PharmaRadar360

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VaccinesDrug intelligence

Abrysvo

RSVpreF

Vaccine against the RSV prefusion F protein (RSVpreF). Developed by Pfizer. Clinical, regulatory, and source evidence are connected below.

Company
Pfizer
Target / MOA
RSV prefusion F protein
Aliases
Abrysvo
Signals
21
Clinical trials
15
Approvals
0
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset

N/A · NOT_YET_RECRUITING · Pfizer

clinical trialClinicalTrials.gov

Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá

N/A · ACTIVE_NOT_RECRUITING · Bogotá District Health Secretariat

clinical trialClinicalTrials.gov

Vaccine Responses in Patients With B Cell Malignancies

Phase 4 · RECRUITING · National Heart, Lung, and Blood Institute (NHLBI)

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 18, 2026.

United States (FDA label)

Abrysvo · BLA125769 · label version 15, effective Jul 14, 2026 · DailyMed

Label section 1

1 INDICATIONS AND USAGE 1.1 Immunization of Pregnant Individuals ABRYSVO is a vaccine indicated for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. 1.2 Immunization of Individuals 60 Years of Age and Older ABRYSVO is a vaccine indicated for active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older. 1.3 Immunization of Individuals 18 Through 59 Years of Age ABRYSVO is a vaccine indicated for active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

European Union (EMA)

Abrysvo · EMEA/H/C/006027 · Authorised, authorised Aug 23, 2023 (Commission decision C(2023) 5839) · EPAR

Abrysvo is indicated for: Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy. Active immunisation of individuals 18 years of age and older for the prevention of lower respiratory tract disease caused by RSV. The use of this vaccine should be in accordance with official recommendations.

EMA's summary; the full indication is in the product information on the EPAR page.

Not covered here: STN 125768 (Also named on FDA's Abrysvo page, but not on the current label or in the Purple Book.)

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 18, 2026.

United States

BLA125769 · Pfizer Inc. · first licensed May 31, 2023

Drugs@FDA does not cover vaccines: the licence date is from FDA's Purple Book, and the linked FDA page lists each approval letter since.

European Union

  • Abrysvo: Authorised since Aug 23, 2023

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 18, 2026.

BLA125769 (Purple Book)

No exclusivity date listed.

Generics and biosimilars

The Purple Book lists no licensed biosimilar.

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 18, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

The list is FDA's for drugs (CDER); safety communications about vaccines come from FDA's CBER and are not covered here.

Clinical trials

Key active studies

A focused view of recently updated studies · 15 linked records.

N/ANOT YET RECRUITINGNCT07235397

Evaluating the Benefits of RSV Maternal Vaccination Using a Scottish National Dataset

Pfizer · Updated Sep 24, 2026

N/AACTIVE NOT RECRUITINGNCT07279298

Effectiveness of Immunization in Preventing Severe Acute Respiratory Infection RSV in Children Under 6 Months in Bogotá

Bogotá District Health Secretariat · Updated Aug 6, 2026

Phase 4RECRUITINGNCT05170399

Vaccine Responses in Patients With B Cell Malignancies

National Heart, Lung, and Blood Institute (NHLBI) · Updated Aug 4, 2026

Phase 4NOT YET RECRUITINGNCT07693166

Study of HIV-Exposed Pregnancies and Transplacental Antibody Delivery Following RSVpreF

University of British Columbia · Updated Jul 9, 2026

N/AACTIVE NOT RECRUITINGNCT07249320

Evaluating ABRYSVO Maternal Vaccine Effectiveness Among Infants

Pfizer · Updated Jun 10, 2026

Phase 3RECRUITINGNCT07232706

Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination

Centre Hospitalier Annecy Genevois · Updated May 27, 2026

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial · Latest Sep 24, 202620Swissmedic - Medical Devices & SaMDofficial · Latest Date unavailable1
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.