Japan Reviews RSV Vaccine Candidate

GSK plc recently announced that a new drug application for its respiratory syncytial virus (RSV) older adult vaccine candidate had been accepted for review by the Japanese Ministry of Health, Labour and Welfare (MHLW).

The proposed indication for RSVPreF3 OA in Japan is for adults aged 60 years and above to prevent lower respiratory tract diseases (LRTD) caused by RSV.

GSK stated on October 21, 2022, further announcements on regulatory progress in the U.S. and E.U. are anticipated before the end of 2022.

There are currently no RSV vaccines for adults approved anywhere in the world.

The filing is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 phase III trial, which showed high overall vaccine efficacy against RSV-LRTD in adults aged 60 years and above, with a favorable safety profile.

Consistent high vaccine efficacy was observed against LRTD in severe disease, adults aged 70-79 years, adults with underlying comorbidities, and across RSV A and B strains.

GSK’s older adult RSV vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant.

Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions.

RSV can exacerbate chronic obstructive pulmonary disease, asthma, and heart failure and lead to severe outcomes.

Adults with underlying conditions are more likely to seek medical advice and have higher hospitalization rates than adults without these conditions.

Each year, RSV causes approximately 57,000 cases and 4,000 fatalities in Japan.

Furthermore, roughly 25% of all RSV patients <2 years in Japan were hospitalized, most without an underlying risk condition. 

Other RSV vaccine candidate news is posted at PrecisionVaccinations.com/RSV.