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(CNN) – Johnson & Johnson said Thursday that it still hopes to meet its commitments for the promised delivery of an additional 24 million doses of its COVID-19 vaccine in April, even after a quality issue at one of the company’s contracted manufacturers.
The plant that had the problem, managed by Baltimore-based Emergent BioSolutions, has not yet been cleared by the US Food and Drug Administration to make the vaccine and has not made any of the doses found. in the current launch of the vaccine.
Emergent told CNN that the problem affected a single batch of “bulk drug substance” used to make the vaccine.
In an emailed statement to CNN, Emergent said its quality control systems detected the batch that “did not meet specifications and our rigorous quality standards” before it went any further. The company said it isolated the material and will now dispose of it.
It did not detail what the ingredient was or how important it was to any resulting vaccine.
The New York Times reported Wednesday. that Emergent workers accidentally mixed some of the ingredients that would have gone into up to 15 million potential doses of vaccine. But Emergent CEO Bob Kramer told CNBC there was no confusion between the vaccines made at the plant.
“It was not the case where one ingredient in one vaccine contaminated or impacted the other,” he said.
It did not confirm the estimate that the batch would have affected 15 million doses.
“Importantly, the quality control systems functioned as designed to detect and isolate this single batch,” the Emergent statement said. “Disposal of a bulk batch of drug substance, while disappointing, occurs occasionally during vaccine manufacture, which is a complex, multi-step biological process.”
Emergent added that he is confident that the company will meet FDA clearance requirements to manufacture this vaccine. Emergent is also working on Covid-19 vaccines made by other companies.
It is not yet clear when Emergent can get FDA clearance. Johnson & Johnson said it continues to work with the FDA and Emergent for the facility’s authorization.
J&J said it sent additional experts in quality, manufacturing and technical operations to be on site to oversee and support the manufacturing of its vaccine.
A source told CNN that the FDA is demanding more information from Johnson & Johnson about what went wrong and said the FDA has been on the phone with J&J almost constantly since Wednesday.
Even without Emergent, Johnson & Johnson was able to meet its commitment to deliver 20 million doses in March, and the company said it is still on track to deliver 24 million more in April.
A Biden administration official said the April launch of the vaccine will likely look a lot like March, where only a few doses come out at the beginning of the month, and then many more doses will be available near the end of the month. month.
For now, the administration said, vaccine materials will continue to come from J & J’s vaccine division, Janssen in the Netherlands, and will go to the filling and finishing plants that have been going through the final stage process of the vaccines.
For the final stages of manufacturing in the US, J&J has worked with contract manufacturers Catalant in Bloomington, Indiana and with Grand River Aseptic Manufacturing in Grand Rapids, Michigan. Both plants have been working 24 hours a day, seven days a week to finish vaccines.
On Wednesday night, Biden administration officials stressed that the quality issue with Johnson & Johnson’s Baltimore manufacturing plant will not affect the president’s ultimate goal of making vaccines available to all Americans by May. .
Local health departments do not believe that supply “will be terribly affected” by this manufacturing problem, according to Lori Freeman, executive director of the National Association of County and City Health Officials.
Freeman said they were told in a White House call this week that “supplies would remain relatively flat for the next three weeks,” with approximately 16 million doses of vaccines made by Pfizer and Moderna, and 5.1 million J&J vaccines. additional sent to the states. , tribes and territories. J & J’s supply will fluctuate, adding an additional 4-6 million doses per week to 16 million per month.
Freeman added that “curiously,” nothing was mentioned about J & J’s challenges during his calls to the White House earlier in the week.
The only potential problem Freeman could foresee is if the federal government adds more vaccine distribution channels.
“The more the distribution channels of the federal government channels expand (to dialysis centers, community health centers, the increase of the Federal Pharmacy Program from 17,000 stores to 40,000 stores), if there are interruptions in the chain of supply, somewhere in these distribution channels, things could change or vaccine delivery could slow down, “Freeman said in an email to CNN.
Jennifer Kates, senior vice president and director of global health and HIV policy for the Kaiser Family Foundation said that, in the grand scheme of things, this is “a setback.”
“It’s an unfortunate setback in some respects, but the good news is that the US government has already bought enough doses that are scheduled to be delivered between Pfizer and Moderna, and Johnson & Johnson.”
The United States is scheduled to receive 600 million doses of the Pfizer and Moderna two-dose vaccines, and now has 20 million doses of Johnson & Johnson’s single-dose injection.
“So that’s enough to vaccinate 320 million people, that’s the goal, enough to vaccinate everyone, in the United States and that’s not affected by this,” Kates said.
She said public health officials are always concerned that stories about a “hiccup” in manufacturing could heighten reluctance from those who hesitate on vaccines, but the positive news is that the problem stopped before it reached the American public and shows that the security systems are working.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CBS This Morning that the incident shows that quality controls are working.
“That’s why the good news is that it was picked up,” Fauci said.
Kates added that if there is any kind of delay with the J&J vaccine, it could negatively affect the people who are hardest to reach.
A Kaiser Family Foundation poll released Tuesday found that most of the people who were on the fence about the COVID-19 vaccine, those who wanted to “wait and see,” preferred a single-dose injection, if they were going to get one. . absolutely.
“So it means that if there is a delay, it could reduce the likelihood that there is an option for those people who may be more reluctant, as well as more difficult to reach people like homeless populations, so it could mean having to work It’s harder to reach people, Kates said.
“But hopefully J&J can figure this out and fix it.” “The good news is that we are in a good place in terms of overall supply.”
This story was first published on CNN.com, “J&J Says Covid-19 Vaccine is Still Going Despite Manufacturing Failures.”
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