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On Saturday, the Biden administration tasked Johnson & Johnson with managing the troubled Emergent BioSolutions plant in Baltimore, where 15 million doses of J & J’s coronavirus vaccine were destroyed due to a manufacturing defect. At that time, AstraZeneca was still in charge of the installation, and the problem was caused by the mixing of the raw materials of the AstraZeneca formulas and the American company. Several government sources told the New York Times that this led regulators to remove the facility from the British-Swedish company.
The Department of Health and Human Services has directed Johnson & Johnson to establish a new management team to oversee all production and manufacturing subtasks at Emergent’s Baltimore plant. The company said it was “assuming full responsibility” for the future vaccine produced at the Emergent plant. They also pledged to provide 100 million doses of the vaccine to the US government by the end of May.
After President Biden made serious efforts to have enough doses available to vaccinate all adults by the end of May, federal officials are concerned that the manufacturing defect erodes public confidence in Covid-19 vaccines. In particular, the AstraZeneca vaccine has raised safety concerns; Germany, France and other European nations briefly discontinued its use after reports of rare blood clots and pulmonary embolism in some vaccinated.
Unlike Johnson & Johnson, AstraZeneca does not yet have an emergency license from the Food and Drug Administration (FDA) to vaccinate. When can three federally approved vaccines (the other two manufactured by Pfizer-BioNTech and Moderna) be used after inadequate and outdated data has been provided to US authorities in documentation submitted at the time of approval?
J&J, although manufactured in the United States, was developed in Europe, and Janssen’s coronavirus vaccine consists of a single dose. So far, the US government has pledged to buy 100 million servings, but US President Joe Biden has said he wants to double that amount. The European Union has also ordered the Janssen vaccine, with 4.4 million doses available in Hungary. The European Medicines Agency (EMA) has been authorized in the EU for three weeks.
The manufacturer distributes the vaccine at a non-profit price, making coronavirus vaccines also available to poorer developing countries.
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