Name
Ashish K James
Roll No.
2017-5LLB-72
Link to the CTRI trial
http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=48057&EncHid=&userName=CTRI/2020/11/028976
No. of words
611 (excluding heading and citations)
Review of Clinical Trial titled: “A Phase 3, Randomized, Double-blind, Placebocontrolled, Multicenter Study to Evaluate the Efficacy, Safety, Immunogenicity,and Lot-to-Lot
consistency of BBV152, a Whole virion Inactivated Vaccine in Adults greater than or equal to
18 Years of Age.”
The clinical trial in question studied the efficacy and safety of Covaxin, the Covid-19 vaccine
developed by Bharat Biotech. It is an event-driven, phase 3, randomized, double-blind,
pacebo-controlled study to evaluate the efficacy, safety, immunogenicity, and lot-to-lot
consistency of BBV152, a Covid-19 vaccine administered to those above 18 years of age. In a
randomized study, subjects are randomly assigned to placebo and intervention groups. In a
double-blind study, neither the patients nor the researchers know who is getting a placebo and
who is getting the treatment. It is “event-driven” because the trial planned to collect data until
130 of its participants, be they in the placebo or intervention groups, underwent the event of
contracting Covid-19. 25,800 test subjects were enrolled in 3 categories of study sites, each
with a different objective.1
Allegations of failure to follow proper procedure have been made vis-à-vis the People’s College
of Medical Sciences and Research Centre in Bhopal, one of the 26 sites of this trial, with respect
to ethical data collection:
1
“Brief Summary,” CTRI/2020/11/028976,
http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=48057&EncHid=&userName=CTRI/2020/11/028976
1
 900 of the subjects were from vulnerable backgrounds, and were allegedly rounded up
in vehicles and not told where they were being taken for the clinical trial. 2 Some of
them were Bhopal Gas tragedy victims.3
o According to the ICMR Guidelines’ general provisions on distributive justice,
vulnerable individuals/groups should be included in research only in a manner
whereby the burdens and benefits of research are equitably distributed.4
 Many subjects, even after getting their first dose, reported not being given a consent
form.5
o The consent form must include certain details that contribute towards informed
consent.6
 Many of the vulnerable participants were illiterate, and they were supposed to be given
the facility of audio-video recording of informed consent,7 but many subjects have said
that no such measure was taken.8
 It has been alleged that poor trial participants were being offered Rs. 750 for each visit
to the trial site as a way to attract volunteers. Bharat Biotech defended this action by
arguing that this payment was allowed by the Institutional Ethics Committee at the
study sites.9
o ICMR guidelines warn against research being misconstrued as a source of
financial incentive by those with limited access.10
2
Kezia Parkins, Covaxin: India’s homegrown Covid-19 vaccine brings hope and controversy, Clinical Trials
Arena, https://www.clinicaltrialsarena.com/analysis/covaxin-indias-homegrown-covid-19-vaccine-brings-hopeand-controversy/
3
Divya Trivedi, Bhopal gas tragedy victims were used as guinea pigs for COVID vaccine trials, The Hindu
Frontline, https://frontline.thehindu.com/the-nation/bhopal-gas-tragedy-victims-used-for-covaxin-trialillegal/article33641560.ece
4
S.2.4, ICMR, National Ethical Guidelines and Health Research Involving Human Participants.
5
Vaccine: Bhopal Patients Say 'Weren't Given Consent Forms or Told It Was a Trial', The Wire,
https://thewire.in/rights/vaccine-bhopal-patients-say-werent-given-consent-forms-or-told-it-was-a-trial
6
Box 5.1, Essential and additional elements of an informed consent document, ICMR, National Ethical
Guidelines and Health Research Involving Human Participants.
7
Entry 28, Standard Operating Procedures (SoPs), Annexure 1, ICMR, National Ethical Guidelines and Health
Research Involving Human Participants.
8
How Covaxin Trial Participants in Bhopal Were Misled, The Wire, https://science.thewire.in/health/peopleshospital-bhopal-covaxin-clinical-trials-exploitation-ethics-ground-report/
9
Anoo Bhuyan, India's COVID-19 Vaccine Trial Participants Claim They Were Misled, IndiaSpend,
https://www.indiaspend.com/covid-19/indias-covid-19-vaccine-trial-participants-claim-they-were-misled713061
10
S.8.6.2., ICMR, National Ethical Guidelines and Health Research Involving Human Participants.
2
 It has been reported that the follow-up of patients on each of the first 7 days after the
first dose was chaotic, and that not all subjects were contacted regularly or at all. 11
 Some subjects who fell ill after getting the dose fell ill and, upon returning to the test
site for treatment, were asked to pay or were turned away. 12
o The researchers are accountable for the consequences of their research and are
bound to pay for any resulting medical treatment.13
 There was one death among the test subjects. Bharat Biotech claimed that the patient
had died due to consuming poison, which is contradicted by the patient’s family’s
account. This explanation has been criticized due to the fact that it was made while the
study was still blinded – it was not known if the patient was in a placebo group or an
intervention group. 14
In addition to the abhorrent ethical violations that were a part of trial as listed above, Covaxin
was approved for emergency use in January 2021 on a “clinical trial mode,” before data from
this Phase III trial was released. Even as late as April, its manufacturer Bharat Biotech only
released interim data that showed a modest level of efficacy at best (78%). Marred by the
exploitation of vulnerable individuals and people groups, poor data collection which defeats
the purpose of the study, failure to ensure informed consent, etc., this clinical trial has the
infamy of being the rotten foundation of a questionable national inoculation policy.
11
No consent, no follow-up, claim Bhopal gas tragedy victims in vaccine trial, Economic Times,
https://economictimes.indiatimes.com/news/politics-and-nation/no-consent-no-follow-up-claim-bhopal-gastragedy-victims-in-vaccine-trial/articleshow/80200879.cms?from=mdr
12
Banjot Kaur, Bhopal Covaxin trial participants allege side-effects, irregularities, DownToEarth,
https://www.downtoearth.org.in/news/health/bhopal-covaxin-trial-participants-allege-side-effectsirregularities-74985
13
S.2.6, ICMR, National Ethical Guidelines and Health Research Involving Human Participants.
14
S.1.1.11, ICMR, National Ethical Guidelines and Health Research Involving Human Participants.
3