Faced with the delivery of several defective batches, the United States Medicines Agency, the FDA requested the suspension of production of the Johnson & Johnson vaccine at a plant in the United States.
15 million vaccine doses deficient
The US Medicines Agency, the FDA, has ordered the temporary stop of production of the Johnson & Johnson vaccine at a plant in Maryland, after the delivery of deficient doses of vaccine. Pharmaceutical group Johnson & Johnson told AFP that it had identified the plant that was behind the poor production. This is a plant located in Baltimore, Maryland, which is managed by Emergent BioSolutions. If the group did not specify the number of defective batches, it still explained that it was about doses ” that did not meet quality standards “.
According to daily information New York Times, the defective batch would contain 15 million doses. In a letter sent Monday, April 20, 2021, to the Securities and Exchange Commission, which is in charge of the control of financial markets, the firm Emergency BioSolutions announced the FDA’s decision to stop production on April 16, 2021. The closure is temporary but the plant must wait for the results of the inspection before they can hope to start producing the vaccine again.
Factory production shut down by the FDA
Thus, Johnson & Johnson announces the decision of the FDA in a press release explaining that “then April 16, 2021, at the request of the FDA, Emergent agreed not to start manufacturing all new equipment at its Bayview plant and isolate existing equipment manufactured at the Bayview plant pending the completion of the inspection and the correction noted during the findings “.
In addition to this pose in production, the drug’s regulators have stopped vaccination with Johnson & Johnson’s product in the United States after six cases of blood clots, one of which was fatal. The European Medicines Agency (EMA) will determine on Tuesday April 20, 2021 whether the vaccine is safe enough to be deployed in the European Union.