Long-Awaited RSV Vaccines Now Available for Older Adults and Pediatric Patients

Publish date: October 5, 2023

Slideshow below.

Respiratory syncytial virus (RSV) is highly contagious and transmitted by large aerosol droplets and fomites, either emitted from an infected person or by making surface-to-eye, -nose, or -mouth contact.¹Severe RSV can increase the risk of bacterial coinfections, pneumonia, and lower respiratory tract infections (LRTI)— particularly in infants and older adults.²

Thankfully, 2023 has been a landmark year for RSV approvals. The FDA approved its first RSV vaccine, called RSV prefusion F protein based (RSVpreF) vaccine, for people aged 60 and over in May 2023.³ In July 2023, the passive monoclonal antibody injection nirsevimab was approved as a preventative option for infants in their first and second winter seasons.⁴ Finally, the FDA approved the RSVpreF vaccine for pregnant individuals in late August 2023, with the goal of protecting infants.⁵ However, results from a recent phase 3 trial did not show significance with respect to the primary end point.⁶

Birth through 6 months is the leading timeframe of RSV-related death because of the low natural defenses and small airways of infants. On August 3, 2023, the CDC Advisory Committee on Immunization Practices unanimously recommended use of nirsevimab for all infants up to 8 months of age at the start of the RSV season and for infants at risk for severe RSV infection until 19 months of age.⁷ This decision was partly based on the MELODY and MEDLEY trials.⁸ In an unprecedented move, this monoclonal antibody will be made available through the Vaccines For Children program, the first monoclonal antibody to receive this designation. It is hoped that uptake of this therapy will result in fewer hospitalizations of infants with RSV bronchiolitis.

References

Jha A et al. Respiratory syncytial virus. In: Hui DS, Rossi GA, Johnston SL, eds. Respiratory Syncytial Virus. SARS, MERS and Other Viral Lung Infections. European Respiratory Society; 2016:chap 5. Accessed May 17, 2023.
Ginsburg SA, Srikantiah P. Lancet Glob Health. 2021;9(12):e1644-e6145. doi:10.1016/S2214-109X(21)00455-1
US Food and Drug Administration. FDA approves first respiratory syncytial virus (RSV) vaccine [press release]. Published May 3, 2023. Accessed May 17, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine
US Food and Drug Administration. FDA Approves New Drug to Prevent RSV in Babies and Toddlers [press release]. Published July 17, 2023. Accessed August 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers
US Food and Drug Administration. FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants. Published August 21, 2023. Accessed August 22, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants
Madhi SA et al. N Engl J Med. 2020;383(5):426-439. doi:10.1056/ NEJMoa1908380
Centers for Disease Control. Advisory Committee on Immunization Practices (ACIP) Meeting recommendations, August 2023. https://www.cdc.gov/vaccines/acip/recommendations.html
Hammit LL et al. N Engl J Med. 2022;386(9):837-846. doi:10.1056/ NEJMoa2110275
Centers for Disease Control and Prevention. RSV in infants and young children. Updated October 28, 2022. Accessed May 30, 2023. https://www.cdc.gov/rsv/ high-risk/infants-young-children.html
Centers for Disease Control and Prevention. RSV in older adults and adults with chronic medical conditions. Updated October 28, 2022. Accessed May 30, 2023. https://www.cdc.gov/rsv/high-risk/older-adults.html
Widmer K et al. J Infect Dis. 2012;206(1):56-62. doi:10.1093/infdis/jis309
Hall CB et al. N Engl J Med. 2009;360(6):588-598. doi:10.1056/NEJMoa0804877
McLaughlin JM et al. Open Forum Infect Dis. 2022;9(7):ofac300. doi:10.1093/ofid/ofac300
Thompson et al. JAMA. 2003;289(2):179-186. doi:10.1001/jama.289.2.179
Hansen CL et al. JAMA Netw Open. 2022;5(2):e220527. doi:10.1001/jamanetworkopen.2022.0527
Walsh EE et al; RENOIR Clinical Trial Group. N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836
Martin JA et al. Natl Vital Stat Rep. 2019;68(13):1-47. PMID:32501202
Townsi N et al. Eur Clin Respir J. 2018;5(1):1487214. doi:10.1080/20018525.20 18.1487214
Malek A et al. Am J Reprod Immunol. 1994;32(1):8-14. doi:10.1111/j.1600-0897.1994.tb00873.x
Kampmann B et al; MATISSE Study Group. N Engl J Med. 2023;388(16):1451- 1464. doi:10.1056/NEJMoa2216480
Synagis (palivizumab) injection prescribing information. Published June 2023. Accessed August 2023. https://www.synagis.com/synagis.pdf

References

Jha A et al. Respiratory syncytial virus. In: Hui DS, Rossi GA, Johnston SL, eds. Respiratory Syncytial Virus. SARS, MERS and Other Viral Lung Infections. European Respiratory Society; 2016:chap 5. Accessed May 17, 2023.
Ginsburg SA, Srikantiah P. Lancet Glob Health. 2021;9(12):e1644-e6145. doi:10.1016/S2214-109X(21)00455-1
US Food and Drug Administration. FDA approves first respiratory syncytial virus (RSV) vaccine [press release]. Published May 3, 2023. Accessed May 17, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine
US Food and Drug Administration. FDA Approves New Drug to Prevent RSV in Babies and Toddlers [press release]. Published July 17, 2023. Accessed August 11, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-new-drug-prevent-rsv-babies-and-toddlers
US Food and Drug Administration. FDA Approves First Vaccine for Pregnant Individuals to Prevent RSV in Infants. Published August 21, 2023. Accessed August 22, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-vaccine-pregnant-individuals-prevent-rsv-infants
Madhi SA et al. N Engl J Med. 2020;383(5):426-439. doi:10.1056/ NEJMoa1908380
Centers for Disease Control. Advisory Committee on Immunization Practices (ACIP) Meeting recommendations, August 2023. https://www.cdc.gov/vaccines/acip/recommendations.html
Hammit LL et al. N Engl J Med. 2022;386(9):837-846. doi:10.1056/ NEJMoa2110275
Centers for Disease Control and Prevention. RSV in infants and young children. Updated October 28, 2022. Accessed May 30, 2023. https://www.cdc.gov/rsv/ high-risk/infants-young-children.html
Centers for Disease Control and Prevention. RSV in older adults and adults with chronic medical conditions. Updated October 28, 2022. Accessed May 30, 2023. https://www.cdc.gov/rsv/high-risk/older-adults.html
Widmer K et al. J Infect Dis. 2012;206(1):56-62. doi:10.1093/infdis/jis309
Hall CB et al. N Engl J Med. 2009;360(6):588-598. doi:10.1056/NEJMoa0804877
McLaughlin JM et al. Open Forum Infect Dis. 2022;9(7):ofac300. doi:10.1093/ofid/ofac300
Thompson et al. JAMA. 2003;289(2):179-186. doi:10.1001/jama.289.2.179
Hansen CL et al. JAMA Netw Open. 2022;5(2):e220527. doi:10.1001/jamanetworkopen.2022.0527
Walsh EE et al; RENOIR Clinical Trial Group. N Engl J Med. 2023;388(16):1465-1477. doi:10.1056/NEJMoa2213836
Martin JA et al. Natl Vital Stat Rep. 2019;68(13):1-47. PMID:32501202
Townsi N et al. Eur Clin Respir J. 2018;5(1):1487214. doi:10.1080/20018525.20 18.1487214
Malek A et al. Am J Reprod Immunol. 1994;32(1):8-14. doi:10.1111/j.1600-0897.1994.tb00873.x
Kampmann B et al; MATISSE Study Group. N Engl J Med. 2023;388(16):1451- 1464. doi:10.1056/NEJMoa2216480
Synagis (palivizumab) injection prescribing information. Published June 2023. Accessed August 2023. https://www.synagis.com/synagis.pdf

Long-Awaited RSV Vaccines Now Available for Older Adults and Pediatric Patients

References

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