FDA Authorizes J&J Vaccine Substance Made At Emergent Facility

By Beth Wang / June 11, 2021 at 1:45 PM
In a bid to increase availability of Johnson & Johnson’s COVID-19 vaccine, FDA on Friday (June 11) announced it will allow two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore to be released for use in the United States or exported to other countries, despite several quality control and facility management issues at the facility. FDA also authorized an extension to the shelf life of J&J’s vaccine from three months to four-and-a-half months. FDA biologics...


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