Non-Disclosure Of Vaccine Trial Data Preventing Independent Evaluation : Prashant Bhushan Tells Supreme Court

On Tuesday, appearing before a Bench comprising Justices L. Nageswara Rao and B.R. Gavai, Mr. Bhushan refuted the arguments of transparency made by the Solicitor General. He stressed upon the petitioner's plea to disclose the clinical trial data as it would permit the independent experts to look into the veracity of the claims of the manufacturers. In this regard, he referred to a United States District Court judgment, wherein the regulatory body was directed to disclose all the information pertaining to the Pfizer vaccine. He also argued to demonstrate the vaccine mandates imposed by the above-mentioned States were irrational and disproportionate. Further, he put forth the flaws in the adverse event reporting mechanism, which he claimed, was alien to many, as its existence has not been adequately advertised by the Union Government.

Previously, Mr. Bhushan had elaborately argued the issues raised in the petition. Countering his arguments the Solicitor General had submitted that adequate statutory provisions and robust mechanisms were in place to ensure that protocol is followed while granting approval to vaccines and while reporting adverse events. The Solicitor had emphasised that all the information sought by the petitioner are already in the public domain. However, it was made abundantly clear that neither was it open to a Public Interest petitioner to seek raw data of the clinical trial of the COVID-19 vaccines, merely to satisfy his curiosity, nor can he sit in judgment of the wisdom of the statutory bodies comprising domain experts. The Solicitor General had vehemently argued that an individual's personal liberty is not absolute and therefore, the court should reconcile competing interests by balancing the interests so involved.

Non-disclosure of Data -Non disclosure is preventing independent experts from making their own determination

Mr. Bhushan contended that the Union Government is preventing independent experts from making their independent determination by not providing data. The reason being cited by the Union Government is that with a multi-layered system in place, Government experts are sufficiently capable of making such determinations.

"We are told that the Subject Expert Committee (SEC) and the National Technical Advisory Group on Immunisation(NTAGI) are good multi-layered systems which take care of everything. So much so, that independent experts are not to be given access. They say why independent experts arrive at their independent conclusion when such a body is already doing the same."

United States District Court had directed FDA to provide all data pertaining to Pfizer vaccine

Reliance was placed on In Public Health and Medical Professionals for Transparency v. Food and Drug Administration, wherein the plaintiff under the Freedom of Information Act (FOIA) sought all data and information for the Pfizer Vaccine with the exception of publicly available reports on the Vaccine Adverse Events Reporting System from the Food and Drug Administration. The United States District Court for the Northern District of Texas, Fort Worth Division had allowed the plea. Bhushan read out the following excerpts from the order : 

"Echoing these sentiments, "[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a democratic society." NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). "FOIA was [therefore] enacted to 'pierce the veil of administrative secrecy and to open agency action to the light of public scrutiny.'" Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (quoting Dep't of the Air Force v. Rose, 425 U.S. 352, 361 (1976)). And "Congress has long recognized that 'information is often useful only if it is timely' and that, therefore 'excessive delay by the agency in its response is often tantamount to denial.'" Open Soc'y Just. Initiative v. CIA, 399 F. Supp. 3d 161, 165 (S.D.N.Y. 2019) (quoting H.R. REP. NO. 93-876, at 6271 (1974)). When needed, a court "may use its equitable powers to require an agency to process documents according to a court-imposed timeline." Clemente v. FBI, 71 F. Supp. 3d 262, 269 (D.D.C. 2014).

Here, the Court recognizes the "unduly burdensome" challenges that this FOIA request may present to the FDA. See generally ECF Nos. 23, 30, 34. But, as expressed at the scheduling conference, there may not be a "more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not [] rush[ed] on behalf of the United States . . . ." ECF No. 34 at 46. Accordingly, the Court concludes that this FOIA request is of paramount public importance."

Pfizer's data in public domain and is being examined by independent scientists

He informed the Bench that Pfizer's data is now in public domain and experts are examining the same.

"One of the important things that has come out is that in the trials they found that half the people were given placebo, half were given vaccines and two people died in the placebo arm and one person died in the vaccine arm. Therefore, they said its efficacy is high because double the number of people who were unvaccinated died."

Disclosure of data encouraged under EU law

Mr. Bhushan submitted that the Solicitor General was not correct in submitting that nowhere in the world such data is disclosed. To counter the same, he contended that the law in the European Union encourages disclosure of data for public scrutiny and future research.

"The European Medicines Agency's document titled "European Medicines Agency policy on publication of clinical data for medicinal products for human use" states that transparency is a key consideration for the Agency in delivering its services to patients and society…The European law seems to encourage further independent analyses of clinical trial data and to examine the regulatory authorities."

Mr. Bhushan stated that the personal information of the patients can be redacted and the rest of it can be provided as had been directed by the United States District Court in case of the Pfizer vaccine.

"All rules the Solicitor read were that patients' information is to be protected. They can redact the same. That is what the US Court also said that you provide everything after redacting patients' particulars."

He added -

"Under the Right to Information Act in India, all the information with the government including regulators, must be disclosed to the public, except for subject confidentiality information and information involving commercial confidence. Even these exemptions are subject to public interest override. In this case the Petitioner has made it amply clear that he is not seeking subject names, which can clearly be redacted. There is no violation of privacy so far as names redacted trial data is concerned and clearly this information has to be provided. In fact, on the COWIN website, where adverse events are recorded, they are recorded by the government along with persons name and other details."

At least segregated data be disclosed

Mr. Bhushan submitted that even though the Government, which claims to be concerned about privacy of the patients, refuse to provide individual data, they ought to make available segregated data. He argued that if no data is provided then the independent experts would not be able to examine the veracity of the claims made by the vaccine manufacturers and to see if they are backed by data.

"Suppose they do not give individual data, at least, they should give data segregate by age, sex, pregnancy status etc. They have that data…At least that data has to be given. Otherwise, how will an independent scientist examine if what they claim is backed by the data?"

Vaccine mandate challenged in the context of COVID-19 as clinical trial data has not been disclosed and informed consent has not been obtained

At the outset, Mr. Bhushan clarified that the petitioner does not question the power of the States to issue the vaccine mandates. The challenge is limited to the mandates issued in the context of COVID-19 vaccines, wherein the clinical trial data is not disclosed and consent obtained is not informed consent.

"We are not saying Govt. does not have the power to issue vaccine mandates. We are not saying mandates can never be issued…We are saying that in the present context of COVID-19 and its vaccines and what we know about them is such that in these circumstances mandates would be unconstitutional."

To impose mandate, States are to demonstrate unvaccinated people pose greater risk; vaccines prevent transmission

He added that in order to impose a mandate in the context of COVID-19 vaccines, the States ought to demonstrate that the unvaccinated people pose greater risk to the public than the ones who are vaccinated and vaccination would prevent transmission. Moreover, they are to show that the vaccines have been reasonably studied and the persons who have recovered from COVID have a tendency to transmit the virus more than the ones vaccinated.

"A mandate can be issued provided they can demonstrate I pose greater risk to others than if I was vaccinated. They will need to demonstrate that the vaccines have been reasonably well studied. Covid recovered would be transmitting the disease more than the vaccinated. Also demonstrate that there is a significant risk of transmission from the unvaccinated and the vaccination would prevent that."

If non-vaccination does not pose threat to the public, not getting vaccinated is a personal choice

Mr. Bhushan further argued that if non-vaccination pose no significant threat to the public, then the decision to get vaccinated or not is a personal decision of an individual and no one can coerce them to decide in favour of getting vaccinated. In this regard, he referred to the judgment in Aruna Shanbaug v. Union of India and Common Cause v. Union of India.

"If I am not posing a risk to others' life then to get vaccinated or not is my decision. There are two judgments - Aruna Shanbaug and Common Cause."

It is not enough for Government or its expert to claim vaccines reduce risk of transmission, without adducing evidence

He emphasised that it is not enough for the Government or its experts to merely assert that in their opinion the vaccines significantly reduces the risk of transmitting the disease or that the vaccines have a lower risk of transmitting the disease, without providing any evidence to that effect. He pointed out that natural immunity has been achieved by majority of the population as almost 80% of the country's population has already had the infection -

"Serological surveys in Delhi show that 97% of Delhi's population has already had the infection. More than 80% of the country's population has already had the infection."

Refuting the Solicitor General's argument that he had adduced evidence pertaining to some scattered opinion of individuals, Mr. Bhushan argued that he has relied on official data of both domestic and foreign Governments and studies published in peer-reviewed scientific journals, which is the gold standard of publication. He submitted that the Government has failed to adduce any evidence to show that those vaccinated have a lower rate of transmitting the disease than the unvaccinated.

He also asserted that those infected are better protected than the ones who have taken the vaccine.

"Someone who had the infection is better protected than one who takes the vaccine. That is the gold standard of immunity. The vaccine only mimics the natural infection."

None of the COVID-19 vaccines in India are licensed vaccines

He emphasised that COVID-19 vaccines were not licensed vaccines. He stated that only Pfizer has a licensed vaccine, but it still uses the one for which emergency use authorisation was granted, only to avoid being sued for vaccine injuries.

Mr. Bhushan submitted that none of the vaccines administered in India has been given license. They are experimental vaccines. In case of Covaxin, he stated, that in the human trial stage the first enrollment was done on 16.11.2020 and on 02.02.2021, Bharat Biotech was given emergency use approval. The trial which was to go on till December 2022 was terminated on 05.01.2021 because they unblinded the placebo arm.

Natural immunity protects better than vaccine immunity

Reading from the deposition of Dr. Aditi Bhargava, Professor in the Department of Obstetrics and Gynecology and the Center for Reproductive Sciences at University of California, San Francisco before the US Senate, Mr. Bhushan pointed out that as per Dr. Bhargava natural immunity protects one far better than the vaccine immunity.

Mere presence of multi-layered expert regime is not enough

Mr. Bhushan submitted that the Solicitor General had emphasised on the existence of a multi-layered regime for vaccine approval, vaccine trials and reporting of adverse events, and therefore, has beseeched the Court not to go into the issues raised by the petitioner as it would promote vaccine hesitancy. He added -

"He also contends that there is an excellent portal called 'COWIN' for reporting adverse events due to the vaccine and a national AEFI committee for evaluating adverse events and that nothing further therefore needs to be done regarding adverse events….He further points out that more than 90% of the country's population has already received at least one dose of the vaccine and therefore this petition is infructuous as vaccines are already a fait accompli."

Mr. Bhushan argued that merely because there was a robust system in place, it would not be outside the ambit of scrutiny.

"Though that report is of the year 2012-2013, the egregious violations of rules, ethical principles, fabrications and conflicts of interest narrated in the case of multiple drugs on multiple occasions shows that it would be totally hazardous to assume that merely because an elaborate system of regulatory approval has been put in place on paper, that everyone should assume that the regulatory approvals are robust and unquestionable. Accepting the argument of Mr. Mehta would mean that the courts should give a go by to the Right to Information Act and deny people the right to even examine what various public authorities have done, merely because an elaborate regulatory approval process is in place on paper. The lapses pointed out in the report make it even more urgent for data with regard to mass vaccination to be disclosed to the public."

On previous occasions expert bodies were by-passed; refused access to clinical trial data

It was pointed out that even though the Government claims to have expert committees in place, it has on a previous occasion by-passed such expert bodies to grant approval for vaccinating 12-14 year children. Moreover, the Bench was apprised that on some occasions the expert bodies are also not provided with trial data while making decisions.

"The recently granted approval for vaccinating 12-14 year of children has been done without the approval of the NTAGI (apex body for approving vaccines)...The top expert advisory bodies like the NTAGI and the SEC are often not provided with the trial data or sometimes proceed to take decisions without even looking at the trial data…This is therefore completely contrary to Mr. Mehta's contention that the data has been seen by the SEC and the NTAGI in accordance with the Rules."

He referred to the Rotavirus case and stated that for the Rotavac vaccine segregated data was not provided to NTAGI or the SEC. Under such circumstances, he submitted that it would be difficult to trust the domain experts who take decision without the data being made available to them.

"In the rotavac case, when the data was denied to the NTAGI, the petitioner was forced to file a PIL seeking that data. In that case, even the SEC was not provided that data, despite intervention of the PMO…Ironically, the government now argues that the court must trust the domain experts, however as shown in the case of the Rotavac gangrene, the government would clearly not trust the domain experts."

Only recommendation was put up on the website, not the data

Mr. Bhushan asserted that the information available on the website pertains only to recommendations made by the expert bodies, but does not indicate the material on the basis of which such recommendations were made.

"Further, there is nothing in the "recommendations" of the SEC available on the website (these are not the minutes) that suggests what data was presented to the SEC and what were the SECs deliberations based on that data…Only recommendation was put up on the website. It only says what was decided."

Approval for Covaxin was essentially given in a span of two days

He highlighted that in the case of Covaxin, the SEC (Subject Expert Committee) had granted the emergency approval in a span of two days.

"In the present case itself, the manner of emergency approval of Covaxin by the SEC shows that the SEC did not look at the trial data before granting emergency use approval…A perusal of the recommendations of the SEC meetings available on the website show that the SEC changed its mind about Bharat Biotech's Covaxin within a span of two days."

Adverse Event Reporting System only allows vaccinators to report

Addressing the issue of the reporting system of adverse events of the vaccines, Mr. Bhushan submitted that unlike in the United States, in India vaccinees cannot report adverse events, only vaccinators can do so -

"The COWIN reporting system only allows the vaccinator to report the adverse event and not the vaccinees. Thus if a vaccinator refuses to report an adverse event or comes to his subjective conclusion that the adverse event is not related to vaccination, the vaccinee has no recourse…The rules currently being followed provide that unless an adverse event is a known adverse reaction to the vaccine, it will not be reported as a vaccine reaction."

He expressed doubt about the official count of adverse events in India. In this regard he submitted -

"Number of vaccine doses administered in India - 176 crores approx. Number of adverse events reported - 76,814 (approx). This comes to approximately 1 adverse event per 23,000 doses. The same vaccine Astrazeneca in Europe has caused 244,603 adverse events in 69 million doses, which translates to approx. 1 adverse event per 282 doses. This level of discrepancy is absurd, and points to the utter callousness in AEFI collection by the Union Government."

Union Government did not produce evidence to rebut the issues raised by the petitioner

Mr. Bhushan emphasised that the Union Government had not adduced any evidence to rebut the issues raised by the petitioner.

"There is no evidence in the compilation filed by the Union to rebut any evidence adduced by the petitioner. In fact many of the documents support the petitioner's claim…The main thrust of our petition is that it is very clear from the data and publication that the vaccine mimics the infection. It only mimics one part of the virus. In this case the spike protein. If you are naturally infected then you are to be better protected than those who are given a vaccine. Union has not filed any paper to rebut this contention…Vaccines do not prevent reinfection, only protect from the seriousness. It is mutating very rapidly. They have not filed anything substantial to rebut that the vaccine will not significantly prevent re-infection and transmission."

Reliance was placed on the recent judgment of the High Court of New Zealand in Yardley v. Minister for Workplace Relations and Safety [2022] NZHC 291

"[91] I take it from this evidence that vaccination may still have some effects in limiting infection and transmission, but at a significantly lower levels than was the case with the earlier variants. It is clear from the evidence that vaccination does not prevent persons contracting and spreading COVID-19, particularly with the Omicron variant. It is equally clear that it does still provide protection from serious illness and death, although this effect wains after the second dose, and seems to wain in a similar way after the booster. I accept on the basis of Dr Town's evidence that vaccination might contribute to preventing contracting and spreading the Delta and Omicron variants to some extent, although not nearly as much as it did against the original versions of COVID-19.

[...]

[96] But the burden still is on the Crown to demonstrate that the limitation on the applicants' rights is reasonable and demonstrably justified in light of the precautionary principle (or the version of it described above). Ultimately this case may be thought to come down to a contest between the fundamental rights of the applicants and this version of the precautionary principle.

[97] I am not satisfied that the Crown has put forward sufficient evidence to justify the measures that have been imposed, even giving it some benefit of the doubt. The apparently low numbers of personnel the Order actually addresses, the lack of any evidence that they are materially lower than would have been the case had the internal policies been allowed to operate, and the evidence suggesting that the Omicron variant in particular breaks through any vaccination barrier means that I am not satisfied that there is a real threat to the continuity of these essential services that the Order materially addresses. If there is a threat to these services it will arise precisely because vaccination and other measures are not able to prevent the risk that Omicron will sweep through workforces."

[...]

[106] COVID-19 clearly involves a threat to the continuity of Police and NZDF services. That is because the Omicron variant in particular is so transmissible. But that threat exists for both vaccinated and unvaccinated staff. I am not satisfied that the Order makes a material difference, including because of the expert evidence before the Court on the effects of vaccination on COVID-19 including the Delta and Omicron variants."

Justice Gavai pointed out that in the said judgment, the issue was that the mandate was disproportionate.

On proportionality

On the issue of proportionality, Mr. Bhushan submitted -

"Those who have been infected pose less risk (certainly not more) of getting infected and transmitting than those vaccinated. This is immunology 101. Therefore, a person infected cannot have less immunity than those vaccinated. The proportionality here fails here for this reason…"

Justice Rao limited the contour of the scrutiny to determine whether the vaccine mandates were proportionate or not.

He further added -

"Can there be a requirement for you to produce a COVID certificate for entry like international travel. We are trying to understand from you, would that be proportionate?"

Mr. Bhushan was of the opinion that the requirement to get tested every time one steps out is also disproportionate.

"Suppose the evidence is 99.9% people had the disease and suppose the later variants are mild. A mandate for getting tested every time you step out would also be disproportionate. But, I understand the requirement of vaccine mandates when the disease is lethal (smallpox)."

He stated that the Government and its experts merely saying that the vaccines would prevent infection without any evidence would not be sufficient. He pointed out that on the contrary he had placed on record scientific publications to counter the opinion of the Government.

"There is a distinction between a Govt. experts merely saying that they believe vaccines will prevent infection. But, I have provided voluminous scientific documents based on publications in scientific journals…The Government and their experts may claim anything but they have not produced evidence. I have produced evidence."

Drawing distinction between the cases referred to by the Union Government and the present case

Mr. Bhushan attempted to draw a distinction between the present case and the judgments cited by the Solicitor General in support of vaccine mandates. Referring to the judgment of the Supreme Court of the United States of America in Jacobson v. Massachusetts as cited to by the Solicitor General, Mr. Bhushan submitted that it pertained to the vaccine mandate for lethal diseases like smallpox. Moreover, the penalty for not adhering to the mandate was a $5 fine, whereas in the mandates imposed by the States in the present case, access to public spaces is being restricted. He distinguished the present case by stating that the diseases in Jacobson and other cases cited by the Solicitor General were lethal diseases.; very few people were affected by those diseases and vaccines therein provided lifelong immunity.

He submitted that the mandates have to be examined taking into account the context in which it has been imposed -

"The vaccine mandates have to be viewed in the context of COVID-19: the disease is not lethal; the disease is not prevented by the vaccine; those who have been infected are better protected; it is an experimental vaccine."

As the Bench protested that the COVID-19 which has claimed the lives of many cannot be said to be not lethal, Mr. Bhushan clarified that it is not like smallpox and only the unhealthy people (with comorbidities) have been seriously affected by COVID-19 virus.

He referred to the judgment of the SCOTUS in the Roman Catholic Diocese of Brooklyn, New York v. Cuomo to counter Jacobson.

"Why have some mistaken this Court's modest decision in Jacobson for a towering authority that overshadows the Constitution during a pandemic? In the end, I can only surmise that much of the answer lies in a particular judicial impulse to stay out of the way in times of crisis. But if that impulse may be understandable or even admirable in other circumstances, we may not shelter in place when the Constitution is under attack. Things never go well when we do.

