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Abrysvo (RSV vaccine, Pfizer)

A vaccine against RSV made by Pfizer. In the United States FDA approved it in August 2023 for pregnant individuals at 32 through 36 weeks of pregnancy, to protect infants from birth through 6 months of age from lower respiratory tract disease caused by RSV. FDA reported a numerical imbalance in preterm births. FDA required postmarketing studies of the preterm-birth signal and of hypertensive disorders of pregnancy, including pre-eclampsia. It is also approved for some adults, which is not covered here.

  • Product
  • In this atlas

Overview

Technical summary

FDA CBER product. The pregnancy indication was approved on 21 August 2023 under BLA STN 125768/0, which FDA then administratively closed, directing correspondence to the original BLA STN 125769 (letter); the FDA product page lists both numbers, the manufacturer Pfizer Inc., the tradename and two further indications for adults, which this page does not describe. openFDA has no label or Drugs@FDA record for it (a search on 2026-10-15 returned 404), so the FDA product page, the news release and the approval letter are the sources. RxNorm lists the branded drug as Abrysvo 60 MCG / 60 MCG per 0.5 ML Injection. The recipient is the pregnant person; the benefit is measured in the infant.

Product details

Type
Medicine
Model or formulation
Respiratory Syncytial Virus Vaccine (RSVpreF), single dose injection into the muscle (FDA news release); RxNorm branded drug Abrysvo 60 MCG / 60 MCG per 0.5 ML Injection.
Version
As approved for use in pregnancy on 2023-08-21 under BLA STN 125768/0 (closed; later submissions go to BLA STN 125769). The page describes that indication only; later FDA supplements were not read.

Intended-use sources

  1. Background FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023

    Regulator · U.S. Food and Drug Administration · Edition Approval letter to Pfizer Inc. dated August 21, 2023, listed on the FDA ABRYSVO product page. The PDF has a text layer. The letter's manufacturing paragraphs are redacted in places. · Published 2023-08-21

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    Not reported
    Source state
    Current
    Snapshot hash
    fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e
    Reuse basis
    FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

  2. Background FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

    Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2023-08-22
    Source state
    Current
    Snapshot hash
    a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
    Reuse basis
    FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

  3. Background ABRYSVO (FDA CBER product page)

    Regulator · U.S. Food and Drug Administration · Edition FDA product page, content current as of 12/19/2025 per the page, as shown on 2026-10-15. openFDA has no drug label or Drugs@FDA record for Abrysvo (a search on 2026-10-15 returned 404, logged as ml-openfda-label-abrysvo-search.json).

    Locator
    Whole source
    How it applies
    Source of the stated intended use
    Retrieved
    Source effective date
    2025-12-19
    Source state
    Current
    Snapshot hash
    2edba9a1053fd2430d1a1d6c941df6828b5143a66bf3de683aab9370bc5eab69
    Reuse basis
    FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

Claims and evidence

Context Infants born to individuals vaccinated with Abrysvo or placebo in FDA's description of the studies

Recipient
Newborn
Population
Infants from birth through 6 months of age born to individuals vaccinated in pregnancy. FDA describes a subgroup of about 1,500 vaccinated and 1,500 placebo participants who were 32 through 36 weeks gestational age. That window is the mother's gestational age at vaccination.
Care setting
International, randomised, placebo-controlled studies (FDA press release; the release does not name the countries).
Geography
Not stated in the FDA press release
Life stage
Infants from birth through 6 months of age
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
LRTD and severe LRTD within 90 days and within 180 days after birth (FDA press release).
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Infants of individuals vaccinated during pregnancy or given placebo
Excluded
  • Not stated in the source that was read

  • Effect Interventional Certainty not assessed

    FDA's approval announcement says that among approximately 3,500 pregnant individuals who received Abrysvo, compared with approximately 3,500 who received placebo, Abrysvo reduced the risk of severe lower respiratory tract disease by 81.8% within 90 days after birth and by 69.4% within 180 days after birth. In a subgroup of individuals who were 32 through 36 weeks gestational age, of whom approximately 1,500 received Abrysvo and 1,500 received placebo, FDA says Abrysvo reduced the risk of lower respiratory tract disease by 34.7% and of severe disease by 91.1% within 90 days after birth, and by 57.3% and 76.5% within 180 days after birth, compared with placebo.

