March 31, 2021 at 10:39 pm #100002477zpodiumKeymaster
The incident at the plant prompted the Food and Drug Administration to delay approving Emergent to help Johnson & Johnson produce vaccine; the company had sought permission via an amendment to the emergency use authorization for its shot.
Emergent was supposed to send its drug substance to Catalent, a New Jersey drug manufacturer, to bottle the vaccine. The FDA approved Catalent’s production role last week, and Emergent had already begun shipping millions of doses to the other firm, people familiar with J&J’s authorization told POLITICO last week. But Catalent cannot release the Emergent doses without the Maryland company’s emergency clearance.
“FDA is aware of the situation, but we are unable to comment further. Questions about a firm’s manufacturing facilities should be directed to that firm,” the FDA said in a statement.
Johnson & Johnson said in a statement that its quality control processes “identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine.”
The company added: “This batch was never advanced to the filling and finishing stages of our manufacturing process. This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA).”
Emergent, Catalent, the Department of Health and Human Services and the White House have not yet responded to requests for comment.
The New York Times was the first to report the story.
The Emergent problems are the latest blow to Johnson & Johnson’s efforts to accelerate production of its vaccine, which — as the only one-dose coronavirus shot cleared for use in the U.S. — is a critical component of President Joe Biden’s vaccination push.
J&J barely met its deadline to deliver 20 million doses by the end of March, and is supposed to deliver 100 million doses by the end of May. Biden officials fretted last week that the company would miss the mark, which would have complicated state vaccination plans that counted on millions of doses coming through. The company significantly boosted the number of shots it was able to provide — from 4 million to 11 million — this week after the FDA allowed contract manufacturer Catalent to begin shipping millions of doses of J&J’s vaccine.
Since then, Jeff Zients, White House coronavirus coordinator, told governors Tuesday to expect fluctuations in the amount of J&J shots states will receive in April. He predicted the number of doses available would increase toward the end of the month, according to two sources with knowledge of the call and notes obtained by POLITICO.
Officials at J&J have over the last week repeatedly pushed back on questions about production being delayed. One official told POLITICO as late as Wednesday afternoon that the company expected the Emergent authorization to come through “imminently.”
Sam Sutton contributed to this report.
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