Vaccine Mandate

Uneasy Calm or Deafening Silence?

Gautam Das & Sthabir Dasgupta

We are passing through a time when, in the name of controlling pandemic, suppression of good science, rampant curbs on civil rights, violation of right to autonomy over one’s body and mandatory public health measures have become the order of the day. It is not only disrupting our social, political and economic lives, it entails a skewed public health policy undermining our public health system which has already been languishing in a rickety state.

In this context, we have found, to our dismay, that some of our friends among human rights activists and rationalists are endorsing the dominant official narrative uncritically and even resorting to advocate public health measures which are essentially detrimental to the interests of the people at large.

We have seen how lockdowns imposed without any scientific rationale have wreaked havoc in our tottering economy. Now we are witnessing another disturbing pattern of local authorities imposing vaccine mandates on the vulnerable groups like employees, students and parents, women of reproductive age, pregnant mothers and uninformed public.

To put the issue of mass vaccination with sporadic incidences of coercion and emerging threat of vaccine mandate into perspective, we need to refer to some relevant facts and raise pertinent questions.

Two Covid-19 vaccines namely Covishield (Serum Institute of India) and Covaxin (Bharat Biotech) were given “emergency and restrictive” approval by DCGI on January 3, 2021. It was followed by restricted authorisation of Russian made Sputnik vaccine in April, and Moderna vaccine in June,2021. It was said in the Jan 3 press release of DGCI that the on-going third phase trial will be continued along with vaccinating “eligible” masses. The terms like “emergency”, “restrictive” and “eligibility” were not explained. However it was presumed that under some emergency condition (without having explanation on how and where it existed), the Covishield and Covaxin were allowed to be used in select groups like health workers and frontline personnel. In a quick succession, the people above 60 years were included (March, 2021)without having any data on public domain as to how the former group benefitted and how risks were estimated against the purported benefit of the two candidate vaccines.

Within a span of few months everyone above the age of 18 were allowed (May1, 2021) to get vaccinated. Within 6 months after vaccine roll out, the pregnant (July 2, 2021) and nursing mothers (May 19, 2021) were hurriedly included in the vaccine recipient lists without any rigorous and long standing study on the mother and unborn baby. In spite of reports of serious adverse effects of Covid vaccines in pregnancy as published in New England Journal of Medicine, the most vulnerable among the adults like the pregnant and lactating mothers were thus exposed to unnecessary and potential health hazards. Now the vaccine advocates and apologists are pitching for including children in this mass vaccination drive. They are ignoring the alarms being sounded by the world renowned paediatric journals, IPHA (Indian Public Health Association, the organization of top public health experts) and even the warning of the chairman of Covid19 working group that “opening up Covid-19 vaccines for young adults will be a gamble with lives”.It also needs to be emphasised that the third phase trial for Astra Zeneca Vaccine (in India it is marketed in the name Covishield) is scheduled to be completed in February, 2023, only.

With these facts coming to the fore at mind boggling speed, let’s put these questions with a sense of urgency to the respective regulatory bodies and the authorities who are bent on pushing the Covid-19 vaccination drive to the point of mandatory mass immunisation.

 Was there any precedence of emergency authorisation of drugs or vaccines in our country? Without any ambiguity,the answer may be‘NO’.

 Has there been any provision of emergency and restrictive use authorisation of vaccine in the regulatory stipulations concerning the clinical trial of any drug or vaccine?If yes, then why was there no reference to those rules or stipulations?If, however, the answer is no, then how could it be done without any revision or repeal of National Ethical Guidelines for Biomedical and Health Research Involving Human Participants? (ICMR, 2017)The afore-mentioned guidelines say, “Early studies inPhase II are designed to estimate the dose response. Later studies are planned to confirm the dose response.” PhaseIII trial is “a) designed to confirm the evidence from Phase II studies about the safety and efficacy ofa drug or vaccine for use in the intended indication and recipient population;b) planned to provide an adequate basis for impact on clinical practice or for obtaining marketing approval”.

