FDA allows troubled Baltimore COVID-19 vaccine factory to resume operations
By Linda A. Johnson
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The CDC updated guidance on masks, saying on July 27, 2021, that people in areas of high COVID-19 transmission should wear them indoors regardless of vaccination status.
BALTIMORE (AP) - The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine, the company said Thursday.
The Baltimore factory was shut down by the FDA in mid-April due to contamination problems that forced the company to trash the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson. The bulk vaccine was contaminated with an ingredient for AstraZeneca’s COVID-19 vaccine, which was being made in the same factory.
•Reaffirms 2021 Full Year Forecast for Revenues and Profit GAITHERSBURG, Md., July 29, 2021-Emergent BioSolutions Inc. (NYSE: EBS) today reported financial results for the second quarter ended June 30, 2021. Our second quarter performance demonstrates the strength of our strategy and diversified business model, said Robert G. Kramer, president and chief executive officer of Emergent BioSolutions. Through continued investment and innovation, we will play an important role in helping deliver solutions to the public health threats we face. We are proud to be resuming production of COVID-19 vaccine batches following additional reviews and collaboration with the Food and Drug Administration and our manufacturing partner.
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FDA allows Emergent factory to resume vaccine work
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LINDA A. JOHNSON THE ASSOCIATED PRESS
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FILE - In this April 8, 2021 file photo, the Johnson & Johnson COVID-19 vaccine is seen at a pop up vaccination site in the Staten Island borough of New York. The U.S. Food and Drug Administration is allowing the problem-plagued factory of contract manufacturer Emergent BioSolutions to resume production of COVID-19 vaccine bulk substance to resume, the company said Thursday, July 29. The Baltimore factory was shut down by the FDA in mid-April due to contamination problems that forced the company to trash the equivalent of tens of millions of doses of vaccine it was making under contract for Johnson & Johnson. (AP Photo/Mary Altaffer, File)
Jul 29 2021, 9:04 PM
July 29 2021, 7:19 PM
July 29 2021, 9:04 PM
(Bloomberg) The U.S. Food and Drug Administration cleared Johnson & Johnsonâs Covid-19 vaccine manufacturer Emergent BioSolutions Inc. to resume production of the shot after a series of mishaps that led it to halt manufacturing.
(Bloomberg) The U.S. Food and Drug Administration cleared Johnson & Johnsonâs Covid-19 vaccine manufacturer Emergent BioSolutions Inc. to resume production of the shot after a series of mishaps that led it to halt manufacturing.
The Gaithersburg, Maryland-based contract manufacturer said in statement on Thursday that U.S. regulators decided to allow it to resume production after completing extensive reviews at its facility in Baltimoreâs Bayview neighborhood. A Biden administration official said that the FDA decided to allow Emergent to resume production after visiting the facility earlier this week.