A Baltimore pharmaceutical plant shut down due to contamination will resume production of the Johnson & Johnson COVID-19 vaccine, following approval from the Food and Drug Administration (FDA) on Thursday.
The factory, operated by Emergent BioSolutions, had been undergoing FDA review following a March contamination incident that resulted in the disposal of 60 million Johnson & Johnson vaccine doses. The company announced in a Thursday statement that the FDA had granted approval for the plant to resume operations after “extensive reviews” of the facility.
“We are proud to be resuming production of bulk Covid-19 vaccine batches following additional reviews and collaboration with FDA and our manufacturing partners,” Emergent BioSolutions CEO Robert Kramer said in the statement.
Workers at the factory contaminated several batches of vaccines in March after they accidentally added an ingredient used in the AstraZeneca vaccine, also produced in the factory, to the Johnson & Johnson vaccine, The New York Times reported. The FDA shut the factory down, conducted reviews of the vaccines as well as the factory’s production methods, before approving 10 million doses in June.
“The American people should have high expectations of the partners its government chooses to help prepare them for disaster, and we have even higher expectations of ourselves,” Kramer said. “We have fallen short of those lofty ambitions over the past few months but resumption of manufacturing is a key milestone and we are grateful for the opportunity to help bring this global pandemic to an end.
The U.S. has moved away from using the Johnson & Johnson vaccine for its own population, instead shipping it to foreign countries. Use of the vaccine was temporarily halted by the Centers for Disease Control and Prevention in April over rare cases of blood clots.
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