🇪🇺 Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose in European Union

Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose (variant-adapted-bnt162b2-omicron-xbb-1-5-3-microgram-dose) regulatory status in European Union.

Marketing authorisation

EMA

Status: approved

Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

🇨🇦 Canada
🇺🇸 United States

Other Immunology approved in European Union

Frequently asked questions

Is Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose approved in European Union?

Yes. EMA has authorised it.

Who is the marketing authorisation holder for Variant-adapted BNT162b2 (Omicron XBB.1.5) 3 microgram dose in European Union?

Pfizer is the originator. The local marketing authorisation holder may differ — check the official source linked above.