Why Bharat Biotech & SII Are Opposing Plea In Supreme Court For Public Disclosure Of Vaccine Trial Data, Are They Scared That This Will Expose Their Fake Vaccine Scam?

COVID-19 vaccines: The Supreme Court has reserved its decision on a petition for clinical trial data; the Centre, Bharat Biotech, and the SII allege misinformation.

Before we go any further in this news, please note that UP Court Has Already Issued Summons Against The CEO of SII Adar Poonawala For The Vaccine Related Matter

The central drugs standard control organization (CDSCO) responded to Puliyel’s petition in November, stating that accepting such a petition would be detrimental to the public interest.

On Tuesday, vaccine developers Bharat Biotech Ltd and Serum Institute of India (SII) argued Supreme Court that they should not incorporate initial information on clinical trials and adverse events of Covid-19 vaccines into property rights. Only drug authorities should have access to such data.

On Tuesday, Bharat Biotech and the Serum Institute of India (SII) told the Supreme Court that such motivated petitions are an “attempt to cause vaccine hesitancy and public hysteria amid an unprecedented global pandemic,” refusing to reveal their vaccination data, which includes adverse events after Covid-19 immunization.

“Covaxin has undergone all relevant clinical trials, and the Phase 3 Efficacy Trials indicated a 77.8% vaccination against symptomatic Covid-19 disease, based on an evaluation of 130 confirmed cases, with 24 in the vaccine group vs 106 in the placebo group,” the company stated.

Senior advocate Guru Krishnakumar, appearing for Bharat Biotech, argued before a bench led by justice L Nageswara Rao that there is no legal requirement to disclose raw data to an individual or a group of individuals when the regulator has already had such data in its possession to conduct evaluations and take appropriate measures.

Bharat Biotech, the maker of Covaxin, told a bench led by Justice LN Rao that it had extensively published the results of clinical trials for its Covid-19 vaccine in publicly available reputed peer-reviewed journals, including its website and the Lancet medical journal, assuring the court that strict protocols were followed and that the allegations of non-disclosure of information were without merit. Today’s petitioner is requesting data that has been censored. He’ll start asking for more details tomorrow. This isn’t going to end anytime soon. Furthermore, the petitioner’s referenced WHO guidelines do not require the disclosure of primary data but merely discuss data interpretation. Krishnakumar claimed that the petitioner, who claims to be a domain expert, should be aware of this.

93.4 per cent effectiveness against severe symptomatic Covid-19 illness has been demonstrated. “Efficacy data shows 63.6 per cent protection against asymptomatic Covid-19,” the company claimed.

Since its founding in 1996 in Hyderabad, it has delivered more than four billion doses of various vaccines to 123 countries. The company contains portfolios of more than 16 vaccines, including polio, rotavirus, Zika, and others, which also said that “amid the global pandemic, the company was able to develop the wholly indigenous Whole-Viron Inactivated SARS-COV-2 virus vaccine” (Covaxin). Inactivated vaccines have a proven track record of over 300 million doses and are the most well-known in the vaccine world.

“Against the backdrop of the international community struggling with an unprecedented global pandemic that has overloaded global health infrastructure and resulted in catastrophic casualties, In these challenging times, it is a source of pride for this country that a domestically developed vaccine has provided solace to not only India but the entire world,” Bharat Biotech attorney Vipin Nair said in a written statement.

SII, the maker of the Covishield vaccine, also opposed any request for information, claiming that the petitioner could not ask for data on principle. “My data is with the regulator. That is where it should be. There is no locus for them (petitioner). Even under the RTI, they have to show there is public interest,” it said.

A former member of the National Technical Advisory Group, Dr Jacob Puliyel, had filed a petition on immunization contesting vaccine requirements, particularly those that made immunization a condition for receiving any benefits or services. He claimed that these mandates were unconstitutional and infringed on citizens’ rights.

The manufacturers claimed that the petitioner intended to use this court’s jurisdiction to initiate a roving inquiry without pointing out any violation or non-compliance of any statutory provision. The plea contained vague, sweeping, and omnibus prayers without concrete basis was an abuse of due process.

Bharat Biotech and India’s Serum Institute oppose the release of vaccine trial data. ‘It Is Where It Should Be,’ says Bharat Biotech’s council.

Non-disclosure of data: Mr Bhushan argued that the Union Government’s experts are correctly capable of making such assessments because of the multi-layered framework.

“We’re told that the Subject Expert Committee (SEC) and the National Technical Advisory Group on Immunisation (NTAGI) are good multi-layered systems that take care of everything, so much so that independent experts are not to be given access, because they say why independent experts arrive at their own conclusions when such a body is already doing so.”

The FDA had been ordered by a US District Court to give all data on the Pfizer vaccination.

In Public Health and Medical Professionals for Transparency v. Food and Drug Administration, the plaintiff sought all data and information for the Pfizer vaccine from the Food and Drug Administration under the Freedom of Information Act (FOIA), except publicly available reports on the Vaccine Adverse Events Reporting System. The plea had been accepted by the United States District Court for the Northern District of Texas, Fort Worth Division.

Pfizer’s data is in the public domain and is being examined by independent scientists.

He informed the Bench that Pfizer’s data is now in the 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. 

Pfizer’s data is available to the public and is being scrutinized by independent scientists.

