The FDA Reportedly Forces J&J to Scrap About 60 Million Doses of Its Covid Vaccine

Allen J. Schaben | Los Angeles Times | Getty Images
  • Federal regulators have decided to scrap about 60 million doses of J&J's Covid vaccine produced at a troubled Emergent BioSolutions plant in Baltimore.
  • About 10 million doses of J&J's vaccine manufactured at the plant will still be distributed in the U.S. and donated to other countries.
  • The FDA hasn't cleared the plant to reopen after shuttering it over safety violations two months ago.

Federal regulators are forcing Johnson & Johnson to scrap about 60 million doses of Covid-19 vaccine produced at a troubled Baltimore plant run by Emergent BioSolutions due to possible contamination, The New York Times reported Friday, citing people familiar with the matter.

The plant was shuttered in April after an inspection revealed several violations, including possible contamination of J&J's vaccines with a key ingredient from AstraZeneca's Covid vaccine. About 170 million doses of both vaccines were in question after the inspection, the Times reported.

The FDA confirmed that several batches weren't "suitable for use," without confirming the exact number of doses that were discarded. The agency said it was clearing two batches of vaccine materials manufactured at the plant for use, according to an emailed statement. The Associated Press reported that the two batches would account for 10 million doses.

"The FDA has determined 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 said in the emailed statement.  

The U.S. currently has more than enough doses of two other vaccines that were approved from Pfizer and Moderna to finish vaccinating the American population.

The roughly 10 million doses of the Johnson & Johnson vaccine will still be distributed in the U.S. and donated to other countries. The salvaged doses will come with a warning stating federal regulators could not guarantee that the manufacturing plant's operator, Emergent BioSolutions, followed good manufacturing practices, the Times reported.

"Before making this decision, the FDA conducted a thorough review of facility records and the results of quality testing performed by the manufacturer," the agency said. "While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management."

"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," Johnson & Johnson's executive vice president Kathy Wengel said in a statement Friday afternoon.

The Biden administration planned to donate more doses of the shots, but those plans were stifled by the investigation into the Emergent facility.

The World Health Organization said 11 billion vaccine doses are needed around the globe to help stop the pandemic from worsening. The U.S. is buying 500 million doses of Pfizer's two-shot vaccine to distribute to countries in need, President Joe Biden is expected to announce at this weekend's G-7 meetings.

-- CNBC's Berkeley Lovelace Jr. contributed to this article.

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