FDA
- Status: approved
BNT162b2 (Omi XBB.1.5)/RIV (bnt162b2-omi-xbb-1-5-riv) regulatory status in United States.
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA has authorised it.
Pfizer is the originator. The local marketing authorisation holder may differ — check the official source linked above.
annual_list: USD 80000.00 per year. Final patient cost depends on reimbursement and any patient access scheme.