Key result
BNT162b2 linked to several new and unexpected adverse reactions compared to clinical trials.
Why the study?
New and unexpected adverse reactions to the BNT162b2 vaccine were identified, prompting a review of its safety profile beyond clinical trial data.
What is the real-world safety profile and incidence of adverse reactions of the BNT162b2 vaccine in healthcare professionals?
Observational (n=2,000)
Yes
What is the real-world safety profile and incidence of adverse reactions of the BNT162b2 vaccine in healthcare professionals?
Real-world pharmacovigilance data identified new and unexpected adverse reactions to the BNT162b2 vaccine, suggesting a need to update its established safety profile.
Answers are grounded in this paper and cite their sources.
May flag new real-world signals for BNT162b2; leaves open confirmation before any safety profile revision.
The first vaccine against SARS-CoV-2 made available in Italy has been BNT162b2, the two-dose mRNA-based vaccine developed by Pfizer-BioNTech. The ASST Fatebenefratelli-Sacco hospital is located in one of the areas most affected by the pandemic, and to date over 2000 healthcare professionals have been injected with both vaccine doses. We have collected all spontaneous safety reports in which BNT162b2 was designated as the possible cause. We also have carried out a descriptive analysis of reports submitted in EudraVigilance in the same time-frame and compared our findings with those observed in clinical trials. We have identified several new and unexpected adverse reactions that will be helpful for reviewing the safety profile defined in the Summary of Product Characteristics for this vaccine.
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Gringeri et al. (2021) conducted an observational in SARS-CoV-2 vaccination (n=2,000). BNT162b2 (Comirnaty) was evaluated on Spontaneous safety reports and adverse reactions. Analysis of spontaneous safety reports for the BNT162b2 vaccine identified several new and unexpected adverse reactions compared to those observed in clinical trials.
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