EMA
- Status: approved
BNT162b5 Bivalent (WT/OMI BA.2) (bnt162b5-bivalent-wt-omi-ba-2) regulatory status in European Union.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. EMA has authorised it.
Pfizer is the originator. The local marketing authorisation holder may differ — check the official source linked above.