[...]

In Jacobson, individuals could accept the vaccine, pay the fine, or identify a basis for exemption. Id., at 12, 14. The imposition on Mr. Jacobson's claimed right to bodily integ- rity, thus, was avoidable and relatively modest. It easily survived rational basis review, and might even have sur- vived strict scrutiny, given the opt outs available to certain objectors. Id., at 36, 38–39. Here, by contrast, the State has effectively sought to ban all traditional forms of worship in affected "zones" whenever the Governor decrees and for as long as he chooses. Nothing in Jacobson purported to address, let alone approve, such serious and long-lasting intrusions into settled constitutional rights. In fact, Jacob- son explained that the challenged law survived only be- cause it did not "contravene the Constitution of the United States" or "infringe any right granted or secured by that instrument." Id., at 25."

He also placed reliance on In re: Distribution of Essential Supplies and Services During Pandemic.

"14 It is trite to state that separation of powers is a part of the basic structure of the Constitution. Policy-making continues to be in the sole domain of the executive. The judiciary does not possess the authority or competence to assume the role of the executive, which is democratically accountable for its actions and has access to the resources which are instrumental to policy formulation. However, this separation of powers does not result in courts lacking jurisdiction in conducting a judicial review of these policies18. Our Constitution does not envisage courts to be silent spectators when constitutional rights of citizens are infringed by executive policies. Judicial review and soliciting constitutional justification for policies formulated by the executive is an essential function, which the courts are entrusted to perform."

[...]

16 Similarly, courts across the globe have responded to constitutional challenges to executive policies that have directly or indirectly violated rights and liberties of citizens. Courts have often reiterated the expertise of the executive in managing a public health crisis, but have also warned against arbitrary and irrational policies being excused in the garb of the "wide latitude" to the executive that is necessitated to battle a pandemic.

17 In grappling with the second wave of the pandemic, this Court does not intend to second-guess the wisdom of the executive when it chooses between two competing and efficacious policy measures. However, it continues to exercise jurisdiction to determine if the chosen policy measure conforms to the standards of reasonableness, militates against manifest arbitrariness and protects the right to life of all persons. This Court is presently assuming a dialogic jurisdiction where various stakeholders are provided a forum to raise constitutional grievances with respect to the management of the pandemic. Hence, this Court would, under the auspices of an open court judicial process, conduct deliberations with the executive where justifications for existing policies would be elicited and evaluated to assess whether they survive constitutional scrutiny."

Countering the reliance placed on Vavřička And Ors v. Czech Republic, he submitted that it was a case where a fine was imposed for refusing to take vaccines for hepatitis B and polio. However, there were provisions for exemption from the mandate. Again, in the judgment of the Constitutional Council of France referred to by the Union Government, there were exemptions from being vaccinated.

Referring to K. Puttaswamy v. Union of India, he submitted that there should first be a legitimate state aim, which in the present case has been established to be prevention of transmission of the COVID-19 virus. He argued that there were alternatives to ensure the same -

"They say the aim is to prevent transmission of COVID. In that case, they can ask me if I have immunity. Vaccination is not preventing transmission anyway."

Mr. Bhushan urged the Court to examine the competing opinions of the expert as had been done by the High Court of New Zealand.

Conclusion

In conclusion, he submitted, the mandates are irrational and disproportionate -

"These mandates fall on the ground of being irrational and disproportionate."

With respect to the issue of disclosure of clinical trial data, he stated that if not individual data, at least the segregated data be provided.

With respect to the release of clinical trial data, they can provide the segregated data if not the individual data."

He beseeched the Bench to look into the shortcomings of the system developed for reporting adverse events -

"With respect to adverse reporting system, these things have to be rectified -

a. only the vaccinator can report;

b.they have not advertised the reporting system;

c.only known adverse effects can be reported."

The Bench has reserved the judgment.

[Case Title: Jacob Puliyel v. Union of India]