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As the U.S., Europe and parts of Asia consume more booster doses than expected, global health advocates hope the emerging vaccine produced by Maryland-based Novavax will fill the supply gap in low- and middle-income countries in 2022.
But while Novavax — after partnering with India’s Serum Institute — obtained regulatory approvals from the World Health Organization and European Commission this month, crucial questions remain about both its ability to obtain Food and Drug Administration approval and to produce enough doses in manufacturing sites other than the Serum Institute.
Without sign-offs from world regulators to produce vaccines at its U.S. and European sites, Novavax could struggle to
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