Positive results from a Phase 3 study of GSK’s vaccine candidate for the prevention of respiratory syncytial virus (RSV) in the elderly were published today in the New England Journal of Medicine. The NEJM publication summarizes pivotal efficacy data (previously presented at IDWeek 2022), showing the vaccine candidate met the primary efficacy endpoint against RSV-respiratory tract disease. lower (Lrtd) in adults 60 years of age and older, with a favorable safety profile. Efficacy was also observed in individuals with comorbidities who are at increased risk of serious outcomes. The company expects the vaccine to be available in 2023.
RSV is a major infectious disease that currently has no vaccine or specific treatment for the elderly, the British company said in a statement. In the Nejm article, the experts acknowledge the significant progress that has been made in vaccine design. GSK is the first company to publish positive phase 3 peer-reviewed data for an RSV vaccine candidate for older adults.
“Our ambition is to protect the many elderly people at risk of RSV disease, including those with other major medical conditions, who account for the majority of severe RSV outcomes,” said Tony Wood, GSK Chief Scientific Officer. in the New England Journal of Medicine. We look forward to making the vaccine available as quickly as possible – we await regulatory decisions – and to share more data from our ongoing clinical development program as we work to get ahead of this potentially debilitating virus “. As noted by Martinón-Torres, Vaccine Clinical Trials Unit coordinator, Instituto de Investigación Sanitaria de Santiago (Spain) and one of the authors of the NEJM publication, ‘although RSV often causes mild symptoms, it can have devastating consequences for the elderly and has a global impact that may approach that of seasonal influenza. The release of these important data shows that, for the first time, we are on the verge of having an effective vaccine that could have a significant impact on public health.”
The company says it is on track to supply its RSV vaccine candidate ahead of the 2023-24 Northern Hemisphere season, and is awaiting decisions from regulatory agencies in the US, EU, Japan and other countries. In this regard – highlights GSK – a meeting of the Advisory Committee for vaccines and related biological products (Vrbpac) of the US Food and Drug Administration will be held on March 1 to examine the application presented. There are currently no RSV vaccines approved anywhere in the world.
GSK is conducting three additional Phase 3 clinical trials that aim to expand the population that can benefit from RSV vaccination in adults aged 50-59 with underlying comorbidities and to provide further evidence on co-administration with other vaccines in older adults. Results are expected in 2023, along with additional data from the Phase 3 efficacy study AReSVi-006 (Adult Respiratory Syncytial Virus) and immunogenicity study AReSVi-004 evaluating an annual revaccination schedule and multi-season protection/immunogenicity after a dose of the vaccine candidate Rsv.
The elderly are at high risk of serious complications from RSV due in part to age-related decline in immunity. Those with other major medical conditions are at even greater risk. RSV can exacerbate conditions including chronic obstructive pulmonary disease (COPD), asthma and chronic heart failure, and can lead to serious outcomes such as pneumonia, hospitalization and death. Each year, RSV causes over 470,000 hospitalizations and 33,000 deaths in adults in high-income countries. Adults with other major medical conditions are more likely to seek medical services and have higher hospitalization rates than adults without these conditions.
GSK’s RSV vaccine candidate for older adults contains a prefusion recombinant RSV F glycoprotein antigen (RSVPreF3), combined with the company’s proprietary AS01 adjuvant. In multiple studies, the vaccine candidate was generally well tolerated with a favorable safety profile. The most frequently observed adverse events were injection site pain, fatigue, myalgia and headache, which were mild to moderate and transient. The AS01 Adjuvant System contains QS-21 STIMULON Adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.