    Applies to Newborn
    • Infants from birth through 6 months of age born to individuals vaccinated in pregnancy. FDA describes a subgroup of about 1,500 vaccinated and 1,500 placebo participants who were 32 through 36 weeks gestational age. That window is the mother's gestational age at vaccination.
    • International, randomised, placebo-controlled studies (FDA press release; the release does not name the countries).
    • Not stated in the FDA press release
    • Infants from birth through 6 months of age
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up LRTD and severe LRTD within 90 days and within 180 days after birth (FDA press release).
    Certainty method
    Not assessed
    Limitations
    These are FDA's summary figures from a press release; no confidence intervals are given there. The trial behind them is MATISSE, whose abstract reports the same 81.8% and 69.4% figures with intervals. FDA's release calls the studies ongoing. The first two figures (81.8% and 69.4%) are for all trial participants, who were vaccinated at 24 through 36 weeks (MATISSE abstract); only the subgroup figures (34.7%, 91.1%, 57.3% and 76.5%) are for the licensed 32 through 36 week window.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (6)

    1. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 5, sentence 1 (part)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    2. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 5, sentence 1 (part 2)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    3. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 5, sentence 2
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    4. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 5, sentence 2 (part 2)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    5. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 5, sentence 2 (part 3)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    6. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 5, sentence 3
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

Context Pregnant individuals at 32 through 36 weeks gestational age (Abrysvo labelled use, United States)

Recipient
Maternal
Population
Pregnant individuals at 32 through 36 weeks gestational age (the lower bound is 32 weeks 0 days; FDA writes the upper end as 36 weeks), who receive the vaccine to protect their infants from birth through 6 months of age. The same FDA product page lists two other indications for adults of 60 years and older and of 18 through 59 years at increased risk; they are outside this context.
Care setting
Prescription biologic given by injection into the muscle (FDA press release).
Geography
United States (FDA)
Life stage
Pregnancy at 32 through 36 weeks gestational age (the source writes the upper end as 36 weeks)
Gestational age
at least 32 weeks 0 days (224 days), measured at the time of measurement
Postnatal age
Not reported
Follow-up
Not applicable (regulatory context)
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Pregnant individuals at 32 through 36 weeks gestational age
Excluded
  • Not stated in the parts of the FDA documents that were read

  • Regulatory Evidence stage not applicable Certainty not assessed

    On 21 August 2023 FDA approved Abrysvo (Respiratory Syncytial Virus Vaccine) for active immunisation of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by respiratory syncytial virus in infants from birth through 6 months of age. FDA called it the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease caused by RSV in infants. It is given as a single dose injection into the muscle. The approval letter for this indication is for Biologics License Application STN BL 125768/0, which FDA administratively closed, directing future correspondence to the original BLA STN 125769; FDA's announcement says it had approved Abrysvo in May for individuals 60 years of age and older.

    Applies to Maternal
    • Pregnant individuals at 32 through 36 weeks gestational age (the lower bound is 32 weeks 0 days; FDA writes the upper end as 36 weeks), who receive the vaccine to protect their infants from birth through 6 months of age. The same FDA product page lists two other indications for adults of 60 years and older and of 18 through 59 years at increased risk; they are outside this context.
    • Prescription biologic given by injection into the muscle (FDA press release).
    • United States (FDA)
    • Pregnancy at 32 through 36 weeks gestational age (the source writes the upper end as 36 weeks)
    • Gestational age at least 32 weeks 0 days, measured at the time of measurement
    • Postnatal age Not reported
    Follow-up Not applicable (regulatory context)
    Certainty method
    Not assessed
    Limitations
    An approval is an FDA decision about a product. It is not a recommendation to use the vaccine for any person. The approved window of 32 through 36 weeks is narrower than the 24 through 36 weeks in the MATISSE trial: FDA says the Prescribing Information warns of a numerical imbalance in preterm births and advises giving the vaccine at 32 through 36 weeks to avoid the potential risk of preterm birth before 32 weeks (see the safety claim). The FDA product page also lists indications for individuals 60 years and older and 18 through 59 years at increased risk; they are not part of this record. openFDA has no label or Drugs@FDA record for Abrysvo, so the submission number is not recorded as a code here; it appears in the letter as BL 125768/0 and BLA STN 125768.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (19)

    1. Supports FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023

      Regulator · U.S. Food and Drug Administration · Edition Approval letter to Pfizer Inc. dated August 21, 2023, listed on the FDA ABRYSVO product page. The PDF has a text layer. The letter's manufacturing paragraphs are redacted in places. · Published 2023-08-21

