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India’s Centre Asks States to Strengthen Monitoring of Adverse Effects of COVID-19 Vaccination

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The Centre has asked states to take steps needed for strengthening surveillance of adverse events following immunisation before the COVID-19 vaccine is introduced, noting that preparations are underway for conducting the vaccinations starting with certain priority groups.

In its letter dated November 18, the Union health ministry listed initiatives which it said are essential to further strengthen the existing adverse events following immunisation (AEFI) surveillance system of India so that timely and complete AEFI reporting for COVID-19 inoculation is possible.

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“I request that these initiatives are implemented at the earliest so that required changes take place well before the COVID-19 vaccine is introduced in the state and district,” the letter written by Dr Manohar Agnani, additional secretary in the ministry, said.

Listing the initiatives, the ministry asked all states and union territories to include medical specialists in addition to paediatricians in state and district AEFI committee saying COVID-19 vaccinations will be given to adults, many of whom may have comorbidities.

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Mentioning events due to pre-existing comorbidities (stroke, heart attacks etc) may be reported as adverse effects following vaccinations, the ministry said that membership of state AEFI committees should be revised to include neurologists, cardiologists, respiratory medicine specialists who can recognise such events and differentiate them from events related to vaccines and vaccinations.

“Similarly, directions may be issued to districts to include medical specialists (neurologists, cardiologists) in the district AEFI committees,” it said.

The ministry further asked each state to choose a medical college to function as the state AFEI technical collaborating centre.

The clinical specialists of the medical college (neurologists, cardiologists, respiratory medicine specialists in addition to paediatricians) and experts from the department of community medicine will assist the state and state AEFI committee in conducting rapid causality assessment, case investigations in districts, laboratory tests in certain cases to find the cause of AEFIs etc, it said.

The new committee members or specialists should be oriented on the immunisation programme, COVID-19 vaccination, AEFI surveillance and conduction of causality assessment for AEFI cases, the letter stated.

While state and district AEFI committees are required to meet once a quarter, it is recommended that AEFI committees meet at least once a month.

The letter highlighted that as COVID-19 vaccinations are scaled up, there will be an increase in AEFI reporting due to increased sensitisation.

“All these cases need to be investigated followed up for completion of documents by the districts and casualty assessed at the state level as soon as possible to elicit safety issues at the earliest for action.

Uttar Pradesh, Madhya Pradesh, Rajasthan, Bihar, Chhattisgarh, Jharkhand, Maharashtra, Gujarat, West Bengal, be Andhra Pradesh, Telangana, Karnataka, Tamil Nadu and Odisha have been requested to ask for funds to hire state AEFI consultants in their pandemic influenza preparedness framework.

Further, as part of expanding reporting network of AEFI surveillance for adults vaccination, the ministry said district immunisation officers may be directed to prepare a list of government and private hospitals and healthcare facilities, medical colleges, health care facilities of other ministries like railways defence, ESIC etc. In the districts, contact the head of institutions to identify a nodal officer (AEFI reporting).

“Ensure that nodal officer conducts one hour sensitisation meetings with all doctors in the institutions to record vaccination history in OPD, casualty/emergency consultations and inpatient admissions (focusing on medical, neurology, cardiology, respiratory medicine, obstetrics and gynaecology in addition to paediatrics),” it said.

According to the ministry, it should be ensured that an AEFI register is available for medical officers to record minor, serious and severe AEFI details and are reviewed. Any unreported serious/severe AEFI should be reported to the district immunization officer (DIO) immediately.

“Around 300 medical colleges and tertiary care hospitals across the country have adverse drug reaction monitoring centres which report vaccine adverse events along with other adverse drug reactions. DIO should contact such AMC and request them to report serious and adverse AEFI directly,” it said.

The Centre also sought involvement of drug inspectors in investigation in the districts. It said that districts should ensure that there is enough stock of injection adrenaline for the coming months for use in anaphylaxis kids and AEFI management kits. Is important to note that adrenaline has short expiry date. It is it is also important that all vaccinators should be trained on use of the anaphylaxis kits.

The ministry stressed that districts should prepare communication plans to manage rumours and myths regarding vaccine safety and crisis situation following serious AEFI.

“Key message for use in managing crisis situation and myths and rumours may be prepared in advance spokespersons maybe identified in advance and oriented on potential vaccine safety issues related to routine vaccines and potential COVID-19 vaccines,” the letter said.

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