❈ ❈ ❈

Statement by All India Drug Action Network, 2 January 2021

Concern Over Emergency Use Approval to Vaccine Candidates of Serum Institute and Bharat Biotech

Immediate Response to: SEC recommendations to grant restricted emergency use (REU) approval to vaccine candidates of Serum Institute and Bharat Biotech

COVISHIELD. Serum Institute

1. We would like to know –

• the efficacy estimates for the dosing regimen and dosing schedule that will be followed in India as concluded by the SEC
• the specific data and analysis of the foreign trials of the AstraZeneca/Oxford vaccine that was the basis of the SEC’s decision
• the extent of the data for safety and immunogenicity from the Phase 2/3 bridging study in India that was submitted and reviewed by the SEC
• the “multiple regulatory conditionalities” proposed by the SEC

2. Any REU granted by the DCGI on the recommendation of the SEC must be accompanied by “the legal provisions under which the approval is granted, the specific approved use of the “vaccine candidate and details of restrictions/ conditions.

3. In the interest of transparency and public welfare, we ask that the regulator share the detailed rationale for the decision along with disclosure of the data, evidence and information” that was reviewed by the SEC and the data and analysis on the basis of which the REU approval is granted.

This is particularly important given the lack of adequate information regarding the UK MHRA’s review of the AstraZeneca/Oxford vaccine and the fact that interim data for safety and immunogenicity from the Serum Institute/ICMR Phase 2/3 study have not been made publicly available. Bear in mind that the objective of a bridging study to assess the vaccine candidate in an Indian population would be undermined if the data generated from the trial is not reviewed in the process of regulatory approval.

COVAXIN, Bharat Biotech

AIDAN is shocked to learn of the SEC’s recommendation to grant REU approval to Bharat “Biotech’s COVAXI N in “clinical trial mode” and “specially in the context of infection by mutant strains”.

Disturbingly, it appears that no efficacy data for the vaccine candidate were submitted from the Phase 3 trials that are ongoing and being conducted by Bharat Biotech and ICMR. The only data for humans, available through publication pre-prints, are for safety and immunogenicity from Phase 1and Phase 2 trials, across a total of 755 participants. In the interest of transparency, it will be in the fitness of things that the trial data on the basis of which decisions have been taken by the SEC are immediately made public.

It is also not clear under which provisions of the extant law the SEC has recommended for grant “of REU approval and in “clinical trial mode” at that.”

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 hypothesis 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. Yet this appears to have been used to justify the totally non-sequitur decision” which has no basis in the science of rational vaccine development.

We are baffled to understand what scientific logic has motivated the top experts in the SEC to approve this vaccine posthaste. Moreover, this is a violation of the criteria in the draft regulatory guidelines for development of COVID-19 vaccines published by CDSCO on 21 September 2020.

“The decision to approve an incompletely studied vaccine, even under accelerated process,” raises more questions than answers and likely will not reinforce faith in our scientific decision making bodies.

In light of the intense concerns arising from the absence of efficacy data and hence the limited regulatory review of the vaccine candidate, the implications of public rollout of an untested product, and lack of transparency we urge the DCGI to reconsider the recommendations of the SEC in granting the REU approval to COVAXIN.

[For further information, contact: Malini Aisola (7838381185), Chinu Srinivasan (9998771064)]

❈ ❈ ❈

PMSF Statement on Clearance Granted to Covid Vaccines by DCGI , 5 January 2021

Progressive Medicos and Scientists Forum

Office Address: 2nd Floor [Left] 1527 C, Gali No. 13, Govindpuri, Kalkaji,

New Delhi India, 110019

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.

While India was quick to criticize China and Russia for emergency approvals without efficacy data, 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 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.” As a group of doctors and researchers actively monitoring the situation, Progressive Medicos and Scientific Forums (PMSF) wishes to raise the following concerns for wider consideration of the scientific community as well as the general public:

1. Role of Universal Vaccination in COVID pandemic: Public health experts in the country (IPHA, IAPSM, IAE) have stated that “Vaccines have no role to play in the current pandemic”. A successful vaccine (both high efficacy and high safety) is unlikely in the short duration of the corona pandemic. Telescoping a decade long process to less than a year is likely to leave some uncovered areas either in safety or in efficacy. A minor mistake can be magnified leading to disastrous consequences for many. Preliminary data suggests that less efficacious vaccine can promote the selection of more virulent mutants.

2. DCGI Approval document stating “clinical trial mode” doesn’t provide any additional details of the same. 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.

3. 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?

4. 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.

5. Last, but certainly not the least, the government and its policy planners ought not to forget that disease is far more a phenomenon that plays out in a given social context, and that no disease can be controlled without winning over the people to the side of such efforts. In this regard we have the following to contend with – practical realities of cold chain efficacy, post vaccination monitoring for adverse effects, and an unholy grail of unethical vaccine trials conducted under the pressure of and funding from big multinational ‘PHILANTHRO-CAPITAL’ vaccine companies and foundations leading even to loss of lives.

6. 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.

It needs emphasis again that the considered opinion of public health experts is that “Vaccines have no role to play in current pandemic”, 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.

In view of the above concerns, PMSF demands 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.

Dr Harjit Singh Bhatti, National President; Dr Vikas Bajpai, Executive Member.

(Both statements courtesy: Mainstream Weekly.)