Two Vaccines Against RSV in Older Adults Approved One Month Apart: It Happened in 2023

Today, the US Centers for Disease Control and Prevention (CDC) Director Rochelle P Walensky, MD, MPH, recommended the use of GSK’s and Pfizer’s new respiratory syncytial virus (RSV) vaccines for older adults. With this authorization, adults 60 years and older are eligible to be vaccinated against RSV as soon as the vaccines are available, like by fall 2023. Individuals should meet with their health care provider to determine whether RSV vaccination is right for them, the CDC stated. Walensky endorsed the vaccination recommendation previously given by the CDC Advisory Committee on Immunization Practices (ACIP). The recommendation came after the US Food and Drug Administration (FDA) had approved Pfizer’s Abrysvo (RSVpreF) and GSK’s Arexvy (RSVPreF3 +AS01E) as the world’s first RSV vaccines. Read more

The US Food and Drug Administration (FDA) on Wednesday approved the Pfizer vaccine against respiratory syncytial virus (RSV) in older adults to be marketed as Abrysvo™. The bivalent RSV prefusion (RSVpreF) vaccine is indicated for prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals aged ≥60 years. The approval is the second milestone reached after more than 50 years of research to create the antigen that would safely elicit the most robust immune response to the virus. The Pfizer approval follows the FDA’s decision last month to greenlight Arexvy (RSVPreF3 +AS01E), the GSK vaccine to prevent LRTD caused by RSV, also in individuals aged ≥60 years. Read more

The US Food and Drug Administration (FDA) today announced approval of the first ever vaccine against respiratory syncytial virus (RSV). The vaccine (Arexvy, GSK) is approved for the prevention of RSV-associated lower respiratory tract disease (LRTD) in adults aged ≥60 years, according to the agency announcement. According to GSK, the shot will be available for older adults prior to the 2023-2024 RSV season, which typically starts in the fall and peaks during the winter. Read more

The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted on March 1, 2023, that that the data supplied by biopharmaceutical company GSK support the safety and effectiveness of the company’s respiratory syncytial virus (RSV) older adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged ≥60 years. The Committee voted unanimously 12-0 on effectiveness and 10-2 on safety, according to a GSK press statement. The VRBPAC vote is based on a compendium of data that includes results from the pivotal phase 3 AReSVi-006 (Adult Respiratory Syncytial Virus) clinical trial. That study, subsequently published in the New England Journal of Medicine, demonstrated overall vaccine efficacy of 82.6% against RSV-lower respiratory tract disease (LRTD) in adults aged ≥60 years, satisfying the trial’s primary endpoint, according to GSK. Read more

Biotechnology company Moderna announced Tuesday that its investigational vaccine against respiratory syncytial virus (RSV) in adults met its primary efficacy endpoints, including vaccine efficacy (VE) of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD) defined by ≥2 symptoms and 82.4% against disease defined by ≥3 symptoms. The results, from the phase 3 ConquerRSV trial of mRNA-1345, followed review by an independent Data Safety Monitoring Board and provide the foundation for the company's planned regulatory submission in the first half of 2023. Read more

The US Food and Drug Administration (FDA) today granted priority review to a biologics license application (BLA) for Pfizer’s respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, for older adults. The BLA for RSVpreF was submitted for the prevention of lower respiratory tract disease caused by RSV in persons aged ≥60 years. “The FDA’s acceptance of the BLA for our RSV vaccine candidate is an important regulatory milestone in Pfizer’s efforts to help protect older adults against RSV and demonstrates additional progress toward what has been an elusive public health goal – reducing the overall burden associated with this infectious disease.” The BLA submission was based on findings from the phase 3 RENOIR trial—an international, randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of a single dose of RSVpreF in adults aged ≥ 60 years. Read more