PFIZER
Subject:
Efficacy and Real-World Evidence: Protecting Adults 60+ Against RSV with ABRYSVO®
From:
Pfizer Medical Affairs & Medical Information
To:
Dr. Aris Thorne
Dear Dr. Thorne,
Respiratory Syncytial Virus (RSV) presents a significant clinical burden in older adults and individuals with
underlying chronic health conditions. In adult populations aged 60 and older, RSV infection can lead to
severe lower respiratory tract disease (LRTD), resulting in increased hospitalization rates, exacerbation of
underlying cardiopulmonary conditions, and prolonged clinical recovery times during peak viral seasons.
THE PFIZER SOLUTION: ABRYSVO® (RESPIRATORY SYNCYTIAL VIRUS VACCINE)
ABRYSVO®
is an FDA-approved, unadvisvanted bivalent recombinant subunit vaccine indicated
for the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years
of age and older, as well as for maternal immunization to protect infants from birth through 6
months of age.
Clinical Value Proposition:
Provide robust, bivalent protection targeting both RSV subgroup A and RSV
subgroup B strains with a single-dose immunization engineered to deliver demonstrated efficacy and a
favorable safety profile in older adults.
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Demonstrated Clinical Efficacy (RENOIR Trial):
In the pivotal Phase 3 RENOIR clinical trial, ABRYSVO
demonstrated 85.7% efficacy in preventing RSV-associated lower respiratory tract disease characterized
by three or more symptoms in adults aged 60 and older.
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Dual Subgroup Coverage Without Adjuvant:
Formulated with stabilized prefusion F proteins from both
RSV-A and RSV-B strains, delivering targeted neutralizing antibody response without the addition of an
adjuvant.
■
Streamlined Clinical Practice Integration:
Administered as a single 0.5 mL intramuscular injection,
offering convenient integration into routine preventative care workflows and clinical immunization
protocols.
Verified Clinical Evidence & Guidelines:
ABRYSVO efficacy data was evaluated in a randomized, double-
blind, placebo-controlled international study involving over 34,000 adults aged 60 and older. CDC Advisory
Committee on Immunization Practices (ACIP) recommendations support RSV vaccination for eligible older
adults using shared clinical decision-making.
IMPORTANT SAFETY INFORMATION & INDICATION SUMMARY:
ABRYSVO is indicated for active immunization of individuals 60 years of age and older for the prevention of lower
respiratory tract disease caused by RSV. ABRYSVO is contraindicated in individuals with a history of severe allergic
reaction (e.g., anaphylaxis) to any component of the vaccine. Syncope (fainting) may occur in association with
administration of injectable vaccines. Immunocompromised persons, including those receiving immunosuppressive
therapy, may have a diminished immune response. The most common solicited adverse reactions in adults 60 years
of age and older were injection site pain, fatigue, headache, and myalgia.
REQUEST CLINICAL EVIDENCE BRIEFING & FULL PRESCRIBING INFORMATION
VACCINES & HOSPITAL CARE DIVISION
