Abstract
Dear Editor,
The US Government reports that it is conducting historically unprecedented intensive monitoring of COVID-19 vaccine safety [1], [2]. However, there are major shortcomings in the FDA’s recent publication of its first “near real-time surveillance” study [3]. The analysis was not sensitive enough to detect safety signals for known adverse reactions: myocarditis was not detected for Moderna vaccine in all data sources, and only detected for Pfizer vaccine in two of three data sources. This raises serious concerns about whether the surveillance system is fit for its purpose.
The US Government reports that it is conducting historically unprecedented intensive monitoring of COVID-19 vaccine safety [1], [2]. However, there are major shortcomings in the FDA’s recent publication of its first “near real-time surveillance” study [3]. The analysis was not sensitive enough to detect safety signals for known adverse reactions: myocarditis was not detected for Moderna vaccine in all data sources, and only detected for Pfizer vaccine in two of three data sources. This raises serious concerns about whether the surveillance system is fit for its purpose.
| Original language | English |
|---|---|
| Article number | 125067 |
| Pages (from-to) | 1-2 |
| Number of pages | 2 |
| Journal | Vaccine |
| Volume | 48 |
| DOIs | |
| Publication status | Published - 27 Feb 2025 |
