Langbahn Team – Weltmeisterschaft

Respiratory syncytial virus vaccine

A respiratory syncytial virus vaccine, or RSV vaccine, is a vaccine that protects against respiratory syncytial virus.[1] RSV affects an estimated 64 million people and causes 160,000 deaths worldwide each year.[2]

The RSV vaccines Arexvy (GSK),[3] Abrysvo (Pfizer),[4] and Mresvia (Moderna)[5] are approved for medical use in the United States.[6][7][8] Arexvy is approved for medical use in the United States,[3] in the European Union,[1][9] and in Canada for people aged 60 years of age and older.[10] Arexvy is approved in the US for people aged 50–59 years of age who are at increased risk.[6][11][12] In June 2024, the US Centers for Disease Control and Prevention (CDC) updated its recommendation for the use of respiratory syncytial virus vaccine in people aged 60 years of age and older.[13] The CDC recommends that people who have not received the respiratory syncytial virus vaccine and are aged 75 years of age and older receive the respiratory syncytial virus vaccine; and that people who have not received the respiratory syncytial virus vaccine and are aged 60–74 years of age who are at increased risk of severe respiratory syncytial virus, meaning they have certain chronic medical conditions, such as lung or heart disease, or they live in nursing homes, receive the respiratory syncytial virus vaccine.[13][14]

A 2013 study led to the approval of RSV vaccines.[15][16] Work on RSV vaccines also supported the rapid development of COVID-19 vaccines.[16][17]

Medical uses

Respiratory syncytial virus vaccine is indicated for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in people 60 years of age and older.[1][3][4][18]

Abrysvo is indicated for active immunization 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 (RSV) in infants from birth through six months of age; for the active immunization for the prevention of lower respiratory tract disease caused by RSV in people 60 years of age and older; and for the active immunization for the prevention of lower respiratory tract disease caused by RSV in people aged 18 through 59 years of age who are at increased risk for lower respiratory tract disease caused by RSV.[4][7][19][20][21][22] Abrysvo is approved for use in pregnant women at 24 through 36 weeks and older adults in the European Union.[23][24] and between 28 through 36 weeks and older adults in the United Kingdom.[19]

Infant-specific issues include the immature infant immune system and the presence of maternal antibodies, which make infantile immunization difficult.[25]

History

Development

Attempts to develop an RSV vaccine began in the 1960s with an unsuccessful inactivated vaccine developed by exposing the RSV virus to formalin (formalin-inactivated RSV (FI-RSV)).[26] This vaccine induced vaccine-associated enhanced respiratory disease, in which children who had not previously been exposed to RSV and were subsequently vaccinated would develop severe RSV disease if exposed to the virus itself, including fever, wheezing, and bronchopneumonia.[26] Some eighty percent of such children (vs. 5% of virus-exposed controls) were hospitalized, and two children died of lethal lung inflammation during the first natural RSV infection after vaccination of RSV-naive infants.[26] This disaster slowed vaccine development for many years.[26]

A 1998 paper reported that research had advanced greatly over the previous ten years.[27] A 2019 paper similarly claimed that research toward developing a vaccine had advanced greatly over the prior 10 years, with more than 30 candidates in some stage of development.[28] The same study predicted that a vaccine would be available within ten years.[28] Candidates included particle-based vaccines, attenuated vaccines, mRNA vaccines, protein subunit vaccines, and vector-based vaccines.[29][30]

A 2013 study detailed the crystal structure of the RSV fusion (F) protein and how its stability could be improved.[15] This provided the basis for finding the most effective F protein constructs, which are used in RSV vaccines.[16] To develop its vaccine, Pfizer engineered 400 different F protein constructs to identify the most immunogenic, and constructed a bivalent RSV prefusion F investigational vaccine.[31]

In February 2023, results of a phase III study of around 25,000 participants age 60+ were published. One dose of the Arexvy vaccine provided 94% efficacy against severe RSV pneumonia and 72% efficacy against RSV acute respiratory infection.[32] An advisory panel to the FDA recommended approval of the vaccine in February 2023.[33][34]

In April 2023, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommended to grant a marketing authorization for Arexvy for the prevention of RSV lower respiratory tract disease in people 60 years of age or older[35][36] after review under the EMA's accelerated assessment program.[35]

In May 2023, Arexvy was approved for people aged 60 years of age and older, making it the first FDA-approved RSV vaccine.[37][38]

