Intended for healthcare professionals

Rapid response to:

Feature BMJ Investigation

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

BMJ 2021; 375 doi: (Published 02 November 2021) Cite this as: BMJ 2021;375:n2635

Read our latest coverage of the coronavirus pandemic

Rapid Response:

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

Dear Editor

It's hard to understand how we can trust the safety data provided by Pfizer [1]; we can see that the official package insert approved by the FDA for Comirnaty [2] states that acute allergic reactions (including anaphylaxis) have been reported only in post-marketing surveillance (including EUA); while in the real world [3] the observed rate of acute allergic reactions is close to 2% (1.95% [95% CI, 1.79%-2.13%] ) and the observed rate of anaphylaxis is close to 1/3700 for mRNA Covid-19 vaccines (Pfizer 0.027% [95% CI, 0.011%-0.056%]). It's impossible to miss that in a cohort of 21,700 vaccinated individuals in a clinical trial.

This observational study has been published online in March 2021, it was clear that we could question the authenticity of the safety data published by Pfizer early in the roll-out of this vaccine.

[1] Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Pérez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Türeci Ö, Nell H, Schaefer A, Ünal S, Tresnan DB, Mather S, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10. PMID: 33301246; PMCID: PMC7745181.
[2] COMIRNATY® (COVID-19 Vaccine, mRNA) suspension for injection, for intramuscular use; Initial U.S. Approval: 2021; section 6.2 page 13
[3] Blumenthal KG, Robinson LB, Camargo CA Jr, Shenoy ES, Banerji A, Landman AB, Wickner P. Acute Allergic Reactions to mRNA COVID-19 Vaccines. JAMA. 2021 Apr 20;325(15):1562-1565. doi: 10.1001/jama.2021.3976. PMID: 33683290; PMCID: PMC7941251.

Competing interests: No competing interests

02 November 2021
Surya ARBY
Rueil-Malmaison, France