FDA says 60M J&J vaccine doses from troubled plant must be thrown out: report
The Food and Drug and Administration (FDA) is forcing Johnson & Johnson to throw out millions of doses of its single-shot COVID-19 vaccine produced at a troubled plant in Baltimore due to contamination concerns.
According to The New York Times, 60 million doses were unusable.
Another 10 million doses from the plant will be allowed to be distributed but with a warning that the FDA cannot guarantee they were produced using good manufacturing practices, according to the Times.
In a statement, the FDA confirmed that it has now authorized two batches of the vaccine.
Federal officials “determined several other batches are not suitable for use, but additional batches are still under review and the agency will keep the public informed as those reviews are completed,” the agency said.
The agency referred questions about specific numbers to Johnson & Johnson, which did not respond.
The FDA said it has not yet determined whether the plant, operated by Emergent BioSolutions, can reopen.
“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
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 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.
The U.S. has enough vaccines from Pfizer-BioNTech and Moderna to vaccinate every American, and the problems at the plant are not holding back Americans’ access to doses.
The cleared doses from Johnson & Johnson will likely be shipped overseas to help President Biden fulfill his pledge to donate vaccines to countries in need. Last week, Biden announced a framework to donate 80 million vaccine doses abroad by the end of June.
Biden on Thursday pledged to donate 500 million doses of the Pfizer-BioNTech vaccine to other countries between August and the first half of next year.
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