Synopsis: Many issues have been highlighted in the Phase-3 trial of Bharat Biotech’s COVID-19 vaccines. Those issues could have been avoided after HPV vaccine trial controversy.
In a previous case, Human papilloma virus (HPV) vaccine trial was carried out on nearly 23,500 girls in the 10-14 age group in Vadodara, Gujarat and Khammam without proper consent. Almost eight years later the Supreme Court of India criticized the government for its inability to take action on illegal clinical trials carried out in India by multinational countries.
Present situation of the approval process in India suggests nothing much has changed.
- The phase-3 clinical trial of Bharat Biotech’s COVID-19 vaccine resembles the HPV vaccine because it seems that the trial is suffering from serious violations.
- The ICMR which has assigned the task of promulgating research ethics guidelines is also the cosponsor of the Covaxin trial.
What are the problems in the Covaxin phase 3 trial?
After the 2013 SC order, The Indian regulator made audio-video recording of the informed consent of each individual participant mandatory in 2019. Written consent from the participant had to certainly be taken before the audio-video recording.
However, the process was not followed properly;
- Firstly, no efforts were made to explain and inform the participants about the pros and cons of taking part in the trial instead; they were deceived by the trial site to think they were getting a COVID-19 vaccine for free.
- Secondly, many participants didn’t know about their rights to get free medical care in case of any adverse events.
- Many aware participants sought medical help from private practitioners whereas some of the participants don’t possess mobile phones, thus medical follow-up was not possible.
- Thirdly, not enough time was given to discuss with the family before signing the consent form. At least in a few instances, the consent was taken after vaccination, which is a serious violation.
- Participants were not given a copy of the consent form and other documents to prove their participation.
- Fourthly, 700 participants in the trial were illiterate and there is no evidence that an impartial witness was present during the entire informed consent process to attach his/her signatures to the consent form.
- Fifthly, communities living close to the hospital have told the media that they were offered ₹750, and luring people in trial for money is unethical.
- Although the company maintained that the amount was the reimbursement for the transportation and loss of wages, an open announcement of remuneration was unethical.
- Lastly, it is not yet confirmed that institutional ethics committee approved the advertisement for inviting people to the trial, in lieu of money.
- India has already approved 2 vaccines for restricted use and the virus spread slowing down, so enrolling participants will be more challenging. Therefore, a thorough and impartial inquiry will bring back confidence in clinical trials.