FDA tells Johnson & Johnson to toss 60M COVID-19 vaccine doses over contamination concerns: report
A J&J spokesperson declined to comment on the matter
Johnson & Johnson confirmed that the FDA authorized two batches of COVID-19 vaccine produced at the Emergent BioSolutions facility but did not comment on a report that the regulatory agency said to throw out 60 million other doses over concerns of possible contamination. The report, published by the New York Times, cited people familiar with the situation and came ahead of an FDA news release that said "several other batches" of vaccine produced at the troubled Baltimore facility were not suitable for use.
The FDA also noted in a news release posted Friday that "additional batches are still under review and the agency will keep the public informed as those reviews are completed." At this time, the agency stated that it is "not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility," and continues to "work through issues there with Janssen and Emergent BioSolutions management."
"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, the company's executive vice president and chief global supply chain officer, said in a statement. "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."
It's not the first time the company was told to discard doses from the troubled facility. The FDA has repeatedly cited Emergent for problems pertaining to poorly trained employees, cracked vials and mold issues, according to the Associated Press.
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The development also follows a report that federal officials suspended new shipments of the vaccine in a bid to relieve states' pileup of expiring doses. The Wall Street Journal reported Thursday that the Centers for Disease Control and Prevention (CDC) temporarily ceased availability to states as several had expressed concerns about unused doses going to waste.
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The backlog in part stems from the 11-day pause in rollout which saw appointments canceled and rescheduled as Moderna or Pfizer-BioNTech vaccines. The FDA also moved to clear the potential backlog by extending the expiration dates of doses by several weeks.
Fox News' Kayla Rivas and the Associated Press contributed to this report.