The mysterious case of the missing information….
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One year ago, PJH Law, on behalf of HART, made a Freedom of Information request 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:
- Pre- and post-authorisation safety and efficacy data for this product.
- All information that allowed a “rigorous scientific assessment” of all the available evidence of quality, safety and effectiveness by the UK Regulator, the MHRA.
- 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.
- Anonymised data from their clinical trials
The full letter is available here.
So what has been happening since?
Perhaps not surprisingly, the first response from the MHRA was:
“This information request in its current format would be exempt under S12 or S14.”
and they advised that we narrowed our request.
Things then hung fire at our end for a while, as discussions occurred around reducing the request but in the end we decided to push ahead, and in April 2023 we notified the MHRA accordingly:
“Considering that this peer review needs to be conducted on all material submitted for licence, the request cannot be narrowed in scope.”
The MHRA issued a further response to our request on 1 June 2023, confirming that section 14(1) applied to the request.
We then submitted a request for an internal review, the result of which was received in August. The full reply is linked here, but in a nutshell:
“this request falls to be considered “vexatious” due to the scope of the request and the disproportionate burden that compliance would create. S14(1) of the FOIA states that “Section 1(1) does not oblige a public authority to comply with a request for information if the request is vexatious”.
They further stated:
“Downloading the dossier of the vaccine is a relatively straightforward task, although it does require time. Due to the voluminous size of the file packages, when downloading the full package of data, the database software may be more prone to freeze. However, the time required to read through the dossiers, to identify exempt information and to consider and make redactions we expect would take many weeks, if not months to complete, as the dossier encompasses gigabytes of data. To meet the request our staff: Would need to read the dossier in full, in order to identify where redactions need to be made.”
“We appreciate that there remains a strong public interest in COVID-19 vaccines, however, we do not feel that the public interest outweighs the resource burden required to meet your request.”
So the next step was an appeal to the Information Commissioner, linked here.
We “challenge both parts of this decision:
A. The disproportionate burden.
B. The public interest does not outweigh the resource burden.”
It is puzzling that this information is so hard to produce – the reader might be forgiven for thinking that there was too much to review and analyse in the time taken for authorisation in the first place! And there is the small matter of a £1m grant for new AI software at the beginning of rollout, which surely could be used to search the documents for items to redact.
It is also hard to see what greater Public Interest there could be than the security of the nation’s health. More Adverse Drug Reactions(ADRs) have been reported on the Covid-19 vaccines than the total ADRs reported from all vaccines over 40 years. Moreover 58% of all Yellow Card Reports of ADRs and deaths were reported from recipients of the AZ vaccine.
As the House of Commons Health Committee pointed out in 2005:
- Pharmaceutical funding would lead the MHRA to “lose sight of the need to protect and promote public health above all else as it seeks to win fee income from the companies”.
- The Committee also criticised the MHRA saying that it “failed to adequately scrutinise licensing data and its post-marketing surveillance is inadequate”.
- “Greater transparency is also fundamental to the medicines regulatory system. There has to be better public access to materials considered by the MHRA prior to licensing”.
An interview last year with Neil Oliver regarding this FOI ended with a promise to let him know when we heard anything, but at present we are still waiting….
STOP PRESS
The Oxford-AstraZeneca Covid-19 vaccine has been branded “defective” in a multi-million pound landmark legal action that will suggest claims over its efficacy were “vastly overstated”. This legal challenge is covered by both the Telegraph and the Mail
Please support the CrowdJustice funding if you can. AstraZeneca is denying liability. https://www.crowdjustice.com/case/vaccine-injured-and-bereaved/
