The lawyer representing the 40-year-old volunteer from Chennai who had alleged a serious adverse event (SAE) linked to the ‘Covishield’ vaccine he received as part of the phase-3 trial, on Monday said Serum Institute of India’s allegations against his client were “ridiculous”.
“A person who volunteers for the vaccine trial and suffers an adverse reaction… and he reports to the Serum Institute of India by way of a legal notice, at least they should have responded to his notice,” R Rajaram, legal counsel for the Chennai-based trial participant, told Moneycontrol.
The participant’s name has been kept confidential.
The Covishield vaccine has been developed by British-Swedish pharma major AstraZeneca and the University of Oxford.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
“If they formed a committee of experts and have done a detailed examination, after that they say that there is no connection, I can understand. They have not done anything and are accusing the volunteer. It’s very unfair,” Rajaram said.
The lawyer said that they have given two weeks’ notice to the respondents, following which they would take appropriate legal action, including filing a writ petition in the Madras High Court.
Volunteer alleges serious side affects
The volunteer has alleged serious side effects, including a neurological breakdown and impairment of cognitive functions and has sought Rs 5 crore compensation in a legal notice to SII and others, besides seeking a halt to the testing, manufacturing and distribution of the vaccine. The participant was administered the vaccine at Chennai’s Sri Ramachandra Institute of Higher Education and Research (SRIHER), one of the trial sites, on October 1.
The participant claimed in his notice that the vaccine administered on him on October 1 was indeed Covishield, and not a placebo, as this was established from a positive test for antibodies against Covid-19 done after he was admitted to the hospital on October 11. He was admitted 11 days after receiving the vaccination.
The legal notice also says that the volunteer took part in the trial on “clear assertion of the safety nature of the test vaccine in the Participant Information Sheet”.
Moneycontrol has seen a copy of the notice.
To be sure, investigators explain the potential associated risks and benefits to volunteers before asking them to decide on participating in a trial. The volunteers also give their consent in writing.
Serum institute dismisses allegations
Serum Institute of India, the clinical trial sponsor of the ‘Covishield’ vaccine in India, called the allegations in the notice “malicious and misconceived” and has threatened to seek damages in excess of Rs 100 crore. The company said that while it is sympathetic with the volunteer’s medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer.
Serum Institute said the volunteer was specifically informed by the medical team that the complications he suffered were independent of the vaccine trial that he participated in.
Activists express concern
But public health activists have expressed concern over the development.
“A bad move by Serum to counter-sue. Volunteers participate in studies mostly out of altruistic reasons. In this case, healthy volunteers. If there is an issue about the SAE, better to engage with the participant to understand their concerns. Rather than try to browbeat them,” tweeted Anant Bhan, a doctor and public health researcher.
The All India Drug Action Network, a network of health activists and NGOs, said it was shocked at this “blatant attempt at intimidation” of a clinical trial participant by Serum Institute.
“Instead of explaining why they have been silent about the reports of the SAE, Serum Institute is attempting to divert public scrutiny of its trial. Bear in mind that in Serum’s Phase 2/3 trial, safety is one of the primary endpoints in addition to immunogenicity,” AIDAN said in a statement.
“An ICMR official has gone on record to say that a decision on the SAE from DCGI/CDSCO is awaited. Given that the SAE took place in October, it is of serious concern that CDSCO did not pause the trial to investigate the SAE when it was reported. The silence from the CDSCO which granted permission for the trial is deafening," the statement added.
CDSCO refers to the Central Drugs Standard Control Organisation (CDSCO), the body that regulates medicines in India. DCGI is the parent of the CDSCO.
AIDAN added that the clinical trial was recruiting healthy volunteers and a participant who received a dose of the vaccine has and continues to suffer neurological problems.
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“The CDSCO must inform the public as to why the trial was not and has not been halted while it is contemplating the serious adverse event. The Serum Institute and ICMR, co-sponsors of the trial, must inform all trial participants about the handling of SAEs and simultaneously release the detailed protocol of the trial, along with any amendments made to the protocol, in the public domain immediately,” it added.
“Taking informed consent doesn’t mean that the sponsor’s or investigator’s role ends there,” said Amar Jesani, a consultant on bioethics and public health. The study participant must be safeguarded throughout a clinical research study, he added.
“What is disappointing is the silence of the institutional ethics committee, the sponsor and the regulator DCGI, even one and half months after the serious adverse event,” said Jesani.
AstraZeneca, which is conducting the clinical trial of the same vaccine in the UK (and the US), had been asked to put its trial on hold after a participant suffered an unknown illness for a neurological problem, and was only allowed to resume the trial following thorough review and clearance, he pointed out.“The Drug Safety Monitoring Board (DSMB) and MHRA of UK have been prompt in communicating about the SAE. Why not have the same thing happen in India. Is an Indian participant any different from a UK participant,” said Jesani.