Another 62 million doses of the vaccine against covid-19 developed by the pharmaceutical company Janssen (Johnson & Johnson) could be contaminated and would have to be thrown away, according to an investigation published by The New York Times newspaper about the production plant that Emergent BioSolutions has in Baltimore, in the USA .
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According to this newspaper, these 62 million doses of Janssen’s vaccine could end, if they are confirmed to be contaminated, just like the 15 million doses that last week were sentenced to destruction after discovering cross-contamination with doses of the vaccine. developed by AstraZeneca .
This production plant that the biotech Emergent BioSolutions has in Baltimore is the main factory for covid-19 vaccines of Janssen and AstraZeneca in the United States, with the capacity to put on the market some 150 million doses so far. However, so far, not a single dose has passed quality controls to be inoculated into the population.
This company is known in the US for being a producer of anthrax vaccines and more than eight years ago the Federal Administration invested in it to turn its Baltimore plant into a place always ready to produce vaccines in the event of a pandemic.
However, as The New York Times reveals, the factory faces “serious problems” for its practices, including a “corporate culture that often ignores or skips steps” and “a government sponsor – the Research and Development Authority. US Advanced Biomedical-, who acts more as a partner than as a policeman. ”
In addition, these two most recent occasions would not be the first time the company has lost production for fear that it is contaminated. Between October 2020 and January 2021, Emergent BioSolutions had to discard five batches of AstraZeneca, of between two and three million doses each, for being contaminated or suspected of being contaminated, according to company, government and government sources. a former company supervisor, all cited by The New York Times .
According to quality auditors who have visited the plant, “some basic industry standards” were not followed and “repeated deficiencies in efforts to disinfect and prevent contamination” were identified .
According to sources from Emergent BioSolutions, cited by Insider , the company’s quality controls work as designed to detect and isolate any batch that does not meet quality standards for whatever reason. ”
“No one, including Emergent employees, wants to see vaccines that cannot be used,” the company said in a statement. He added: “Any allegation that our safety, quality and compliance systems are not working or that we do not take these responsibilities seriously is unequivocally false .”