60M J&J vaccines could be disposed over potential contamination

• Johnson & Johnson was reportedly advised by the FDA to dispose of 60 million COVID-19 vaccine doses over potential contamination.
• The FDA had previously cited J&J’s Emergent BioSolutions facility for poor employee training, cracked vials, and mold issues.
• The company is currently working with the agency to work through the issues.

The FDA reportedly told Johnson & Johnson to dispose of 60 million COVID-19 vaccine doses due to potential contamination.

The New York Times cited individuals familiar with the situation in the report.

A news release from the regulatory agency also confirmed that “several other batches” of vaccine produced at the troubled Emergent BioSolutions facility were unsuitable for use.

J&J stated that two batches of vaccine produced at the facility have been authorized by the FDA, but have not yet commented on the Times report.

On Friday, the FDA noted in a news release that they are still reviewing additional batches and will update the public after completing those reviews.

The agency concluded that it is “not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility” but will “work through issues there with Janssen and Emergent BioSolutions management.” 

J&J’s executive vice president Kathy Wengel assured everyone that the company continues to be “committed to producing safe, high-quality vaccines in order to bring health and hope to people everywhere.”

Wengel, who is also the company’s chief global supply chain officer, continued, “Today’s decisions represent progress in our continued efforts to make a difference in this pandemic on a global scale. We appreciate the close collaboration with the FDA and global health authorities.” 

But the company’s troubled facility has been repeatedly cited by the FDA for numerous problems such as poor employee training, cracked vials, and mold issues, according to an Associated Press report. They have also been instructed to dispose of vaccine doses before.

New vaccine shipments have also been suspended by federal officials, following a pileup in unused, expiring doses. Availability to states was also temporarily halted by the Centers for Disease Control and Prevention (CDC), according to a Wall Street Journal report on Thursday.

The pileup was partly caused by an 11-day pause in vaccine rollout. While the FDA tried to clear the backlog by extending the expiration dates of doses by several weeks, several have canceled their appointments and switched to Moderna or Pfizer-BioNTech vaccines.

Source: FOX News