Pfizer’s data is now in the public domain, he told the Bench, and specialists are looking into it.

“One of the most important findings is that in the trials, half of the participants were given placebo and half were given vaccines, with two people dying in the placebo group and one person dying in the vaccine group. As a result, they claim that its efficacy is strong because twice as many people who were not vaccinated perished.”

Under EU rules, at least segregated data disclosure is encouraged.

Mr Bhushan said that the Solicitor General was incorrect in claiming that such data is not disclosed anywhere globally. He claimed that European Union law fosters data disclosure for public criticism and future research to counter this.

Transparency is a significant issue for the European Medicines Agency in providing services to patients and society, according to a document titled “European Medicines Agency policy on disclosure of clinical data for medicinal products for human use.” The European regulation encourages more independent clinical trial data analysis and regulatory authority scrutiny.”

Mr Bhushan noted that the patients’ personal information could be redacted. The remainder of the material can be released, as the United States District Court instructed in the Pfizer vaccination case.

“All of the rules the Solicitor read stated that patient information must be kept private. They can redact the same. The US Court further stated that “you offer everything after redacting patients’ personal information.”

In the case of COVID-19, the vaccine mandate is being contested since clinical trial data has not been released, and informed consent has not been acquired.

Mr Bhushan noted that the petitioner does not contest the States’ authority to implement immunization requirements. The issue is restricted to mandates made in the context of COVID-19 vaccinations, in which clinical trial data are not released, and informed consent is not acquired.

“We’re not denying that the government has the authority to impose vaccine mandates. We’re not saying mandates won’t be issued in the future…We are arguing that mandates would be illegal in the current framework of COVID-19 and its vaccines, based on what we now know about them.”

States must establish that unvaccinated people pose a greater danger; vaccinations reduce transmission. He went on to say that to implement a requirement in the case of COVID-19 vaccines, states must show that unvaccinated people pose a more significant risk to the public than vaccinated people and that immunization will prevent this.

He went on to say that to enforce a compulsion in the case of COVID-19 vaccines; states must show that unvaccinated people pose a more significant risk to the public than vaccinated people and that immunization will prevent transmission. Furthermore, they are intended to demonstrate that the vaccines have been thoroughly researched and that those who have recovered from COVID tend to transmit the virus more than those who have not been vaccinated.

“If they can show that I pose a larger risk to others than if I was vaccinated, they can issue a mandate.” They’ll have to show that the vaccines have been thoroughly researched.

He went on to say that to enforce a compulsion in the case of COVID-19 vaccines; states must show that unvaccinated people pose a more significant risk to the public than vaccinated people and that immunization will prevent transmission. Furthermore, they intended to demonstrate that the vaccines have been thoroughly researched and that those who have recovered from COVID tend to transmit the virus more than those who have not been vaccinated.

“If they can show that I pose a larger risk to others than if I was vaccinated, they can issue a mandate.” They’ll have to show that the vaccines have been thoroughly researched.

If not getting vaccinated does not represent a public health risk, it is a personal choice.

Mr Bhushan went on to say that if non-vaccination poses no considerable risk to the public, then the option to get vaccinated or not is a personal one, and no one can force people to do so. He cited the decisions in Aruna Shanbaug v. Union of India and Common Cause v. Union of India in this regard.

“It is my choice whether or not to get vaccinated if I am not endangering the lives of others. Aruna Shanbaug and Common Cause are the two rulings.”

It is insufficient for the government or its experts to assert that vaccines lessen the danger of transmission without providing proof to support their claims. He emphasized that it is inadequate for the government or its experts to state that the vaccines significantly reduce the risk of disease transmission or have a lower risk of transmission without giving any data to support their claims. He noted that the majority of the people had developed natural immunity because over 80% of the country’s population had previously been infected.

Mr Bhushan argued that he relied on official data from domestic and foreign governments and studies published in peer-reviewed scientific journals, which is the gold standard of publication, to refute the Solicitor General’s argument that he had adduced evidence about some scattered opinions of individuals. He claimed that the government has failed to present any evidence that those vaccinated had a lower rate of disease transmission than those who have not been vaccinated.

He also said that people infected are better protected than those who have received the vaccine.

He also said that people infected are better protected than those who have received the vaccine. A person who has been contaminated is better protected than someone who has received the vaccine. That is the pinnacle of immunity. The vaccination imitates the symptoms of genuine sickness.

In India, none of the COVID-19 vaccines is licensed.

COVID-19 vaccinations, he stressed, were not licensed vaccines. Only Pfizer has a registered vaccine, he claims. Still, the company continues to use the one for which an emergency use authorization was provided to avoid being sued for vaccine injuries.

Mr Bhushan asserted that no vaccinations used in India had been granted a license. They are vaccines that are still being tested. In the instance of Covaxin, he indicated that the initial enrolment in the human trial stage occurred on 16.11.2020, and Bharat Biotech received emergency use approval on 02.02.2021. The trial was supposed to go until December 2022, was called off on January 5, 2021, after the placebo arm was unblinded.

Natural immunity outperforms vaccination immunity in terms of protection.

Dr Aditi Bhargava, Professor in the Department of Obstetrics and Gynecology and the Center for Reproductive Sciences at the University of California, San Francisco, testified before the US Senate. According to Dr Bhargava, Mr Bhushan pointed out that natural immunity protects one far better than vaccines.