In May 2023, the FDA's expert panel unanimously recommended Abrysvo for approval in pregnant women.[39] The panel was split on the safety of the vaccine in respect of preterm births.[40]

In June 2023, Arexvy was approved for medical use in the European Union.[41]

The mRNA vaccine Mresvia was approved for medical use in the United States in May 2024.[42][43][18]

In June 2024, the FDA approved Arexvy for use in people aged 50 to 59 years of age who are at an increased risk of RSV-caused lower respiratory tract disease.[11] The approval is based on data from a phase III study (NCT05590403),[44] which showed that immune responses were non-inferior in people aged 50–59 years of age at increased risk for RSV disease compared to people aged 60 years of age and older.[45][44]

In October 2024, the FDA approved Abrysvo for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for lower respiratory tract disease caused by RSV. Since 2023, Abrysvo has been approved for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older and for use in 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 RSV in infants from birth through six months of age.[46] Abrysvo is manufactured by Pfizer.[46]

Mresvia was approved for medical use in the European Union in August 2024.[47][48]

Clinical trials

As of October 2022, phase III trials by multiple companies are ongoing to test RSV vaccines for people aged 60 years of age and older. These include vaccines by GSK, Pfizer, Johnson & Johnson, Moderna, and Bavarian Nordic.[49][50][51] As of April 2023, other vaccines were in development, including vaccines for pregnant women to immunize their fetuses by passing maternal antibodies to them, and vaccines for children.[16][49]

GSK

Respiratory Syncytial Virus Vaccine, Adjuvanted
Vaccine description
TargetRSVPreF3 antigen
Vaccine typeProtein subunit
Clinical data
Trade namesArexvy
Other namesGSK3844766A,[52][53] respiratory syncytial virus vaccine, adjuvanted[3]
AHFS/Drugs.com
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
KEGG

In November 2020, GSK's vaccine, GSK3888550A, entered phase III trials for pregnant women.[57] The vaccine's antigen is a stabilized version of the RSV F protein, which was developed using structure-based vaccine design.[58][59] This trial was terminated in February 2022, on the advice of an external Data Monitoring Committee, because of an excess of premature births in the trial arm.[60]

The FDA analyzed data from an ongoing, randomized, placebo-controlled clinical study conducted in the US and internationally in individuals 60 years of age and older.[37] The main clinical study was designed to assess the safety and effectiveness of a single dose administered to individuals 60 years of age and older.[37] Participants agreed to remain in the study through three RSV seasons to assess the duration of effectiveness and the safety and effectiveness of repeat vaccination.[37] Data from the first RSV season of the study were available for the FDA's analysis.[37] In this study, approximately 12,500 participants received vaccine and 12,500 participants received a placebo.[37] The vaccine reduced the risk of developing RSV-associated lower respiratory tract disease by 82.6% and reduced the risk of developing severe RSV-associated lower respiratory tract disease by 94.1%.[37] The FDA granted the application priority review designation and granted approval of Arexvy to GlaxoSmithKline Biologicals.[37]

In October 2022, GSK started a phase III, observer-blind, randomized, placebo-controlled study to evaluate the safety of the vaccine in people 50–59 years of age compared to people 60 years of age and older.[45][44] The vaccine elicited an immune response in people aged 50 to 59 years of age at increased risk for RSV disease due to select underlying medical conditions that was non-inferior to that observed in people aged 60 years of age and older, meeting the trial's primary co-endpoint.[45]

Pfizer

Respiratory syncytial virus vaccine
Vaccine description
TargetRSVPreF3 antigen
Vaccine typeProtein subunit
Clinical data
Trade namesAbrysvo
AHFS/Drugs.com
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
KEGG

RSVpreF (Abrysvo) is a bivalent recombinant protein subunit vaccine which consists of equal amounts of stabilized prefusion F antigens from the two major RSV subgroups: RSV A and RSV B.[65]

In April 2023, Pfizer published their interim results of their phase III study of a RSV vaccine for adults age 60 and older in over 34,000 participants. One dose of the vaccine was 67% efficacious in preventing infections with at least two symptoms and it was 86% effective against more severe disease, in people with three related symptoms. The vaccine's protection was consistent across different subgroups, and was 62% effective in preventing acute respiratory illness caused by RSV infection.[66][67]

In April 2023, Pfizer published interim results of their double blind phase III study in about 3,600 pregnant women, with another 3,600 women receiving a placebo. One dose of the vaccine provided 81% efficacy in preventing severe infection within three months after birth and 69% in six months after birth.[68] The most common side effects were pain at the injection site, headache, muscle pain and nausea.[21]

