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Feature BMJ Investigation

Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2635 (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635

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Rapid Response:

Re: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial

Dear Editor

I think John Stone is mistaken regarding the evaluation and testing of the Pfizer-BioNtech Covid-19 vaccine for approval in UK (EAU).

The Pfizer website indicates that in fact clinical trials of the Pfizer-Biotech vaccine were carried out last year at 69 trial sites across UK, this involved some 977 patient subjects. These are listed on the NHS trials website.

I have put in some FOI requests to clarify whether in fact only UK trials data was used for approving the Pfizer-BioNtech vaccine in UK or if data from EU and USA trial sites were used. I have also asked whether due diligence and inspection of all UK trial sites was carried out by MHRA or other body, in order to ensure regulatory and safety compliance and importantly identify any deviations from clinical trials protocols, unblinding subjects, data integrity issues etc as detailed in this report.

In relation to the Pfizer-BioNtech booster shot, I have asked MHRA to confirm whether this is a brand new vaccine formulation or if it is exactly the same as in the first two vaccine doses. If it is an entirely new vaccine formulation, I have asked MHRA in my FOI request to provide details whether it has undergone trials and separate approval.

https://www.pfizer.co.uk/clinical-trials

https://www.nihr.ac.uk/search-results.htm?search=pfizer+biontech+vaccine

Competing interests: No competing interests

24 November 2021
Thomas Finnegan
Immunologist
Glasgow, Scotland