The Food and Drug Administration told Johnson & Johnson that about 60 million doses of its COVID-19 vaccine made at a Baltimore plant cannot be used, according to a new report.
The New York Times was the first to report on Friday, “The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices.”
The report added, “The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months because of regulatory concerns.”
“More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were put on hold after Emergent discovered in March that its workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used to produce AstraZeneca’s. Federal officials then ordered the plant to pause production, stripped Emergent of its responsibility to produce AstraZeneca’s vaccine and instructed Johnson & Johnson to assert direct control over the manufacturing of its vaccine there.”
In a statement, the FDA said, “Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer. Based on this review and considering the current COVID-19 public health emergency, the FDA concluded these batches are suitable for use.
“While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.”
NEW: Just got this update from the FDA on the J&J vaccines after NYT reporting that it ordered 60 million doses from the Emergent BioSolutions plant discarded. See area in red which could have implications for doses in Gqeberha#sabcnews pic.twitter.com/A9qeckrtiD
— Sherwin Bryce-Pease (@sherwiebp) June 11, 2021
Politico, meanwhile, reported, “FDA ordered Emergent to stop producing vaccines for Johnson & Johnson and AstraZeneca in March after Emergent inadvertently contaminated 15 million J&J shots with the active ingredient from the AstraZeneca vaccine.”
It added, “Tens of millions of doses of each company’s vaccine have been in limbo while federal regulators tested them to rule out contamination and determine if they are safe to use.”
Emergent BioSolutions is a Maryland-based contractor for Johnson & Johnson.
Emergent is a government-endorsed supplier of a COVID-19 vaccine.
The Hill reported, “The loss of 60 million doses is the latest setback for Emergent. The plant, which has been under scrutiny for months, was shuttered in April for a host of violations, including contamination of Johnson & Johnson’s vaccine with an ingredient for the AstraZeneca vaccine, which were both being manufactured by Emergent at the time.”
The report added, “The federal government has paid Emergent more than $271 million in taxpayer money, but the ensuing delays have meant that none of the millions of doses of the J&J vaccine produced at the plant have been distributed.”
In March, reports claimed the Biden administration knew about a contaminated coronavirus vaccine batch that forced 15 million doses to be trashed but hid the debacle from the public.
Just a few dozen cases were reported among the approximately 9 million doses administered, NBC News reported in May, citing the CDC.
The CDC lifted the pause shortly afterward. The vaccine is now accompanied by a warning label that notes the extremely slim possibility of developing a serious blood clot after receiving it.
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