U.S. regulators are allowing the release of about 10 million doses of Johnson & Johnson's COVID-19 vaccine from a troubled Baltimore factory, but many more doses can't be used and must be thrown out.
The Food and Drug Administration announced Friday that it had determined that two batches could be released from the plant, which is owned by Emergent BioSolutions and has been shuttered for eight weeks. But it said several other batches are not suitable for use and additional batches are still under review.
The agency wouldn't specify the size of those batches or why they can't be used, but a person familiar with the decision told The Associated Press that they could have yielded tens of millions of doses and that they possibly were contaminated. Another person familiar with the situation said the doses to be discarded were made about the same time as a vaccine batch equal to about 15 million doses that was contaminated earlier this year and thrown out.
Neither person was authorized to release details about the decision and spoke to the AP on condition of anonymity.
J&J and Emergent wouldn't give any details on the size of the batches that are usable, nor those being discarded.
The two batches from the factory known as Bayview can be used in the U.S. or exported to other countries. They are the first J&J vaccines from Bayview approved for use.
The FDA said if any of the vaccine is exported, J&J and Emergent must allow the agency to share information about the manufacture of those batches confidentially with regulators in other countries.
The FDA statement implied that the batches didn't meet all of the agency's manufacturing quality standards. “This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s” manufacturing requirements, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.