The UK equivalent of the Pfizer Files awaits response
“A nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of the people” – John F Kennedy
Last week, lawyers from PJHLaw submitted an FOI request (linked here) on behalf of HART to the Medicines and Healthcare Product Regulatory Agency (MHRA), requiring all the data that was submitted by AstraZeneca in the application for licence of their Covid-19 vaccine (AZD1222/Vaxzevria) and relied upon in granting a Conditional Marketing Authorisation for its use. Specifically, the following was requested:
1. Pre- and post-authorisation safety and efficacy data for this product.
2. All information that allowed a “rigorous scientific assessment” of all the available evidence of quality, safety and effectiveness by the UK Regulator, the MHRA.
3. All information and full data set that the MHRA stated their expert scientists and clinicians reviewed from the laboratory preclinical studies, clinical trials, manufacturing and quality controls, product sampling and testing of the final vaccine and the conditions for its safe supply and distribution.
4. Anonymised data from their clinical trials
Why is this necessary?
AstraZeneca’s Vaxzevria is a British product. Approved for use in the UK on 30th December 2020, it was heralded as a triumph for UK science. Pre-ordered by and prioritised for Britain, the then Prime Minister, Boris Johnson boasted that the Oxford vaccine was not just a mark of a ‘Global Britain’ but was also safe and effective. Yet by March 2021 concerns about the vaccine (whose trials have been paused twice – see here and here) were emerging, with Denmark suspending its use following possible links to a serious blood clotting condition, and several other European countries following suit over the next couple of days. By April, reports were appearing in the scientific literature. By May 2021, the JCVI were still insisting it was still safe, but advised it should not be given to anyone under 40 years old. By that stage, millions of doses had been administered.
The first pay-out in June 2022 under the Vaccine Damage Payment scheme, was to the widow of a 48-year-old who died of brain blood clots commencing days after his dose of AZ vaccination. His death in May 2021 occurred two months after AZ use had been restricted in several European countries. It is notable that the US never purchased the AZ vaccine because health officials publicly criticised them for using “outdated information” with an incomplete view of the shot’s effectiveness.
Today, after 21 months, a total of 49.16m (AZ) doses have been administered. And it remains the vaccine with the largest number of Yellow Card adverse reports, totalling 246,393 at the last report. Despite being the vaccine the most disproportionately associated with adverse events and fatalities, it has not been withdrawn and has, unaccountably, still been administered to children (AZ: 11,500 children 1st doses, plus 8,700 2nd doses & ‘extremely limited boosters’ resulting in 266 Yellow Cards – a rate of 1 in 43).
The British people have a right to see all the data provided by AstraZeneca to the MHRA, both as a basis for the initial conditional use authorisation, and subsequently as part of AstraZeneca’s ongoing safety surveillance. Firstly, because a large sum of tax-payers money was allocated to the development and subsequent rollout of this vaccine, but second and most importantly because people put their faith in the safety of this home-produced vaccine. Many were anxious at the mRNA description of Pfizer vaccine, not realising that the DNA-viral vector method in the AZ product still relies entirely on genetic material being transported into the cell and instructing the recipient to make their own spike protein, in unspecified quantities, for an unspecified duration and at unspecified locations. Like the mRNA vaccines, this technology has never before been rolled out to entire healthy populations.
The AstraZeneca product remains in clinical trials until 2023, though like the other vaccines, volunteers in the control arm were vaccinated early on, negating much of the scientific basis for a randomised controlled trial. The latest autumn booster programme states that AstraZeneca is ‘currently unavailable’ but at no point has the public been told why this is the case. Does the company or the regulator know something that has not been shared?
Background:
Since March 2020, many, including leading doctors and scientists, have been questioning the scientific evidence for much of the pandemic management, in particular restrictions driven by a narrative of fear and the lack of any early treatment protocols, which all laid the groundwork for the rapid development of “vaccines” rolled out to an entire healthy population. When told that vaccines were our way out of the pandemic, who wouldn’t want to get jabbed? Indeed, the WHO’s definition of herd immunity was changed in November 2020 to remove all mention of naturally acquired immunity, leaving only vaccination as the new ‘gold standard’ – ‘fool’s gold?’ one wonders.
