New Delhi: The Narendra Modi government has asked states and union territories to strengthen the mechanism for reporting side effects of Covid vaccines, anticipating that the immunisation drive will begin soon.
“You may be aware that preparations are underway for conducting Covid-19 vaccinations in states and districts, starting with certain priority groups,” Dr Manohar Agnani, additional secretary in Ministry of Health and Family Welfare, wrote in the letter sent to all states and union territories on 18 November.
“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 safety of vaccines,” Agnani said.
He added that the health ministry has identified initiatives which are essential to further strengthen the existing AEFI surveillance system so that “timely and complete AEFI reporting for Covid-19 vaccination is possible”.
India has been running AEFI surveillance since 1988. The national AEFI guidelines were revised in 2005, 2010 and 2015. It has been monitoring vaccine programmes for children and pregnant women, but now, with the Covid-19 vaccine, new requirements have emerged.
The central government has requested 14 initiatives to be “implemented at the earliest so that required changes take place well before the Covid-19 vaccine is introduced in the district or state”.
It has also instructed the states and districts to ensure that there is enough stock of adrenaline injection for use in anaphylaxis kits — emergency kits that are deployed when people suffer a severe allergic reactions in response to some medicine or food. Adrenaline is injected into the arm to treat life-threatening allergic reactions.
“It is important to note that adrenaline has a short expiry date. It is also important that all vaccinators (including temporary hires for routine immunisation and for Covid-19 vaccinations) should be trained in the use of anaphylaxis kits,” Agnani’s letter stated.
Find specialists, train staff, plan communication strategy
According to the Modi government’s directive, the states and UTs must include medical specialists in addition to paediatricians in 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 (such as strokes, heart attacks, etc.) may be reported as AEFIs following Covid-19 vaccinations,” the letter stated.
It further recommended that the membership of state AEFI committees should be revised to include neurologists, cardiologists and respiratory medicine specialists who can recognise such events and differentiate them from events related to vaccines or vaccinations.
The letter also said each state must choose a medical college to function as a state’s AEFI technical collaborating centre. “The clinical specialists of the medical college and experts from the Department of Community Medicine will assist the state AEFI committee in conducting rapid causality assessments, case investigations in districts, laboratory tests in certain cases to find the cause of AEFIs, etc. These specialists may be invited to attend AEFI committee meetings,” it advised.
The letter also recommended training drives for specialists of state AEFI committees, apart from suggesting more frequent meetings of state and district AEFI committees.
“While state and district AEFI committees are required to meet once a quarter, in view of the need to clear the backlog of existing cases for investigations and causality assessments… it is recommended that the AEFI committees meet at least once a month,” it said. “The state AEFI committees should track whether district AEFI committee meetings are being held every quarter or more frequently, if required.”
The ministry also recommended hiring state AEFI consultants. “As Covid-19 vaccinations are scaled up, there will be an increase in AEFI reporting due increased sensitisation. All these cases need to be investigated, followed up for completion of documents by the districts and causality assessed at the state level as soon as possible to elicit safety issues at the earliest for action,” it said.
The government has also asked states and UTs to devise communication plans to manage rumours and myths.
Adverse drug reaction monitoring centres
According to the ministry, around 300 medical colleges and tertiary care hospitals across the country have adverse drug reaction monitoring centres to report reactions to vaccines and other drugs. District immunisation officers should contact such centres and request them to report serious and severe AEFIs directly.
The letter also advised the involvement of drug inspectors in investigations.
“The drug inspector of the district should be a member of the district AEFI committee and may be involved in AEFI investigations, whenever required,” it said.