Back to previous page

Summary

Video transcript

On Screen Text

SUMMARY

PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.

On Screen Text

AREXVY (RESPIRATORY SYNCYTIAL VIRUS VACCINE, ADJUVANTED)

Audio

Here is a summary of AREXVY's efficacy data, and insights on how to protect your appropriate older adult patients before the RSV season begins.

We know that AREXVY has proven to protect individuals who are 60 and up from RSV lower respiratory tract disease.

On Screen Text

AREXVY Is Proven to Protect Individuals Aged 60 Years and Older from RSV-LRTD1

AReSVi-006, an ongoing phase 3 study, randomized participants ≥60 years of age to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494). Median follow-up for this analysis was 6.7 months.

PRIMARY ENDPOINT 82.6%

OVERALL EFFICACY AGAINST RSV-LRTD (96.95% CI, 57.9, 94.1)

AREXVY (7 cases out of 12,466), placebo (40 cases out of 12,494)

SECONDARY ENDPOINT 94.6% EFFICACY AGAINST RSV-LRTD

IN PARTICIPANTS WITH AT LEAST 1 COMORBIDITY* (95% CI, 65.9, 99.9)

AREXVY (1 case out of 4937), placebo (18 cases out of 4861)

*Comorbidities of interest: chronic obstructive pulmonary disease (COPD), asthma, any chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2, and advanced liver or renal disease.

The most commonly reported adverse reactions (greater than or equal to 10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%).

LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.

1. Prescribing Information for AREXVY.

PLEASE SEE IMPORTANT SAFETY INFORMATION AND FULL PRESCRIBING INFORMATION AVAILABLE ON THIS WEBSITE.

Audio

Which was resulting from the Phase 3 randomized placebo-controlled trial of a single dose of AREXVY in adults 60 and up, which showed the efficacy we described earlier. With a median follow up of 6.7 months. Again, 82.6% vaccine efficacy against RSV-LRTD, which was our primary objective. But when you look at individuals with at least 1 preexisting comorbidity of interest, 94.6% vaccine efficacy.

The most commonly reported adverse reactions were injection site pain, fatigue, myalgia, headache, and arthralgia.

On Screen Text

AREXVY (RESPIRATORY SYNCYTIAL VIRUS VACCINE, ADJUVANTED)

Audio

So, you're protecting not only the older individuals, but you're also protecting older individuals with significant comorbidities. That's what we want to do -- and that's what we feel is extremely important.

On Screen Text

Intended for US healthcare professionals only.

Trademarks are owned by or licensed to the GSK group of companies.

©2023 GSK or licensor.

RSAVID230044 July 2023

Produced in USA.

close