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Nirsevimab

A long-acting antibody against RSV, given to babies as an injection to help prevent severe RSV lung illness. In the MELODY trial it lowered RSV lung infections that needed medical attention in healthy babies born at 35 weeks or later. For hospital admission for RSV, a secondary outcome, the reported result was P = 0.07. The brand name is Beyfortus.

Also called MEDI8897

  • Drug
  • In this atlas

Overview

Technical summary

Substance record (level substance): a monoclonal antibody to the RSV fusion protein with an extended half-life (MELODY abstract). RxNorm ingredient RXCUI 2642401 (RxNav properties); UNII VRN8S9CW5V (US label record in openFDA). The active ingredient is listed in the US drug approvals database as nirsevimab-alip under BLA761328. The antibody is given to the infant, so the infant is both the recipient and the person measured. The registry intervention name is MEDI8897.

About this drug

Level
Substance
Mechanism
A monoclonal antibody to the RSV fusion protein that has an extended half-life (MELODY abstract).

Claims and evidence

Context Healthy late-preterm and term infants born at 35 weeks or later, in their first RSV season (MELODY)

Recipient
Child
Population
Healthy infants in their first year of life, born at or after 35 weeks 0 days of gestation, who were entering their first RSV season at screening. Infants who met national or local criteria for palivizumab were excluded. The abstract randomised 1490 infants in the primary cohort.
Care setting
International, randomised, placebo-controlled phase 3 trial (many sites across Europe, the Americas, Asia, Africa and Oceania; see the study page).
Geography
Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, Finland, France, Germany, Israel, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Panama, Poland, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, the United Kingdom and the United States (ClinicalTrials.gov locations)
Life stage
Infants from birth to 1 year of age, dosed before or at the start of their first RSV season
Gestational age
at least 35 weeks 0 days (245 days), measured at birth
Postnatal age
Not reported
Follow-up
150 days after the injection for the efficacy end points; follow-up to day 361 for safety and antidrug antibodies (abstract).
Eligibility: 2 inclusion criteria; 3 exclusion criteria
Included
  • Healthy infants in their first year of life and born at or after 35 weeks 0 days GA
  • Infants who are entering their first RSV season at the time of screening
Excluded
  • Meets national or other local criteria to receive commercial palivizumab
  • Active RSV infection or known prior history of RSV infection
  • Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination

  • Effect Interventional Certainty not assessed

    In MELODY, hospitalisation for RSV-associated lower respiratory tract infection through 150 days after the injection, the secondary efficacy end point, occurred in 6 infants (0.6%) in the nirsevimab group and in 8 infants (1.6%) in the placebo group (efficacy 62.1%; 95% confidence interval -8.6 to 86.8; P = 0.07).

    Applies to Child
    • Healthy infants in their first year of life, born at or after 35 weeks 0 days of gestation, who were entering their first RSV season at screening. Infants who met national or local criteria for palivizumab were excluded. The abstract randomised 1490 infants in the primary cohort.
    • International, randomised, placebo-controlled phase 3 trial (many sites across Europe, the Americas, Asia, Africa and Oceania; see the study page).
    • Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, Finland, France, Germany, Israel, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Panama, Poland, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, the United Kingdom and the United States (ClinicalTrials.gov locations)
    • Infants from birth to 1 year of age, dosed before or at the start of their first RSV season
    • Gestational age at least 35 weeks 0 days, measured at birth
    • Postnatal age Not reported
    Follow-up 150 days after the injection for the efficacy end points; follow-up to day 361 for safety and antidrug antibodies (abstract).
    Certainty method
    Not assessed
    Limitations
    Only the PubMed abstract was read; the full text was not. This is a secondary end point, and the abstract reports P = 0.07 for it. The abstract does not describe it as meeting or missing a prespecified criterion. The trial was funded by MedImmune/AstraZeneca and Sanofi.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (3)

    1. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, METHODS, sentence 3
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    2. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, RESULTS, sentence 3, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    3. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, RESULTS, sentence 3, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

  • Effect Interventional Certainty not assessed

    In the MELODY trial, infants born at a gestational age of at least 35 weeks were randomly assigned 2:1 to a single intramuscular injection of nirsevimab or placebo before the start of an RSV season. Medically attended RSV-associated lower respiratory tract infection through 150 days after the injection occurred in 12 infants (1.2%) in the nirsevimab group and in 25 infants (5.0%) in the placebo group, an efficacy of 74.5% (95% confidence interval 49.6 to 87.1; P<0.001).