      Locator
      Header, date
      How it applies
      FDA approval letter.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    2. Supports FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023

      Regulator · U.S. Food and Drug Administration · Edition Approval letter to Pfizer Inc. dated August 21, 2023, listed on the FDA ABRYSVO product page. The PDF has a text layer. The letter's manufacturing paragraphs are redacted in places. · Published 2023-08-21

      Locator
      Page 1, STN line
      How it applies
      FDA approval letter.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    3. Supports FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023

      Regulator · U.S. Food and Drug Administration · Edition Approval letter to Pfizer Inc. dated August 21, 2023, listed on the FDA ABRYSVO product page. The PDF has a text layer. The letter's manufacturing paragraphs are redacted in places. · Published 2023-08-21

      Locator
      Page 1, paragraph 1 (part)
      How it applies
      FDA approval letter.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    4. Supports FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023

      Regulator · U.S. Food and Drug Administration · Edition Approval letter to Pfizer Inc. dated August 21, 2023, listed on the FDA ABRYSVO product page. The PDF has a text layer. The letter's manufacturing paragraphs are redacted in places. · Published 2023-08-21

      Locator
      Page 1, paragraph 1 (part 2)
      How it applies
      FDA approval letter.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    5. Supports FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023

      Regulator · U.S. Food and Drug Administration · Edition Approval letter to Pfizer Inc. dated August 21, 2023, listed on the FDA ABRYSVO product page. The PDF has a text layer. The letter's manufacturing paragraphs are redacted in places. · Published 2023-08-21

      Locator
      Page 1, LICENSING, sentence 1
      How it applies
      FDA approval letter.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    6. Supports FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023

      Regulator · U.S. Food and Drug Administration · Edition Approval letter to Pfizer Inc. dated August 21, 2023, listed on the FDA ABRYSVO product page. The PDF has a text layer. The letter's manufacturing paragraphs are redacted in places. · Published 2023-08-21

      Locator
      Page 1, LICENSING, sentence 3 (part 1)
      How it applies
      FDA approval letter.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    7. Supports FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023

      Regulator · U.S. Food and Drug Administration · Edition Approval letter to Pfizer Inc. dated August 21, 2023, listed on the FDA ABRYSVO product page. The PDF has a text layer. The letter's manufacturing paragraphs are redacted in places. · Published 2023-08-21

      Locator
      Page 1, LICENSING, sentence 3 (part 2)
      How it applies
      FDA approval letter.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    8. Supports FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023

      Regulator · U.S. Food and Drug Administration · Edition Approval letter to Pfizer Inc. dated August 21, 2023, listed on the FDA ABRYSVO product page. The PDF has a text layer. The letter's manufacturing paragraphs are redacted in places. · Published 2023-08-21

      Locator
      Page 1, LICENSING, sentence 3 (part 3)
      How it applies
      FDA approval letter.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    9. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 1, sentence 2
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    10. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 1, sentence 3
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    11. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 1, sentence 1 (part 1)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    12. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 1, sentence 1 (part 2)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    13. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 1, sentence 1 (part 3)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    14. Background FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 13
      How it applies
      FDA news release (context for the claim).
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    15. Background FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 1, sentence 4
      How it applies
      FDA news release (context for the claim).
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    16. Background ABRYSVO (FDA CBER product page)

      Regulator · U.S. Food and Drug Administration · Edition FDA product page, content current as of 12/19/2025 per the page, as shown on 2026-10-15. openFDA has no drug label or Drugs@FDA record for Abrysvo (a search on 2026-10-15 returned 404, logged as ml-openfda-label-abrysvo-search.json).

      Locator
      Product header
      How it applies
      FDA web page (context for the claim).
      Retrieved
      Source effective date
      2025-12-19
      Source state
      Current
      Snapshot hash
      2edba9a1053fd2430d1a1d6c941df6828b5143a66bf3de683aab9370bc5eab69
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    17. Background ABRYSVO (FDA CBER product page)

      Regulator · U.S. Food and Drug Administration · Edition FDA product page, content current as of 12/19/2025 per the page, as shown on 2026-10-15. openFDA has no drug label or Drugs@FDA record for Abrysvo (a search on 2026-10-15 returned 404, logged as ml-openfda-label-abrysvo-search.json).

