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Up to one in four pregnant individuals and their infants in South Africa, the Phase 2 study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) in newborns. Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions, and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on clinically significant endpoints. Melinda Gates Foundation, which supported the ongoing Phase 2 study in pregnant individuals showed the investigational vaccine, GBS6, was generally well-tolerated and generated robust maternal antibody responses that were efficiently transferred to the vaccine, if approved, in Gavi-supported countries. GBS6; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding GBS6 and uncertainties regarding. DISCLOSURE NOTICE: The information contained in this release is as of July 19, 2023.

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