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Manufacturing Johnson & Johnson vaccine partner Emergent still lacks FDA's manufacturing green light


The U.S. manufacturing partner turning out drug substance for Johnson & Johnson's single-dose COVID-19 vaccine is still waiting on an FDA green light, potentially putting a squeeze on J&J's supply pipeline. The FDA is weighing an emergency nod for Emergent BioSolutions, tapped in July 2020 to provide large-scale drug substance manufacturing for J&J's shot, Politico reported, citing two people familiar with the company's emergency use authorization process. The regulator could clear Emergent 'very soon,' one source said.

FiercePharma - March 30, 2021

View the full story here: https://www.fiercepharma.com/manufacturing/j-j-covid-19-vaccine-partner-emergent-could-soon-win-fda-manufacturing-nod-reports