# Beyfortus (nirsevimab) Product · id `maternal:beyfortus` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Browse, life stage: Newborn; Infant follow-up Browse, care area: The baby's first year ## In plain language 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. ## 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. ## Claims, with the population each applies to ## 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) ### 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. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: 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) - 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 - Sources: 1. Supports: Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda (Regulator, edition openFDA drugsfda endpoint as served on 2026-10-15.) Locator: results\[0\].application\_number. Retrieved 2026-10-15T13:51:05Z. Source state: Current. Snapshot hash: b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e. How it applies: openFDA record. 2. Supports: Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda (Regulator, edition openFDA drugsfda endpoint as served on 2026-10-15.) Locator: results\[0\].products\[0\].brand\_name. Retrieved 2026-10-15T13:51:05Z. Source state: Current. Snapshot hash: b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e. How it applies: openFDA record. 3. Supports: Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda (Regulator, edition openFDA drugsfda endpoint as served on 2026-10-15.) Locator: results\[0\].submissions\[2\].submission\_status\_date. Retrieved 2026-10-15T13:51:05Z. Source state: Current. Snapshot hash: b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e. How it applies: openFDA record. 4. Supports: Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda (Regulator, edition openFDA drugsfda endpoint as served on 2026-10-15.) Locator: results\[0\].submissions\[2\].submission\_type. Retrieved 2026-10-15T13:51:05Z. Source state: Current. Snapshot hash: b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e. How it applies: openFDA record. 5. Supports: Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda (Regulator, edition openFDA drugsfda endpoint as served on 2026-10-15.) Locator: results\[0\].submissions\[2\].submission\_status. Retrieved 2026-10-15T13:51:05Z. Source state: Current. Snapshot hash: b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e. How it applies: openFDA record. 6. Supports: BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39) (Label, 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). Retrieved 2026-10-15T13:51:06Z. Source state: Current. Snapshot hash: 22a59314f36de5dc0b1705d6e13329ec12380e29a7e44378546819f0a88ab205. How it applies: openFDA record. 7. Supports: BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39) (Label, 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). Retrieved 2026-10-15T13:51:06Z. Source state: Current. Snapshot hash: 22a59314f36de5dc0b1705d6e13329ec12380e29a7e44378546819f0a88ab205. How it applies: openFDA record. 8. Supports: BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39) (Label, 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). Retrieved 2026-10-15T13:51:06Z. Source state: Current. Snapshot hash: 22a59314f36de5dc0b1705d6e13329ec12380e29a7e44378546819f0a88ab205. How it applies: openFDA record. 9. Background: BEYFORTUS (nirsevimab-alip) injection label, openFDA drug label (set id 2f08fa60-f674-432d-801b-1f9514bd9b39) (Label, 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. Retrieved 2026-10-15T13:51:06Z. Source state: Current. Snapshot hash: 22a59314f36de5dc0b1705d6e13329ec12380e29a7e44378546819f0a88ab205. How it applies: openFDA record (context for the claim). 10. Background: Drugs@FDA record for BLA761328 (BEYFORTUS), openFDA drugsfda (Regulator, edition openFDA drugsfda endpoint as served on 2026-10-15.) Locator: results\[0\].sponsor\_name. Retrieved 2026-10-15T13:51:05Z. Source state: Current. Snapshot hash: b6f517e394dd0dd65c136d24cff37699d0779c49b5ef37250dbc5ba27b5e273e. How it applies: openFDA record (context for the claim). ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-bla761328` - Product: Beyfortus (nirsevimab) (`maternal:beyfortus`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 2023-07-17 - Product version: BEYFORTUS (nirsevimab-alip) injection, BLA761328 - Pathway: BLA - Submission: 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. - Jurisdictions: United States; note: United States - Applies to: 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) - Basis: claim `maternal:claim-fda-bla761328-approval` ## Connected pages - Active ingredient: Nirsevimab (`maternal:nirsevimab`) - Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`) ## Provenance Content hash: e55a2bbd008814e61e7405fd2e04f0a5cc1553fb8796ae2b56b4af659ffe537e Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-15