The EMA has responded with various administrative/legal arguments to explain the absence of these studies. Amongst these arguments:
- The resources required for these studies (It takes time and it is expensive)
- The limitation to a low dose of exposure related to only 2 injections of ALC0159 for the Pfizer vaccine which the EMA comments conditionally as "risk should be low" with 2 injections.
- They are not aware of any other biologically plausible mechanisms of concern... .