“Science can’t be compromised in the pursuit of private profit and political gains. If the current trend is not called out and checked, it will help the complete takeover of science by corporate,” the PMSF said.
The Progressive Medicos and Scientists Forum (PMSF), the New Delhi-based body of doctors and scientists, has released a statement regarding the clearance given by Drugs Controller General of India (DCGI) to two vaccine candidates. The body has said that the approval was given in undue haste without sufficient scientific data on the safety and efficacy of the vaccines.
“India ranks high among the countries worst affected by COVID19 pandemic. It need also be acknowledged that when developed in strict conformity with the principles of science and epidemiological rationale, vaccines have played an important role in advancement of health and wellbeing of the human race as also of other species that exist in our close environment. To this extent the efforts made by different governments and companies, including Indian companies like the Serum Institute of India and Bharat Biotech appeared to be steps in the right direction to serve the interest of the people, until the undue haste and disconcerting exigency in pushing for approval and deployment of the vaccine without sufficient scientific data on the
safety and efficacy of the vaccines,” the PMSF said in its statement.
The body also reminded that India was quick to criticize China and Russia for emergency approvals without efficacy data, however, it failed to exercise diligence when its turn arrived. “There are many reasons to suspect that profit and political gains have taken precedence over science,” the body said.
“The current incoherent messaging regarding vaccine efficacy, statements like 110% certain of vaccine efficacy by DCGI, “LIKELY” to be effective against UK strain of COVID19 statement by 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”,” PMSF said in its statement.
Raising the question whether those facing ill-effects after being administered the vaccine will get compensation, the PMSF said: “Will informed consent be taken from all those who take the vaccine and experience adverse effects be eligible for compensation? Serum Institute has threatened a participant in
clinical trial with 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.”
Talking about the Bharat Biotech’s vaccine, the PMSF said: “It is not clear if there is any scientific basis to claim that COVAXIN will be effective in the “context of 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. Experts have already warned that current vaccines may not protect against South African mutant strain. With such worldwide uncertainty of vaccine against mutants, what is the basis of these claims made?”
Enquiring about the Serum Institute’s Covishield, the body asked: “How was non-inferiority/equivalence of COVISHIELD to the AstraZeneca/Oxford vaccine established without efficacy data available for the former? Without efficacy data, the purpose of conducting a study in Indian population is lost. Preliminary data suggested that in the dosing regimen followed by Serum Institute of India, efficacy was 62% compared to 70% elsewhere.”
The body also raised serious questions over political connections of the vaccine manufacturer companies. “Another issue that needs further investigation is the business interests and financial stakes involved for the companies and for their political collaborators, including the members of the ruling party in this great vaccine enterprise. It is a case of financial interests of the companies whose relations with ruling dispensation are being talked of and need further elaboration, trumping over scientific approach to the pandemic control. This could well explain the undue haste in pushing vaccine approvals while throwing all caution to winds despite the fact that the epidemiological situation of the pandemic in the country does not
demand so,” PMSF said in the statement.
The PMSF stressed that “Vaccines have no role to play in current pandemic” as the pandemic in India at national and provincial levels has plateaued and is on its way down with very few cases being reported across all cities and most of rural areas as well and moreover, there is no role whatsoever for universal immunization against Covid as is being promoted.”
The body demanded revoking of the approval of vaccine candidates and revisiting of the vaccination and approval strategy based on the efficacy data and other considerations mentioned above.
“Science can’t be compromised in the pursuit of private profit and political gains. If the current trend is not called out and checked, it will help the complete takeover of science by corporate,” the PMSF said.
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