Trial paused for respiratory virus vaccine in pregnant women

pharmafile | February 18, 2022 | News story | Medical Communications  

GlaxoSmithKline (GSK) has hit pause on a Phase III clinical trial on safety grounds. The late-stage trial for GSK’s vaccine candidate against the respiratory syncytial virus (RSV) in pregnant women was cancelled, based on safety recommendations, the British drugmaker has shared. 

GSK is the world’s biggest vaccine maker by sales. The company has additionally shared that two other unnamed trials investigating its drug candidate in pregnant women had also been paused. GSK did not give further details on why it paused the GRACE clinical trial, nor the two other studies.

The company has however shared that the AReSVi 006 Phase III trial of its experimental RSV vaccine for adults aged 60 and over would continue, and has shared that the trial remains on track, with the initial data readout expected sometime in the first half.

“Monitoring safety signals is an integral part of the clinical development process for potential new vaccines,” GSK said in a statement.

RSV is a leading cause of pneumonia in toddlers and the elderly, but vaccine development has been hindered by setbacks for decades. RSV is a common respiratory virus that usually causes mild, cold-like symptoms. Most patients recover in a few weeks. However, RSV can be serious for infants, and older adults. Many drugmakers are working to bring a candidate to the market over the next few years. GSK’s RSV vaccine for pregnant women aimed to confer immunity to protect unborn children from the virus.

RSV is also the most common cause of bronchiolitis, the inflammation of the small airways in the lung, in children younger than 1 year of age in the US.

Ana Ovey

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