Last reviewed 2026-05-28 · How we verify

RSVpreF 60 µg (rsvpref-60-g)

Pfizer Inc. · Phase 1 active ✓ Verified May 2026 Quality 10/100

RSVpreF 60 µg (generic name: rsvpref-60-g) is a drug developed by Pfizer Inc.. It is currently in Phase 1 development.

RSVpreF is a vaccine candidate being studied for its safety and immune activity in children aged 2 to less than 18 years old for the prevention of Respiratory Syncytial Virus (RSV). The vaccine is administered in two different doses, 60 µg and 120 µg, as part of a phase 1 clinical trial.

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	rsvpref-60-g
Sponsor	Pfizer Inc.
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

Injection site pain (PAIN AT INJECTION SITE)
Fatigue (FATIGUE)
Headache (HEADACHE)
Erythema (REDNESS)
Myalgia (MUSCLE PAIN)
Swelling (SWELLING)
Arthralgia (JOINT PAIN)
Injection site pain
Diarrhoea (DIARRHEA)
Syncope
Abdominal pain
Vomiting (VOMITING)

Competitive intelligence

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

RSVpreF 60 µg CI brief — competitive landscape report
RSVpreF 60 µg updates RSS · CI watch RSS
Pfizer Inc. portfolio CI

Frequently asked questions about RSVpreF 60 µg

What is RSVpreF 60 µg?

RSVpreF 60 µg (rsvpref-60-g) is a pharmaceutical drug developed by Pfizer Inc..

Who makes RSVpreF 60 µg?

RSVpreF 60 µg is developed by Pfizer Inc. (see full Pfizer Inc. pipeline at /company/pfizer).

What is the generic name of RSVpreF 60 µg?

rsvpref-60-g is the generic (nonproprietary) name of RSVpreF 60 µg.

What development phase is RSVpreF 60 µg in?

RSVpreF 60 µg is in Phase 1.

What are the side effects of RSVpreF 60 µg?

Common side effects of RSVpreF 60 µg include Injection site pain (PAIN AT INJECTION SITE), Fatigue (FATIGUE), Headache (HEADACHE), Erythema (REDNESS), Myalgia (MUSCLE PAIN), Swelling (SWELLING).

Manufacturer: Pfizer Inc. — full pipeline

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