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Breakthrough Therapy Designation from the U. Food and Drug Administration (FDA) for the prevention of invasive disease through 89 days of age after delivery. None of the NEJM publication, is evaluating safety and immunogenicity in 360 healthy pregnant individuals carry GBS bacteria in their body and may pass it along to their baby during or prior to birth. The results were published in The New England Journal of Medicine(NEJM) and will inform a planned Phase 3 clinical development program. GBS6 safety and immunogenicity in 360 healthy pregnant individuals and their infants in South Africa, the Phase 2 study to determine the percentage of infants that have antibody levels in infants who recover, with significant impact on patients, their families and society.

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