In a subgroup of pregnant individuals who were 32 through 36 weeks gestational age, of whom about 1,500 received Abrysvo and 1,500 received placebo, Abrysvo reduced the risk of lower respiratory tract disease by 34.7%, and reduced the risk of severe lower respiratory tract disease by 91.1% within 90 days after birth when compared to placebo. Within 180 days after birth, Abrysvo reduced the risk of lower respiratory tract disease by 57.3% and by 76.5% for severe lower respiratory tract disease, when compared to placebo. In a second study, about 100 pregnant individuals received Abrysvo and approximately 100 pregnant women received placebo.[21]

Moderna

Respiratory syncytial virus vaccine
Clinical data
Trade namesMresvia
AHFS/Drugs.com
License data
Pregnancy
category
Routes of
administration		Intramuscular
ATC code
Legal status
Legal status
Identifiers
KEGG

Mresvia is an mRNA vaccine that was studied in clincal trial NCT05127434.[5][70] It was approved for medical use in the United States in May 2024.[5][42][43][18]

Society and culture

In June 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Mresvia, intended for the prevention of lower respiratory tract disease caused by respiratory syncytial virus.[47][71] The applicant for this medicinal product is Moderna Biotech Spain S.L.[47] Mresvia was approved for medical use in the European Union in August 2024.[47][48][72]

