Question : AEFI

(a) whether the Government has directed States/UTs to track the number of Adverse Events following Immunization (AEFI), if so, the details thereof and the number of AEFI cases and the deaths among them reported from commencement of vaccination till date, vaccine-wise;
(b) whether expansion of vaccination drive has lowered down the AEFI being reported indicative of underreporting of such cases in the country, if so, the details thereof;
(c) whether AEFI for every 100,000 doses in India is lower than developed countries, if so, reason therefor;
(d) whether Government proposes replacing the passive AEFI reporting system, where doctors are not bound to report AEFI, with an active surveillance system to solicit such information from healthcare providers, if so, details thereof; and
(e) whether the Government has initiated action on reports of poor training and awareness among district authorities for the slow pace and poor quality of evidence for AEFI reporting, if so, the steps taken to strengthen AEFI surveillance?

THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE
(DR. BHARATI PRAVIN PAWAR)

(a) to (e) The operational guidelines for Covid-19 vaccination, provide guidance on classification, prevention, reporting and management aspect of Adverse Events Following Immunization (AEFI). Frequent communication to States/UTs in the form of letters, advisories (like inclusion of Obstetrics/Gynecologist in the State/District AEFI committee) have been issued to improve reporting of minor, severe and serious AEFI. As on 30th January 2022, a total of 70,102 cases (Covishield - 63,315 , Covaxin - 6,757 and Sputnik - 30) of Adverse Events Following Immunization (AEFI) and 1013 cases of Death (Covishield - 921, Covaxin - 92, and Sputnik ‘Nil’) are reported.
AEFI reported in developed countries is more as self-reporting of adverse drug reactions and using internet for reporting AEFI online is well established in these countries.
Adverse Event Following Immunization (AEFI) are monitored through a well-structured & robust AEFI surveillance system in India. Causality Assessment of all serious and severe AEFIs are done by the designated AEFI committee to determine if AEFI is related to vaccine or vaccination process or otherwise. The National Adverse Event Following Immunization (AEFI) Committee monitors vaccine safety and recommends action to improve AEFI surveillance. There is no recommendation to make reporting of AEFIs mandatory for healthcare service providers. Periodic letters and monthly state specific presentations on performance of AEFI surveillance with action points is also shared with the States/UTs. States/UTs have been asked to regularly sensitize health care service providers including private health care providers to report AEFI following vaccination.
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