April 03, 2021
Johnson & Johnson said it will still be able to deliver on its commitment to provide 24 million doses of its COVID-19 vaccine this month, despite an issue at one of the company's contract manufacturers.
A batch of 15 million doses of the vaccine had to be thrown out last week after they were contaminated during production at Baltimore-based plant Emergent BioSolutions.
That plant had not yet been authorized by the US Food and Drug Administration to make the vaccine, CNN reported. None of the discarded doses were a part of this round of vaccine shipments.
Johnson & Johnson delivered 20 million more doses in March and said it is still on track to deliver 24 million more in April.
The plant said the problem affected a batch of "bulk drug substance" that is used to make the vaccine, and its quality control systems caught the problem.
Emergent CEO Bob Kramer did not confirm to CNN if the contaminated batch would impact 15 million doses.
"Importantly, the quality control systems worked as designed to detect and isolate this single batch," Emergent's statement said. "Discarding a batch of bulk drug substance, while disappointing, does occasionally happen during vaccine manufacturing, which is a complex and multi-step biological process."
Johnson & Johnson said it will still work with Emergent to get it authorized by the FDA. It's not yet clear when that could happen.
The company is working with other contract manufacturers in Indiana and Michigan, which are both working 24 hours a day, seven days a week to get the vaccines ready.
The Biden administration said that the quality issue and discarded vaccines will not affect the president's ultimate goal of vaccinating everyone in the country by the end of May.
The US is set to receive 600 million doses of the two-shot vaccines from Pfizer and Moderna, on top of the 20 million doses of Johnson & Johnson's single-shot dose.
"So, that's enough to vaccinate 320 million people, that's the goal, enough to vaccinate everybody, in the US and that's not affected by this," Jennifer Kates, the senior vice president and director of global health and HIV policy at the Kaiser Family Foundation said.