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Centre asks states to be medically ready for COVID-19 vaccination side effects

Centre asks states to be medically ready for COVID-19 vaccination side effects

Centre asks states to be medically ready for COVID-19 vaccination side effects
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By Timsy Jaipuria  Nov 23, 2020 7:06:15 PM IST (Published)

As we wait for the first successful COVID-19 vaccination to be declared and being used for mass consumption, the government anticipates that the vaccine could have some serious side-effects and has thus asked states to be ready at district levels to deal with these.

As we wait for the first successful COVID-19 vaccination to be declared and being used for mass consumption, the government anticipates that the vaccine could have some serious side-effects and has thus asked states to be ready at district levels to deal with these.

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In a recent communication sent to states last week, with about a dozen of mandatory requirements, to prepare states in advance, to deal with side-effects of the COVID-19 vaccine, the union health ministry has asked all states and Union territories to gear up medical surveillance for reporting side-effects during the immunization drive.
“The letter was written by the centre on November 18, in the backdrop of a series of communications to prepare the backend infrastructure ready for covid-19 vaccination. Since it is anticipated that vaccination process will get started soon, centre’s health ministry has asked states and union territories to strengthen the mechanism for reporting side-effects of Covid vaccines after its administration,” said a senior state health ministry source.
“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, Ministry of Health and Family Welfare said in the letter sent to all states and union territories on November 18.
CNBC-TV18 has accessed a copy of the letter which adds, “In connection with this, steps need to be taken to strengthen Adverse Events Following Immunization (AEFI) surveillance following COVID-19 vaccinations to maintain confidence in the safety of vaccines,” he said while adding that the 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.”
Centre has asked states to involve 300 medical colleges & other tertiary care hospitals across the country to handle adverse events or cases of side effects on people post-vaccination. In addition, states have been told to keep ready neurologists, cardiologists, respiratory medicine experts obstetrics, gynaecologists and paediatricians to deal with post-vaccination side effects, sources said.
The union health ministry, according to the letter has recommended that the 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 or vaccinations.
The letter also said that 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 has further recommended that the membership of state AEFI committees should be revised to include neurologists, cardiologists. respiratory medicine specialists who can recognise such adverse events and differentiate them from events related to vaccines or vaccinations.
It also said that 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.”
Also, states have been told to ramp –up the already existing adverse events following immunization committees or AEFI Committees. States have been told to include Drug inspectors in these AEFI committees to help investigate the reason of side-effects due to vaccination, sources said quoting the letter.
“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 attack, etc.) may be reported as AEFIs following COVID-19 vaccinations,” it said.
India has been running AEFI surveillance since 1988. The national AEFI guidelines were revised in 2005, 2010 and 2015. However, it has been monitoring vaccine programs for children and pregnant women. However, now, with Covid19 vaccine, new requirements have emerged.
The union health ministry has requested 12 initiatives to be “implemented at the earliest so that required changes take place well before the COVID19 vaccine is introduced in the district or state,” source added.
Apart from this, States have been clearly told that they should also keep enough stock of adrenalin injections used to control immediate life-threatening allergic reactions and specific staff trained to use these injections, is another warning and mandatory requirement outlined by the centre.
“States and districts to ensure that there is enough stock of injection Adrenaline for the coming months for use in Anaphylaxis kits,” source said.
It is an emergency kit used when people suffer a severe allergic reaction in response to some medicine or food. The Adrenaline injection is shot in 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 immunization and for COVID-I9 vaccinations) should be trained on the use of the Anaphylaxis kits,” the letter said.
According to the union health ministry, 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 attack, etc.) may be reported as AEFIs following COVID-19 vaccinations,” it said.
The letter has 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...”
“The state AEFI committees should track whether district AEFI committee meetings are being held every quarter or more frequently if required,” it suggests.
The hiring of state AEFI consultants is also being recommended. “As COVID19 vaccinations are scaled up, there will be an increase in AEFI reporting due to increased sensitization. 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.”
The centre has further asked states, UTs to device communication plans to manage rumours and myths. “Districts should prepare communication plans to manage rumours and myths regarding vaccine safety and crisis situations following serious AEFIs.”
According to the letter, with the help of around 300 medical colleges and tertiary care hospitals, India can have adverse drug reaction monitoring centres which report vaccine adverse events along with other adverse drug reactions. District immunisation officers (DIO) should contact such centres and request them to report serious and severe AEFIs directly.
Ensure involvement of drug inspectors in investigations in the districts, the letter said.
“The drug inspector of the district should be a member of the district AEFI committee and may be involved in AEFI investigations, whenever required.”
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