Express shows nearly 95% protection! GSK's marketing application for RSV vaccine is imminent

GSK today announced positive results
in a pivotal Phase 3 clinical trial of its bivalent respiratory syncytial virus (RSV) vaccine candidate.
The data shows that the trial has achieved the main endpoint, and the vaccine under study has more than 80% of the overall efficacy in participants over 60 years old, and more than 90% of the protection against severe RSV respiratory diseases! Based on the Phase 3 results, GSK expects to submit a regulatory application
for the vaccine in the second half of this year.

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.

The AReSVi-006 trial is a randomized, placebo-controlled phase 3 trial involving about 25,000 adults over 60 years of age 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
.

The vaccine under study has also shown good tolerability, and most of the observed mild and moderate adverse reactions
are temporary.

Dr Tony Wood, GSK's Chief Scientific Officer, said: "These results are remarkable
given that RSV is still a major infectious disease for which no vaccine has been approved even after more than 60 years of research.
Based on the high efficacy demonstrated in this pivotal trial, we believe the vaccine has the potential to significantly reduce the global burden of RSV-related diseases, including those with comorbidities and older adults
.
" ”