Experts included in Covid-19 adverse event committee

Senior doctors in the fields of neurology, cardiology and pulmonology have been included in the district-level Adverse Event Following Immunisation (AEFI) committee, which has been reconstituted for the Covid-19 vaccination programme. It is for the first time that the committee will have experts to monitor and study the adverse health events after inoculation.

An AEFI is an untoward medical occurrence following immunisation, which does not necessarily have a causal relationship with the usage of the vaccine, as defined by the World Health Organisation (WHO).

Before the outbreak of the SARS-CoV-2 virus pandemic, the AEFI committee existed only to check adverse events in routine universal immunisation programmes, mostly limited to child and maternal health care.

Due to Covid-19, the committee had to be revamped, considering that the vaccination drive will include a larger section of the population in different phases of vaccination. This may lead to increased reportage of adverse events.

The district-level AEFI committee was revamped on December 7 and is likely to hold its first meeting next week, said Dr MP Singh, district immunisation officer.

“The committee has been extended to 15 members from the existing 12 members. Medical officer, a representative from WHO, Indian Medical Association (IMA), chief medical officer and paediatricians are the existing members. Doctors with expertise in cardiology, pulmonology and neurology from two private hospitals are also included in the committee to examine the patients who will report severe or serious adverse events related to Covid-19,” said Singh.

Singh said that some cases might need confirmation and planned study if there is a sign of an unexpected adverse event.

As per the Covid-19 guidelines, there are three categories of adverse events — minor AEFI, which includes common reactions like pain and swelling at the injection site, fever and irritability; severe AEFI, which can be disabling and rarely life threatening but do not lead to long-term problems; serious AEFI, which can require hospitalisation and death.

Serious cases are extremely rare, pointed out Singh, as vaccines are introduced only after stringent safety guidelines followed during the vaccine trials. In AEFI, cases that will show symptoms even after a few days of inoculation will be included.

“As per the guidelines, vaccine beneficiaries are to be observed at the session site for 30 minutes post vaccination to detect, manage and treat immediate adverse reactions, if any. The committee will work on the management of such cases as to how they can be immediately reported and handled,” said Singh.

For handling such cases, an AEFI management centre has to be identified in each block, which will be linked with the session site. At the session site, the vaccine beneficiaries will be counselled about these events.

Recently at the state-level, health department officials have been imparted training on infection prevention and control practices during vaccination. Dr Dhruv Chaudhary, state nodal officer for Covid-19 management and co-principal investigator on the Covaxin trials at Post Graduate Institute of Medical Sciences (PGIMS), Rohtak, said, “AEFI is a pharmacological intervention to ensure the vaccine is administered safely. Sometimes in normal immunisation, people develop pain, swelling or fever which are common and varies in people. Through AEFI management, vaccinators will be trained to handle and record such cases.”

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