    Applies to Child
    • Healthy infants in their first year of life, born at or after 35 weeks 0 days of gestation, who were entering their first RSV season at screening. Infants who met national or local criteria for palivizumab were excluded. The abstract randomised 1490 infants in the primary cohort.
    • International, randomised, placebo-controlled phase 3 trial (many sites across Europe, the Americas, Asia, Africa and Oceania; see the study page).
    • Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, Finland, France, Germany, Israel, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Panama, Poland, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, the United Kingdom and the United States (ClinicalTrials.gov locations)
    • Infants from birth to 1 year of age, dosed before or at the start of their first RSV season
    • Gestational age at least 35 weeks 0 days, measured at birth
    • Postnatal age Not reported
    Follow-up 150 days after the injection for the efficacy end points; follow-up to day 361 for safety and antidrug antibodies (abstract).
    Certainty method
    Not assessed
    Limitations
    Only the PubMed abstract was read; the full text was not. The abstract counts 1490 infants randomised: 994 to nirsevimab and 496 to placebo. ClinicalTrials.gov lists 3012 enrolled; its participant flow lists the Primary Cohort of 496 placebo and 994 nirsevimab infants (the 1490 the abstract randomised) and, for All Subjects, 1003 placebo and 2009 nirsevimab infants. The trial was funded by MedImmune/AstraZeneca and Sanofi. The trial studied healthy late-preterm and term infants; it says nothing about infants born before 35 weeks.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (15)

    1. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, METHODS, sentence 1, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    2. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, METHODS, sentence 1, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    3. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, METHODS, sentence 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    4. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, RESULTS, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    5. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, RESULTS, sentence 2, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    6. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, RESULTS, sentence 2, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    7. Background Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, CONCLUSIONS, sentence 2
      How it applies
      PubMed abstract (context for the claim).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    8. Background A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-02-28. · NCT: NCT03979313

      Locator
      protocolSection.designModule.enrollmentInfo.count
      How it applies
      ClinicalTrials.gov record (context for the claim).
      Retrieved
      Source effective date
      2024-02-28
      Source state
      Current
      Snapshot hash
      e45fd93804bb04eb549cefae55382ef29c44a5e0e7777f55b68e2693cd421c82
      Reuse basis
      Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/ml-ctgov-NCT03979313.json.

    9. Background A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-02-28. · NCT: NCT03979313

      Locator
      protocolSection.eligibilityModule.eligibilityCriteria
      How it applies
      ClinicalTrials.gov record (context for the claim).
      Retrieved
      Source effective date
      2024-02-28
      Source state
      Current
      Snapshot hash
      e45fd93804bb04eb549cefae55382ef29c44a5e0e7777f55b68e2693cd421c82
      Reuse basis
      Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/ml-ctgov-NCT03979313.json.

    10. Background A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-02-28. · NCT: NCT03979313

      Locator
      resultsSection.participantFlowModule.periods[0].title
      How it applies
      ClinicalTrials.gov record (context for the claim).
      Retrieved
      Source effective date
      2024-02-28
      Source state
      Current
      Snapshot hash
      e45fd93804bb04eb549cefae55382ef29c44a5e0e7777f55b68e2693cd421c82
      Reuse basis
      Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/ml-ctgov-NCT03979313.json.

    11. Background A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-02-28. · NCT: NCT03979313

      Locator
      resultsSection.participantFlowModule.periods[1].title
      How it applies
      ClinicalTrials.gov record (context for the claim).
      Retrieved
      Source effective date
      2024-02-28
      Source state
      Current
      Snapshot hash
      e45fd93804bb04eb549cefae55382ef29c44a5e0e7777f55b68e2693cd421c82
      Reuse basis
      Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/ml-ctgov-NCT03979313.json.

    12. Background A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-02-28. · NCT: NCT03979313

      Locator
      resultsSection.participantFlowModule.periods[1].milestones[0].achievements[0].numSubjects
      How it applies
      ClinicalTrials.gov record (context for the claim).
      Retrieved
      Source effective date
      2024-02-28
      Source state
      Current
      Snapshot hash
      e45fd93804bb04eb549cefae55382ef29c44a5e0e7777f55b68e2693cd421c82
      Reuse basis
      Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/ml-ctgov-NCT03979313.json.