References

  1. ^ a b c d "Arexvy EPAR". European Medicines Agency (EMA). 16 June 2023. Archived from the original on 22 August 2023. Retrieved 19 June 2023.
  2. ^ "Respiratory Syncytial Virus (RSV) – NIH: National Institute of Allergy and Infectious Diseases". National Institute of Allergy and Infectious Diseases. 22 July 2022. Archived from the original on 24 April 2023. Retrieved 24 April 2023.
  3. ^ a b c d e "Arexvy- respiratory syncytial visus vaccine recombinant, adjuvanted kit". DailyMed. 3 May 2023. Archived from the original on 22 August 2023. Retrieved 2 June 2023.
  4. ^ a b c d "Abrysvo- respiratory syncytial virus vaccine kit". DailyMed. 12 July 2023. Archived from the original on 7 August 2023. Retrieved 6 August 2023.
  5. ^ a b c d "Mresvia- respiratory syncytial virus vaccine suspension". DailyMed. 31 May 2024. Archived from the original on 16 June 2024. Retrieved 16 June 2024.
  6. ^ a b c "Arexvy". U.S. Food and Drug Administration (FDA). 3 May 2023. Archived from the original on 22 August 2023. Retrieved 6 May 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  7. ^ a b c "Abrysvo". U.S. Food and Drug Administration (FDA). 1 June 2023. Retrieved 2 June 2023.
  8. ^ "US FDA approves Pfizer's RSV vaccine". Reuters. 31 May 2023. Archived from the original on 22 August 2023. Retrieved 1 June 2023.
  9. ^ a b "Arexvy Product Information". Union Register of medicinal products. 9 June 2023. Archived from the original on 22 August 2023. Retrieved 12 June 2023.
  10. ^ La Grassa J (4 August 2023). "Health Canada approves 1st RSV vaccine for people 60 and older". CBC News. Canadian Broadcasting Corporation. Archived from the original on 13 September 2023. Retrieved 9 September 2023.
  11. ^ a b "US FDA approves expanded age indication for GSK's Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk". GSK (Press release). 7 June 2024. Archived from the original on 10 June 2024. Retrieved 11 June 2024.
  12. ^ "FDA approval letter". U.S. Food and Drug Administration (FDA). Archived from the original on 11 June 2024. Retrieved 11 June 2024.
  13. ^ a b "CDC Updates RSV Vaccination Recommendation for Adults". U.S. Centers for Disease Control and Prevention (CDC). 26 June 2024. Archived from the original on 7 July 2024. Retrieved 27 June 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  14. ^ Mandavilli A (26 June 2024). "Federal Officials Revise Recommendations for R.S.V. Vaccine". The New York Times. Archived from the original on 27 June 2024. Retrieved 27 June 2024.
  15. ^ a b McLellan JS, Chen M, Joyce MG, Sastry M, Stewart-Jones GB, Yang Y, et al. (November 2013). "Structure-based design of a fusion glycoprotein vaccine for respiratory syncytial virus". Science. 342 (6158): 592–598. Bibcode:2013Sci...342..592M. doi:10.1126/science.1243283. PMC 4461862. PMID 24179220.
  16. ^ a b c d Haelle T (20 March 2023). "RSV Vaccines Are Nearly Here after Decades of False Starts". Scientific American. Archived from the original on 12 April 2023. Retrieved 13 April 2023.
  17. ^ Graham BS (February 2023). "The Journey to RSV Vaccines — Heralding an Era of Structure-Based Design". The New England Journal of Medicine. 388 (7): 579–581. doi:10.1056/NEJMp2216358. PMID 36791157. S2CID 256900516.
  18. ^ a b c "FDA Roundup: May 31, 2024". U.S. Food and Drug Administration (FDA) (Press release). 31 May 2024. Archived from the original on 31 May 2024. Retrieved 31 May 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  19. ^ a b c "Abrysvo powder and solvent for solution for injection". (emc). 29 May 2024. Archived from the original on 2 June 2024. Retrieved 2 June 2024.
  20. ^ a b "Abrysvo EPAR". European Medicines Agency (EMA). 26 September 2023. Archived from the original on 1 October 2023. Retrieved 6 October 2023.
  21. ^ a b c "FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants". U.S. Food and Drug Administration (FDA). 21 August 2023. Archived from the original on 21 August 2023. Retrieved 21 August 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  22. ^ Fleming-Dutra KE (6 October 2023). "Use of the Pfizer Respiratory Syncytial Virus Vaccine During Pregnancy for the Prevention of Respiratory Syncytial Virus–Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023". MMWR. Morbidity and Mortality Weekly Report. 72 (41): 1115–1122. doi:10.15585/mmwr.mm7241e1. PMC 10578951. PMID 37824423. S2CID 263810212.
  23. ^ "EU approves Pfizer's RSV vaccine to protect infants and older adults". Reuters. 24 August 2023. Archived from the original on 25 August 2023. Retrieved 25 August 2023.
  24. ^ "Abryvso product characteristics" (PDF). European Medicines Agency. 2023. Archived (PDF) from the original on 2 December 2023. Retrieved 2 December 2023.
  25. ^ Jha A, Jarvis H, Fraser C, Openshaw PJ (2016). "Respiratory Syncytial Virus". In Hui DS, Rossi GA, Johnston SL (eds.). SARS, MERS and other Viral Lung Infections. ERS Society Monographs. European Respiratory Society. ISBN 978-1-84984-070-5. PMID 28742304. Bookshelf ID: NBK442240. Archived from the original on 28 December 2020.
