Freedom of Information request (FOI 22/1053)
Published 17 January 2024
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FOI 22/1053
17th November 2022
Dear
Thank you for your email of 24 October 2022 requesting under the Freedom of Information Act:
In February this year GSK terminated their trial of a recombinant subunit pre-fusion antigen (RSVprevF3) vaccine to assess its efficacy in preventing Respiratory Syncytial Virus (RSV) disease in the new-born when given to pregnant women.
Their press release states that this was due to “safety data” and that the relevant regulatory authorities have been informed. https://www.gsk.com/en-gb/media/pressreleases/gsk-provides-further-update-on-phase-iii-rsv-maternal-vaccine-candidateprogramme#
1) would you confirm whether GSK has notified the MHRA of these safety data concerns; and if so
2) explain in broad terms the nature of these safety signals (e.g. whether they were concerns in the pregnant woman or the new-born, and the types of problems identified.)
I am pleased to provide you with the information requested, please see below:
1) Yes, the Sponsor has informed the MHRA informed of the safety signal.
2) The signal is of pre-mature births. Enrolment of new patients was stopped as soon as the Sponsor recognised a potential safety signal.
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Clinical Investigations and Trials