BioNTech

Comirnaty

Active

The mRNA COVID-19 vaccine (BNT162b2 / tozinameran) co-developed and commercialized with Pfizer - the first mRNA vaccine authorized for human use and the product that validated the platform at global scale.

Latest update Sep 20, 2026

Comirnaty

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Current status

Marketed globally as an updated seasonal COVID-19 vaccine; the XFG-adapted formulation is now authorized in the EU (July 29, 2026), the US (FDA approval August 27, 2026, for adults 65+ and higher-risk 5-64 year-olds), and Canada (Health Canada authorization September 17, 2026, for ages 6 months and older, with inventory due in the coming days and weeks). Still BioNTech's primary revenue driver, but sales have collapsed faster than guided - Q2 2026 revenue was just €105.6M - driving the August 2026 guidance cut and the manufacturing-network pullback.

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Specifications2

First Authorized
Dec 2020 (EUA)
Platform
mRNA (with Pfizer)

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Upcoming milestones1

Announced next steps from BioNTech that mention Comirnaty.

  1. Fall 2026

    Ship Health Canada XFG Comirnaty through Canadian channels

    Pfizer Canada and BioNTech said September 17 that Health Canada authorized XFG-adapted COMIRNATY for ages 6 months and older and that inventory for federal and provincial programs would move through distribution channels in the coming days and weeks. Watch provincial eligibility rules and whether people outside public programs can buy the shot at participating pharmacies.

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In the news1

  1. Health Canada authorizes BioNTech XFG Comirnaty shot

    Pfizer Canada and BioNTech said September 17 that Health Canada authorized the XFG variant-adapted COMIRNATY vaccine for people aged 6 months and older for the 2026-2027 season. The partners said the decision rests on prior clinical, non-clinical, and real-world evidence, and Pfizer Canada said it has enough inventory for federal and provincial contracts, with distribution in the coming days and weeks. The Canadian clearance covers a broader age group than the August 27 FDA approval, which applied to adults 65 and older and higher-risk people ages 5 to 64.

    CNW / Pfizer Canada BioSpace

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