{ "release_id": "c7fb95f1d15a7d13", "id": "maternal:maternal-rsv-vaccination", "owner": "maternal", "kind": "intervention", "slug": "maternal-rsv-vaccination", "name": "RSV vaccination in pregnancy to protect the infant", "aliases": [], "atlases": [ "maternal" ], "summary_plain": "A single RSV vaccine injection given to a pregnant person so that her baby is protected from serious RSV lung illness after birth. In the MATISSE trial the vaccine lowered severe RSV illness in babies in the first 90 and 180 days after birth; it did not meet the trial's statistical success criterion for RSV illness of any severity at 90 days. In the United States the vaccine is approved for use at 32 through 36 weeks of pregnancy, and the regulator reported a numerical imbalance in preterm births that it could neither link to the vaccine nor rule out.", "summary_technical": "The vaccine is given to the mother and the outcomes are measured in her infant, so the claims use separate maternal and infant contexts. MATISSE (NCT04424316) randomised women at 24 through 36 weeks to the vaccine or placebo; the interim analysis met the success criterion for one of two primary end points. The licensed window is 32 through 36 weeks. The trial's safety summary reports no safety signals; the regulator's description of the licensed product reports numerical imbalances in pre-eclampsia and preterm births, with postmarketing studies required. The licensed product has its own page. MedlinePlus lists the vaccine as available between 32 and 36 weeks of pregnancy.", "editorial_state": "draft", "last_substantive_edit": "2026-10-15", "last_evidence_check": "2026-10-15", "next_review_due": null, "identifiers": [], "navigation": { "maternal": { "life-stage": [ "pregnancy", "infant-follow-up" ], "care-area": [ "infant-health" ] } }, "payload": { "subtype": "medicine", "mechanism": null, "components": null }, "content_digest": "668cc6057e1197d1a3de9e7021fa5e7c59cfceb0da85617c8d82f73faba4a89a", "review": { "content_digest": "668cc6057e1197d1a3de9e7021fa5e7c59cfceb0da85617c8d82f73faba4a89a", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-matisse-any-rsv-lrti-90-days", "owner": "maternal", "subject_entity_id": "maternal:maternal-rsv-vaccination", "category": "effect", "statement": "In MATISSE, medically attended RSV-associated lower respiratory tract illness of any severity within 90 days after birth occurred in 24 infants of women in the vaccine group and 56 infants of women in the placebo group (vaccine efficacy 57.1%; 99.5% confidence interval 14.7 to 79.8). The authors state that these results did not meet the statistical success criterion.", "context": { "id": "maternal:ctx-matisse-infants-of-vaccinated-women", "label": "Infants born to women who received RSVpreF or placebo in pregnancy, followed to 180 days after birth (MATISSE)", "recipient": "newborn", "population": "Infants of the women randomised in MATISSE. The 24 to 36 week window is the mother's gestational age at vaccination; it is not a limit on the infant's gestational age at birth, which the abstract does not restrict. The abstract evaluated 3570 infants of vaccinated women and 3558 infants of placebo recipients.", "care_setting": "Prenatal and paediatric care settings in 18 countries (international, placebo-controlled trial).", "geography": "18 countries listed in ClinicalTrials.gov (see the MATISSE study page)", "life_stage_note": "Infants from birth, with RSV illness counted within 90, 120, 150 and 180 days after birth", "life_stage_terms": { "maternal": [ "newborn", "infant-follow-up" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "RSV-associated illness within 90, 120, 150 and 180 days after birth; safety follow-up of infants and toddlers up to 24 months of age (abstract).", "eligibility": { "inclusion": [ "Liveborn infants of women randomised in MATISSE" ], "exclusion": [ "Not stated in the source that was read" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Only the PubMed abstract was read; the full text was not. This is one of the trial's two primary end points, reported at the interim analysis, and the statistical success criterion was not met for it. The abstract does not say whether later analyses changed this result. The trial was funded by Pfizer.", "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 2, fragment 1 of 2", "applicability_note": "PubMed abstract.", "snapshot": { "id": "maternal:pubmed-37018474-2026-10-15", "retrieved_at": "2026-10-15T13:48:54Z", "content_hash": "0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1056-nejmoa2216480", "source_type": "publication", "title": "Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants", "canonical_url": "https://doi.org/10.1056/NEJMoa2216480", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa2216480", "normalized_value": "10.1056/nejmoa2216480", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37018474", "normalized_value": "37018474", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-04-20", "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": "bbb0755a09bccb66a91d5ea56960a4d1001175e0103186de8427f6c4bb5169cb", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-matisse-any-rsv-lrti-90-days.