{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:nirsevimab", "owner": "maternal", "kind": "drug", "slug": "nirsevimab", "name": "Nirsevimab", "aliases": [ "MEDI8897" ], "atlases": [ "maternal" ], "summary_plain": "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.", "summary_technical": "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.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-15", "next_review_due": null, "identifiers": [ { "scheme": "rxnorm", "value": "2642401", "normalized_value": "2642401", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "unii", "value": "VRN8S9CW5V", "normalized_value": "VRN8S9CW5V", "match": "exact", "version": null, "label": null, "from_source": false } ], "navigation": { "maternal": { "life-stage": [ "newborn", "infant-follow-up" ], "care-area": [ "infant-health" ] } }, "payload": { "level": "substance", "mechanism": "A monoclonal antibody to the RSV fusion protein that has an extended half-life (MELODY abstract)." }, "content_digest": "cfdd7b6175e33b0396334de3b36bb5c3f122048c2eb035018dfa1c0058016516", "review": { "content_digest": "cfdd7b6175e33b0396334de3b36bb5c3f122048c2eb035018dfa1c0058016516", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-melody-hospitalisation", "owner": "maternal", "subject_entity_id": "maternal:nirsevimab", "category": "effect", "statement": "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).", "context": { "id": "maternal:ctx-melody-late-preterm-and-term-infants", "label": "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_note": "Infants from birth to 1 year of age, dosed before or at the start of their first RSV season", "life_stage_terms": { "maternal": [ "newborn", "infant-follow-up" ] }, "gestational_age_min_days": 245, "gestational_age_max_days": null, "gestational_age_basis": "at_birth", "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "150 days after the injection for the efficacy end points; follow-up to day 361 for safety and antidrug antibodies (abstract).", "eligibility": { "inclusion": [ "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" ], "exclusion": [ "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" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-15", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, METHODS, sentence 3", "applicability_note": "PubMed abstract.", "snapshot": { "id": "maternal:pubmed-35235726-2026-10-15", "retrieved_at": "2026-10-15T13:48:54Z", "content_hash": "e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1056-nejmoa2110275", "source_type": "publication", "title": "Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants", "canonical_url": "https://doi.org/10.1056/NEJMoa2110275", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa2110275", "normalized_value": "10.1056/nejmoa2110275", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "35235726", "normalized_value": "35235726", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-03-03", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. 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The full text and the version of record were not fetched.", "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.", "public_text": "quote" } } ], "review": { "content_digest": "3d923673e4b652d041bb461db8e5cfaf18cef96bd8245dfd3151662b6ab56292", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-melody-hospitalisation.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-melody-ma-rsv-lrti", "owner": "maternal", "subject_entity_id": "maternal:nirsevimab", "category": "effect", "statement": "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).", "context": { "id": "maternal:ctx-melody-late-preterm-and-term-infants", "label": "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_note": "Infants from birth to 1 year of age, dosed before or at the start of their first RSV season", "life_stage_terms": { "maternal": [ "newborn", "infant-follow-up" ] }, "gestational_age_min_days": 245, "gestational_age_max_days": null, "gestational_age_basis": "at_birth", "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "150 days after the injection for the efficacy end points; follow-up to day 361 for safety and antidrug antibodies (abstract).", "eligibility": { "inclusion": [ "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" ], "exclusion": [ "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" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "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.", "editorial_state": "draft", "checked_at": "2026-10-15", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, METHODS, sentence 1, fragment 1 of 2", "applicability_note": "PubMed abstract.", "snapshot": { "id": "maternal:pubmed-35235726-2026-10-15", "retrieved_at": "2026-10-15T13:48:54Z", "content_hash": "e10e9dacc692992614d7b67c68e0e85ab8664f8c35669e71c042127f4f51f585", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1056-nejmoa2110275", "source_type": "publication", "title": "Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants", "canonical_url": "https://doi.org/10.1056/NEJMoa2110275", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa2110275", "normalized_value": "10.1056/nejmoa2110275", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "35235726", "normalized_value": "35235726", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2022-03-03", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. 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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.", "context": { "id": "maternal:ctx-melody-late-preterm-and-term-infants", "label": "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. 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