The FDA is reportedly forcing J&J to scrap about 60 million doses of its Covid vaccine
A detail of the Janssen Johnson & Johnson COVID-19 vaccine that is not currently being issued because it has been put on hold.
Allen J. Cockroaches | Los Angeles Times | 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 that several lots were not “suitable for use” without confirming the exact number of doses discarded. According to an email statement, the agency announced that it is releasing two batches of vaccine materials made at the facility 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 notify the public of the completion of these tests,” the statement emailed said.
The US currently has more than enough doses of two other vaccines approved by Pfizer and Moderna to complete vaccination of the American population.
The approximately 10 million doses of the Johnson & Johnson vaccine will 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.”
“Today’s decisions represent a step forward in our ongoing efforts to make a difference in this pandemic on a global scale, and we appreciate working closely with the FDA and global health authorities,” said Kathy Wengel, Executive Vice President, Johnson & Johnson. in a statement on Friday afternoon.
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 of vaccine worldwide 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.