Exploring regulatory data sets of the Comirnaty vaccine - 12a

What does the FDA package insert and SmPC report about the harms outcomes that matter?

The Package inserts provide warnings and precautions that report those serious side effects that might occur, and the recipient of the vaccine should be made aware of them.  

The European regulators consider myocarditis and pericarditis “very rare” (< 1/10 000), whereas the FDA report the chance is “very low”. The FDA considers serious, low-frequency adverse events generally to be listed when there is reason to suspect that the drug may have caused the event.  Both sets of regulators report that the risk is highest in young males: the FDA in males aged 12 through 17, whereas EMA and the MHRA report the risk up to 29 years old. Limited data indicates the risk in younger children is lower than in older children.  

There is no information on death, and as we previously reported in post 11b, it is wrapped up in a composite outcome, which means there is no interpretable data. We also found no information on hospitalisation or secondary complications beyond the FDA report that “serious advers…