28th Feb 2022 09:34
(Alliance News) - GlaxoSmithKline PLC said on Monday it had stopped enrolment and vaccination in pregnant women for its respiratory syncytial virus vaccine candidate, following a voluntary pause earlier this month.
The Brentford, England-based pharmaceutical company had said earlier in February that it paused the phase three trials voluntarily, following safety recommendations from the Independent Data Monitoring Committee. It now has decided to stop enrolment and vaccination for the RSV vaccine trials in pregnant women, halting its 'Grace' trial and two others.
"Further analysis to better understand safety data from these trials is ongoing, and the relevant regulatory authorities have been informed," GSK said.
RSV is one of the main causes of respiratory infections such as bronchitis and viral pneumonia in infants, with 33 million cases recorded every year. Phase three vaccine trials in pregnant women had started in late November, after phase one & two trials had shown promising results in non-pregnant women.
GSK reaffirmed that the ongoing phase three trial in older adults will continue, and is still anticipated to delivery a data readout in the first half of this year.
Shares in GSK were down 1.4% to 1,542.00 pence each in London on Monday morning.
By Elizabeth Winter; [email protected]
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