The Food and Drug Administration has ordered Johnson & Johnson to dispose of 60 million doses of its COVID-19 vaccine following concerns of possible contamination, the New York Times reported.
The doses, produced in a Baltimore factory operated by Emergent BioSolutions, had been undergoing review after a contamination incident affected more than 100 million doses in March, according to the New York Times. The FDA had ordered the factory to halt production of the vaccine pending inspection.
FDA announcing today that it is authorizing for use, under the emergency use authorization (EUA) for the Janssen #COVID19 vaccine, two batches of vaccine drug substance manufactured at the Emergent BioSolutions facility in Baltimore. https://t.co/oSUDlxpw9r pic.twitter.com/4kTxLk7hJX
— U.S. FDA (@US_FDA) June 11, 2021
“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,” the statement read.
“The FDA has 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 FDA said.
When asked to confirm how many doses would be discarded, the FDA directed the Daily Caller News Foundation to Johnson & Johnson, who did not respond for comment. Use of the Johnson & Johnson vaccine had been temporarily paused in April due to reported blood clots.
The decision to dispose of the doses will likely not impact U.S. vaccination efforts given the U.S.’s vaccine surplus. However, the move hampers the Biden administration’s plan to distribute the Johnson & Johnson vaccine to foreign countries.