U.S. regulators are clearing 10 million doses of Johnson & Johnson’s COVID-19 vaccine from a struggling Baltimore plant, but material to make many more must be discarded due to possible contamination, said to the Associated Press someone familiar with the decision. Friday.
The Food and Drug Administration announced that it had determined that two batches of the plant could be released. But he said several other lots are unsuitable for use and additional lots are still under review.
A second person familiar with the decision confirmed that it would release 10 million doses. The two spoke to the AP on condition of anonymity as they were not authorized to release details about it.
The doses came from an Emergent BioSolutions plant, known as Bayview, which makes the vaccine for J&J. These doses would be the first the plant approved for use. The doses of J&J that had been administered were from other plants.
Emergent is one of the many subcontractors of J&J that produces 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 were set aside for further testing by FDA staff after plant workers accidentally contaminated a 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.
The problems forced J&J to import millions of doses from its factory in the Netherlands 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 British drugmaker, which has yet to apply for approval to distribute it in the United States.