Intended for healthcare professionals

Letters Pfizer’s covid vaccine trial

How significant is the Ventavia scandal?

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2953 (Published 30 November 2021) Cite this as: BMJ 2021;375:n2953
  1. Roger Fisken, retired consultant physician
  1. Ashampstead, UK
  1. daardon{at}yahoo.com

The behaviour of Ventavia in relation to Pfizer’s covid-19 vaccine1 is serious and demands a full investigation, either by the US Food and Drug Administration or the World Health Organization. The same applies to the senior management of Pfizer, both as regards those who were directly involved in commissioning work from Ventavia and in terms of Pfizer’s overall corporate culture.

But what does this affair tell us about the effectiveness and safety of the vaccine? Thacker reports that Ventavia was responsible for three out of 153 sites participating in vaccine evaluation and that their work involved “more than 1000” out of 44 000 participants—around 2.5%.1 A recent systematic review and grading of recommendations, assessment, development, and evaluation of the Pfizer vaccine by a US Centers for Disease Control and Prevention group was positive about its efficacy and safety.2 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.

Footnotes

  • Competing interests: None declared.

References

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