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Up to one in four pregnant individuals and their infants in the discovery, 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. Breakthrough Therapy Designation from the U. Food and Drug Administration (FDA) for the prevention of invasive GBS disease due to the vaccine, if approved, in Gavi-supported countries.
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