Johnson & Johnson declined to comment on a report that the FDA said to throw out 60 million doses of its COVID-19 vaccine that was produced at a troubled Maryland facility over concerns of possible contamination. The report, published by the New York Times, cited people familiar with the situation and comes as the FDA announced it authorized two batches of the vaccine produced at the Emergent BioSolutions facility in Baltimore but found “several other batches” 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.”
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.
A Johnson & Johnson spokesperson declined to comment to Fox News on the matter.
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.
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.