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2023-05-08| Trials & Approvals

GSK Wins Approval For World’s First RSV Vaccine

by Joy Lin
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GSK has announced the US FDA approval of Arexvy, a vaccine against respiratory syncytial virus (RSV), making it the first vaccine of its kind to be approved in the world. 

While RSV, a common and contagious virus, typically afflicts adults with cold-like symptoms, it can lead to potentially serious respiratory illnesses such as bronchitis and pneumonia, especially in high-risk groups including young children, older adults, and those with weakened immune systems. Each year, RSV causes approximately 177,000 hospitalizations and an estimated 14,000 deaths in adults aged 65 and older. 

Hailing the approval as a ‘turning point”, GSK CEO Tony Wood stated the company will focus on ensuring access to the vaccine for eligible older adults in the US as quickly as possible and progressing regulatory review in other countries. 

In June 2023, the Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of the vaccine in the US. The vaccine will be available for older adults before the 2023/24 RSV season, which typically starts ahead of the winter months.

In Europe, Arexvy is expecting a final regulatory decision in the upcoming months. In April, Arexvy received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending the vaccine for adults aged 60 years and older. The vaccine is also awaiting approval in Japan and other countries. 

Related article: Pfizer and GSK Neck and Neck for First FDA-Approved RSV Vaccine

Arexvy Shows Overall Efficacy of 82.6% 

Arexvy is designed to prevent lower respiratory tract disease (LRTD) caused by RSV (RSV-LRTD). It combines a recombinant subunit protein derived from the RSV F glycoprotein antigen (RSVPreF3) with GSK’s AS01E adjuvant, which is also used in GSK’s vaccines for tuberculosis, shingrix and malaria. 

The US nod is based on data from GSK’s Phase 3 trial, AReSVi-006 (Adult Respiratory Syncytial Virus). In the trial, the vaccine presented an overall efficacy of 82.6% against RSV-LRTD in adults aged 60 years and older, meeting the primary endpoint. The efficacy goes up to 94.1% against severe cases of RSV-LRTD, defined as an episode preventing day-to-day activities. 

In addition, efficacy was 94.6% in older adults with at least one underlying medical condition of interest, such as diabetes and chronic heart and lung disease. 

The vaccine was generally well tolerated with an acceptable safety profile. The most frequently observed solicited adverse events were injection site pain, fatigue, muscle aches, headache, and joint pain. These were generally mild to moderate and temporary.

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