The Food and Drug Administration (FDA) has determined that Johnson & Johnson must discard approximately 60 million doses of its coronavirus disease (COVID-19) vaccine from a Baltimore factory due to potential contamination, according to an article from The New York Times.
Approximately 10 million doses of the Johnson & Johnson vaccine will still be distributed with a warning attached regarding the questionable manufacturing practices of the company operating the plant, according to the article. The plant’s production has been paused since April after the discovery of quality control issues, including the contamination of Johnson & Johnson vaccines with a key ingredient for the AstraZeneca vaccine.
“These actions followed an extensive review of records, including the production history of the facility and the testing performed to evaluate the quality of the product,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, according to a press release. “This review has been taking place while Emergent BioSolutions prepares to resume manufacturing operations with corrective actions to ensure compliance with the FDA’s current good manufacturing practice requirements.”
Since the pause on the plant’s production, more than 100 million doses of the Johnson & Johnson vaccine and at least 70 million of the AstraZeneca doses had been put on hold, according to the article. So far, the Johnson & Johnson doses distributed in the U.S. have all come from a plant in the Netherlands, not Emergent BioSolutions. Additional batches of the vaccine are still under review, according to the release.
Just yesterday, the FDA extended the expiration date on millions of Johnson & Johnson doses by six weeks following a warning from state officials that many in storage would expire later this month, according to an article from the Associated Press. Johnson & Johnson said the FDA concluded their vaccine remains safe and effective for at least four and a half months.
But Pfizer and Moderna have already more than fulfilled the need for vaccines in the U.S., according to the article. The two companies’ vaccines account for more than 129 million fully vaccinated Americans, whereas the Johnson & Johnson vaccine accounts for just 11 million.
Johnson & Johnson vaccinations previously were paused throughout the country in April upon recommendation from the FDA and the Centers for Disease Control and Prevention (CDC) due to the rise of a rare and severe blood clot in six recipients, The Daily Targum reported. The FDA and CDC lifted the pause 11 days later after determining the vaccine’s benefits outweighed the risks.