RSV Updates: Prophylaxis Approval and Hospitalization for Severe RSV

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RSV Updates: Prophylaxis Approval and Hospitalization for Severe RSV
References

1.  Pfizer announces positive top-line results from phase 3 study of ABRYSVO® in adults aged 18 to 59 at increased risk for RSV disease. Press release. Pfizer; April 9, 2024. Accessed May 22, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-results-phase-3-study-1

2.  Pfizer announces positive top-line data for full season two efficacy of ABRYSVO® for RSV in older adults. Press release. Pfizer; February 29, 2024. Accessed May 22, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-full-season-two

3.  CDC study shows effectiveness of RSV immunization for infants. Press release. US Centers for Disease Control and Prevention; March 7, 2024. Accessed May 22, 2024. https://www.cdc.gov/media/releases/2024/s0307-rsv-immunization.html

4.  Moline HL, Tannis A, Toepfer AP, et al. Early estimate of nirsevimab effectiveness for prevention of respiratory syncytial virus–associated hospitalization among infants entering their first respiratory syncytial virus season — new vaccine surveillance network, October 2023–February 2024. MMWR Morb Mortal Wkly Rep. 2024;73(9):209-214. doi:10.15585/mmwr.mm7309a4

5.  Havers FP, Whitaker M, Melgar M, et al; for the RSV-NET Surveillance Team. Characteristics and outcomes among adults aged 60 years hospitalized with laboratory-confirmed respiratory syncytial virus ─ RSV-NET, 12 states, July 2022–June 2023. MMWR Morb Mortal Wkly Rep. 2023;72(40):1075-1082. doi:10.15585/mmwr.mm7240a1

6.  Walsh EE, Pérez Marc G, Zareba AM, et al; for the RENOIR Clinical Trial Group. Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836

7.  Fleming-Dutra KE, Jones JM, Roper LE, et al. 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 Morb Mortal Wkly Rep. 2023;72(41):1115-1122. doi:10.15585/mmwr.mm7241e1

8.  Baker J, Aliabadi N, Munjal I, et al. Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: results of a randomized phase 3 study. Vaccine. 2024;42(13):3172-3179. doi:10.1016/j.vaccine.2024.03.070

9.  New data for AREXVY, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease. Press release. GSK; October 25, 2023. Accessed May 22, 2024. https://us.gsk.com/en-us/media/press-releases/new-data-for-arexvy/                                    

 

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Riddhi Upadhyay, MD
Attending Staff Physician
Division of Critical Care
Geisinger Community Medical Center
Scranton, PA

Dr. Upadhyay has no relevant financial disclosures.

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Riddhi Upadhyay, MD
Attending Staff Physician
Division of Critical Care
Geisinger Community Medical Center
Scranton, PA

Dr. Upadhyay has no relevant financial disclosures.

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Riddhi Upadhyay, MD
Attending Staff Physician
Division of Critical Care
Geisinger Community Medical Center
Scranton, PA

Dr. Upadhyay has no relevant financial disclosures.

References

1.  Pfizer announces positive top-line results from phase 3 study of ABRYSVO® in adults aged 18 to 59 at increased risk for RSV disease. Press release. Pfizer; April 9, 2024. Accessed May 22, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-results-phase-3-study-1

2.  Pfizer announces positive top-line data for full season two efficacy of ABRYSVO® for RSV in older adults. Press release. Pfizer; February 29, 2024. Accessed May 22, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-full-season-two

3.  CDC study shows effectiveness of RSV immunization for infants. Press release. US Centers for Disease Control and Prevention; March 7, 2024. Accessed May 22, 2024. https://www.cdc.gov/media/releases/2024/s0307-rsv-immunization.html

4.  Moline HL, Tannis A, Toepfer AP, et al. Early estimate of nirsevimab effectiveness for prevention of respiratory syncytial virus–associated hospitalization among infants entering their first respiratory syncytial virus season — new vaccine surveillance network, October 2023–February 2024. MMWR Morb Mortal Wkly Rep. 2024;73(9):209-214. doi:10.15585/mmwr.mm7309a4

5.  Havers FP, Whitaker M, Melgar M, et al; for the RSV-NET Surveillance Team. Characteristics and outcomes among adults aged 60 years hospitalized with laboratory-confirmed respiratory syncytial virus ─ RSV-NET, 12 states, July 2022–June 2023. MMWR Morb Mortal Wkly Rep. 2023;72(40):1075-1082. doi:10.15585/mmwr.mm7240a1

