Exposes Manipulated Data: Revealing the Vaccine Approval Scandal
In the early months of 2021, TrialSite raised a crucial question regarding the clinical development of the Covaxin COVID-19 vaccine by Bharat Biotech: Did the Indian regulatory authorities turn a blind eye? Recent revelations shed light on the matter, with news surfacing about significant procedural errors and inaccurate data reports. These revelations raise pertinent concerns about the vaccine’s introduction for widespread use. Various Indian newspapers, such as the Deccan Chronicle, have covered this news extensively, providing valuable insights into the situation.
There is growing concern among scientists and patient representatives regarding the expedited approval of two COVID-19 vaccine trials in India. Despite Indian Prime Minister Narendra Modi’s celebratory tweet about the “independence of the Indian scientific community,” there are doubts about whether the vaccine approvals are being unreasonably rushed. According to a report by TrialSite, V.G. Somani, the Director General of the Indian Medicines Agency, explained that although the Covaxin study had not yet been completed, he approved the vaccine as a precautionary measure in case the more contagious mutant strain from the UK enters India. Mr. Somani’s organization granted approval for both the AstraZeneca vaccine (known as Covishield in India), which was originally developed at the University of Oxford and licensed to the Serum Institute of India (SII) for production in the country, and the Covaxin developed by Indian biotech company Bharat Biotech. Both vaccines were approved for “restricted use” under emergency conditions. However, both SII and Bharat Biotech are required to continue their clinical trials.
On November 28, 2022, news regarding significant reporting inaccuracies, including some potentially deliberate errors, concerning the clinical trials of the COVID-19 vaccine surfaced in the world’s second most populous nation.
Could individuals within Bharat Biotech have tampered with specific clinical data?
If manipulation did occur, was it in pursuit of a predetermined objective?
Was the purported fraud and misrepresentation orchestrated to expedite the approval process?
Blasphemous
In the field of clinical trials, tampering with clinical study data is almost seen as sacrilegious. The company has submitted its findings to the expert-reviewed journal The Lancet for publication. Nevertheless, accusations have emerged suggesting that the medical editors who reported on the study results “failed to disclose certain critical and potentially risky alterations that, if accurately reported, might have impeded the vaccine’s approval at the speed it eventually gained,” according to reporter Balu Pulipaka.
Problems with the test location
During the initial phase of the study, the researchers stated in a publication released on the 21st of January 2021 in the digital edition of The Lancet that “two intramuscular vaccine doses were given on day 0 (the day of randomization) and day 14”.
Nonetheless, the journalist asserts: “This statement does not hold true, especially in certain testing facilities in India.” In these specific locations, it was revealed that none of the participants in the phase 1 trial actually received “intramuscular vaccine doses”, contrary to what the authors had claimed in the article titled “Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomized, phase 1 trial.”
It is important to note that the authors of the aforementioned papers, who are now under scrutiny, are some of the founders of Bharat Biotech. They are recognized by the Indian media as the “leading figures of the Indian Council for Medical Research and the All India Institute of Medical Sciences” located in New Delhi.
Did the company lie?
Following the revelation of the allegations, doctors at various locations, known as exaters, expressed their concerns regarding potential side effects of the experimental COVID-19 vaccine during the clinical trials. Contrary to the prescribed protocol of administering the vaccine intramuscularly, the doctors at the experimental centers chose to administer it intravenously. However, the company has failed to address these claims in the documents published in The Lancet.
A doctor, who preferred to remain anonymous, shared their thoughts with the Indian media:
“We had to exercise extreme caution. What if an accident occurred after administering the vaccine? After all, it was the first time the vaccine was being tested. If a participant were to experience any adverse effects, it would be incredibly challenging to establish an infusion line to provide immediate medical assistance. That’s why we opted for regular infusion lines to administer the vaccine during phase 1.”
Balu Pulipaka writes,
“This disturbing finding raises serious questions about how Bharat Biotech presented its results from the world’s clinical trials and the Indian drug authorities. It also raises the question of how effective Covaxin was during the experiments to develop antibodies in humans to fight the coronavirus that causes Covid-19.”
This issue was previously raised in January 2021, prompting us to inquire whether the approval process was compromised due to various factors, including the urgency to expedite vaccine availability. The repercussions of this situation are significant, not only for Covaxin but potentially for other vaccines in India as well.
Brazilian Government Suspends Contract with Bharat Biotech for Covaxin Market
The Brazilian government has halted a $300 million deal to purchase 20 million doses of the Covaxin vaccine from India. The suspension comes as a result of controversy surrounding the contract, putting President Jair Bolsonaro in a difficult position. Health Minister Marcelo Queiroga made the announcement based on the recommendation of the federal comptroller general, who is investigating alleged irregularities in the agreement. The contract is currently under examination and could be canceled within 10 to 15 days. The deal has been a focus of the parliamentary commission of inquiry investigating the government’s pandemic response.
CNN Brasil’s investigation uncovered details of a contract with Madison Biotech that resulted in the contract being suspended. The reasons for the suspension, as outlined in the report, include unauthorized advance payments, payment through an unapproved company, failure to meet contractual deadlines, lack of price justification, and breaches of contract by Bharat Biotech, its offshore partner, and its Brazilian representative. In February 2021, the Indian company entered into an agreement with Precisa Medicamentos for the sale of 20 million doses of Covaxin, a vaccine not yet approved by Brazil’s National Health Surveillance Agency. This scandal is tarnishing the reputation of both the Brazilian government and Bharat Biotech.
Amid damaging disclosures, speculations have engulfed the capital city for days about the government’s plan to cancel the agreement. Insiders in Brasilia say those near the presidential residence are keen to distance themselves from the deal. A senior official, who chose to remain anonymous, said, “It’s not a question of if the government will terminate the contract, but when. The investigations into the agreement are causing delays.” The official also said, “Nobody wants anything to do with this vaccine anymore. It is toxic.”
