Condition Watch: Respiratory Syncytial Virus

Updated Filling Line Is Expected to Improve Supply of Nirsevimab for 2024-2025 Season

In preparation for this year’s respiratory syncytial virus (RSV) season, Sanofi and AstraZeneca are preparing a newly approved filling line for nirsevimab-alip (Beyfortus) to avoid supply issues encountered during the previous RSV season. The companies announced that, with the help of partners, they intend to provide enough coverage for all eligible infants in the US.¹ This includes all babies younger than 8 months who were born to mothers who did not receive a maternal vaccine, as well as children aged 8 through 19 months who are at increased risk for severe RSV.²

Image credit: Bonn | stock.adobe.com

“This upcoming season, we look forward to Beyfortus offering its demonstrated real-world protection to as many infants as possible,” Thomas Grenier, Sanofi’s head of vaccines for North America, said in a news release.¹

The companies noted that shipments of 50-mg and 100-mg doses of nirsevimab-alip are in place to be distributed via private health care providers and the CDC’s Vaccines for Children Program.¹

Because of the limited supply of nirsevimab-alip during the 2023-2024 RSV season, the CDC recommended that health care providers prioritize the 100-mg dose of nirsevimab for infants with the highest risk for severe RSV.³ However, with this year’s new filling line, health care providers should not have to face similar issues this season. The companies said they are confident that the filling line will add capacity and market enough vaccines for infants born during and after RSV season.¹ —Kennedy Ferruggia, Assistant Editor

REFERENCES

1. Becker Z. With amped up manufacturing effort, Sanofi and AZ look to avoid Beyfortus shortfalls this year. Fierce Pharma. September 17, 2024. Accessed September 19, 2024. https://www.fiercepharma.com/manufacturing/sanofi-and-az-look-sidestep-last-years-beyfortus-shortage-enough-supply-every

2. Nirsevimab-alip intramuscular injection (Beyfortus). ASHP. April 1, 2024. Accessed September 19, 2024. https://www.ashp.org/drug-shortages/current-shortages/drug-shortage-detail.aspx?id=999&loginreturnUrl=SSOCheckOnly#:~:text=Due%20to%20the%20limited%20supply,risk%20for%20severe%20RSV%20disease

3. Immunizations to protect infants. CDC. August 30, 2024. Accessed September 19, 2024. https://www.cdc.gov/rsv/vaccines/protect-infants.html

Nirsevimab Displays 82% Reduction in Infant RSV Hospitalization During 2023-2024 Season

Evidence published in The Lancet showed that nirsevimab (Beyfortus; Sanofi Pasteur, Inc/AstraZeneca AB) resulted in an 82% reduction in infant hospitalizations due to respiratory syncytial virus (RSV) during the 2023-2024 season compared with no intervention.¹ The results are part of the 3-year NIRSE-GAL study (NCT06180993), conducted in Galicia, Spain, and were from the first RSV season after the introduction of nirsevimab. The results reinforce other real-world evidence from several broad infant immunization programs in the US, Spain, and France during the 2023-2024 RSV season.¹

Additionally, results of an interim analysis of 2023 and 2024 surveillance data published by the CDC showed that a single dose of nirsevimab was 90% effective in preventing RSV-related hospitalizations among infants who were immunized before 8 months of age. Data from the report, which evaluated infants hospitalized with acute respiratory illness, found that receipt of nirsevimab was more frequent among infants with high risk medical conditions vs those without (46% vs 6%).²

Regarding this year’s RSV season, nirsevimab is expected to provide similar protection among infants at risk for severe RSV as the first immunization designed for all infants to shield against the virus through their first RSV season. This includes infants born healthy at term or preterm, those with conditions that make them more vulnerable to RSV, and children up to 2 years of age who remain vulnerable in their second season. —Aislinn Antrim, Assistant Managing Editor

REFERENCES

1. Beyfortus real-world evidence published in The Lancet shows 82% reduction in infant RSV hospitalizations. Press release. Sanofi; May 2, 2024. Accessed May 2, 2024. https://www.sanofi.com/en/media-room/press-releases/2024/2024-05-02-05-00-00-2873804

2. 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

Data Demonstrate Cost Savings Are Associated With RSV Vaccination

Researchers found cost-effective benefits with vaccination against respiratory syncytial virus (RSV) among individuals 60 years and older, according to findings from a study conducted by the University of Michigan and the CDC.

Researchers assessed 2 RSV vaccines—Arexvy (GSK plc) and Abrysvo (Pfizer Inc)—that were granted FDA approval for adults 60 years and older to prevent RSV lower respiratory tract disease. Following the approval, the CDC issued a recommendation that adults 60 years and older receive a single dose of RSV vaccination. The study aimed to evaluate the cost-effectiveness of the 2 vaccines compared with no vaccination among older adults in the US. The study authors noted that the analysis focused on the extent of RSV vaccination in connection with cost-effectiveness in adults 60 to 65 years of age and adults older than 65 years.

The results showed that the costs differed by age group and type of vaccine, and further findings revealed that vaccine efficacy, the incidence of RSV-related hospitalizations, and vaccine costs had the most significant impact on the cost per quality adjusted life year (QALY) saved, according to study authors.

The authors noted that the societal cost per QALY saved was $196,842 for Arexvy and $176,557 for Abrysvo for adults 60 years and older, and $162,138 for Arexvy and $146,543 for Abrysvo for adults 65 years and older. However, the cost per QALY saved was higher for adults aged 60 to 64 years, at $385,829 for Arexvy and $331,486 for Abrysvo.

The findings suggest that RSV vaccination could be cost effective among adults 60 years and older, with the ability to decrease vaccine costs and sustain efficacy. However, the researchers noted that further investigation needs to be conducted to determine the long-term efficacy of RSV vaccination. —Kennedy Ferruggia, Assistant Editor

REFERENCE

Hutton DW, Prosser LA, Rose AM, et al. Cost-effectiveness of vaccinating adults aged 60 years and older against respiratory syncytial virus. Vaccine. 2024;42(24):126294. doi:10.1016/j.vaccine.2024.126294