FDA
- Status: approved
Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose (variant-adapted-bnt162b2-omicron-xbb-1-5-3-microgram-dose) 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.