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-matisse-safety-infants", "owner": "maternal", "subject_entity_id": "maternal:maternal-rsv-vaccination", "category": "safety", "statement": "In MATISSE, the authors reported that no safety signals were detected in infants and toddlers up to 24 months of age. Adverse events reported within 1 month after birth were similar in the vaccine group and the placebo group: 37.1% of infants of vaccinated women and 34.5% of infants of placebo recipients.", "context": { "id": "maternal:ctx-matisse-infants-of-vaccinated-women", "label": "Infants born to women who received RSVpreF or placebo in pregnancy, followed to 180 days after birth (MATISSE)", "recipient": "newborn", "population": "Infants of the women randomised in MATISSE. The 24 to 36 week window is the mother's gestational age at vaccination; it is not a limit on the infant's gestational age at birth, which the abstract does not restrict. The abstract evaluated 3570 infants of vaccinated women and 3558 infants of placebo recipients.", "care_setting": "Prenatal and paediatric care settings in 18 countries (international, placebo-controlled trial).", "geography": "18 countries listed in ClinicalTrials.gov (see the MATISSE study page)", "life_stage_note": "Infants from birth, with RSV illness counted within 90, 120, 150 and 180 days after birth", "life_stage_terms": { "maternal": [ "newborn", "infant-follow-up" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "RSV-associated illness within 90, 120, 150 and 180 days after birth; safety follow-up of infants and toddlers up to 24 months of age (abstract).", "eligibility": { "inclusion": [ "Liveborn infants of women randomised in MATISSE" ], "exclusion": [ "Not stated in the source that was read" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Only the PubMed abstract was read; the full text was not. The abstract gives these figures in one sentence for women and infants together, in the order women then infants; the pairing of 37.1% and 34.5% with infants follows that order. The abstract does not give the types of events, and it does not report preterm birth, low birth weight or jaundice, which FDA reported as imbalances in its description of the safety studies of the licensed vaccine.", "editorial_state": "draft", "checked_at": "2026-10-15", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 5", "applicability_note": "PubMed abstract.", "snapshot": { "id": "maternal:pubmed-37018474-2026-10-15", "retrieved_at": "2026-10-15T13:48:54Z", "content_hash": "0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1056-nejmoa2216480", "source_type": "publication", "title": "Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants", "canonical_url": "https://doi.org/10.1056/NEJMoa2216480", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa2216480", "normalized_value": "10.1056/nejmoa2216480", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37018474", "normalized_value": "37018474", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-04-20", "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": "d08e7b360ff8ec9e32a0e17d7ccaf005f2f2998a08b632d496d6322b44271152", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-matisse-safety-infants.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-matisse-safety-women", "owner": "maternal", "subject_entity_id": "maternal:maternal-rsv-vaccination", "category": "safety", "statement": "In MATISSE, the authors reported that no safety signals were detected in maternal participants. Adverse events reported within 1 month after injection or within 1 month after birth were similar in the vaccine group and the placebo group: 13.8% of women in the vaccine group and 13.1% of women in the placebo group.", "context": { "id": "maternal:ctx-matisse-women-24-36w", "label": "Healthy pregnant women at 24 to 36 weeks vaccinated with RSVpreF or placebo (MATISSE)", "recipient": "maternal", "population": "Healthy women aged 49 years or younger with an uncomplicated singleton pregnancy at no known increased risk of complications, between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, who each received one injection of RSVpreF vaccine or placebo.", "care_setting": "Prenatal care settings in 18 countries (international, placebo-controlled trial).", "geography": "Argentina, Australia, Brazil, Canada, Chile, Denmark, Finland, Japan, Mexico, the Netherlands, New Zealand, the Philippines, South Africa, South Korea, Spain, Taiwan, The Gambia and the United States (ClinicalTrials.gov locations)", "life_stage_note": "Pregnancy, from vaccination to birth and the safety follow-up after injection", "life_stage_terms": { "maternal": [ "pregnancy" ] }, "gestational_age_min_days": 168, "gestational_age_max_days": 252, "gestational_age_basis": "at_enrolment", "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Adverse events within 1 month after injection (abstract); the registry lists longer maternal safety outcomes.", "eligibility": { "inclusion": [ "Healthy women aged 49 