Naturally, the questions that deserve answers from all the stake holders of Covid-19 Vaccines are:

 As per press release of SII (Serum Institute of India), months before the emergency approval they produced and stock piled 40 million doses of Covishield by at-risk license. What was that ‘at-risk’ license?

 How could a vaccine be brought in the market before knowing the safety and efficacy ascertained by phase III trial? Without knowing the risk- benefit ratio of a candidate vaccine how could it be applied en masse? How could it be procured and dispensed by private parties?

 What should this vaccination drive be called as per existing guidelines? Is it a parallel study of side effects along with on-going phase III trial? If that being so, how is it designed from epidemiological viewpoint? Where is the control group? Without control group (those who are given placebo), or without a controlled study, how can the emergingadverse events be attributed to vaccines?

 Is it a de-facto approval for marketing vaccine? Then, where is the post marketing phase IV trial or post marketing surveillance?

 The guidelines clearly require the display of detailed data of previous trials and updates on on-going trial in public domain. It leads us to ask why were SII and BB (Bharat Biotech) allowed to publish only very brief information, mostly the conclusion and results.

 Why are they sitting over the raw data precluding the interpretation of the data by independent analysts? Why are the Govt and regulatory authorities keeping mum on this issue, despite the fact that a plea in the form of PIL was moved in Supreme Court?

 Why are various court orders equating the request for publication of data with questioning the honesty of the vaccination drive and fueling confusion among the masses about Covid-19 vaccine?

 What is the point of hiding the trial data from public view? If there is really nothing alarming, then why do not the stake holders of these vaccines come out clean? Do all these inexplicable hesitancy and resistance to data release infringe upon our right to information?

Overseas trial of Astra Zeneca Oxford Covid-19 vaccine, was paused for a brief period in September, 2020, but SII went on their trial against the guidelines (to pause/stop the trial with same vaccine/drug if any serious adverse event occurs). Emboldened by the inaction of CDSCOand silence of ICMR, the funding agency of the trial, the SII dared to slap a defamation suit of Rs. 1 crore against a victim of their trial, who suffered grave neurological problems and got admitted in a very serious condition. The guidelines require all the stake holders of under-trial vaccine to investigate and resolve the issue within 14 days.Until it is unequivocally proved by transparent investigation that vaccine is unrelated to the event, they have to bear the expenses of the treatment. Even there is provision of compensation for injury or death and ancillary compensation for seemingly unrelated event. But the draconian and aggressive response of the SII sets an unprecedented instance of trampling down all national and international ethical standards,codes, declarations and human rights covenants at one go. In this regard,the deafening silence of most of the human rights activist friends of us augurs a very ominous trend of falling in line with dominant official narrative.

Similar kind of blatant violation of clinical trial guidelines have been witnessed in Bhopal, by Covaxin maker Bharat Biotech. People were misguided by suppression of the fact that they were subjected to the trial of a vaccine. As a consequence, a number of people who received the vaccine sustained serious side effects and one among them died. The death was attributed to poisoning and treatment to the victims were denied by the hospital where trial took place. Again the rights activists remained muted on this issue. The outside world would not even have had any clue about such gross violation of human rights and medical ethics, had some dedicated activists fighting for the Bhopal Gas Victims notraised the alarm and brought it to the notice of local media.

With regard to obligation of stake holder of vaccines and mandatory informed consent the pertinent questions that need to be raised are as follows :

 The guidelines saythat ‘informed consent’ is mandatory before initiating any study/trial, and that consent should be voluntary, non-coercive and free from inducements.

 It protects individual’s autonomy and should explain medical terminology in a language that the participant understands.

 An informed consent form must include any foreseeable risks, discomfort or inconvenience to the participant resulting from participation in the study.

