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bnt162b2
BNT162b2 (Comirnaty)
Modified-nucleoside mRNA vaccine encoding the SARS-CoV-2 prefusion-stabilized (2P) spike, delivered in a lipid nanoparticle. Co-developed by Pfizer and BioNTech; first authorized vaccine against COVID-19 (UK, Dec 2 2020; FDA EUA Dec 11 2020).
Entry Metadata
| Field | Value |
|---|---|
| ID | bnt162b2 |
| Name | BNT162b2 (Comirnaty) |
| Status | stub |
| Last reviewed | 2026-06-04 |
| Platform | 01 — mRNA |
| Delivery system | lipid-nanoparticle (LNP); ALC-0315 ionizable lipid (Acuitas), ALC-0159 PEG-lipid, cholesterol, DSPC |
| Adjuvants | None |
| Route | intramuscular |
| Dose — primary series adult | 2 doses, 21 days apart, 30 µg each (adults ≥12) |
| Dose — pediatric 10ug | 2 doses, 21 days apart, 10 µg (ages 5–11) |
| Dose — pediatric 3ug | 3 doses, 3 µg each (ages 6 months–4 years) |
| Dose — booster | single 30 µg dose; updated bivalent / monovalent formulations followed |
| Developer | BioNTech SE (Mainz, Germany) and Pfizer Inc. (New York) |
| Partners | Acuitas Therapeutics (LNP IP), Polymun Scientific (early LNP manufacturing) |
| Cold chain | Originally −80°C ultra-cold (6 months); reformulated to −20°C (10 weeks) and 2–8°C (10 weeks) |
| MHRA (2020-12-02) | Conditional authorization (first globally) |
| FDA (2020-12-11) | EUA |
| EMA (2020-12-21) | Conditional Marketing Authorization |
| WHO (2020-12-31) | Emergency Use Listing |
| FDA (2021-08-23) | BLA-approved (Comirnaty) |
Cross-Atlas Connections
Sources
- Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. NEJM. 2020;383(27):2603-2615. · PubMed 33301246
- Walsh EE, Frenck RW Jr, Falsey AR, et al. Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates. NEJM. 2020;383(25):2439-2450. · PubMed 33053279