EMA
- Status: approved
bivalent BNT162b2 (original/Omi BA.4/BA.5) (bivalent-bnt162b2-original-omi-ba-4-ba-5) 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.