Lok Sabha Question No. 71 (STARRED), answered on 2021-02-05
Subject: Adverse Effects of COVID-19 Vaccines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Vincent H Pala, Sajda Ahmed

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

## LOK SABHA STARRED QUESTION NO. 71 TO BE ANSWERED ON THE 5 TH FEBRUARY , 2021 ADVERSE EFFECTS OF C OVID - 19 VACCINES

## *71. SHRI VINCENT H. PALA: SHRIMATI SAJDA AHMED :

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

- (a)  whether  adverse  effects  on  health  have  been  reported  in  relation COVID - 19 vaccines currently being administered/developed in the country so, the de tails of such events reported and the corrective measures being tak
- (b) whether the Government had taken inputs from technical experts and S Governments  while  drawing  up  its  COVID - 19  Vaccine  strategy,  if  so,  the details thereof;
- (c)  whether  COVID - 19  vaccine  was  allegedly  tested  on  citizens/candidate without  their  consent,  if  so,  the  details  thereof  including  the  de companies which have misguided the candidates about the trial of vaccine them and the potential side - eff ects of vaccine;
- (d)  whether  the  Government  intends  to  investigate  such  incidents,  if  s details thereof along with the compensation proposed to be paid to the vi and
- (e) whether the Government has finalized the next phase of vaccination, so, the details thereof?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. HARSH VARDHAN)

- (a)to ( e)A Statement is laid on the Table of the House.

## STATEME NT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 71* FOR 5 TH FEBRUARY , 202 1

(a) to  (e)    Adverse  Event  Following  Immunization  (AEFI)  are  monitored through  a  well - structured  &  robust  AEFI  surveillance  system.  AEFI  is  any untoward  medical  occurrence  which  follows  immunization  and  may  not necessarily have a causal relationship with the va ccine. Causality assessment by the  designated  AEFI  committee  helps  in  determining  if  AEFI  is  related vaccine or vaccination process or otherwise.

For COVID19 vaccinations, same process is being followed. A total o 7,580  AEFIs  i.e.  0.2%  AEFIs  cases  have been  reported  out  of  total  number vaccinated till 31st January 2021 under COVID - 19 vaccination roll - out across the country. Most of these are minor AEFIs like Anxiety, vertigo, giddi dizziness,  fever,  pain,  rashes,  and  headache  which  are  self - limitin g  and  all people have recovered. 14 hospitalizations i.e. 0.000372% hospitalization have been reported out of total number vaccinated till 31 st January  2021.  12 deaths  i.e.  0.000319%  death  cases  out  of  total  number  vaccinated  till st January  2021  n ot  causally  related  to  vaccination  presently,  have  also  b reported. These deaths were investigated and examined by the experts and per  current  evidence  none  of  these  deaths  have  causal  relationship  wit COVID - 19  vaccination.  In  addition,  measures have  been  put  in  place  like availability of anaphylaxis kits at each vaccination site, immediate ref AEFI management center and observation of vaccine recipients for 30 minut at session site for any adverse events so as to take timely corrective measure.

A  National  Expert  Group  on  Vaccine  Administration  for  COVID - 19 (NEGVAC)  has  been  established,  which  provides  guidance  on  all  aspects  o COVID - 19 vaccination including prioritization of population grou procurement  and  inventory  management,  va ccine  selection,  vaccine  delivery and tracking mechanism etc. NEGVAC is chaired by Member (Health), NITI Aayog and co - chaired by Secretary (H&FW). NEGVAC has representation of Secretaries from Ministry of External Affairs, Department of Expenditure, of Biotechnology, Dept. of Health Research, Dept. of Pharmaceuticals, Mini of  Electronics  and  Information  Technology,  representative  from  five  S Governments i.e. Tamil Nadu (South), Assam (East), Maharashtra (West), Utt Pradesh (North) and Madhya Pradesh (Central) and technical experts.

It  is  not  a  fact  that  the  COVID - 19  vaccine  was  allegedly  tested  on citizens/candidates  without  their  consent.  During  clinical  trials,  all were tested only after obtaining consent of the clinical trial part icipants under a prescribed  procedure.  The  New  Drugs  &  Clinical  Trials  Rules  2019,  clea prescribe the modalities of payment of compensation in specific instances.

AEFI system of the country has been put in place so as to capture al AEFIs  to  analyze for  any  causal  relationship  with  COVID - 19  vaccination. Clinical trials of vaccines are required to be conducted in human subje compliance  with  the  provisions  prescribed  in  New  Drugs  and  Clinical  Tr Rules, 2019 and Good Clinical Practices (GCP) gu idelines.

NEGVAC has also recommended the prioritization of population groups for  COVID- 19  vaccination.  The  prioritized  groups  comprise  Health  Car Workers, Front Line Workers, persons above the age of 50 years and perso below 50 years with associated co morbidities.

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