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Johnson & Johnson COVID Vaccine Maker Emergent BioSolutions Asked To Stop Making Doses While FDA Investigation Underway

BALTIMORE (WJZ) -- Emergent BioSolutions, the Baltimore, Maryland-based company manufacturing the Johnson & Johnson coronavirus vaccines, was asked to stop manufacturing COVID-19 related products, while the Food & Drug Administration continues its investigation into quality control issues at the plant that ruined 15 million potential doses of the vaccine.

The FDA initiated an inspection of the company's Bayview facility on April 12. At the request of the FDA, Emergent BioSolutions agreed on April 16 not to make any new COVID-19 materials at this facility and to quarantine existing materials already manufactured there pending results of the inspection.

"I think people should be absolutely confident that we have a system that is working, so it is still a safe vaccine," said Tinglong Dai, associate professor with Johns Hopkins' Carey Business School.

In a statement Monday, Emergent BioSolutions's officials said, "This inspection is ongoing. While we await the FDA's full feedback, we are working with J&J and the FDA on strengthening the supply chain for this vitally important vaccine."

"We recognize the confusion these recent events may have caused our customers, our employees, and the public," the statement continued. "We are steadfastly committed to full compliance with the FDA's strict requirements. We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes.

It was allegedly human error that botched the doses after employees "accidentally conflated the vaccines" ingredients several weeks ago. A New York Times article initially reported the issues in late March.

The one-shot vaccine was deemed a "game-changer" by Maryland officials.

In an interview with CNBC earlier this month, CEO of Emergent BioSolutions Robert Kramer disputed published reports that the problem stemmed from employees mixing up ingredients from Johnson & Johnson and Astrazeneca vaccines, which are both made at the Baltimore Bayview Plant.

"So, again, it was out of specification result for one batch of product," Kramer said. "I've seen as well where that has been equated to 15 million doses, all I can say is it's one batch,"

Officials said none of the vaccines from the Baltimore plant has been distributed for use. The pause will remain in place until the FDA completes its inspection of the facility.

It's the latest setback for the Johnson & Johnson COVID vaccine.

Last week, the FDA and CDC advised states to temporarily stop using the J&J vaccine "out of an abundance of caution" after six women developed a rare but potentially deadly blood clotting disorder.

"I think, short-term, the impact is very low," Dai said.

Health care analytic experts like Dai say until the FDA authorizes Emergent's plant and restarts J&J vaccinations, there won't be any significant impacts on vaccine supply.

"We need both to happen for any difference to be made," Dai said.

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