      Locator
      Indication, item 1 (part 1)
      How it applies
      FDA web page (context for the claim).
      Retrieved
      Source effective date
      2025-12-19
      Source state
      Current
      Snapshot hash
      2edba9a1053fd2430d1a1d6c941df6828b5143a66bf3de683aab9370bc5eab69
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    18. Background ABRYSVO (FDA CBER product page)

      Regulator · U.S. Food and Drug Administration · Edition FDA product page, content current as of 12/19/2025 per the page, as shown on 2026-10-15. openFDA has no drug label or Drugs@FDA record for Abrysvo (a search on 2026-10-15 returned 404, logged as ml-openfda-label-abrysvo-search.json).

      Locator
      Indication, item 1 (part 2)
      How it applies
      FDA web page (context for the claim).
      Retrieved
      Source effective date
      2025-12-19
      Source state
      Current
      Snapshot hash
      2edba9a1053fd2430d1a1d6c941df6828b5143a66bf3de683aab9370bc5eab69
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    19. Background Respiratory Syncytial Virus Infections (MedlinePlus health topic)

      Webpage · MedlinePlus, National Library of Medicine · Edition The health topic page as shown on 2026-10-15. The page carries no edition date.

      Locator
      Summary, Can RSV infections be prevented?, paragraph 2
      How it applies
      MedlinePlus health topic summary (context for the claim).
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      234a38a10cca920623a2eae8c2ac85ffb8edeb6ee17a5f6b9fe58d976db69de7
      Reuse basis
      MedlinePlus page Linking to and Using Content (fetched as ml-medlineplus-using-content.html, sha256 f70c0b8c67574e30377aab0c22b44038364a37e2e9f54a2ffa67597383b3de34) lists summaries on health topic pages as public-domain content. The page bytes are not committed. Short quotations with attribution.

Context Pregnant recipients of Abrysvo or placebo and their births (FDA safety statements)

Recipient
Mixed recipients
Population
Pregnant individuals who received Abrysvo or placebo in the safety studies, and the births and infants that followed. FDA reports pre-eclampsia in the pregnant individuals and preterm birth, low birth weight and jaundice in the births and infants, so the outcomes are mixed between mother and baby.
Care setting
Two safety studies (about 3,600 and about 100 pregnant individuals per group) (FDA press release).
Geography
Not stated in the FDA press release
Life stage
Pregnancy, birth and early infancy
Gestational age
Not reported
Postnatal age
Not reported
Follow-up
Not stated in the press release.
Eligibility: 1 inclusion criterion; 1 exclusion criterion
Included
  • Pregnant individuals who received Abrysvo or placebo in the safety studies
Excluded
  • Pregnant individuals at increased risk of preterm birth were generally excluded from the clinical studies (FDA press release)

  • Safety Interventional Certainty not assessed

    FDA's approval announcement reports that the most common side effects in pregnant individuals who received Abrysvo were pain at the injection site, headache, muscle pain and nausea. Pre-eclampsia occurred in 1.8% of pregnant individuals who received Abrysvo compared with 1.4% of those who received placebo. In the safety studies, low birth weight and jaundice in infants occurred at a higher rate in the pregnant Abrysvo recipients than in the pregnant placebo recipients. The Prescribing Information warns of a numerical imbalance in preterm births (5.7% with Abrysvo and 4.7% with placebo). FDA says the available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo, and advises giving Abrysvo at 32 through 36 weeks gestational age to avoid the potential risk of preterm birth with use before 32 weeks. FDA required postmarketing studies of the signal of serious risk of preterm birth and of hypertensive disorders of pregnancy, including pre-eclampsia, and said that pregnant individuals at increased risk of preterm birth were generally excluded from the clinical studies.

    Applies to Mixed recipients
    • Pregnant individuals who received Abrysvo or placebo in the safety studies, and the births and infants that followed. FDA reports pre-eclampsia in the pregnant individuals and preterm birth, low birth weight and jaundice in the births and infants, so the outcomes are mixed between mother and baby.
    • Two safety studies (about 3,600 and about 100 pregnant individuals per group) (FDA press release).
    • Not stated in the FDA press release
    • Pregnancy, birth and early infancy
    • Gestational age Not reported
    • Postnatal age Not reported
    Follow-up Not stated in the press release.
    Certainty method
    Not assessed
    Limitations
    These are FDA's figures from a press release of 2023, not the label or the trial papers; the safety studies' sizes are about 3,600 and about 100 pregnant individuals per group. The figures are reported as differences without confidence intervals, and FDA says the preterm birth and pre-eclampsia signals need further study. The label may have changed since 2023; it was not read.
    Last checked
    2026-10-15
    Next evidence check due
    Not scheduled
    Sources and citations (15)