“Safe and Effective” the marketing banner whenever the “vaccines” were being discussed by the MHRA, MSM or Pharma, gave grave concerns, especially when it came to the vaccination of healthy children. But at all ages, it is clear that properly informed consent has been set aside, in contravention of the General Medical Council Good Practice Guidelines.
Raw data surrounding all the vaccines and the contracts involved, have been shrouded in mystery – there has also been a climate of secrecy. This is contrary to standard practice of drug research, where full publication in peer review journals should include access to anonymised raw data. Indeed, the capture of academic science by Big Pharma and by the Gates Foundation and Wellcome foundations threatens to undermine evidence-based medicine.
The overstating of efficacy and understating of harms continues unabated and the UK efforts to persuade its population have been matched by more serious coercion in many countries.
MHRA regulatory responsibilities and funding:
- Ensuring that medicines meet applicable standards of safety, quality, and efficacy
- Helping to educate the public and healthcare professionals about the risks and benefits of medicines leading to safer and more effective use
The MHRA retains responsibility for pharmacovigilance (PV) across the UK. The underlying objectives of PV:
o Prevent harm from Adverse Drug Reactions (ADRs) in humans arising from the use of authorised medicinal products.
- Promote the safe and effective use of medicinal products, through providing timely information about the safety of medicinal products to patients, Healthcare Professionals and the public.
At the press briefing on the Astra-Zeneca vaccines (30.12.2020), CEO, Dr June Raine stated:
- Safety of the public comes first, and this comes after a thorough and scientifically rigorous review of all the evidence in terms of safety, effectiveness and quality.
- “We are facing one of the biggest threats to health, in UK and around the world”
- the vaccine “protects” against Cov-19 and will save many thousands of lives.
- There are no specific precautions if you have had Cov-19 and you do not need testing before the injection.
- Vaccines should be considered for pregnancy (and those breastfeeding) when the potential benefit outweighs the risks following individual talks with every woman and their healthcare professional.
The MHRA receives 86% of its funding from the Pharmaceutical Industry, the very companies whose products the MHRA regulates with the aim of protecting the public from harm. This is not new – most of their funding has always come from the pharmaceutical industry through fees for licensing their products. This may not be ideal but it should not be conflated with the switch to an enabling role – this is a June Raine unilateral initiative and no doubt influenced by her Oxford cronies including her pal Kate Bingham (see here at 1:24hr).
June Raine stated, “Here in the UK, the MHRA worked really hard to overcome some of the obstacles within the structure of clinical trials taking place in different jurisdictions, and that was one of the reasons we were able to license vaccines here in the UK faster than anywhere else because of the flexibility yet robustness shown by the MHRA.” (For a review see here)
The bottom line is Raine has gone way beyond her statutory duty and exploited her position to corrupt the MHRA’s regulation and monitoring purpose. The MHRA is now intending to operate as an “Enabler” instead of a “Regulator” and as such, aims to bring medicines to market within 100 days (The CEPI 100-day promise with justification of “safety”). The MHRA is also helping to create a self-appointed global regulatory body. This has neither been debated in or approved by Parliament. Has the Department of Health, to whom the MHRA is responsible, sanctioned this corruption of the MHRA’s regulation and monitoring purpose?
It is against this background of complete lack of transparency that an FOI request has been made. We need to know that these first examples of a new technology are in fact ‘safe and effective’, and that their data has been robustly reviewed as stated.
Our Astrazeneca Freedom of Information request is modelled on and follows the legal battle that has taken place in the US for the release by the FDA for Pfizer files outlined below.
