Sunday September 26, 2021

NBC refuses to allow placebo trials of Covid-19 vaccines

NBC refuses to allow placebo trials of Covid-19 vaccines

KARACHI: The National Bioethics Committee (NBC) of Pakistan has refused to allow at least five double-blind, placebo-controlled Phase-III clinical trials of mRNA and conventional Covid-19 vaccines on ‘ethical grounds’ in Pakistan, arguing Pakistani citizens could not be treated as ‘guinea pigs’ anymore.

“Some local and multinational pharmaceutical companies have applied for conducting placebo-controlled trials of mRNA and conventional Covid-19 vaccines in Pakistan but we have told them that use of placebo cannot be allowed anymore during trials when different types of conventional vaccines are available while Pakistan is going to acquire mRNA vaccine very soon,” an official of the National Bioethics Committee (NBC) of Pakistan told The News.

The National Bioethics Committee officials said principal investigators at the Aga Khan University Hospital (AKUH) and University of Health Sciences (UHS), Lahore had applied for conducting global and multinational, randomized, double-blind, placebo-controlled, Phase III clinical studies to evaluate protective efficacy, safety and immunogenicity of SARS-CoV-2 mRNA and different conventional vaccines at their centers. “These under-trial vaccines include a Chinese Messenger Ribonucleic Acid (mRNA) vaccine as well as various conventional vaccines including inactivated Vero cells, recombinant Covid-19 vaccine (Sf9 cells) and Fusion Protein Vaccine (V-01) in adults aged 18 and above. The NBC’s expert committee suggested that instead of using placebo, vaccines available in Pakistan should be used, which is not acceptable to investigators and manufacturers,” the official added.

According to experts, a placebo is a medicine or procedure prescribed for the psychological benefit to the patient rather than for any physiological effect. It is a substance or treatment which is designed to have no therapeutic value, including inert injections, pills, or any other kind of fake treatment. The NBC official said injecting placebo to hundreds of people at a time when there are around six vaccines available in Pakistan and are being used to inoculate people, would ‘ethically wrong’ and it cannot be allowed in the present circumstances. “A person, who is given a placebo instead of a vaccine, can contract the coronavirus infection and even die. This would be happening at a time when he or she would be assured that they have received the vaccine jabs. This is not acceptable on ethical grounds,” the official added.

On the recommendations from the expert committee of NBC, the official said, Principal Investigators were asked to review the course of their studies and if they agree to use any of the vaccines available in the country instead of placebo, they could be allowed studies but added that so far, they were not willing to change the design of their studies on technical grounds.

“Earlier, the NBC allowed placebo-controlled trials including the trials of Cansino vaccine, while phase-III clinical trials of triple-dose Chinese vaccine titled ZF-2001 are also underway at UHS Lahore but that happened when Covid-19 vaccines were not available,” the official said, adding that now there was no need to conduct placebo-controlled trials as efficacy, safety and immunogenicity of the vaccines could be ascertained against other vaccines too.

Vice Chancellor, UHS Lahore Prof. Javed Akram confirmed that NBC was not approving the placebo-controlled trials and added they were now changing the design and protocols of the studies.