Lok Sabha Question No. 466 (UNSTARRED), answered on 2022-02-04
Subject: AEFI
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Pradyut Bordoloi, Maneka Sanjay Gandhi

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION No. 466 TO BE ANSWERED ON THE  4 TH   FEBRUARY 2022

## AEFI

## 466. SHRI PRADYUT BORDOLOI: SHRIMATI MANEKA SANJAY GANDHI:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (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?

## ANSWER 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 30 th 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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