The European Union’s drug regulator announced Friday it will not use batches of the Johnson & Johnson COVID-19 vaccine that were made at a Baltimore, Maryland-based plant around the time that manufacturing problems were reported at the facility.
The European Medicines Agency (EMA) said that vaccines that it obtained from the Emergent Biosolutions plant weren’t affected by any contamination. The move on Friday to suspend using the vaccines is being done out of an abundance of caution, the agency said.
“Authorities in the EU are aware that a batch of the active substance for COVID-19 Vaccine Janssen had been contaminated with materials for another vaccine manufactured at the same site,” the statement said, adding that the “batch concerned was not intended for the EU market.”
“Based on available information, batches of the vaccine released in the EU are not affected by the cross-contamination,” the EMA said. “However, as a precaution and to safeguard the quality of vaccines, the supervisory authorities have recommended not releasing vaccine batches containing the active substance made at around the same time that the contamination occurred.”
It’s not clear how many J&J doses would be affected by the EU decision.
The decision came amid reports, citing anonymous sources, that claimed that up to 60 million doses were tossed out due to the decision, although spokespersons for the Food and Drug Administration (FDA) or Johnson & Johnson did not respond for comment after The Epoch Times’ inquiries about the doses.
A Johnson & Johnson spokesperson, in an email to The Epoch Times, pointed to a news release from Kathy Wengel, a vice president, who said that the recent actions “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.” A spokesperson for the FDA, in an email, referred to J&J.
The FDA, in a news release on Thursday, said that two batches manufactured at the Baltimore plant can be used under the emergency use authorization.
“The FDA’s decision to include these two batches of vaccine drug substance in the [emergency use authorization] for the Janssen COVID-19 vaccine means that Janssen vaccine made with this drug substance can be used in the U.S. or exported to other countries,” the FDA said.
But the FDA said it has discovered that “several other batches are not suitable for use, but additional batches are still under review and the agency will keep the public informed as those reviews are completed.” The agency not make any mention of how many Johnson & Johnson single-shot vaccine doses, known as the Janssen vaccine, would be affected—if any.
“Additionally,” the news release said, “the FDA has extended the expiration dating for the refrigerated Janssen COVID-19 vaccine after reviewing information submitted by Janssen and determining that the vaccine can be stored at 2-8 degrees Celsius for 4.5 months instead of 3 months.”
Emergent Biosolutions is one of several J&J contractors that make the vaccine in bulk, which is then shipped to other factories to finalize. In April, there were reports that a human error caused millions of doses to be ruined.
The Epoch Times has contacted Emergent Biosolutions for comment.