FDA tells J&J to discard more batches of vaccine from Baltimore plant
The FDA has told Johnson & Johnson that more batches of COVID-19 vaccine produced at a plant under scrutiny for its manufacturing practices must be discarded.
In a statement, the FDA said it determined “several” batches from the Emergent BioSolutions manufacturing facility in Baltimore “are not suitable for use.” It did not say how many doses of the country’s only authorized one-shot COVID-19 vaccine were impacted, but The New York Times reported that the agency asked the drug maker to throw out around 60 million doses because of potential contamination.
Johnson & Johnson had already discarded a batch of COVID-19 vaccine totaling a reported 15 million doses earlier this year after a quality check at the Baltimore facility “identified one batch of drug substance that did not meet quality standards,” the company said at the time. The plant was manufacturing both the Johnson & Johnson and AstraZeneca COVID-19 vaccines when workers “accidentally conflated” the ingredients of the two vaccines earlier this year, leading to the contaminated doses, The New York Times first reported.
The plant has been under review by the FDA, which said Friday that it is still not ready to include the facility as an authorized manufacturing facility for the Johnson & Johnson vaccine, which has been available under and emergency use authorization (EUA) since February.
The FDA said, however, that it has authorized two batches of vaccine from the plant to be used in the United States or shipped to other countries. The New York Times reported that the two batches total 10 million doses.
“The FDA’s decision to include these two batches of vaccine drug substance in the EUA for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S. or exported to other countries,” the FDA said, referencing the Johnson & Johnson subsidiary that developed the vaccine. “A condition on any export of these batches, or of vaccine manufactured from these batches, is that Janssen and Emergent agree that the FDA may share relevant information about the manufacture of the batches under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used.”
The FDA also said that it has extended the time that the vaccine can be refrigerated from 3 months to 4 1/2 months.
LaFraniere S, et al. FDA tells Johnson & Johnson to throw out about 60 million doses made at troubled plant. New York Times. June 11, 2021. Accessed June 11, 2021. https://www.nytimes.com/2021/06/11/us/politics/johnson-covid-vaccine-emergent.html?smid=tw-nytimes&smtyp=cur.