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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:

How significant is the Ventavia scandal?

Dear Editor,

The behaviour of Ventavia in relation to Pfizer's Covid-19 vaccine is extremely serious and demands a full investigation, either by the FDA or the WHO. The same applies to the senior management of Pfizer, both as regards those who were directly involved in commissioning work from Ventavia and as regards Pfizer's overall corporate culture.

But what does this affair tell us about the effectiveness and safety of the vaccine? Your article reports that Ventavia was responsible for 3 out of 153 sites involved in vaccine evaluation and that their work involved "more than 1,000" out of 44,000 participants, i.e. around 2.5%. A recent systematic review and GRADE evaluation of the Pfizer vaccine by a CDC group (https://www.cdc.gov/vaccines/acip/recs/grade/covid-19-pfizer-biontech-va...) was very positive about its efficacy and safety. What should now happen is for the CDC or a similar non-commercial agency to re-evaluate the evidence after removing the data from Ventavia. There should also be a random audit of data from a sizeable sample of the other 150 sites that were involved in the vaccine's development.

Competing interests: No competing interests

06 November 2021
Roger Fisken
Retired consultant physician
none
Crow Croft, Holly Lane, Ashampstead