Lok Sabha Question No. 3976 (UNSTARRED), answered on 2021-03-19
Subject: Compensation to COVID Vaccine Recipients
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Asaduddin Owaisi

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

LOK SABHA UNSTARRED QUESTION NO. 3976 TO BE ANSWERED ON 19 TH March, 2021

## COMPENSATION TO COVI D VACCINE RECIPIENTS

## 3976. SHRI ASADUDDIN OWAISI:

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

- (a)  whether  all  the  vaccines  for  COVID - 19  which  are on  different  trial  stages  globally, including India, do not provide any guarantee of their side effects;
- (b) if so, the details thereo f and the reasons therefor;
- (c) whether some of the health workers are not eager to have the vaccine shots;
- (d) if so, the details thereof and reasons therefor;
- (e) whether the Government has informed the public about the side effects of the approved vaccines, if so, the details thereof and if not, the reasons therefor; and
- (f) the steps taken or being taken by the Government to ensure that people who develop side effects after vaccination are suitably compensated?

## ANSWER THE MINISTER OF STATE IN TH E MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

(a) to (b): The approval of any new drugs including COVID - 19 vaccine for manufacturing  and  marketing  is  based  on  the  submission  of  adequate  data  includi Chemistry,  Manufacturing  and Control  (CMC),  non - clinical  (animal  studies),  clinical  trial data as per the provisions of New Drugs and Clinical Trials Rules,2019 providing favou risk - benefit profile of the Drugs or vaccine. The data emerging from clinical trials pro inform ation about solicited and unsolicited adverse reaction limited to trial populatio

Monitoring  of  safety  by  a  Data  Safety  Monitoring  Board  (DSMB)  is  a  critica component of any clinical trial for reporting of adverse events, if any, during the tr ials.

(c) to (d) : At the start of COVID - 19 vaccination drive, fewer than planned beneficiaries attended  vaccination  sessions  due  to  transient  technical  issues  in  Co - WIN  portal,  vaccine hesitancy etc. which have progressively been addressed and the rate of vaccination coverage has subsequently increased. Till 17 th March 2021, more than 1.20 crore doses of COVID - 19 vaccine have been administered among the Health Care Workers.

(e) : COVID - 19 Vaccines C ommunication Strategy has been prepared to raise awareness about the COVID - 19 vaccines and address misinformation against vaccination. The strategy aims  to  promptly  disseminate  factual  information  about  the  vaccines  and  the  vaccin process.  This  is  bei ng  done  through  multimedia  platforms  (print/electronic/social  media) through MoHFW websiteand engagement of various stakeholders, community leaders and influencers to reach out to the last mile.

(f) : There is no provision of compensation for recipients of COVID - 19 vaccine against any  kind  of  side  effects  or  medical  complications  that  may  arise  due  to  inoculatio COVID - 19 vaccination is entirely voluntary for the beneficiary.

However, measures have been put in place like availability of anaphylaxis kits at e ch vaccination  site,  immediate  referral  to  Adverse  Event  Following  Immunization  (AEF management center and observation of vaccine recipients for 30 minutes at session si any adverse events so as to take timely corrective measure. Also, t he AEFI management of such cases are provided free of cost treatment in Public Health Facilities.