But the question is, what quantum of risks the authorities foresaw while initiating the phase III trial and starting to apply it en masse? After 10 months into the vaccination drive what is the risk benefit analysis? And, if any, why is it not there in the public domain? Without such analysis how can vaccination drive as well as the on-going trial be continued or even accelerated?

With regard to AEFI (Adverse events following immunisation), the Covid-19 Vaccine: Operational guideline published by MoHFW says “COVID-19 vaccines have limited safety data. Therefore, it is important to monitor the safety of these vaccines when administered to a large population”.

A grey area has been ostensibly left behind to confuse the public about the category to which the vaccination belongs. Is it a pharmaco-vigilance study on a large group of population to monitor side- effects? Is it a prospective case- control study? Is it a phase IV or post marketing surveillance? Whichever be the case, why has there been no provision of informed consent for the participants? Why has there been no notifications informing the public about the possible side-effects and the clinical conditions in which such vaccines should be avoided?

In the absence of provision for informed consent, it became easier to by-pass the related ethical guidelines. One such is coercing the employees by the employer, the teachers and students by the heads of the institutes and prescribing the Covid-19 vaccines to pregnant and nursing mothers by the treating physician or pressurizing them by family members. The whole gamut of these coercive practices is prohibited by the aforesaid ICMR guidelines. These clusters of people were described as “vulnerable groups” in any clinical trial or study, because they “have diminished autonomy due to dependency or being under a hierarchical system”.

It needs to be emphasised that there has been consistent effort to do away with informed consent which remains the bedrock of any medical research, clinical trial or application of any medical intervention on human subjects. It was envisioned in Nuremberg Code(1947) which was adopted by the world medical community to forestall any repetition or replication of inhuman and cruel medical experiments perpetrated by the Nazis. It was revised and updated by Helsinki declaration 2013. Both of these international code of clinical researches were recognized and invoked by the ICMR guidelines,2017.

A very disturbing part of the same ICMR guidelines should not be glossed over by the rationalists, science and patient right activists and human right activists of our country. In the chapter titled Public Health Researches, the very cornerstone of medical research or clinical trial which is informed consent, have been tampered with and trampled upon. There has been provision for curbing the informed consent in the name of protecting community interest. It says that “sometimes individual autonomy may not be appropriate as a stand-alone for application at the community level. While respect for the rights and dignity of all participants need to be considered and ensured, the same should be observed about the community,”

Since post WWII period, it has been recognised all over the world that for any study or medical intervention on human subject, the provision of informed consent is of paramount importance and inviolable. Citing health emergency or community interest to do away with this provision and creating a binary between the individual right and community good and showing them in mutually antagonistic relation is clearly a fascistic design envisaged by medical-political elite complex.

Our right to autonomy over our own body is well protected by the article 6.1 of UNESCO Universal Declaration on Bioethics and Human rights. It reads, “Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information.”

Even though the Government of India has reiterated many times that the vaccination against Covid-19 is voluntary, enforcing vaccination on unwilling people or endangering their livelihood in case of non-compliance to vaccination is undoubtedly an inhuman, degrading and punitive exercise on the part of the individual or local authority pushing for vaccine mandates. In such instances of gross human rights abuse, we are also protected by ICCPR (International Covenant on Civil and Political Rights, 1976). It reads, “Article 7 states that no person "shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment.” The fact that under any circumstances, this safeguard cannot be taken away from us is reaffirmed by the following statement,”… "no justification or extenuating circumstances may be invoked to excuse a violation of article 7 for any reasons, including those based on an order from a superior officer or public authority".

The onus of protecting basic human rights and upholding medical ethics including the right to autonomy over our own body certainly lies with every citizen of a democratic society, but the question lingers on, whyhave the human rights activists and organizations barring a handful of few individuals chose to remain muted and hesitant to rise to this critical hour? Is it an uneasy calm or deafening silence?

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Vol. 54, No. 23, Dec 5 - 11, 2021