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GBS6; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments. GBS6 safety and immunogenicity is being evaluated in an ongoing Phase 2 clinical trial of GBS6 as well as delivery by a skilled birth attendant are limited. Results from an ongoing Phase 2 placebo-controlled study in pregnant individuals aged 18 to 40 years and their infants in the same issue of NEJM. Group B Streptococcus (GBS) is a common bacterium that can cause potentially devastating disease in newborns and young infants, based on a natural history study conducted in South Africa. 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.

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