the safety profile of the vaccines,” the guidelines stated. Meanwhile, Dr Sudhakar K, Minister for Health and Medical Education, said, the Centre has begun to put in place an elaborate mechanism for monitoring adverse events following immunisation (AEFI).
“The Covid vaccination programme will be unique also because it will only target adults, and state governments have been asked to rapidly detect and promptly respond to any AEFIs to ensure that public confidence in the new vaccine does not wane. Potential vaccinators are being trained with detailed instructions on infection prevention and control practices and management of minor, severe or serious AEFIs,” Sudhakar said.
States have been asked to identify at least one AEFI management centre in each block, which can be a primary health care centre or a community health centre, a district hospital or even a private health facility that has medical officers and paramedical staff. Every vaccination site will be linked to a designated AEFI management centre. All such adverse events will be reported through the Co-Win application developed to monitor and manage the Covid-19 vaccination programme.
Dr Sudhakar added that the Central guidelines state that beneficiaries must be counselled about adverse events which may occur after being vaccinated. These are expected to be minor such as local pain and swelling, and mild to moderate fever, etc. However, the list of expected events could be different based on the safety profile of the Covid-19 vaccine(s) that finally get(s) approved for use. All serious or severe AEFIs will be investigated by the district immunisation officer or the district AEFI committee.
Meanwhile, experts from Karnataka have welcomed the guidelines. “Mass vaccination campaigns for Covid-19 would require heightened levels of AEFI surveillance than currently available levels (which are designed) to monitor AEFIs in infants and children who are immunised with vaccines that have proven efficacy and have been used for years. We should not hurry with anything related to Covid-19 vaccines. We should also wait for trial data efficacy before we pressure manufacturing companies to give us the vaccine early,” said Dr C N Manjunath, director, Jayadeva Institute of Cardiology and nodal testing officer for Covid 19.
He added that not just acute adverse effects, but even interim adverse reactions should be observed and listed. Another senior health expert said the state must be prepared for AEFI. “Even when we undertake a universal immunisation programme which has been done for decades, some adverse effects are seen in children and pregnant women. We are seeing adverse events already in other countries (with Covid-19) so our states must be prepared for this and monitor it well,” he said.
The Central guidelines say that preparation is required at all levels before and during the immunisation programme, “First of all, the readiness assessment has to be made prior to vaccine introduction. The teams will have to do field visits, review of data should be done. Later, there has to be daily evening meetings, standardised monitoring tools, mobile-based app, real-time data from the planning unit has to be sent to the national level.”