Three RSV Vaccine Studies Placed on 'Pause'

London-based GlaxoSmithKline plc (GSK) today announced that it has voluntarily paused enrolment and vaccination in the GRACE phase III clinical trial evaluating RSV MAT, its potential respiratory syncytial virus (RSV) maternal vaccine candidate.

This study was launched in November 2020.

GSK's press release issued on February 18, 2022, also stated two other clinical trials investigating the RSV candidate in pregnant women (NCT04980391, NCT05229068) were also paused.

'This decision was made following a recommendation from the Independent Data Monitoring Committee based on an observation from a routine safety assessment.'

However, today's 'decision does not impact the ongoing AReSVi 006 phase III trial (RSVPreF3) for adults 60 years and above. This trial remains on track with an anticipated data readout in the first half of 2022,' says GSK.

RSV is an RNA virus of the genus Orthopneumovirus and is primarily spread via respiratory droplets when a person coughs or sneezes. Infants, children, and older adults with chronic medical conditions are at risk of severe disease from an RSV infection, says the U.S. CDC.

For further information, please visit www.gsk.com/about-us.

Note: various RSV vaccine candidates are conducting late-stage studies. Currently, the U.S. FDA has not authorized/approved an RSV vaccine.