Maternal & Newborn Atlas
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RSV vaccination in pregnancy to protect the infant

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.

  • Intervention
  • In this atlas

Overview

Technical summary

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.

About this intervention

Type
Medicine
Mechanism
Not reported

Claims and evidence

Context 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
Pregnancy, from vaccination to birth and the safety follow-up after injection
Gestational age
24 weeks 0 days (168 days) to 36 weeks 0 days (252 days), measured at enrolment
Postnatal age
Not reported
Follow-up
Adverse events within 1 month after injection (abstract); the registry lists longer maternal safety outcomes.
Eligibility: 3 inclusion criteria; 1 exclusion criterion
Included
  • 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
Excluded
  • The registry lists further exclusion criteria that were not read in full

  • Safety Interventional Certainty not assessed

    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.

    Applies to Maternal
    • 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.
    • Prenatal care settings in 18 countries (international, placebo-controlled trial).
    • 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)
    • Pregnancy, from vaccination to birth and the safety follow-up after injection
    • Gestational age 24 weeks 0 days to 36 weeks 0 days, measured at enrolment
    • Postnatal age Not reported
    Follow-up Adverse events within 1 month after injection (abstract); the registry lists longer maternal safety outcomes.
    Certainty method
    Not assessed
    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.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (6)

    1. Supports Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 5
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 6, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 6, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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. Background Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 2
      How it applies
      PubMed abstract (context for the claim).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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. Background Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, CONCLUSIONS, sentence 1
      How it applies
      PubMed abstract (context for the claim).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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. Background A Trial to Evaluate the Efficacy and Safety of RSVpreF in Infants Born to Women Vaccinated During Pregnancy.

      Registry · U.S. National Library of Medicine (ClinicalTrials.gov) · Edition ClinicalTrials.gov API v2 record, last update posted 2025-02-11. · NCT: NCT04424316

      Locator
      protocolSection.eligibilityModule.eligibilityCriteria
      How it applies
      ClinicalTrials.gov record (context for the claim).
      Retrieved
      Source effective date
      2025-02-11
      Source state
      Current
      Snapshot hash
      dd4a074aad5cabb6dcae2a3f0a8063d20590ff9ea27e40700fdbb1520537b632
      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-NCT04424316.json.

Context 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
Infants from birth, with RSV illness counted within 90, 120, 150 and 180 days after birth
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
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: 1 inclusion criterion; 1 exclusion criterion
Included
  • Liveborn infants of women randomised in MATISSE
Excluded
  • Not stated in the source that was read

  • Effect Interventional Certainty not assessed

    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.

    Applies to Newborn
    • 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.
    • Prenatal and paediatric care settings in 18 countries (international, placebo-controlled trial).
    • 18 countries listed in ClinicalTrials.gov (see the MATISSE study page)
    • Infants from birth, with RSV illness counted within 90, 120, 150 and 180 days after birth
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up 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).
    Certainty method
    Not assessed
    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.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (6)

    1. Supports Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, METHODS, sentence 2, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, METHODS, sentence 2, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      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
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      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
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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. Background Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, METHODS, sentence 3, fragment 1 of 2
      How it applies
      PubMed abstract (context for the claim).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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. Background Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, METHODS, sentence 3, fragment 2 of 2
      How it applies
      PubMed abstract (context for the claim).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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.

  • Safety Interventional Certainty not assessed

    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.

    Applies to Newborn
    • 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.
    • Prenatal and paediatric care settings in 18 countries (international, placebo-controlled trial).
    • 18 countries listed in ClinicalTrials.gov (see the MATISSE study page)
    • Infants from birth, with RSV illness counted within 90, 120, 150 and 180 days after birth
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up 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).
    Certainty method
    Not assessed
    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.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (4)

    1. Supports Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 5
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 6, fragment 1 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 6, fragment 2 of 2
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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. Background Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 2
      How it applies
      PubMed abstract (context for the claim).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 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).

    Applies to Newborn
    • 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.
    • Prenatal and paediatric care settings in 18 countries (international, placebo-controlled trial).
    • 18 countries listed in ClinicalTrials.gov (see the MATISSE study page)
    • Infants from birth, with RSV illness counted within 90, 120, 150 and 180 days after birth
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up 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).
    Certainty method
    Not assessed
    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. The trial was funded by Pfizer.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (8)

    1. Supports Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, METHODS, sentence 1, fragment 1 of 3
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, METHODS, sentence 1, fragment 2 of 3
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, METHODS, sentence 1, fragment 3 of 3
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 1
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 3, fragment 1 of 3
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 3, fragment 2 of 3
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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. Supports Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      Locator
      Abstract, RESULTS, sentence 3, fragment 3 of 3
      How it applies
      PubMed abstract.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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 Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in 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 2023-04-20 · DOI: 10.1056/NEJMoa2216480 · PMID: 37018474

      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
      0c20a3db223731033cecc187e895c1b4bebdc724eb28c58a4e8873b90bf72892
      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:maternal-rsv-vaccination
Content hash
668cc6057e1197d1a3de9e7021fa5e7c59cfceb0da85617c8d82f73faba4a89a