Maternal & Newborn Atlas
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Beyfortus (nirsevimab)

A brand-name injection of the RSV antibody nirsevimab. FDA approved it in July 2023. The current US label covers newborns and infants in their first RSV season, and some children up to 24 months who stay at risk through a second season.

  • Product
  • In this atlas

Overview

Technical summary

US BLA761328, original application approved 2023-07-17 (Drugs@FDA through openFDA); the active ingredient is nirsevimab-alip. Sponsor in openFDA: AstraZeneca AB; the label record names Sanofi Vaccines US as manufacturer. The indication on this page is the current label's (effective 2026-07-13), not the 2023 label's; later efficacy and labelling supplements are listed in openFDA and were not read. Label SPL set id 2f08fa60-f674-432d-801b-1f9514bd9b39. The recipient is the infant.

Product details

Type
Medicine
Model or formulation
Nirsevimab-alip injection for intramuscular use, 50 mg and 100 mg products (openFDA Drugs@FDA product list; the label record gives the route as intramuscular).
Version
As approved under BLA761328 on 2023-07-17; label text is the current label effective 2026-07-13 as served by openFDA.

Intended-use sources

  1. Background BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39)

    Label · U.S. Food and Drug Administration (openFDA) · Edition Current label as served by openFDA on 2026-10-15; the label's effective time is 2026-07-13.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2026-07-13
    Source state
    Current
    Snapshot hash
    22a59314f36de5dc0b1705d6e13329ec12380e29a7e44378546819f0a88ab205
    Reuse basis
    openFDA JSON, committed at research/snapshots/ml-openfda-label-2f08fa60-f674-432d-801b-1f9514bd9b39.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

  2. Background Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda

    Regulator · U.S. Food and Drug Administration (openFDA) · Edition openFDA drugsfda endpoint as served on 2026-10-15.

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e
    Reuse basis
    openFDA JSON, committed at research/snapshots/ml-openfda-drugsfda-BLA761328.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

Claims and evidence

Context Neonates, infants and children up to 24 months at risk of RSV lower respiratory tract disease (Beyfortus labelled use, United States)

Recipient
Child
Population
Neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season, as the current label words the indication.
Care setting
Prescription biologic given by injection into the muscle (openFDA marketing status in the label record).
Geography
United States (FDA)
Life stage
Neonates, infants and children up to 24 months
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not applicable (regulatory context)
Eligibility: 2 inclusion criteria; 1 exclusion criterion
Included
  • Neonates and infants born during or entering their first RSV season
  • Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season
Excluded
  • Not stated in the parts of the label that were read; see the label for contraindications and warnings

  • Regulatory Evidence stage not applicable Certainty not assessed

    Drugs@FDA, through openFDA, lists the original application for Beyfortus (nirsevimab-alip), BLA761328, as approved on 17 July 2023. The current label, effective 13 July 2026, words the indication as the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

    Applies to Child
    • Neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season, as the current label words the indication.
    • Prescription biologic given by injection into the muscle (openFDA marketing status in the label record).
    • United States (FDA)
    • Neonates, infants and children up to 24 months
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory context)
    Certainty method
    Not assessed
    Limitations
    An approval is an FDA decision about a product. It is not a recommendation to use the medicine for any person. The indication is quoted from today's label, not from the 2023 label; openFDA lists later efficacy and labelling supplements, and the 2023 indication was not read. openFDA's sponsor is AstraZeneca AB and the label record names Sanofi Vaccines US as manufacturer; the atlas does not trace that arrangement. openFDA says its data is unvalidated.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (10)

    1. Supports Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition openFDA drugsfda endpoint as served on 2026-10-15.

      Locator
      results[0].application_number
      How it applies
      openFDA record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e
      Reuse basis
      openFDA JSON, committed at research/snapshots/ml-openfda-drugsfda-BLA761328.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

    2. Supports Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition openFDA drugsfda endpoint as served on 2026-10-15.

      Locator
      results[0].products[0].brand_name
      How it applies
      openFDA record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e
      Reuse basis
      openFDA JSON, committed at research/snapshots/ml-openfda-drugsfda-BLA761328.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

    3. Supports Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition openFDA drugsfda endpoint as served on 2026-10-15.

      Locator
      results[0].submissions[2].submission_status_date
      How it applies
      openFDA record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e
      Reuse basis
      openFDA JSON, committed at research/snapshots/ml-openfda-drugsfda-BLA761328.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

    4. Supports Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition openFDA drugsfda endpoint as served on 2026-10-15.

      Locator
      results[0].submissions[2].submission_type
      How it applies
      openFDA record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e
      Reuse basis
      openFDA JSON, committed at research/snapshots/ml-openfda-drugsfda-BLA761328.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

    5. Supports Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition openFDA drugsfda endpoint as served on 2026-10-15.

      Locator
      results[0].submissions[2].submission_status
      How it applies
      openFDA record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e
      Reuse basis
      openFDA JSON, committed at research/snapshots/ml-openfda-drugsfda-BLA761328.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

    6. Supports BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39)

      Label · U.S. Food and Drug Administration (openFDA) · Edition Current label as served by openFDA on 2026-10-15; the label's effective time is 2026-07-13.