    13. Background A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-02-28. · NCT: NCT03979313

      Locator
      resultsSection.participantFlowModule.periods[1].milestones[0].achievements[1].numSubjects
      How it applies
      ClinicalTrials.gov record (context for the claim).
      Retrieved
      Source effective date
      2024-02-28
      Source state
      Current
      Snapshot hash
      e45fd93804bb04eb549cefae55382ef29c44a5e0e7777f55b68e2693cd421c82
      Reuse basis
      Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/ml-ctgov-NCT03979313.json.

    14. Background A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-02-28. · NCT: NCT03979313

      Locator
      resultsSection.participantFlowModule.periods[0].milestones[0].achievements[0].numSubjects
      How it applies
      ClinicalTrials.gov record (context for the claim).
      Retrieved
      Source effective date
      2024-02-28
      Source state
      Current
      Snapshot hash
      e45fd93804bb04eb549cefae55382ef29c44a5e0e7777f55b68e2693cd421c82
      Reuse basis
      Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/ml-ctgov-NCT03979313.json.

    15. Background A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2024-02-28. · NCT: NCT03979313

      Locator
      resultsSection.participantFlowModule.periods[0].milestones[0].achievements[1].numSubjects
      How it applies
      ClinicalTrials.gov record (context for the claim).
      Retrieved
      Source effective date
      2024-02-28
      Source state
      Current
      Snapshot hash
      e45fd93804bb04eb549cefae55382ef29c44a5e0e7777f55b68e2693cd421c82
      Reuse basis
      Registry record. The raw API JSON is committed. The ClinicalTrials.gov terms page is rendered by JavaScript and its text was not read by a script, so the redistribution basis is unverified; any quotation stays short. The raw file is committed at research/snapshots/ml-ctgov-NCT03979313.json.

  • Safety Interventional Certainty not assessed

    In MELODY, serious adverse events were reported in 67 of 987 infants (6.8%) who received nirsevimab and in 36 of 491 infants (7.3%) who received placebo. Among infants with data available to day 361, antidrug antibodies after baseline were detected in 58 of 951 (6.1%) in the nirsevimab group and in 5 of 473 (1.1%) in the placebo group.

    Applies to Child
    • Healthy infants in their first year of life, born at or after 35 weeks 0 days of gestation, who were entering their first RSV season at screening. Infants who met national or local criteria for palivizumab were excluded. The abstract randomised 1490 infants in the primary cohort.
    • International, randomised, placebo-controlled phase 3 trial (many sites across Europe, the Americas, Asia, Africa and Oceania; see the study page).
    • Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile, Colombia, Czechia, Estonia, Finland, France, Germany, Israel, Italy, Japan, Latvia, Lithuania, Mexico, New Zealand, Panama, Poland, Russia, South Africa, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine, the United Kingdom and the United States (ClinicalTrials.gov locations)
    • Infants from birth to 1 year of age, dosed before or at the start of their first RSV season
    • Gestational age at least 35 weeks 0 days, measured at birth
    • Postnatal age Not reported
    Follow-up 150 days after the injection for the efficacy end points; follow-up to day 361 for safety and antidrug antibodies (abstract).
    Certainty method
    Not assessed
    Limitations
    Only the PubMed abstract was read; the full text was not. The abstract does not give the types of serious adverse events or say whether the antidrug antibodies had any clinical effect.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (3)

    1. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, RESULTS, sentence 4, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    2. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, RESULTS, sentence 4, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

    3. Supports Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants

      Publication · The New England journal of medicine · Edition PubMed record (abstract and bibliographic data) from NCBI E-utilities. The full text and the version of record were not fetched. · Published 2022-03-03 · DOI: 10.1056/NEJMoa2110275 · PMID: 35235726

      Locator
      Abstract, RESULTS, sentence 5
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585
      Reuse basis
      PubMed record fetched through NCBI E-utilities. Only the hash of the bytes is kept, because publisher copyright may apply to the abstract (https://pubmed.ncbi.nlm.nih.gov/disclaimer/). Short factual quotations under 25 words, with the citation.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Record details

Record id
maternal:nirsevimab
Content hash
cfdd7b6175e33b0396334de3b36bb5c3f122048c2eb035018dfa1c0058016516