How India Plans To Identify And Report Side Effects Of COVID-19 Vaccine Once It Is Rolled Out

Like the rest of the world, India too is trying to expedite the rollout of the COVID-19 vaccine, whenever it is available.

Most of the vaccine candidates are either still in clinical test phases or have just completed them. Vaccine makers like Pfizer, Moderna and Serum Institute are in the process of obtaining emergency clearance for their vaccines to be used for frontline healthcare workers.

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Though the vaccine makers vouch for the efficiency and safety of their drug, the long-term side effects of them if any will only emerge later.

Directions given to states and UTs

Keeping this in mind, the Union Health Ministry has directed the States and Union Territories to take necessary actions to deal with Adverse Events Following Immunisation (AEFI) surveillance following Covid -19 vaccinations.

In a letter to all National Health Mission directors of the states and UTs, a senior health ministry official said: "The preparations are underway for conducting COVID-19 vaccinations in the states and districts, starting with certain priority groups. In connection with this, steps need to be taken to strengthen Adverse Events Following Immunisation (AEFI) surveillance following Covid-19 vaccinations to maintain confidence in the safety of vaccines."

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"The Union Health Ministry has identified initiatives which are essential to further strengthen the existing AEFI surveillance system of India so that timely and complete AEFI reporting for Covid-19 vaccination is possible 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," read the letter.

The Central government has pointed out key initiatives to strengthen AEFI surveillance system for Covid-19 vaccination.

Key pointers:

The health ministry has asked the states and UTs to include medical specialists in addition to paediatricians in the state and district AEFI committees.

"The Covid-19 vaccinations will be given to adults, many of whom may have comorbidities. Events due to pre-existing comorbidities (stroke, heart attacks etc) may be reported as AEFIs following Covid-19 vaccinations. 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/vaccinations. Similarly, directions may be issued to districts to include medical specialists (neurologists, cardiologists) in the district AEFI committees," noted the letter.

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Each state must choose a medical college to function as state AFEI technical collaborating centre in conducting rapid causality assessment, case investigations in districts, laboratory tests in certain cases to find the cause of AEFIs etc.

Besides, there should be a training of specialists of state AEFI committees and AEFI technical collaborating Centre for investigation and causality assessments.

States asked to hire AEFI consultants

As COVID-19 vaccinations are scaled up, there will be an increase in AEFI reporting due increase the sensitization, hence, the health ministry has asked States to hire state AEFI consultants.

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The health ministry has further informed that there are 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 government has directed the states to ensure the involvement of drug inspectors in the investigation in the districts.

"The drug inspector of the district should be a member of the District AEFI committee and maybe involved in AEFI investigations whenever required," stated the letter.

The Central government has said that the district should ensure that there is enough stock of injection adrenaline for the coming months for use in anaphylaxis kids and AEFI management kits.

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"It is important to note that adrenaline has short expiry date. It is also important that all vaccinator is including temporarily temp temporary higher hires for routine immunisation and for COVID-19 vaccination should be trained on use of the anaphylaxis kits," read the letter.

The District Immunization Officer (DIO) has to initiate trainings and sensitization meetings in healthcare workers in public and health facilities for immediate reporting of serious and severe AEFI.

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"The focus on sensitisation should include AEFI following adult vaccinations which will become important when Covid-19 vaccinations are initiated. Data entry operator in the office of the DIO should be oriented on SAFEVAC, the online reporting software for AEFI," stated the letter.

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, it said.