  26. ^ a b c d Acosta PL, Caballero MT, Polack FP (December 2015). "Brief History and Characterization of Enhanced Respiratory Syncytial Virus Disease". Clinical and Vaccine Immunology. 23 (3): 189–195. doi:10.1128/CVI.00609-15. PMC 4783420. PMID 26677198.
  27. ^ Dudas RA, Karron RA (July 1998). "Respiratory syncytial virus vaccines". Clinical Microbiology Reviews. 11 (3): 430–439. doi:10.1128/CMR.11.3.430. PMC 88889. PMID 9665976.
  28. ^ a b Mejias A, Rodriguez-Fernandez R, Peeples ME, Ramilo O (October 2019). "Respiratory Syncytial Virus Vaccines: Are We Making Progress?". The Pediatric Infectious Disease Journal. 38 (10): e266 – e269. doi:10.1097/INF.0000000000002404. PMC 8404780. PMID 31335571.
  29. ^ Mazur NI, Higgins D, Nunes MC, Melero JA, Langedijk AC, Horsley N, et al. (October 2018). "The respiratory syncytial virus vaccine landscape: lessons from the graveyard and promising candidates". The Lancet Infectious Diseases. 18 (10): e295 – e311. doi:10.1016/S1473-3099(18)30292-5. hdl:10044/1/61037. PMID 29914800. S2CID 49300571.
  30. ^ Powell K (December 2021). "The race to make vaccines for a dangerous respiratory virus". Nature. 600 (7889): 379–380. Bibcode:2021Natur.600..379P. doi:10.1038/d41586-021-03704-y. PMID 34893769. S2CID 245021172.
  31. ^ Che Y, Gribenko AV, Song X, Handke LD, Efferen KS, Tompkins K, et al. (April 2023). "Rational design of a highly immunogenic prefusion-stabilized F glycoprotein antigen for a respiratory syncytial virus vaccine". Science Translational Medicine. 15 (693): eade6422. doi:10.1126/scitranslmed.ade6422. PMID 37023209. S2CID 258007860.
  32. ^ Papi A, Ison MG, Langley JM, Lee DG, Leroux-Roels I, Martinon-Torres F, et al. (February 2023). "Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults". The New England Journal of Medicine. 388 (7): 595–608. doi:10.1056/NEJMoa2209604. hdl:1959.4/unsworks_84474. PMID 36791160. S2CID 256900243. Archived from the original on 30 March 2023. Retrieved 22 August 2023.
  33. ^ Fick M (9 March 2023). "GSK expects US launch of RSV vaccine with no supply issues". Reuters. Archived from the original on 12 April 2023. Retrieved 12 April 2023.
  34. ^ Bendix A (28 February 2023). "Paving the way for the world's first RSV vaccine, FDA advisers recommend shot from Pfizer". NBC News. Archived from the original on 28 February 2023. Retrieved 28 February 2023.
  35. ^ a b "Arexvy: Pending EC decision". European Medicines Agency. 26 April 2023. Archived from the original on 27 April 2023. Retrieved 27 April 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  36. ^ "First vaccine to protect older adults from respiratory syncytial virus (RSV) infection". European Medicines Agency (EMA) (Press release). 26 April 2023. Archived from the original on 27 April 2023. Retrieved 27 April 2023.
  37. ^ a b c d e f g h "FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine" (Press release). U.S. Food and Drug Administration (FDA). 3 May 2023. Archived from the original on 4 May 2023. Retrieved 3 May 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  38. ^ "First vaccine targeting RSV wins FDA approval. More are coming". The Washington Post. 3 May 2023. Archived from the original on 22 August 2023. Retrieved 3 May 2023.
  39. ^ Hensley S, Stein R (18 May 2023). "FDA advisers support approval of RSV vaccine to protect infants". NPR. Retrieved 24 May 2023.
  40. ^ "Pfizer's Maternal RSV Vaccine First to Win FDA Panel Support". Bloomberg.com. 18 May 2023. Archived from the original on 22 May 2023. Retrieved 1 June 2023.
  41. ^ "European Commission authorizes GSK's Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults". GSK (Press release). 7 June 2023. Archived from the original on 13 June 2023. Retrieved 12 June 2023.
  42. ^ a b c "Mresvia Respiratory Syncytial Virus Vaccine, mRNA (mRNA-1345)". U.S. Food and Drug Administration (FDA). 31 May 2024. Archived from the original on 2 June 2024. Retrieved 2 June 2024.
  43. ^ a b "Moderna Receives U.S. FDA Approval for RSV Vaccine Mresvia" (Press release). Moderna. 31 May 2024. Archived from the original on 31 May 2024. Retrieved 31 May 2024 – via Accesswire.
  44. ^ a b c "A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above". ClinicalTrials.gov. Archived from the original on 4 March 2024. Retrieved 11 June 2024.
  45. ^ a b c "New data for Arexvy, GSK's RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease". GSK (Press release). 25 October 2023. Archived from the original on 18 January 2024. Retrieved 11 June 2024.
  46. ^ a b "FDA Roundup: October 25, 2024". U.S. Food and Drug Administration (FDA) (Press release). 25 October 2024. Retrieved 27 October 2024. Public Domain This article incorporates text from this source, which is in the public domain.