The Bolsonaro government is embroiled in a controversy regarding the acquisition of Covaxin and hydroxychloroquine from India, leading to the scandal being referred to as CovaxinGate. Even though the deal has been halted, the ongoing investigation by senators overseeing the parliamentary inquiry suggests that there may be more to uncover in terms of financial transactions. Ricardo Miranda, the health official who brought to light the $45 million prepayment, is now being recognized as a whistleblower by the CPI.
The Miranda brothers testified in front of the senate that President Bolsonaro was informed about corruption in a deal but chose not to act. The government has been striving to address the accusations against Bolsonaro, yet has become entangled in the process. The government sought to accuse Ricardo Miranda of altering the invoice account, but it was verified that the document was within the ministry’s computer system. Additionally, the government contended that the complaint had been forwarded to the health minister, Eduardo Pazuello, but this assertion was dismissed just three days after the brothers’ meeting.
The senate’s examination of corruption, particularly in the Covaxin deal, may be extended for a few weeks as per CPI’s request. The focus of the investigation is on the invoice from Madison Biotech submitted by Ricardo Miranda. Bolsonaro’s silence regarding the Miranda brothers’ testimony indicates his forthcoming actions. The termination of the Covaxin contract might be an attempt by the government to avoid a difficult situation, but it could be considered too little, too late. Francisco Maximiano, the representative of Bharat Biotech in Brazil, is scheduled to participate in the senate hearing.
Covaxin in India:
Bharat Biotech, in collaboration with the Indian Council of Medical Research, has developed Covaxin, India’s first domestically produced COVID-19 vaccine. Covaxin received approval from the Drug Controller General of India (DCGI) for human clinical trials in June 2020, and the initial phase of trials concluded in July. These trials involved 365 healthy volunteers from 12 different institutes across India, including the prestigious All India Institute of Medical Sciences (AIIMS) in New Delhi, AIIMS Patna, and the Post Graduate Institute (PGI) of Medical Sciences in Rohtak.
Covaxin is an inactivated vaccine that poses no significant health risks to the recipient. It utilizes a fully inactivated SARS-CoV-2 viral particle, consisting of RNA enclosed in a modified protein capsid that impedes viral replication. The vaccine primarily comprises an entire inactivated SARS-CoV-2 antigen (strain NIV-2020–770), along with 250g of aluminum hydroxide gel as an adjuvant, 15g of TLR 7/8 agonist (imidazoquinolinone), 2.5mg of TM 2-phenoxyethanol, and phosphate buffer saline to achieve a concentration of 0.5ml.
One notable advantage of Covaxin is that it does not require subzero storage or reconstitution. It is available in multidose vials that remain stable at temperatures ranging from 2 to 6°C. An adjuvant, such as the aluminum hydroxide-based one used in Covaxin, is employed to enhance the specific immune response against the targeted antigen present in the vaccine formulation. By adding alkali to the aluminum salt solution, a crystalline aluminum oxyhydroxide adjuvant is generated.
COVID-19 vaccine-triggered thrombotic thrombocytopenia, cerebral venous thrombosis, and neurogenic stunned myocardium.
Feb 2023: A 19-year-old lady presented with altered sensorium for 2 days. Prior to her current visit, she had low-grade fever for 2 days and holocranial headache with vomiting for one week after COVID-19 vaccination with COVAXIN® (Bharat Biotech).
17 January 2023: Facial Palsy Induced by Covaxin in Adolescent Female – Report
1. A 15-year-old girl had a stromal and sub-epithelial rejection 9 days after 1st dose of SARS-CoV-2 vaccine BBV152 (COVAXIN, Bharat Biotech, India).
2. An 18-year-old man had a stromal rejection 13 days after 2nd dose of ChAdOx1 SARS-CoV-2 vaccine (COVISHIELD, Serum Institute of India, India).
A Case of Neuroretinitis* following Inactivated Virion COVID-19 [COVAXIN] Vaccination
Inflammation of the anterior optic nerve and peripapillary retina. It presents as a triad of vision loss, optic disc swelling, and macular exudates in the formation of a star.
A 14-year-old girl experienced symptoms three days after receiving a dose of the COVID-19 vaccine, resulting in sudden unilateral vision loss. The clinical and radiological findings indicate a diagnosis of neuroretinitis.
Psoriasis Flare-Up After COVAXIN BBV152 Whole Virion Inactivated Vaccine
A 21-year-old gentleman with chronic plaque psoriasis of three years, who developed generalized pustular Psoriasis eruption after administration of the first dose of COVAXIN was reported, which was the first case of this complication associated with COVAZIN.
Abstract
Psoriasis is an inflammatory skin condition with a chronic relapsing course that can negatively impact a patient’s quality of life. Various triggering factors can cause the flare-up of psoriasis, which also include vaccination. The most common vaccine associated with this is influenza. In this global pandemic of coronavirus disease 2019 (COVID-19), emergency authorization for mass vaccination has been adopted by many countries in the world. Psoriasis flare has been reported after the Pfizer COVID-19 vaccine and CoronaVac vaccine. Currently, both the virus-causing disease and the vaccines are still being studied owing to their dynamicity. We report a case of a 21-year-old gentleman with chronic plaque psoriasis of three years, who developed generalized pustular psoriasis eruption after administration of the first dose of COVAXIN. To the currently available literature, this was the first case of this complication associated with COVAXIN.
Download Covaxin Side Effects:
Source: Wikipedia, NIH, Eye Rounds-Image, US Today -Image, BioVoice News-Image,
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