New Delhi: The Progressive Medicos and Scientists Forum have demanded the rollback of approvals for emergency use authorisation given to two vaccine candidates by the Drug Controller General of India (DCGI).
“Science can’t be compromised in the pursuit of private profit and political gains. PMSF demands revoking the approval of vaccine candidates and revisiting the vaccination and approval strategy based on the efficacy data and other considerations,” the forum said.
“The current incoherent messaging regarding vaccine efficacy, statements like 110 per cent certain of vaccine efficacy by DCGI, ‘LIKELY’ to be effective against UK strain of Covid-19 statement by the Health Minister, have taken the scientific community and general public by surprise. The Director of AIIMS is on record stating ‘Covaxin will be used as a backup for Covishield which doesn’t have proven efficacy’. As a group of doctors and researchers actively monitoring the situation, PMSF wishes to raise the concerns for wider consideration of the scientific community as well as the general public,” it added.
The DCGI had approved Covaxin by Bharat Biotech and Covishield by Serum Institute of India for emergency use authorization on Sunday. While Covishield was approved with certain riders, Covaxin was permitted for restricted emergency use in clinical trial mode by the drug controller. It was also reasoned that the Covaxin, which is ‘Inactivated Whole Virion, Corona Virus Vaccine,’ has the potential to target mutated coronavirus strains.
However, the scientist community and public health experts have strongly objected to the approval of Bharat Biotech’s vaccine as the firm is yet to present the efficacy data of its Phase 3 trials.
“DCGI’s approval document stating ‘clinical trial mode’ doesn’t provide any additional details. Will informed consent be taken from all those who take the vaccine and experience adverse effects be eligible for compensation?” PMSF President Dr Harjit Bhatti asked.
He also cautioned about the likelihood of violation of clinical trial protocols during the immunisation. “Serum Institute had threatened a participant in a clinical trial with a defamation suit demanding financial compensation. Instances where the trial was conducted without adequate information and consent are being brought to notice already. If adherence to protocol has been violated even while under trial, there is less likelihood of the same during large scale deployment,” Bhatti said.
Meanwhile, the forum also doubted upon the claim that the Covaxin is effective in targeting the mutant strains of SARS-CoV-2 since it is not backed by any data.
“It is not clear if there is any scientific basis to claim that Covaxin will be effective in controlling the infection by mutant strains when its efficacy has not been established and is currently unknown against any strain of the virus. The claim being propagated that the whole virion inactivated vaccine is likely to be effective against mutations of the virus is not being supported by any efficacy from the trial because no data have as yet been generated in the Phase 3 trial,” it stated.
“Experts have already warned that current vaccines may not protect against South African mutant strain. With such worldwide uncertainty of vaccines against mutants, what is the basis of these claims made?” Dr Vikas Bajpai, Professor at Centre of Social Medicine and Community Health in JNU and executive member of PMSF, asked.