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BNT162b2.B.1.351
BNT162b2.B.1.351 is a mRNA vaccine Biologic drug developed by BioNTech SE. It is currently in Phase 3 development for COVID-19 prevention (variant-specific booster or primary series against B.1.351 variant).
BNT162b2.B.1.351 is an mRNA vaccine encoding a modified spike protein from the B.1.351 (Beta) variant of SARS-CoV-2, designed to elicit immune responses against this variant.
BNT162b2.B.1.351 is a COVID-19 booster vaccine being studied in a clinical trial for its effects on individuals with autoimmune diseases who did not respond to initial vaccinations. The conditions being studied in this trial include Rheumatoid Arthritis, Systemic Lupus Erythematosus, Pemphigus Vulgaris, Multiple Sclerosis, and Systemic Sclerosis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BNT162b2.B.1.351 |
|---|---|
| Sponsor | BioNTech SE |
| Drug class | mRNA vaccine |
| Target | SARS-CoV-2 spike protein (B.1.351 variant) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
This vaccine delivers lipid nanoparticle-formulated mRNA that encodes an optimized spike protein antigen from the B.1.351 variant. Upon intramuscular injection, the mRNA is translated by host cells to produce the spike protein, which triggers both CD8+ T-cell and antibody-mediated immune responses. This variant-specific formulation was developed to address potential immune escape by the Beta variant.
Approved indications
- COVID-19 prevention (variant-specific booster or primary series against B.1.351 variant)
Common side effects
- Injection site pain
- Fatigue
- Headache
- Myalgia
- Fever
Key clinical trials
- COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (PHASE2)
- COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders (PHASE2)
- Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines (PHASE1, PHASE2)
- Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults (PHASE3)
- A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants (PHASE3)
- Immunogenicity and Reactogenicity Following a Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech) and Two Adjuvanted Sub-unit Vaccines (SP/GSK) Administered in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine as a Primary Vaccination (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- BNT162b2.B.1.351 CI brief — competitive landscape report
- BNT162b2.B.1.351 updates RSS · CI watch RSS
- BioNTech SE portfolio CI
Frequently asked questions about BNT162b2.B.1.351
What is BNT162b2.B.1.351?
How does BNT162b2.B.1.351 work?
What is BNT162b2.B.1.351 used for?
Who makes BNT162b2.B.1.351?
What drug class is BNT162b2.B.1.351 in?
What development phase is BNT162b2.B.1.351 in?
What are the side effects of BNT162b2.B.1.351?
What does BNT162b2.B.1.351 target?
Related
- Drug class: All mRNA vaccine drugs
- Target: All drugs targeting SARS-CoV-2 spike protein (B.1.351 variant)
- Manufacturer: BioNTech SE — full pipeline
- Therapeutic area: All drugs in Immunology / Infectious Disease
- Indication: Drugs for COVID-19 prevention (variant-specific booster or primary series against B.1.351 variant)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing