FDA orders J&J to toss 60M possibly tainted COVID-19 vaccine doses

The FDA told Johnson & Johnson to throw away 60 million doses of its COVID-19 vaccine because of possible contamination at Emergent BioSolutions' manufacturing plant in Baltimore, The New York Times reported June 11. 

The agency has been reviewing the vaccine doses made at the plant for weeks after discovering Emergent BioSolutions workers mixed up ingredients for Johnson & Johnson's vaccine with ingredients for AstraZeneca's COVID-19 vaccine. 

The FDA is expected to allow about 10 million doses from the plant to be distributed in the U.S. or sent to other countries, but with a warning that it cannot guarantee Emergent followed good manufacturing practices, the Times reported. The agency hasn't decided if the plant can reopen. It's been closed for two months due to regulatory concerns. 

More than 100 million doses of Johnson & Johnson's vaccine and at least 70 million doses of AstraZeneca's vaccine were put in limbo after the ingredient mixup, the Times reported. 

The loss of 60 million COVID-19 vaccine doses shouldn't hurt the U.S.' vaccination campaign, as the country has ample supply of Moderna and Pfizer vaccines, but may affect the Biden administration's plan to distribute vaccines to other countries that need them, according to the Times

When reached for comment, a Johnson & Johnson spokesperson did not acknowledge to Becker's the 60 million vaccine doses that must be tossed, but said that two batches of the vaccine made at the Emergent BioSolutions plant have been authorized by the FDA for distribution. 

"Since establishing our COVID-19 vaccine program, Johnson & Johnson has committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere," Kathy Wengel, Johnson & Johnson's executive vice president and chief global supply chain officer, said in a statement shared with Becker's. "Today's decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale, and we appreciate the close collaboration with the FDA and global health authorities."

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