Last reviewed · How we verify
Raxtozinameran 12 years of age and older (raxtozinameran-12-years-of-age-and-older)
Raxtozinameran 12 years of age and older (generic name: raxtozinameran-12-years-of-age-and-older) is a BNT162b2 OMI XBB.1.5 (grey cap) is administered intramuscularly as a single dose of 0.3 mL for indiv drug developed by Pfizer Inc.. It is currently in preclinical development.
Raxtozinameran is an oligonucleotide-based vaccine, specifically designed for individuals 12 years of age and older, used to prevent COVID-19 and its associated adverse effects. It is part of a post-marketing surveillance study to assess its safety in this age group.
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Baseline preclinical → approval rate
+5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2036–2040 | — |
| EMA | EU | 2037–2041 | +0.7 yr |
| MHRA | GB | 2037–2041 | +0.7 yr |
| Health Canada | CA | 2037–2042 | +0.9 yr |
| TGA | AU | 2037–2042 | +1.2 yr |
| PMDA | JP | 2037–2042 | +1.5 yr |
| NMPA | CN | 2038–2043 | +2.3 yr |
| MFDS | KR | 2037–2042 | +1.4 yr |
| CDSCO | IN | 2037–2043 | +1.8 yr |
| ANVISA | BR | 2038–2043 | +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 | raxtozinameran-12-years-of-age-and-older |
|---|---|
| Sponsor | Pfizer Inc. |
| Drug class | BNT162b2 OMI XBB.1.5 (grey cap) is administered intramuscularly as a single dose of 0.3 mL for indiv |
| Therapeutic area | Infectious Disease |
| Phase | preclinical |
Approved indications
Pipeline indications
- COVID-19 — preclinical
Common side effects
Key clinical trials
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:
- Raxtozinameran 12 years of age and older CI brief — competitive landscape report
- Raxtozinameran 12 years of age and older updates RSS · CI watch RSS
- Pfizer Inc. portfolio CI
Frequently asked questions about Raxtozinameran 12 years of age and older
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Related
- Drug class: All BNT162b2 OMI XBB.1.5 (grey cap) is administered intramuscularly as a single dose of 0.3 mL for indiv drugs
- Manufacturer: Pfizer Inc. — full pipeline
- Therapeutic area: All drugs in Infectious Disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing