Sent to the MHRA asking for clarifcation on the date discrepancies

Not going to hold my breath for a sensible answer but the more you dig the more discrepancies and missing information there is

Update:

Finally received an acknowledgement from the MHRA stating they will deal with the questions under the FOIA and not as “information” as they do sometimes.

They have 20 working days now to respond or ask for an extension.

I expect their answers to be:

1. we do not hold that information

2. we hold that information but under section 40/41 cannot release it

3. the information is held in a different format from what you asked for so you are not getting it

Sirs,

Time and time again in nearly every FOI answer the MHRA has answered along the lines of “all the information we used to issue the EUA for the SARS-CoV-2 vaccines is included in the Public Assessment reports which we have sent you already”.

In your latest e-mail reply you supplied the link https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19 and which I have read the documents contained within it many times already.

But here are the key dates:

October 2020 UK Government changes the Human Medicines Regulations 2012 to allow the MHRA to grant temporary authorisation of a covid-19 vaccine without needing to wait for the EMA to be published

November 2020 Pfizer publish documentation how how the clinical trials for their “covid vaccine” would be run. They had not started yet according to what I can understand from the document.

Authorisation for the temporary supply of BNT162b2 was granted in the UK on 01 December 2020 based on information received from the Pfizer data supplied for the time period between October 2020 and December 2020. 

MHRA issue the EUA for the Pfizer vaccine on 02 December 2020

First Pfizer vaccine given on 08 December 2020

EMA Public Assessment Report was published 19th February 2021. This was then used to update the MHRA Public Assessment Report published 04th June 2021 with no previous copies available but the original has been updated a few times since 02 December 2020 with only a statement saying original text hasn’t changed. I think thelast  update is for giving it to 12-15 year olds from the bottom statements at the end. 

The EMA PAR published 19th February 2021 the first report in the public domain that discussed side-effects of the Pfizer vaccine.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1112667/COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH_ext_of_indication_11.6.2021.pdf

MHRA’s marketing authorisation granted for the Pfizer jab following a European Commission (EC) decision on 21 December 2020 (PLGB 53632/0002).

Automatically converted to a GB CMA on 01 January 2021

Pfizer did not issue the documentation on post-marketing side-effects up to 28th February 2021 until 30th April 2021

All the regulatory releases are supposedly on the page you sent referenced above.

But when you read the initial MHRA PAR for the Pfizer vaccine from early December 2020:

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1112667/COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH_ext_of_indication_11.6.2021.pdf

the wording matches almost exactly - almost like a copy and paste job of selected bits - of the EMA Public Assessment Report, which wasn’t published for another 6 weeks or more. This PAR is bsaically a copy and paste document from a Pfizer document with the title  PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines) Protocol C4591001 which was published in November 2020 and which described how the clinical trial woudl be run, the trial had not actually started at this point.

But then there is another discrepancy.

The authorisation was dated the beginning of December and it is stated that it is based on trial data from October 2020 to December 2020.

So some questions that need asked as these discrepancies require clarification based on FOI answers and other documentation supplied by the MHRA - all questions refer to the Pfizer “covid vaccine":

Q1 - If the EUA was issued on the 01st December 2020 how can it be based on an assessment of data for the period October 2020 to December 2020?

Q2 - How much data was supplied on the 01st December 2020 between the time that the MHRA office opened and the time the EUA was authorised that day?

Q3 - How can only 2 months (October 2020 to November 2020) of a trial for a medicinal product that has never before been used in humans and which contains ingredients that have never before been used in humans be deemed as sufficient to give even a marginal or possibly “safe” designation?

Q4 - Was there any documentation available from Pfizer prior to 01st December 2020 which was used to base the initial MHRA PAR on and then to “write” it?

Q5 - Was the Pfizer document that described the future running of the vaccine trials that was published in November 2020 used as part of the authorisation process?

Q6 - if the Pfizer trial had not yet commenced in November 2020 how could possible side-effects be considered prior to the MHRA authorisation that was issued on 01 December 2020?

Q7 - between 01 October 2020 and the 21 February 2021 was the MHRA advised by either the EMA, Pfizer or other authority of any possible side-effects that had been reported from the trial that commenced at an unknown date?

Q8 - How can a medicinal product that has never before been used in humans and which contains ingredients that have never before been used in humans be deemed as sufficiently “safe" enough to be give a temporary authorisation for use when it seems that the clinical trial to determine it’s safety and efficacy had been running for only a matter of days when the authorisation was issued?

Q9 - what was the exact date that the Pfizer clinical trial study commenced as referred to in their document referenced above?

I look forward to your explanation and clarifications on these date and information discrepancies.

Yours sincerely