The Pfizer files:
Public Health and Medical Professionals for Transparency (PHMPT) was set up for the sole purpose of disseminating to the public the data and information in the biological product files for each of the COVID-19 vaccines. As part of its commitment to transparency, PHMPT it successfully sought to obtain the data and information relied upon by the FDA to license the Pfizer Vaccine via a FOIA request.
Initially the FDA refused the request on the basis that PHMPT did “not demonstrate a compelling need that involves an imminent threat to the life or physical safety of an individual”, nor “that there exist(ed) an urgency to inform the public concerning actual or alleged Federal Government activity.”
Their request was however eventually granted by court order, requiring the FDA to release all the data over a period 8 months, despite the FDA planning to retain it for 75 years.
451,000 pages of information are now being analysed by 3500 experts and 250 lawyers. Evidence of fraud would, if found, negate any indemnity for Pfizer. More recently, the same legal team in the US have forced access to anonymised V-Safe registry data and have made it fully accessible.
European experience:
It is ten months since six MEPs held up the redacted Pfizer contracts at a press conference. This same group reported their disgust following the EU Covid Committee meeting on 11th October 2022 when Albert Bourla, CEO of Pfizer, failed to attend in person, sending a representative in his place. Dutch MEP Robert Roos asked her a straight question about any knowledge of infection and transmission prior to marketing and got a surprisingly straight ‘No’. On 14th October, EU officials confirmed in a brief statement an “ongoing investigation into the acquisition of Covid-19 vaccines in the European Union.” They added that the case follows “extremely high public interest”.
We are pursuing a similar information release in the UK. A legally produced, effective FOIA request has been sent to the MHRA on behalf of HART, requesting that the MHRA fully produce all the data, information and documents submitted to them by AstraZeneca that underlies the Conditional Marketing Authorisation of their vaccine. In Europe and around the world, many questions are being asked about the Covid-19 vaccines. and this will continue until answers are provided.
A previous rushed vaccine – a lesson for the present:
In 2009 influenza A (H1N1) spread worldwide and was declared a pandemic. GlaxoSmithKline’s pandemrix was rapidly approved with 30 million doses administered in Europe, accompanied by 3807 ADRs, 1138 serious, 47 fatal.
By 31.3.2010 after 73 million vaccinations, this had risen to 5069 SADRs; 1300 narcolepsy; 12 facial palsy; 51 convulsions. GSK failed to produce a copy of safety reviews of the vaccine before it was finally removed from the market.
In 2018, Prof Peter Doshi, associate editor of the BMJ, wrote, “Pandemrix was removed from the market after the pandemic, but the number of reported events indicate a need for a stronger screening process for pandemic vaccinations in the future.” “The events of 2009-10 raise fundamental questions about the transparency of information. When do public health officials have a duty to warn the public over possible harms of vaccines detected through pharmacovigilance? How much detail should the public be provided with, who should provide it, and should the provision of such information be proactive or passive?
If history were to repeat itself, does the public have a right to know?”
Yellow card reports are estimated to represent <10% of the actual adverse events. The number of deaths is now 45 times the level at which Pandemrix was withdrawn. Does the MHRA have a defined point at which it pulls a drug or vaccine and if not, why not?
Conclusion:
The government has invested millions of taxpayers’ monies to develop and market the AZ product. A large percentage of its population have been injected with a liability-free vaccine and we therefore require complete transparency. It would show utter contempt for our democracy, if the British people are denied access to this information.
The medical and scientific community and the public have a substantial interest in reviewing the data shared between the MHRA and AstraZeneca. Reviewing this information will settle the ongoing public debate regarding the MHRA’s review process. If their due diligence has been thorough, then releasing this data should confirm their oft repeated declaration that the A-Z vaccine is safe and effective, thus providing reassurance. The public’s need for this information is urgent, given that the vaccination programme is ongoing. Despite the evidence of unprecedented harms (deaths and debilitating injuries) on their own pharmacovigilance databases, governments across the world have told their citizens and our children, that the covid-19 genetic vaccines are safe. It is time for total transparency and honesty.
