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Hind Al Soulia - Riyadh - WASHINGTON — The US Food and Drug Administration (FDA) on Friday said that a number of Janssen COVID-19 vaccine batches are not suitable for use, due to contamination concerns at Baltimore plant.
In a statement, the FDA said that it allowed Johnson & Johnson to distribute two batches of the vaccine, while millions of doses will be thrown out.
According to The New York Times, over 60 million doses were unusable, while another 10 million doses from the plant would be allowed to be distributed but with a warning that the FDA cannot guarantee they were produced using good manufacturing practices.
Janssen Pharmaceuticals is owned by Johnson & Johnson.
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 also said that it has extended the time that the vaccine can be refrigerated from 3 months to 4 1/2 months. — Agencies
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