The exterior view of the Emergent BioSolutions facility on April 01, 2021 in Baltimore, Maryland. In that laboratory in Baltimore, 15 million doses of Johnson & Johnson vaccine were destroyed, which will delay shipments of the vaccine to the United States.
Tasos Katopodis | Getty Images
Federal regulators are forcing Johnson & Johnson to scrap approximately 60 million doses of the Covid-19 vaccine made at a troubled Baltimore facility operated by Emergent BioSolutions due to possible contamination, the New York Times reported on Friday, citing with people familiar with the matter.
The facility closed in April after an inspection revealed several violations, including possible contamination of J & J’s vaccines with a key ingredient from AstraZeneca’s Covid vaccine. About 170 million doses of both vaccines were eligible after the inspection, the Times reported.
The FDA confirmed to CNBC that several lots were not “suitable for use” without confirming the exact number of doses discarded. According to a statement sent via email, two batches of factory-made vaccine materials will be released for use. The Associated Press reported that the two batches would make 10 million cans.
“The FDA has determined that several other lots are unsuitable for use, but additional lots are still being tested and the agency will inform the public of the completion of these tests,” said a statement sent via email.
The US currently has more than enough doses of two other vaccines approved by Pfizer and Moderna to complete vaccination of the American population.
Approximately 10 million doses of the Johnson & Johnson vaccine continue to be distributed in the United States and donated to other countries. The rescued cans will come with a warning stating that federal regulators cannot guarantee that the manufacturing facility operator, Emergent BioSolutions, is following good manufacturing practices, the Times reported.
“Before making this decision, the FDA conducted a thorough review of the facility records and the results of the manufacturer’s quality checks,” the agency said. “Although the FDA is not yet ready to include the Emergent BioSolutions facility in the Janssen EUA as an authorized manufacturing facility, the agency continues to address issues with Janssen and the management of Emergent BioSolutions.”
The Biden government planned to donate more cans of the shots, but those plans were stifled by the investigation of the emergent facility.
The World Health Organization said it would take 11 billion doses around the world to stop the pandemic from getting worse. The US is buying 500 million doses of Pfizer’s two-shot vaccine to be distributed to countries in need, President Joe Biden is expected to announce at G-7 meetings this weekend.
CNBC’s Berkeley Lovelace Jr. contributed to this article.