According to the newspaper “The New York Times”, this is an “extraordinary measure” of the Department of Health and Human Services (HHS), after it was reported that in the facility located in Baltimore (Maryland) they were mixed Johnson & Johnson vaccines and AstraZeneca pharmaceuticals.
The decision also provides that the laboratory will no longer produce the vaccine from AstraZeneca, which has not yet obtained authorization from the Food and Drug Administration (FDA) to be distributed in the United States.
In a statement, Johnson & Johnson indicated on Saturday that it is taking “full responsibility for the manufacture of the drug substance for its covid-19 vaccine at the Emergent BioSolutions facilities”.
“The company is gathering staff dedicated to operations and quality, and significantly increasing the number of employees and technicians in manufacturing and quality operations, to work with the company’s specialists who are already at Emergent,” the statement said, without more details.
The pharmaceutical company, based in New Brunswick (Nor Jersey), stressed that the doses of its vaccine distributed so far “met the company’s strict quality standards and regulations” and anticipated that, by the end of May, it would deliver “about 100 million individual doses “to the United States Government.
“The company continues to work closely with the United States Food and Drug Administration to secure emergency use authorization for Emergent’s facilities,” he added.
On Wednesday, the company announced that it had identified a batch that “did not meet the quality standards at Emergent Biosolutions” and assured that the manufacturing process for these vaccines had not been finalized.
According to the statement, the factory is not yet authorized to manufacture the drug for its vaccine.
The New York Times reported that the FDA has yet to deliver any of Johnson & Johnson’s doses manufactured by Emergent for distribution and said it would take weeks before it was authorized to distribute those it had already produced.
The Emergent plant received $ 628 million in June 2020 as part of an initiative led by then-Donald Trump administration to develop vaccines against the SARS-Cov-2 coronavirus, adds the New York daily.
This unit was contracted by Johnson and Johnson and AstraZeneca, he added.
The United States has a total of 30,668,826 confirmed cases of covid-19 and has so far recorded 554,779 deaths due to the disease.
According to the Centers for Disease Control and Prevention (CDC), 104.2 million people (about 31.4% of the American population) have already received at least one dose of the vaccine, with 59.8 million (18%) fully inoculated.
The covid-19 pandemic caused at least 2,847,182 deaths worldwide, resulting from more than 130.6 million cases of infection, according to a report made by the French agency AFP.
The disease is transmitted by a new coronavirus detected in late 2019 in Wuhan, a city in central China
Get the latest news delivered to your inbox
Follow us on social media networks