Re: Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
It's hard to understand how we can trust the safety data provided by Pfizer ; we can see that the official package insert approved by the FDA for Comirnaty  states that acute allergic reactions (including anaphylaxis) have been reported only in post-marketing surveillance (including EUA); while in the real world  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.
 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.
 COMIRNATY® (COVID-19 Vaccine, mRNA) suspension for injection, for intramuscular use; Initial U.S. Approval: 2021; section 6.2 page 13 https://www.fda.gov/media/151707/download
 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