    1. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 8, sentence 1
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    2. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 9, sentence 1
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    3. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 9, sentence 1 (part 2)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    4. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 9, sentence 2
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    5. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 9, sentence 2 (part 2)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    6. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 10, sentence 1
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    7. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 10, sentence 1 (part 2)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    8. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 10, sentence 2
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    9. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 10, sentence 3 (part 1)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    10. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 10, sentence 3 (part 2)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    11. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 10, sentence 4
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    12. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 11
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    13. Supports FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 11 (part 2)
      How it applies
      FDA news release.
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    14. Background FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 7, sentence 1
      How it applies
      FDA news release (context for the claim).
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

    15. Background FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release)

      Regulator · U.S. Food and Drug Administration · Edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023. · Published 2023-08-21

      Locator
      Paragraph 7, sentence 2
      How it applies
      FDA news release (context for the claim).
      Retrieved
      Source effective date
      2023-08-22
      Source state
      Current
      Snapshot hash
      a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9
      Reuse basis
      FDA website policies page (fetched as ml-fda-website-policies.html, sha256 55a5b4fce88a043c5ae9dfb1f0ce276b5bd3cef79755ca246907c70272b848a1) says that, unless otherwise noted, the contents of www.fda.gov are not copyrighted, are in the public domain, and may be republished without permission. The bytes are not committed. Short quotations with attribution.

Authorization

Regulatory decision: Abrysvo (RSV vaccine, Pfizer)

Applies to Maternal
  • Pregnant individuals at 32 through 36 weeks gestational age (the lower bound is 32 weeks 0 days; FDA writes the upper end as 36 weeks), who receive the vaccine to protect their infants from birth through 6 months of age. The same FDA product page lists two other indications for adults of 60 years and older and of 18 through 59 years at increased risk; they are outside this context.
  • Prescription biologic given by injection into the muscle (FDA press release).
  • United States (FDA)
  • Pregnancy at 32 through 36 weeks gestational age (the source writes the upper end as 36 weeks)
  • Gestational age at least 32 weeks 0 days, measured at the time of measurement
  • Postnatal age Not reported
Follow-up Not applicable (regulatory context)
Authority
U.S. Food and Drug Administration
Decision
Approval,
Pathway
BLA
Submission
BLA125768
Jurisdictions
United States; note: United States
Product version
ABRYSVO (Respiratory Syncytial Virus Vaccine), Pfizer Inc., approved under BLA STN 125768/0 (administratively closed; future submissions go to the original BLA STN 125769)
Indication
Active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age, as the approval letter words the indication.
Basis
On 21 August 2023 FDA approved Abrysvo (Respiratory Syncytial Virus Vaccine) for active immunisation of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease and severe lower respiratory tract disease caused by respiratory syncytial virus in infants from birth through 6 months of age. FDA called it the first vaccine approved for use in pregnant individuals to prevent lower respiratory tract disease caused by RSV in infants. It is given as a single dose injection into the muscle. The approval letter for this indication is for Biologics License Application STN BL 125768/0, which FDA administratively closed, directing future correspondence to the original BLA STN 125769; FDA's announcement says it had approved Abrysvo in May for individuals 60 years of age and older.

Limitations. An approval is an FDA decision about a product. It is not a recommendation to use the vaccine for any person. The approved window of 32 through 36 weeks is narrower than the 24 through 36 weeks in the MATISSE trial: FDA says the Prescribing Information warns of a numerical imbalance in preterm births and advises giving the vaccine at 32 through 36 weeks to avoid the potential risk of preterm birth before 32 weeks (see the safety claim). The FDA product page also lists indications for individuals 60 years and older and 18 through 59 years at increased risk; they are not part of this record. openFDA has no label or Drugs@FDA record for Abrysvo, so the submission number is not recorded as a code here; it appears in the letter as BL 125768/0 and BLA STN 125768.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Record details

Record id
maternal:abrysvo
Content hash
50a75a68a893a05b96f19fed031ad2f4d38685b48e45914860428c2ec8b56484