- GSK plc GSK announced positive Phase 3 study results for its respiratory syncytial virus (RSV) vaccine candidate for adults 60 years and older will be presented at IDWeek 2022.
- The company announced this Headline results in June.
- “These are truly extraordinary results considering that despite over 60 years of research, RSV remains one of the most important infectious diseases without a vaccine,” said Tony Wood, GSK’s chief scientific officer, in a statement.
- The vaccine candidate was highly potent, demonstrating an overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (RSV-LRTD), meeting the study’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 70 to 79 years of age.
- Vaccine efficacy was consistent across both RSV-A and RSV-B subtypes.
- Regulatory filings based on the Phase 3 data are expected in the second half of 2022. No RSV vaccines are currently approved worldwide.
- In February, GSK halted registration and vaccination in three trials of its experimental respiratory syncytial virus (RSV) vaccine. pregnant woman.
- Previously, a late-stage study called GRACE and two other studies were suspended based on safety recommendations from an independent committee.
- Contest: A late reading on Johnson & Johnson’s JNJ RSV vaccination in older adults is also expected by the end of 2022 while an interim review is being made Moderna Inc MRNA Phase 3 data is also expected this winter.
- Jefferies analysts forecast a global peak of $2.5 billion in RSV vaccines sale in older adults for GSK, Reuters reported.
- Price promotion: GSK shares are down 0.03% to $30.36 during the premarket session on the last check Thursday.
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