6.  Walsh EE, Pérez Marc G, Zareba AM, et al; for the RENOIR Clinical Trial Group. Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836

7.  Fleming-Dutra KE, Jones JM, Roper LE, et al. 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 Morb Mortal Wkly Rep. 2023;72(41):1115-1122. doi:10.15585/mmwr.mm7241e1

8.  Baker J, Aliabadi N, Munjal I, et al. Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: results of a randomized phase 3 study. Vaccine. 2024;42(13):3172-3179. doi:10.1016/j.vaccine.2024.03.070

9.  New data for AREXVY, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease. Press release. GSK; October 25, 2023. Accessed May 22, 2024. https://us.gsk.com/en-us/media/press-releases/new-data-for-arexvy/                                    

 

References

1.  Pfizer announces positive top-line results from phase 3 study of ABRYSVO® in adults aged 18 to 59 at increased risk for RSV disease. Press release. Pfizer; April 9, 2024. Accessed May 22, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-results-phase-3-study-1

2.  Pfizer announces positive top-line data for full season two efficacy of ABRYSVO® for RSV in older adults. Press release. Pfizer; February 29, 2024. Accessed May 22, 2024. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-data-full-season-two

3.  CDC study shows effectiveness of RSV immunization for infants. Press release. US Centers for Disease Control and Prevention; March 7, 2024. Accessed May 22, 2024. https://www.cdc.gov/media/releases/2024/s0307-rsv-immunization.html

4.  Moline HL, Tannis A, Toepfer AP, et al. Early estimate of nirsevimab effectiveness for prevention of respiratory syncytial virus–associated hospitalization among infants entering their first respiratory syncytial virus season — new vaccine surveillance network, October 2023–February 2024. MMWR Morb Mortal Wkly Rep. 2024;73(9):209-214. doi:10.15585/mmwr.mm7309a4

5.  Havers FP, Whitaker M, Melgar M, et al; for the RSV-NET Surveillance Team. Characteristics and outcomes among adults aged 60 years hospitalized with laboratory-confirmed respiratory syncytial virus ─ RSV-NET, 12 states, July 2022–June 2023. MMWR Morb Mortal Wkly Rep. 2023;72(40):1075-1082. doi:10.15585/mmwr.mm7240a1

6.  Walsh EE, Pérez Marc G, Zareba AM, et al; for the RENOIR Clinical Trial Group. Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836

7.  Fleming-Dutra KE, Jones JM, Roper LE, et al. 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 Morb Mortal Wkly Rep. 2023;72(41):1115-1122. doi:10.15585/mmwr.mm7241e1

8.  Baker J, Aliabadi N, Munjal I, et al. Equivalent immunogenicity across three RSVpreF vaccine lots in healthy adults 18-49 years of age: results of a randomized phase 3 study. Vaccine. 2024;42(13):3172-3179. doi:10.1016/j.vaccine.2024.03.070

9.  New data for AREXVY, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease. Press release. GSK; October 25, 2023. Accessed May 22, 2024. https://us.gsk.com/en-us/media/press-releases/new-data-for-arexvy/                                    

 

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In 2023, significant progress was made in preventing RSV lower respiratory tract disease (LRTD) with the FDA approval of 3 vaccines and a monoclonal antibody. Published efficacy rates and ongoing trials, like the MONeT (RSV IMmunizatiON Study for AdulTs with a Higher Risk of Severe Illness) trial for high-risk 18- to 59-year-olds, continue to advance RSV prophylaxis.1 Early 2024 results showed that the RSVpreF vaccine (Abrysvo) effectively protected against RSV A and B, with a 77.8% effectiveness in preventing RSV LRTD in adults aged ≥ 60 years in its second season.2 The CDC reported nirsevimab was 90% effective in preventing RSV hospitalization in infants during their first RSV season.3,4 Further, results from a study published in June 2023 identified obesity, COPD, and congestive heart failure (CHF) as common comorbidities in patients who were ≥ 60 years and hospitalized with RSV. The study also found that those aged ≥ 75 years experienced worse outcomes.5 This data aids in performing risk assessments for patients with RSV by age and comorbidities. Ongoing research for preventing RSV in different populations with various risks and comorbidities is imperative. Additional FDA approvals will help protect more individuals from this potentially life-threatening disease.

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