FDA
- Status: approved
Combination BNT162b2 and BNT162b2 OMI (combination-bnt162b2-and-bnt162b2-omi) 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.