# Abrysvo (RSV vaccine, Pfizer) Product · id `maternal:abrysvo` · Maternal & Newborn Atlas · release `c7fb95f1d15a7d13` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Browse, life stage: Pregnancy; Infant follow-up Browse, care area: The baby's first year ## In plain language 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. ## 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. ## Claims, with the population each applies to ## 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). ### 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. - Category: Effect - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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). - 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 - Sources: 1. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 5, sentence 1 (part). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 2. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 5, sentence 1 (part 2). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 3. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 5, sentence 2. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 4. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 5, sentence 2 (part 2). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 5. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 5, sentence 2 (part 3). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 6. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 5, sentence 3. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. ## 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) ### 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. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: 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) - 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 - Sources: 1. Supports: FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023 (Regulator, 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.) Locator: Header, date. Retrieved 2026-10-15T13:50:44Z. Source state: Current. Snapshot hash: fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e. How it applies: FDA approval letter. 2. Supports: FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023 (Regulator, 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.) Locator: Page 1, STN line. Retrieved 2026-10-15T13:50:44Z. Source state: Current. Snapshot hash: fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e. How it applies: FDA approval letter. 3. Supports: FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023 (Regulator, 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.) Locator: Page 1, paragraph 1 (part). Retrieved 2026-10-15T13:50:44Z. Source state: Current. Snapshot hash: fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e. How it applies: FDA approval letter. 4. Supports: FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023 (Regulator, 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.) Locator: Page 1, paragraph 1 (part 2). Retrieved 2026-10-15T13:50:44Z. Source state: Current. Snapshot hash: fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e. How it applies: FDA approval letter. 5. Supports: FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023 (Regulator, 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.) Locator: Page 1, LICENSING, sentence 1. Retrieved 2026-10-15T13:50:44Z. Source state: Current. Snapshot hash: fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e. How it applies: FDA approval letter. 6. Supports: FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023 (Regulator, 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.) Locator: Page 1, LICENSING, sentence 3 (part 1). Retrieved 2026-10-15T13:50:44Z. Source state: Current. Snapshot hash: fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e. How it applies: FDA approval letter. 7. Supports: FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023 (Regulator, 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.) Locator: Page 1, LICENSING, sentence 3 (part 2). Retrieved 2026-10-15T13:50:44Z. Source state: Current. Snapshot hash: fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e. How it applies: FDA approval letter. 8. Supports: FDA approval letter for Respiratory Syncytial Virus Vaccine (ABRYSVO), STN BL 125768/0, 21 August 2023 (Regulator, 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.) Locator: Page 1, LICENSING, sentence 3 (part 3). Retrieved 2026-10-15T13:50:44Z. Source state: Current. Snapshot hash: fe7c7d16b4bc2cd4e2436ef95116542a6f59a6ed51bda5f46a0c38931932d07e. How it applies: FDA approval letter. 9. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 1, sentence 2. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 10. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 1, sentence 3. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 11. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 1, sentence 1 (part 1). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 12. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 1, sentence 1 (part 2). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 13. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 1, sentence 1 (part 3). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 14. Background: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 13. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release (context for the claim). 15. Background: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 1, sentence 4. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release (context for the claim). 16. Background: ABRYSVO (FDA CBER product page) (Regulator, 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. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: 2edba9a1053fd2430d1a1d6c941df6828b5143a66bf3de683aab9370bc5eab69. How it applies: FDA web page (context for the claim). 17. Background: ABRYSVO (FDA CBER product page) (Regulator, 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). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: 2edba9a1053fd2430d1a1d6c941df6828b5143a66bf3de683aab9370bc5eab69. How it applies: FDA web page (context for the claim). 18. Background: ABRYSVO (FDA CBER product page) (Regulator, 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). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: 2edba9a1053fd2430d1a1d6c941df6828b5143a66bf3de683aab9370bc5eab69. How it applies: FDA web page (context for the claim). 19. Background: Respiratory Syncytial Virus Infections (MedlinePlus health topic) (Webpage, 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. Retrieved 2026-10-15T13:49:53Z. Source state: Current. Snapshot hash: 234a38a10cca920623a2eae8c2ac85ffb8edeb6ee17a5f6b9fe58d976db69de7. How it applies: MedlinePlus health topic summary (context for the claim). ## 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. ### 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. - Category: Safety - Evidence stage: Interventional - Certainty: Certainty not assessed - Applies to: 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. - 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 - Sources: 1. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 8, sentence 1. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 2. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 9, sentence 1. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 3. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 9, sentence 1 (part 2). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 4. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 9, sentence 2. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 5. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 9, sentence 2 (part 2). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 6. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 10, sentence 1. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 7. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 10, sentence 1 (part 2). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 8. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 10, sentence 2. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 9. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 10, sentence 3 (part 1). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 10. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 10, sentence 3 (part 2). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 11. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 10, sentence 4. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 12. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 11. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 13. Supports: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 11 (part 2). Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release. 14. Background: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 7, sentence 1. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release (context for the claim). 15. Background: FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants (FDA news release) (Regulator, edition Press announcement dated August 21, 2023. The page says its content was current as of 08/22/2023.) Locator: Paragraph 7, sentence 2. Retrieved 2026-10-15T13:49:54Z. Source state: Current. Snapshot hash: a9e38eeb5dbd394c4f249e8b4d31fc3c3355e93cb9f55b6dfe2607eb460623d9. How it applies: FDA news release (context for the claim). ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-bla125768` - Product: Abrysvo (RSV vaccine, Pfizer) (`maternal:abrysvo`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Approval, 2023-08-21 - 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) - Pathway: BLA - Submission: BLA125768 - 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. - Jurisdictions: United States; note: United States - Applies to: 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) - Basis: claim `maternal:claim-fda-abrysvo-approval-pregnancy` ## Connected pages - Active substance (the A and B prefusion F protein drug substances): RSVpreF (bivalent RSV prefusion F protein vaccine) (`maternal:rsvpref-vaccine`) - Filed under this front: Medicines and vaccines (`maternal:front-medicines-and-vaccines`) - Required by: RSV vaccination in pregnancy to protect the infant (`maternal:maternal-rsv-vaccination`) ## Provenance Content hash: 50a75a68a893a05b96f19fed031ad2f4d38685b48e45914860428c2ec8b56484 Last substantive edit: 2026-10-15 Evidence last checked: 2026-10-15