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Vaccines given to pregnant women 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 is designed to expedite the development of GBS6.

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The most common AEs and serious adverse events (SAEs) were conditions 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.

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