Monday, April 15, 2024
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It’s time to open the AstraZeneca files


THE AstraZeneca Covid-19 vaccine has all but disappeared from use. We need to know why, and whether troubling evidence from its trials was ignored by the regulators or withheld from the public. That is why HART, the independent Health Advisory and Recovery Team, has demanded a ‘Pfizer files’ style data release from the Medicines and Healthcare Product Regulatory Agency (MHRA).

Last week, we submitted an FoI request to the MHRA prepared by PJH Law requiring the release of all data submitted by AstraZeneca in their application for a licence for their Covid-19 vaccine (AZD1222/Vaxzevria), the data that the MHRA relied on before granting a conditional marketing authorisation for its use. 

We asked for:

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 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 was approved for use in the UK on December 30 2020 to a fanfare for UK science. It had been pre-ordered and prioritised for Britain by Prime Minister Boris Johnson, who boasted it was not just safe and effective but a triumph for ‘Global’ Britain. To date the failings of this novel technology vaccine have been brushed under the carpet, never explained and never apologised for. 

Within weeks of AZ’s rollout, concerns about the vaccine (trials of which had been paused twice, see here and here) were being flagged. In a short time successive European governments followed Denmark’s lead in suspending its use. The UK’s advisory body, the Joint Committee on Vaccination and Immunisation (JCVI) continued to insist it was still safe, but in May advised it should not be given to anyone under 40. By that stage millions of doses had been administered. From the start, the vaccine was disproportionately associated with adverse reactions, yet it was administered to children: some 11,500 have received 1st doses and 8,700 second doses and ‘extremely limited boosters’. These have resulted in 266 Yellow Cards at an adverse reaction reporting rate of 1 in 43 children. 

To date, 49.16million adult AZ doses have been administered and 246,393 people impacted by adverse effects, according to the MHRA’s Yellow Card adverse reports, admitted by the MHRA to be likely to be only 10 per cent of the true number.

The first pay-out under the vaccine injuries compensation scheme was to the widow of a 48-year-old who died of brain blood clots commencing days after his AZ vaccination, a death that occurred two months after Denmark had suspended AZ use because of side effects. The US never purchased the AZ vaccine because of health officials’ concerns. 

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 taxpayers’ money was allocated to the development and subsequent rollout of this vaccine, but secondly because people put their faith in the safety of this home-produced vaccine. 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. 

The AstraZeneca product officially remains in clinical trials until next year, 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?    

‘Safe and effective’, the marketing banner whenever the ‘vaccines’ were being discussed by the MHRA, MSM or Pharma, is of grave concern, especially when it comes 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.

The battle to obtain the data and information relied upon by the US Food and Drug Administration (FDA) to licence the Pfizer vaccine pointed to the secrecy that had shrouded these trials. The FDA planning to retain the material for 75 years, but a court granted an FoI request and required the FDA to release all the data over eight months. This has resulted in 451,000 pages of information now being analysed by 3,500 experts and 250 lawyers. Evidence of fraud would negate any indemnity for Pfizer.  

The overstating of efficacy and understating of harms continues unabated not least by the MHRA, the very same UK body responsible for ensuring that medicines meet applicable standards of safety, quality and efficacy, and for pharmacovigilance across the UK, the objectives of which are to:

·         Prevent harm from adverse drug reactions 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 a press briefing on the AstraZeneca vaccines in December 2020, the MHRA chief Dr June Raine glibly 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 the 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 Covod-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 latter directly contradicted the MHRA’s own summary assessment that ‘it is considered that sufficient reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time’. 

Dr Raine’s alarming unilateral declaration of the MHRA’s switch from a regulatory function to  an enabling role alongside her consistent ‘playing down’ of vaccine injuries and treating adverse effects as coincidental, further underlined the need for the AZ trials data disclosure.

We need to know whether the MHRA has a defined point at which it pulls a drug or vaccine and if not, why not?


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.

If their due diligence has been thorough, releasing this data should confirm their oft-repeated declaration that the AZ 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.

The full background report to the HART FoI and the FoI itself can be found on HART’s website here. 

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Dr Ros Jones
Dr Ros Jones
Dr Ros Jones MD FRCPCH is a retired consultant paediatrician, grandparent and member of HART.

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