GSK Touts 'Exceptional Results' From RSV Vaccine Candidate In Older Adults

GSK plc GSK announced positive Phase 3 trial results for its respiratory syncytial virus (RSV) vaccine candidate for adults aged 60 years and above to be presented at IDWeek 2022.
The company announced the headline results in June.
"These are truly exceptional results given that today RSV remains one of the major infectious diseases without a vaccine, despite over 60 years of research," said Tony Wood, GSK Chief Scientific Officer, in a statement.
The vaccine candidate was highly efficacious, demonstrating overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (RSV-LRTD), meeting the trial's primary endpoint.
Efficacy against severe RSV-LRTD was 94.1%. In participants with pre-existing comorbidities, vaccine efficacy was 94.6%, with 93.8% efficacy observed in adults aged 70-79.
Vaccine efficacy was consistent across both RSV-A and RSV-B subtypes.
Regulatory submissions based on the phase 3 data are anticipated in the second half of 2022. There are currently no RSV vaccines approved anywhere in the world.
In February, GSK halted enrollment and vaccination in three trials of its experimental vaccine against the respiratory syncytial virus (RSV) in pregnant women.
Earlier it paused a late-stage trial, dubbed "GRACE," and two other studies based on safety recommendations from an independent committee.
Competition: A late-stage readout on Johnson & Johnson's JNJ RSV vaccine in older adults is also expected by the end of 2022, while an interim look at Moderna Inc's MRNA Phase 3 data is also anticipated this winter.
Jefferies analysts have forecast $2.5 billion in global RSV vaccine peak sales in older adults for GSK, Reuters reported.
Price Action: GSK shares are down 0.03% at $30.36 during the premarket session on the last check Thursday.

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