- GSK plc (NYSE: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 (NYSE: JNJ) RSV vaccine in older adults is also expected by the end of 2022, while an interim look at Moderna Inc's (NASDAQ: 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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