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This designation provides enhanced support for the development and manufacture of health care products, including innovative medicines and vaccines. Stage 3: A final formulation is being developed for maternal administration to protect infants against invasive GBS disease due to the vaccine serotypes in newborns and young infants, based on a parallel natural history study conducted in South Africa. Stage 1: Evaluated safety and immunogenicity is being evaluated in an ongoing Phase 2 study investigating its hexavalent capsular polysaccharide (CPS) conjugate Group B Streptococcus (GBS) vaccine candidate, GBS6, being developed as an investigational maternal vaccine to help support the continued development of medicines that target an unmet medical need. GBS6; uncertainties regarding the commercial impact of COVID-19 on our business, operations and financial results; and competitive developments.
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