      Locator
      results[0].indications_and_usage[0] (part 1)
      How it applies
      openFDA record.
      Retrieved
      Source effective date
      2026-07-13
      Source state
      Current
      Snapshot hash
      22a59314f36de5dc0b1705d6e13329ec12380e29a7e44378546819f0a88ab205
      Reuse basis
      openFDA JSON, committed at research/snapshots/ml-openfda-label-2f08fa60-f674-432d-801b-1f9514bd9b39.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

    7. Supports BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39)

      Label · U.S. Food and Drug Administration (openFDA) · Edition Current label as served by openFDA on 2026-10-15; the label's effective time is 2026-07-13.

      Locator
      results[0].indications_and_usage[0] (part 2)
      How it applies
      openFDA record.
      Retrieved
      Source effective date
      2026-07-13
      Source state
      Current
      Snapshot hash
      22a59314f36de5dc0b1705d6e13329ec12380e29a7e44378546819f0a88ab205
      Reuse basis
      openFDA JSON, committed at research/snapshots/ml-openfda-label-2f08fa60-f674-432d-801b-1f9514bd9b39.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

    8. Supports BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39)

      Label · U.S. Food and Drug Administration (openFDA) · Edition Current label as served by openFDA on 2026-10-15; the label's effective time is 2026-07-13.

      Locator
      results[0].indications_and_usage[0] (part 3)
      How it applies
      openFDA record.
      Retrieved
      Source effective date
      2026-07-13
      Source state
      Current
      Snapshot hash
      22a59314f36de5dc0b1705d6e13329ec12380e29a7e44378546819f0a88ab205
      Reuse basis
      openFDA JSON, committed at research/snapshots/ml-openfda-label-2f08fa60-f674-432d-801b-1f9514bd9b39.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

    9. Background BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39)

      Label · U.S. Food and Drug Administration (openFDA) · Edition Current label as served by openFDA on 2026-10-15; the label's effective time is 2026-07-13.

      Locator
      results[0].effective_time
      How it applies
      openFDA record (context for the claim).
      Retrieved
      Source effective date
      2026-07-13
      Source state
      Current
      Snapshot hash
      22a59314f36de5dc0b1705d6e13329ec12380e29a7e44378546819f0a88ab205
      Reuse basis
      openFDA JSON, committed at research/snapshots/ml-openfda-label-2f08fa60-f674-432d-801b-1f9514bd9b39.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

    10. Background Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda

      Regulator · U.S. Food and Drug Administration (openFDA) · Edition openFDA drugsfda endpoint as served on 2026-10-15.

      Locator
      results[0].sponsor_name
      How it applies
      openFDA record (context for the claim).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e
      Reuse basis
      openFDA JSON, committed at research/snapshots/ml-openfda-drugsfda-BLA761328.json. openFDA data is CC0 under the openFDA terms; the harvester does not check for works that openFDA marks as not public domain. openFDA says its data is unvalidated.

Authorization

Regulatory decision: Beyfortus (nirsevimab)

Applies to Child
  • Neonates and infants born during or entering their first RSV season, and children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season, as the current label words the indication.
  • Prescription biologic given by injection into the muscle (openFDA marketing status in the label record).
  • United States (FDA)
  • Neonates, infants and children up to 24 months
  • Gestational age Not reported
  • Postnatal age Not reported
Follow-up Not applicable (regulatory context)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
BLA
Submission
BLA761328
Jurisdictions
United States; note: United States
Product version
BEYFORTUS (nirsevimab-alip) injection, BLA761328
Indication
Prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season, as the current label (effective 2026-07-13) words the indication.
Basis
Drugs@FDA, through openFDA, lists the original application for Beyfortus (nirsevimab-alip), BLA761328, as approved on 17 July 2023. The current label, effective 13 July 2026, words the indication as the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Limitations. An approval is an FDA decision about a product. It is not a recommendation to use the medicine for any person. The indication is quoted from today's label, not from the 2023 label; openFDA lists later efficacy and labelling supplements, and the 2023 indication was not read. openFDA's sponsor is AstraZeneca AB and the label record names Sanofi Vaccines US as manufacturer; the atlas does not trace that arrangement. openFDA says its data is unvalidated.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
maternal:beyfortus
Content hash
e55a2bbd008814e61e7405fd2e04f0a5cc1553fb8796ae2b56b4af659ffe537e