years or younger", "Between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination", "Uncomplicated singleton pregnancy at no known increased risk of complications" ], "exclusion": [ "The registry lists further exclusion criteria that were not read in full" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Only the PubMed abstract was read; the full text was not. The abstract gives these figures in one sentence for women and infants together, in the order women then infants; the pairing of 13.8% and 13.1% with women follows that order. The abstract does not break the women's adverse events down by type, and it does not report pre-eclampsia or preterm birth; FDA's description of the safety studies of the licensed vaccine, which reports numerical imbalances in both, is on the Abrysvo page.", "editorial_state": "draft", "checked_at": "2026-10-15", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "Abstract, RESULTS, sentence 5", "applicability_note": "PubMed abstract.", "snapshot": { "id": "maternal:pubmed-37018474-2026-10-15", "retrieved_at": "2026-10-15T13:48:54Z", "content_hash": "0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:pubmed-10-1056-nejmoa2216480", "source_type": "publication", "title": "Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants", "canonical_url": "https://doi.org/10.1056/NEJMoa2216480", "identifiers": [ { "scheme": "doi", "value": "10.1056/NEJMoa2216480", "normalized_value": "10.1056/nejmoa2216480", "match": "exact", "version": null, "label": null, "from_source": false }, { "scheme": "pmid", "value": "37018474", "normalized_value": "37018474", "match": "exact", "version": null, "label": null, "from_source": false } ], "publication_date": "2023-04-20", "publisher": "The New England journal of medicine", "edition": "PubMed record (abstract and bibliographic data) from NCBI E-utilities. 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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-NCT04424316.json.", "public_text": "quote" } } ], "review": { "content_digest": "14d2503a171f5a643bfe7e055e20fca13a7c706c7ac22a74c43bc3140e90ee75", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-matisse-safety-women.json" }, { "release_id": "c7fb95f1d15a7d13", "id": "maternal:claim-matisse-severe-rsv-lrti-efficacy", "owner": "maternal", "subject_entity_id": "maternal:maternal-rsv-vaccination", "category": "effect", "statement": "In the phase 3, double-blind MATISSE trial, pregnant women at 24 through 36 weeks' gestation were randomly assigned 1:1 to a single intramuscular injection of 120 micrograms of a bivalent RSV prefusion F protein vaccine (RSVpreF) or placebo. At a prespecified interim analysis the success criterion was met for one primary end point. Medically attended severe RSV-associated lower respiratory tract illness within 90 days after birth occurred in 6 infants of women in the vaccine group and 33 infants of women in the placebo group (vaccine efficacy 81.8%; 99.5% confidence interval 40.6 to 96.3); 19 cases and 62 cases, respectively, occurred within 180 days after birth (vaccine efficacy 69.4%; 97.58% confidence interval 44.3 to 84.1).", "context": { "id": "maternal:ctx-matisse-infants-of-vaccinated-women", "label": "Infants born to women who received RSVpreF or placebo in pregnancy, followed to 180 days after birth (MATISSE)", "recipient": "newborn", "population": "Infants of the women randomised in MATISSE. The 24 to 36 week window is the mother's gestational age at vaccination; it is not a limit on the infant's gestational age at birth, which the abstract does not restrict. The abstract evaluated 3570 infants of vaccinated women and 3558 infants of placebo recipients.", "care_setting": "Prenatal and paediatric care settings in 18 countries (international, placebo-controlled trial).", "geography": "18 countries listed in ClinicalTrials.gov (see the MATISSE study page)", "life_stage_note": "Infants from birth, with RSV illness counted within 90, 120, 150 and 180 days after birth", "life_stage_terms": { "maternal": [ "newborn", "infant-follow-up" ] }, "gestational_age_min_days": null, "gestational_age_max_days": null, "gestational_age_basis": null, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "RSV-associated illness within 90, 120, 150 and 180 days after birth; safety follow-up of infants and toddlers up to 24 months of age (abstract).", "eligibility": { "inclusion": [ "Liveborn infants of women randomised in MATISSE" ], "exclusion": [ "Not stated in the source that was read" ] } }, "evidence_stage": "interventional", "certainty": "not_assessed", "certainty_method": null, "limitations": "Only the PubMed abstract was read; the full text was not. The result is from an interim analysis, and only one of the two primary end points met the statistical success criterion (see the separate claim on illness of any severity). The abstract gives 99.5% intervals at 90 days and 97.58% intervals at later time points. Women were vaccinated at 24 through 36 weeks in the trial, a wider window than the 32 through 36 weeks FDA approved. 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