A third senior official said the Department of Health and Human Services found out last week that Emergent had botched the 15 million doses, and how. “It was no secret that Emergent did not have a deep bench of pharmaceutical manufacturing experts,” that official said.
The federal government expects that Emergent’s problems will delay future shipments of Johnson & Johnson’s vaccine, and distribution of doses to states will be patchy during the next several weeks, two other senior administration officials said. One of those officials said that Johnson & Johnson should still to be able to deliver the doses it promised under its contract with the federal government by the end of April.
The company, which barely met its goal of shipping out 20 million doses to the U.S. by the end of March, has promised the government 100 million doses by the end of May.
The Biden administration has asked Johnson & Johnson to directly supervise Emergent’s vaccine production going forward, said a senior administration official. Getting the facility back on track — and up to regulatory standards — could take a matter of days or weeks, the official added.
The incident at the Baltimore 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.
Without the Emergent authorization, it is unclear whether Johnson & Johnson will be able to meet its June target, one senior Biden official working on the administration’s Covid-19 response said.
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, which comes two weeks after Biden canceled a visit to the Emergent plant in West Baltimore with less than a day’s notice.
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.
Biden officials fretted last week that the company would miss its 20-million-dose goal for March, 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.