No provision for compensation for recipients of Covid19 vaccine against any side effects

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 inoculation. The COVID-19 vaccination is entirely voluntary for the beneficiary”

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

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

COMPENSATION TO COVID 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 thereof 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 THE 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 including 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 favorable risk-benefit profile of the Drugs or vaccine. The data emerging from clinical trials provide the information about solicited and unsolicited adverse reaction limited to trial population.

Monitoring of safety by a Data Safety Monitoring Board (DSMB) is a critical component of any clinical trial for reporting of adverse events, if any, daring the clinical trials.

(c) to (d): At the start of COVED-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 Communication 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 vaccination process. This is being done through multimedia platforms (print/electronic/social media), through MoHFW website and 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 inoculation. The COVID-19 vaccination is entirely voluntary for the beneficiary.

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

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