Last reviewed 2026-04-20 · How we verify

BNT162b4 30 mcg (bnt162b4-30-mcg)

Pfizer Inc. · Phase 1 active RNA therapeutics Quality 0/100

BNT162b4 30 mcg (generic name: bnt162b4-30-mcg) is a RNA therapeutics drug developed by Pfizer Inc.. It is currently in Phase 1 development.

Likelihood of approval

12.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+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	bnt162b4-30-mcg
Sponsor	Pfizer Inc.
Modality	RNA therapeutics
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Headache
COVID-19

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

BNT162b4 30 mcg CI brief — competitive landscape report
BNT162b4 30 mcg updates RSS · CI watch RSS
Pfizer Inc. portfolio CI

Frequently asked questions about BNT162b4 30 mcg

What is BNT162b4 30 mcg?

BNT162b4 30 mcg (bnt162b4-30-mcg) is a RNA therapeutics drug developed by Pfizer Inc..

Who makes BNT162b4 30 mcg?

BNT162b4 30 mcg is developed by Pfizer Inc. (see full Pfizer Inc. pipeline at /company/pfizer).

What is the generic name of BNT162b4 30 mcg?

bnt162b4-30-mcg is the generic (nonproprietary) name of BNT162b4 30 mcg.

What development phase is BNT162b4 30 mcg in?

BNT162b4 30 mcg is in Phase 1.

What are the side effects of BNT162b4 30 mcg?

Common side effects of BNT162b4 30 mcg include Headache, COVID-19.

Manufacturer: Pfizer Inc. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing