Arexvy:

A Battle of the RSV Vaccines

Jae H Joe, PharmD

Ambulatory Care Journal Club
December 28, 2023
 Respiratory Syncytial Virus (RSV)

Common respiratory virus with 2 major subtypes (A and B)

Spread through air via respiratory droplet or direct contact

Typically causes cold symptoms lasting 1 to 2 weeks

Causes 60,000 to 160,000 hospitalizations in adults each year

www.cdc.gov/vaccines/vpd/rsv
Hamid S, et al. MMWR Morb Mortal Wkly Rep. 2023 Apr 7;72(14):355-361
 Risk Factors
• Adults vs Children
o Higher hospitalization and mortality rate in adult
population especially older adult age > 65,
with chronic lung and/or heart diseases, and
weakened immune system
o Comorbidities that can affect the hospitalization
 Stroke
 Congestive heart failure
 Chronic obstructive pulmonary disease (COPD)
 Chronic kidney disease
 Hematologic malignancy

www.cdc.gov/vaccines/vpd/rsv
 Current ACIP Recommendations

Arexvy (GSK)

• Adults aged 60+ using shared clinical decision-

making
Abrysvo (Pfizer)

• Adults aged 60+ using shared clinical decision-

making
• Pregnant patients between 32-36 weeks gestation
www.cdc.gov/vaccines/vpd/rsv
AREXVY
 Objective

Primary Secondary
Evaluate the efficacy Evaluation of efficacy against
• RSV related acute respiratory infection
• Severe RSV-related lower respiratory diseases
• RSV-related lower respiratory tract diseases
according to RSV subtype (A and B), participant
age, the presence or absence of coexisting
conditions at baseline
 • A Phase 3, international, randomized, placebo-controlled,
observer-blind, multi-country study
o 17 countries in Africa, Asia, Australia, Europe, and North America
Method and  Northern Hemisphere (Oct 1 – Apr 30) : Belgium, Canada, Estonia, Finland,
Germany, Italy, Japan, Mexico, United Kingdom, and the United States

Design  Southern Hemisphere (Mar 1 – Sep 30): Australia, New Zealand, and
South Africa
o From 2021 to 2022
• Randomly assigned, in a 1:1 ratio to give 0.5ml of vaccine
or placebo
 Participants
Inclusion criteria
• A male of female > 60 years old age
• Participants who, in the opinion of the
investigator, can and will comply with the
requirements of the protocol
• Participants who are medically stable in
the opinion of the investigator
Exclusion Criteria
• Immunocompromised
• Hypersensitivity to any vaccine
• Hypersensitivity to latex
• Serious or unstable chronic illness
• Neurological disorder
• Use of any investigational or non-
registered product (drug, vaccine, or
medical devices)
• Previous vaccination with an RSV vaccine
 Participants

Papi, A., Ison, M. G., Langley, J. M., Lee, D. G., Leroux-Roels, I., Martinon-Torres, F., Schwarz, T. F., van Zyl-Smit, R. N., Campora, L., Dezutter, N., de Schrevel, N., Fissette, L., David, M. P., Van der Wielen, M.,
Kostanyan, L., Hulstrøm, V., & AReSVi-006 Study Group (2023). Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. The New England journal of medicine, 388(7), 595–608.
https://doi.org/10.1056/NEJMoa2209604
 Baseline characteristics

Characteristics Arexvy Group (N=12,467) Placebo Group (N=12,499)

Age (mean) 69.5 ± 6.5 69.6 ± 6.4

Female Sex – no (%) 6,488 (52.) 6,427 (51.4)

Race- no (%)
Black 1,064 (8.5) 1,101 (8.8)
Asian 953 (7.6) 956 (7.6)
White 9,887 (79.3) 9,932 (79.5)
Other 563 (4.5) 510 (4.1)
Frailty status – no (%)
Frail 189 (1.5) 177 (1.4)
Prefrail 4,793 (38.4) 4,781 (38.3)
Fit 7,464 (59.9) 7,521 (60.2)
Preexisting condition of interest – no (%)
Any pre-existing condition 4,937 (39.6) 4,864 (38.9)
Cardiorespiratory condition 2,496 (20) 2,422 (19.4)
Endocrine or metabolic condition 3,200 (25.7) 3,236 (25.9)
 Result

Papi, A., Ison, M. G., Langley, J. M., Lee, D. G., Leroux-Roels, I., Martinon-Torres, F., Schwarz, T. F., van Zyl-Smit, R. N., Campora, L., Dezutter, N., de Schrevel, N., Fissette, L., David, M. P., Van der Wielen, M.,
Kostanyan, L., Hulstrøm, V., & AReSVi-006 Study Group (2023). Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. The New England journal of medicine, 388(7), 595–608.
https://doi.org/10.1056/NEJMoa2209604
 Time frame: From day 15 post-vaccination up to
Efficacy Outcome end of season 1

Arexvy group Placebo group Vaccine efficacy

No of participants No of events No of participants No of events %

RSV related lower respiratory tract diseases

Overall 12,466 7 12,494 40 82.6 (57.9-94.1)

RSV-related acute respiratory infection

Overall 12,466 27 12,494 95 71.7 (56.2-82.3)

Papi, A., Ison, M. G., Langley, J. M., Lee, D. G., Leroux-Roels, I., Martinon-Torres, F., Schwarz, T. F., van Zyl-Smit, R. N., Campora, L., Dezutter, N., de Schrevel, N., Fissette, L., David, M. P., Van der Wielen, M.,
Kostanyan, L., Hulstrøm, V., & AReSVi-006 Study Group (2023). Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. The New England journal of medicine, 388(7), 595–608.
https://doi.org/10.1056/NEJMoa2209604
 Time frame: From day 15 post-vaccination upto
Efficacy outcome end of season 1

Arexvy group Placebo group Vaccine efficacy

No of No of Incident rate No of No of Incident rate %

participants events (no. of events/ participants events (no of events/
1000 participant yr) 1000 participant yr)

According to RSV subtype

RSV A 12,466 2 0.3 12,494 13 1.9 84.6 (32.1-98.3)

RSV B 12,466 5 0.7 12,494 26 3.8 80.9 (49.4-94.3)

Papi, A., Ison, M. G., Langley, J. M., Lee, D. G., Leroux-Roels, I., Martinon-Torres, F., Schwarz, T. F., van Zyl-Smit, R. N., Campora, L., Dezutter, N., de Schrevel, N., Fissette, L., David, M. P., Van der Wielen, M.,
Kostanyan, L., Hulstrøm, V., & AReSVi-006 Study Group (2023). Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. The New England journal of medicine, 388(7), 595–608.
https://doi.org/10.1056/NEJMoa2209604
 Time frame: From day 15 post-vaccination upto
Safety outcome end of season 1

Arexvy group Placebo group

No of Incidence (95% CI) % No of Incidence (95% CI) %
participants participants
Solicited reaction
Any solicited reaction (n=879) 632 71.9 (68.8 - 74.9) 245 27.9 (25.0 - 31.0)

Pain (injection site reaction) 535 60.9 (57.5 - 64.1) 81 9.3 (7.4 - 11.4)

Fatigue (systemic reaction) 295 33.6 (30.4 - 36.8) 141 16.1 (13.7 - 18.7)

Papi, A., Ison, M. G., Langley, J. M., Lee, D. G., Leroux-Roels, I., Martinon-Torres, F., Schwarz, T. F., van Zyl-Smit, R. N., Campora, L., Dezutter, N., de Schrevel, N., Fissette, L., David, M. P., Van der Wielen, M.,
Kostanyan, L., Hulstrøm, V., & AReSVi-006 Study Group (2023). Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older Adults. The New England journal of medicine, 388(7), 595–608.
https://doi.org/10.1056/NEJMoa2209604
 • A single dose of the Arexvy vaccine had an acceptable
Author's safety profile and prevented RSV-related lower respiratory
tract infections and diseases in adult 60 years of age or
conclusion older, regardless of RSV subtype and the presence of
underlying coexisting conditions
Critique

Strength

• Multi-centered, multi country study

Limitation

• Potential biased in participant selection

• The selection of participants was based on the decision of the investigator.
• Limited number of incidents (total 47 cases in 24,966 participants)
• Additional RSV seasons need to be studied to better understand vaccine efficacy
Presenter's conclusion
 References

1. CDC RSV Vaccine Information. Available at: https://www.cdc.gov/vaccines/vpd/rsv/index.html

2. Hamid S, Winn A, Parikh R, et al. Seasonality of Respiratory Syncytial Virus - United States, 2017-2023.
MMWR Morb Mortal Wkly Rep. 2023 Apr 7;72(14):355-361. doi: 10.15585/mmwr.mm7214a1.
3. Papi A, Ison MG, Langley JM, et al. Respiratory Syncytial Virus Prefusion F Protein Vaccine in Older
Adults. N Engl J Med. 2023 Feb 16;388(7):595-608. doi: 10.1056/NEJMoa2209604.
4. Walsh EE, Pérez Marc G, Zareba AM, et al. Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in
Older Adults. N Engl J Med. 2023 Apr 20;388(16):1465-1477. doi: 10.1056/NEJMoa2213836.