GSK pauses trials of RSV vaccine in pregnant women
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GlaxoSmithKline (NYSE:GSK)
paused a late stage trial of its potential respiratory syncytial virus (RSV) vaccine candidate in pregnant women based on safety assessment by an independent committee.
The British drugmaker said it voluntarily paused enrolment and vaccination in the GRACE phase 3 trial (NCT04605159) and two other trials investigating the candidate in pregnant women (NCT04980391, NCT05229068).

GSK noted that the decision was made following a recommendation from the Independent Data Monitoring Committee based on an observation from a routine safety assessment.
The company added that the decision does not impact the ongoing AReSVi 006 phase 3 trial (NCT04886596) for RSV older adults (60 years and above) and data is expected in H1 2022.
GSK said it will provide a further update on the RSV maternal vaccine candidate in due course.
According to the U.S CDC, RSV can be serious, especially for infants and older adults. The virus is the most common cause of inflammation of the small airways in the lung and pneumonia in children younger than 1 year of age in the U.S.
Several companies are in the race to develop a RSV vaccine. Johnson & Johnson's (NYSE:JNJ)
began a phase 3 trial of its RSV vaccine in September 2021, while Bavarian Nordic (OTCPK:BVNRY) is planning to begin a late stage study of its vaccine candidate MVA-BN RSV in H1 2022. Moderna's (NASDAQ:MRNA) RSV vaccine has already received the FDA's fast track status.
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