  47. ^ a b c d e "Mresvia EPAR". European Medicines Agency. 27 June 2024. Archived from the original on 29 June 2024. Retrieved 29 June 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  48. ^ a b c "Mresvia Product information". Union Register of medicinal products. 23 August 2024. Retrieved 27 August 2024.
  49. ^ a b Goodman B (31 October 2022). "By the next RSV season, the US may have its first vaccine". CNN. Archived from the original on 14 April 2023. Retrieved 13 April 2023.
  50. ^ "For decades, fear and failure in the hunt for an RSV vaccine. Now, success". The Washington Post. 10 October 2022. Archived from the original on 10 October 2022. Retrieved 11 October 2022.
  51. ^ "This UT Scientist Helped Spare Millions From COVID-19. Now He's Unmasking Other Killer Viruses". Texas Monthly. 10 October 2022. Archived from the original on 13 October 2022. Retrieved 13 October 2022.
  52. ^ "GSK starts Phase III RSV candidate vaccine programme for older adults". GSK (Press release). 16 February 2021. Archived from the original on 6 May 2023. Retrieved 6 May 2023.
  53. ^ "GSK presents positive clinical data on maternal and older adults RSV candidate vaccines". GSK US (Press release). 21 October 2020. Archived from the original on 25 March 2023. Retrieved 6 May 2023.
  54. ^ a b c "Arexvy APMDS". Therapeutic Goods Administration (TGA). 22 January 2024. Archived from the original on 7 March 2024. Retrieved 7 March 2024.
  55. ^ "Summary Basis of Decision (SBD) for Arexvy". Health Canada. 18 November 2023. Archived from the original on 10 March 2024. Retrieved 11 December 2023.
  56. ^ "Arexvy powder and suspension for suspension for injection". (emc). 8 February 2024. Archived from the original on 18 May 2024. Retrieved 7 July 2024.
  57. ^ "Hoping for an endgame, GSK kick-starts phase 3 RSV vaccine trial in pregnant women". Fierce Biotech. 24 November 2020. Archived from the original on 3 June 2021. Retrieved 3 June 2021.
  58. ^ Cohen J (November 2013). "Structural biology triumph offers hope against a childhood killer". Science. 342 (6158): 546–547. Bibcode:2013Sci...342Q.546C. doi:10.1126/science.342.6158.546-a. PMID 24179197.
  59. ^ Crank MC, Ruckwardt TJ, Chen M, Morabito KM, Phung E, Costner PJ, et al. (August 2019). "A proof of concept for structure-based vaccine design targeting RSV in humans". Science. 365 (6452): 505–509. Bibcode:2019Sci...365..505C. doi:10.1126/science.aav9033. PMID 31371616.
  60. ^ Boytchev H (May 2023). "Maternal RSV vaccine: Further analysis is urged on preterm births". BMJ (Clinical Research Ed.). 381: 1021. doi:10.1136/bmj.p1021. PMID 37164373. S2CID 258591002.
  61. ^ a b "Abrysvo APMDS". Therapeutic Goods Administration (TGA). 21 May 2024. Archived from the original on 10 June 2024. Retrieved 10 June 2024.
  62. ^ "Regulatory Decision Summary for Abrysvo (Respiratory Syncytial Virus Stabilized Prefusion F Subunit Vaccine)". Health Canada. 21 December 2023. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
  63. ^ "Summary Basis of Decision for Abrysvo". Health Canada. 10 May 2024. Archived from the original on 8 June 2024. Retrieved 8 June 2024.
  64. ^ "Abrysvo Product Information". Union Register of medicinal products. 24 August 2023. Archived from the original on 1 October 2023. Retrieved 2 October 2023.
  65. ^ U.S. Food and Drug Administration (18 May 2023). "Vaccines and Related Biological Products Advisory Committee May 18, 2023 Meeting Briefing Document" (PDF). U.S. Food and Drug Administration (FDA). Archived from the original on 2 June 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  66. ^ Walsh EE, Pérez Marc G, Zareba AM, Falsey AR, Jiang Q, Patton M, et al. (April 2023). "Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults". The New England Journal of Medicine. 388 (16): 1465–1477. doi:10.1056/NEJMoa2213836. PMID 37018468. S2CID 257984112.
  67. ^ "Pfizer Publishes Phase III RSV Data Ahead of May Decision". BioSpace. 6 April 2023. Archived from the original on 13 April 2023. Retrieved 13 April 2023.
  68. ^ Kampmann B, Madhi SA, Munjal I, Simões EA, Pahud BA, Llapur C, et al. (April 2023). "Bivalent Prefusion F Vaccine in Pregnancy to Prevent RSV Illness in Infants" (PDF). The New England Journal of Medicine. 388 (16): 1451–1464. doi:10.1056/NEJMoa2216480. PMID 37018474. S2CID 257982982. Archived (PDF) from the original on 10 March 2024. Retrieved 26 November 2023.
  69. ^ "Mresvia product information". Health Canada. 3 December 2024. Retrieved 27 December 2024.
  70. ^ "A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age". ClinicalTrials.gov. Archived from the original on 16 June 2024. Retrieved 16 June 2024.
  71. ^ "Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 June 2024". European Medicines Agency. 28 June 2024. Archived from the original on 12 July 2024. Retrieved 12 July 2024.
  72. ^ "Moderna Receives European Commission Approval for RSV Vaccine Mresvia". Moderna (Press release). 23 August 2024. Retrieved 27 August 2024.
Quelle: http://en.wikipedia.org/wiki/RSV_vaccine