Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has approved Abrysvo™ (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years and older. Abrysvo is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective.
RSV is a contagious virus and a common cause of respiratory illness worldwide. The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death. In the U.S., the burden RSV causes in older adults is considerable. The severity of RSV disease can increase with age and comorbidities, such as chronic obstructive pulmonary disease, asthma, and congestive heart failure.
The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet on June 21, 2023, to discuss recommendations for the appropriate use of RSV vaccines in older adults. Pending the outcome of this meeting, Pfizer anticipates supply availability in Q3 2023 ahead of the anticipated RSV season this fall.
Earlier this month, Pfizer reported positive top-line results from the Phase 3 study evaluating the safety and immunogenicity of Abrysvo co-administered with seasonal inactivated influenza vaccine (SIIV) in adults 65 years and older. Pfizer intends to publish these results in a peer-reviewed scientific journal. Earlier this month, Pfizer also announced it would be initiating multiple clinical trials evaluating RSVpreF in healthy children ages 2-5; children ages 5-18 with underlying medical conditions; adults ages 18-60 at high-risk due to underlying medical conditions; and adults ages 18 and older who are immunocompromised and at high-risk for RSV.
The FDA’s decision is based on the data from the pivotal Phase 3 clinical trial (NCT05035212) RENOIR (RSV vaccine Efficacy study in older adults immunized against RSV disease). RENOIR is a global, randomized, double-blind, placebo-controlled study designed to assess the efficacy, immunogenicity, and safety of a single dose of the vaccine in adults 60 years of age and older. RENOIR has enrolled approximately 37,000 participants, randomized to receive RSVpreF 120 μg or placebo in a 1:1 ratio. The results were recently published in The New England Journal of Medicine. RENOIR is ongoing, with efficacy data being collected in the second RSV season in the study.
