U.S. regulators are clearing about 10 million doses of Johnson & Johnson’s COVID-19 vaccine from a struggling Baltimore plant, but many more doses cannot be used and must be discarded.
The Food and Drug Administration announced Friday that it has determined that two batches could be released from the plant, which is owned by Emergent BioSolutions and has been shut down for eight weeks. But he said several other lots are unsuitable for use and additional lots are still under review.
The agency did not specify the size of these batches or why they cannot be used, but a person familiar with the decision told The Associated Press they could have produced tens of millions of doses and that ‘they may have been infected. Another person familiar with the situation said the throw-away doses were made around the same time as a batch of vaccine equal to around 15 million doses that was contaminated earlier this year and thrown away.
Neither person was allowed to release details of the decision and spoke to the AP on condition of anonymity.
J&J and Emergent would not give any details on the size of the lots that can be used, nor on those that are discarded.
Both batches from the factory known as Bayview can be used in the United States or exported to other countries. These are Bayview’s first J&J vaccines approved for use.
The FDA has said that if any of the vaccines are exported, J&J and Emergent must allow the agency to share information about the manufacture of those lots confidentially with regulators in other countries.
The FDA statement implied that the lots did not meet all of the agency’s manufacturing quality standards. “This review took place as Emerging BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with FDA manufacturing requirements,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and FDA Research, in a statement.
The agency said the vaccines were “essentially necessary” given the current public health emergency, and that it made the decisions after reviewing records and quality test results.
The FDA, however, has not allowed the plant to restart vaccine production. The agency said it was resolving issues with management at J&J and Emerging BioSolutions.
Emergent is one of J&J’s many contractors that produce its single-injection bulk vaccine. The concentrated vaccine is then shipped to other factories for the final steps, including dilution to the appropriate concentration, bottling and packaging.
About 100 million doses made from bulk vaccines produced at the Emergent plant, including those just approved, have been set aside for further review by FDA staff after employees from the factory accidentally contaminated a previous batch.
This contamination led the FDA to close the plant in mid-April and send a team of inspectors. They spent a week walking around the plant and examining footage from security cameras that showed employees carelessly handling vaccines. Inspectors reported unsanitary conditions, poorly trained employees and other problems.
The failures have hampered J&J’s efforts to be a major player in immunizing people, especially in remote areas and poor countries, as it is the only drug maker with a licensed vaccine that does not require single dose and standard refrigeration. It is also cheaper than some other vaccines.
Production problems forced J&J to import millions of doses from its factory in the Netherlands to the United States and to miss its supply commitments.
The Emergent plant had a history of FDA citations for issues such as mold, dirty walls and floors, poorly trained employees, and an inadequate strategy to prevent contamination, but the Trump administration told it a huge role in the production of COVID-19 vaccines. Emergent has secured a lucrative contract to manufacture several million COVID-19 vaccines for J&J and AstraZeneca at the Bayview plant.
Emerging’s general manager blamed the contamination and other issues on the complexity of expanding the plant in just a few months to make two different vaccines.
The Biden administration is working to find another US manufacturing partner for the UK drugmaker, which has yet to apply for approval to distribute it in the US.