Representative image. Photo: Reuters / Baz Ratner
New Delhi: A paper released by the pharmaceutical company Bharat Biotech, which is running out of volunteers for its ongoing phase 3 trials for its COVID-19 vaccine candidate, Covaxin, to address inquiries raised by volunteers at testing sites for Covaxin, has received criticism from public health experts.
According to The impression, a query on the list of frequently asked questions (FAQ) in the document read: “Why should I participate in the phase 3 efficacy trial for covaxin and get vaccinated, when the government announced that people over 50 will be vaccinated shortly?”
The paper, in response, said that lead investigators should inform potential volunteers that the vaccine would protect them against COVID-19 and that it was “recommended” that recruits over 50 years of age participate in the trial, as it “may take many months “before. they are given a government-approved vaccine, even if they are identified as belonging to a priority group.
The document also cited an announcement from the Center that said there was a possibility of “limited availability of the vaccine” in the first month. He further added that, according to the recommendations of the Ministry of Health’s panel of experts, the vaccine would be “distributed first into three groups”, with the highest priority being one crore of health workers followed by two crore of front-line workers, including the police and the armed forces.
“Finally, people over 50 and those under 50 with comorbidities. The estimated population of the latter category is close to 27 million rupees. ” The impression he quoted the document as saying.
“It may take many months for subjects over 50 years of age to be immunized for the COVID-19 vaccine, based on government recommendations,” he said, adding that as a result, “it will be advisable to participate in the Phase 3 Efficacy Trial to Covaxin and get vaccinated to protect yourself against COVID-19. “
However, some experts have raised concerns about the company paper because they say it “misleads” leading researchers and participants and highlighted the risk associated with misleading those who would receive a placebo and leave them unprotected.
“The document clearly has problematic language. The purpose of a phase 3 study is to establish efficacy. This document presupposes effectiveness, but on what basis? “Anant Bhan, researcher in global health, health policy and bioethics, said The impression.
“They are assuming their vaccine is good enough already. How can sponsors take 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 and not later, the company violated the “cardinal principle” of clinical balance or an ethics of medical research that requires researchers to be unsure of the effectiveness of different interventions. offered at trial.
Jesani also said that half of the trial participants were in the placebo arm, so a person’s body can stimulate healing if they think they are receiving treatment even when they are not. “By reassuring participants that they are safe after receiving the injections, participants can become complacent. People in the placebo group actually have a zero level of protection, which increases their chances of contracting infection, ”he said.
He also asked the company to withdraw the document as it could affect the final results of the vaccine trial, as, as more participants in the placebo group become infected, “the outcome of those who received the vaccine would obviously look better. “.
However, Dr. Venkat Rao, a principal investigator at the Odisha-based Institute of Medical Sciences, a Covaxin trial center, said it was “better to get something than nothing.”
Dr Rao said the FAQs in question were issued after a discussion in which experts expressed concern that trial participants would not be able to take the actual vaccine when the Indian government finally released it.
“It is not about influencing the participants. We all know that vaccine implementation is a difficult process. When two people participate in the trial, at least one of them is likely to receive the vaccine, if the other receives a placebo. It’s better to get something than nothing, “Rao said. The impression.
Just a few weeks ago, the Hyderabad-based pharmaceutical company had applied to the central drug regulator for an emergency use authorization for its COVID-19 Covaxin vaccine, developed indigenously in collaboration with the Indian Council of Medical Research. On October 23, the Comptroller General of Medicines of India (DCGI) granted permission to the company to conduct a phase 3 clinical trial of its candidate vaccine after evaluating the safety and immunogenicity data from the phase 1 and 2 trials. .
In a study that has not yet been peer-reviewed from its phase 2 trial, Bharat Biotech said its vaccine was safe and “led to tolerable safety results and an improved humoral and cell-mediated immune response.”
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 required participants, since the study was launched in November.
