Representative image. Photo: Reuters/Baz Ratner
New Delhi: A document released by pharmaceutical firm Bharat Biotech, which is running short of volunteers for its ongoing phase-3 trials for its COVID-19 vaccine candidate Covaxin, to address queries raised by volunteers at Covaxin trial sites has drawn flak from public health experts.
According to The Print, one query on the list of frequently asked questions (FAQs) in the document read, “Why should I participate in the Phase 3 Efficacy Trial for Covaxin and get vaccinated, when the government announced that persons above the age of 50 years will be vaccinated shortly?”
The document, in response, said principal investigators should inform potential volunteers that the vaccine would protect them against COVID-19 and that it was “advisable” for recruits aged over 50 years to participate in the trial as “it may take many months” before a government-approved vaccine is administered to them, even if they are identified as belonging to a priority group.
The document also quoted a Centre announcement that said that there was a chance of “limited availability of the vaccine” in the first month. It further added that, in accordance with the health ministry expert panel recommendations, the vaccine would be “distributed first in three groups” – with top priority for one crore healthcare workers followed by two crore frontline workers, including the police and the armed forces.
“Finally, people above the age of 50 years and those under the age of 50 years with co-morbidities. The estimated population of the last category is close to 27 crore,” The Print quoted the document as saying.
“It may take many months for the subjects above the age of 50 years to be immunised for COVID-19 vaccine, as per the government’s recommendations,” it said and added that, as a result, “it will be advisable to participate in the Phase 3 Efficacy Trial for Covaxin and get vaccinated to protect yourself against COVID-19”.
Some experts have, however, raised concerns about the company’s document because they say it “misguides” principal investigators and participants and highlighted the risk associated with misleading those who would receive a placebo and would be left unprotected.
“The document clearly has troubled language. The whole purpose of a phase 3 study is to establish efficacy. This document presupposes efficacy but on what basis?” Anant Bhan, a researcher on global health, health policy and bioethics, told The Print.
“They are assuming that their vaccine is already good enough. How can sponsors assume it?” editor of the Indian Journal of Medical Ethics Amar Jesani also said. According to Jesani, by saying that the vaccine can be given now rather than later on, the company had violated the “cardinal principle” of clinical equipoise or a medical research ethic which requires researchers to be uncertain about the effectiveness of different interventions offered in a trial.
Jesani also said half of the trial participants were in the placebo arm, whereby an individual’s body can stimulate healing if it believes it is receiving treatment even when it isn’t.“By giving the confidence to participants that they are safe after taking the shots, the participants may become complacent. The people in the placebo group, in reality, have got zero level of protection, hence increasing their chances of getting the infection,” he said.
He also called on the company to withdraw the document as it was liable to impact the final results of the vaccine trial since, as more participants in the placebo arm would become infected, “the result of those getting the vaccine would obviously look better”.
However, Dr Venkat Rao, the principal investigator of the Odisha-based Institute of Medical Sciences, a Covaxin trial site, said that it was “better to get something than nothing”.
Dr Rao said that the FAQ in question was issued following a discussion in which experts expressed concerns about trial participants who wouldn’t be able to take the actual vaccine when the Indian government would eventually launch it.
“It’s not about influencing the participants. We all know that rolling out of the vaccines is a difficult process. When two people participate in the trial, it is likely that at least one of them will get the vaccine, if the other is getting placebo. It is better to get something than nothing,” Rao told The Print.
Only a few weeks ago, the Hyderabad-based pharmaceutical firm had applied to the central drug regulator seeking emergency use authorisation for its COVID-19 vaccine Covaxin, indigenously developed in collaboration with the Indian Council of Medical Research. The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting phase-3 clinical trial of its vaccine candidate after assessing the safety and immunogenicity data of phase 1 and 2 trials.
In a yet to be peer-reviewed study of its phase 2 trial, Bharat Biotech said that its vaccine was safe and “led to tolerable safety outcomes and enhanced humoral and cell-mediated immune responses”.
For its phase 3 trials, which require a significantly larger pool of participants, the company has been struggling to recruit the number of volunteers needed. Bharat Biotech had reportedly recruited 13,000 volunteers, out of a total of 25,800 participants needed, since the study was launched in November.