Express: Potential first RSV vaccine expected to prevent serious disease by up to 95% in the elderly

GSK today announced that the US FDA has accepted a Biologics License Application (BLA) for its investigational bivalent respiratory syncytial virus (RSV) vaccine candidate and granted priority review status
.
FDA expects to complete the review
by May 3, 2023.
If approved, GSK's RSV vaccine could become the first vaccine
to protect adults over 60 years of age from lower respiratory tract disease caused by RSV infection.
Prior to this, European and Japanese regulators have accepted marketing applications
for this vaccine candidate.

RSV is a common contagious virus that falls into two subtypes: type A and type B
.
In China, RSV is the leading pathogen
leading to acute respiratory infections in all ages.
It is a seasonal disease that usually begins in autumn and peaks
in winter.
The virus affects people of all ages, and for most young people, symptoms can resemble the common cold, but for infants, immunocompromised people, and the elderly, the risk of developing severe illness is higher, potentially life-threatening
.
RSV can exacerbate conditions such as chronic obstructive pulmonary disease (COPD), asthma, chronic heart failure, and lead to pneumonia, hospitalization, and death
.
Globally, RSV causes more than 336,000 hospitalizations and 14,000 deaths
each year.
It is one of
the major infectious diseases for which effective vaccines and targeted treatments are not currently available.

RSVPreF3 OA is GSK's RSV vaccine candidate for the elderly, consisting of
a combination of RSV prefusion F glycoprotein (RSVPreF3) and GSK's proprietary adjuvant.
This prefusion F glycoprotein is required
by RSV virus to enter human cells.

Image source: 123RF

This BLA application is based on the results of the
AReSVi-006 Phase 3 clinical trial.
The trial involved about 25,000 adults over the age of 60 from 17 countries
.
Data analysis showed that the RSV vaccine had a total vaccine efficacy of up to 82.
6% (96.
95% CI: 57.
9-94.
1) to help participants avoid RSV-induced lower respiratory tract diseases (number of infections, vaccine group: 7/12466, placebo group: 40/12494).

The results of the analysis of other scheduled secondary endpoints were also consistent
.
The efficacy of the vaccine in preventing severe RSV lower respiratory tract disease was 94.
6% (95% CI: 65.
9-99.
9, number of infections, vaccine group: 1/4937, placebo group: 18/4861) among those with comorbidities such as cardiorespiratory disease and endocrine metabolism, compared with 93.
8% (95% CI: 60.
2 to 99.
9, number of infections, vaccine group: 1/4487, placebo group: 16/4861) among those older participants (70-79 years) 4487）
。 In this trial, severe RSV lower respiratory tract disease was defined as having at least 2 lower respiratory symptoms, or severe symptoms
assessed by the investigators and confirmed by an external adjudication committee.
In addition, the vaccine also showed consistent efficacy in preventing RSV infection types A (84.
6%, CI: 32.
1-98.
6) and B (80.
9%, CI: 49.
4-94.
3), and neutralizing antibody responses were seen in participants
.

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Resources:

[1] GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA.
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