F.D.A. Tells Johnson & Johnson60 Million Vaccine Doses Cannot Be Used

WASHINGTON — Federal regulators said on Friday that millions of doses of Johnson & Johnson’s coronavirus vaccine produced at a troubled Baltimore factory could not be used, the latest in a series of setbacks for a company whose single-shot vaccine was once considered crucial to the nation’s inoculation campaign.

The Food and Drug Administration will still allow about 10 million doses from the factory to be distributed in the United States or sent to other countries, but with a proviso that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed proper manufacturing practices, according to people familiar with the agency’s decision. About 60 million doses will not be usable because of possible contamination.

The agency has not yet decided whether Emergent can reopen the factory, which closed two months ago because of concerns about cross-contamination with another vaccine manufactured at the same site. That verdict is most likely a few weeks away, according to people familiar with the situation.

All 21 million Johnson & Johnson vaccine doses distributed in the United States so far were manufactured at Johnson & Johnson’s plants in the Netherlands, not by Emergent. Still, the shot has suffered in popularity after the government investigated its possible link to a rare clotting disorder. And state health officials have in recent weeks scrambled to use Johnson & Johnson doses before they expire.

Regulators have put the Baltimore facility under a microscope since March, when they discovered that a major production mishap had resulted in the contamination of a batch of Johnson & Johnson vaccines. Emergent later discarded the equivalent of 15 million doses. The New York Times has documented months of problems at the plant, including failures to properly disinfect equipment and to protect against viral and bacterial contamination.

The federal government has paid Emergent roughly $200 million so far to manufacture coronavirus vaccines, but until Friday, regulators had not cleared a single dose produced by Emergent for use in the United States.

In a statement, Johnson & Johnson cast Friday’s decision as “progress in our continued efforts to make a difference in this pandemic on a global scale.” And Robert G. Kramer, president and chief executive officer of Emergent, said in a statement: “We are pleased that these initial doses of the Johnson & Johnson Covid-19 vaccine will be available to protect millions of people from this deadly disease.”

But both companies had been hoping that the F.D.A. would agree not only to release tens of millions of doses but to let the plant reopen, according to people familiar with the companies’ operations who did not want to be identified because they were not authorized to comment publicly.

While the United States is now awash in vaccine from other suppliers, the 60 million discarded doses might have been snapped up by other countries that for weeks have been asking the United States to share its surplus supplies. Johnson & Johnson’s vaccine is used in 24 countries, including in Africa.

The F.D.A.’s move brings to 75 million the total number of doses that Johnson & Johnson has had to discard because of the manufacturing lapses. Still to be decided is the fate of more than 100 million other doses of the Johnson & Johnson and AstraZeneca vaccines that Emergent has produced.

Regulators are combing through records to determine whether those are safe to release. “The agency will keep the public informed as those reviews are completed,” the F.D.A. said in a statement.

Emergent’s troubles have become a serious problem for the Biden administration, which had been counting on exporting tens of millions of Johnson & Johnson and AstraZeneca doses produced at the plant. Federal officials cracked down on Emergent in April, pausing the plant’s operations, stripping Emergent of its responsibility for manufacturing AstraZeneca’s vaccine and instructing Johnson & Johnson to take control of manufacturing at the site.

Because of Emergent’s problems, Johnson & Johnson has fallen far behind on its promise to deliver 100 million doses to the U.S. government by the end of June. Johnson & Johnson also encountered a significant setback in April when federal health officials recommended that states stop using its vaccine temporarily while the F.D.A. and the Centers for Disease Control and Prevention investigated possible ties to a rare blood-clotting disorder.

Although officials reversed that recommendation about 10 days later, the pause appears to have helped sap interest in the Johnson & Johnson shot. Dr. Rupali J. Limaye, a Johns Hopkins University researcher who studies vaccine use, said that Emergent’s lapses might further diminish the public’s faith in Johnson & Johnson’s shot and might lead to wariness about other coronavirus vaccines.

“It’s a great product — it’s safe, efficacious and allows us to reach people who are more transient,” she said. “But this undermines the confidence in the product more generally.”

President Biden announced in late April that the U.S. would send as many as 60 million doses of AstraZeneca’s vaccine abroad once they had F.D.A. clearance, even though the Emergent plant was already under intense scrutiny from regulators. The agency is continuing to evaluate the safety of at least 70 million AstraZeneca doses produced there, people familiar with the matter said.

After he arrived in Britain for the Group of 7 summit this week, Mr. Biden announced another donation plan: 500 million doses from Pfizer that the company is selling the administration at cost for donation to about 100 countries over the next year. While significant, that is still far short of the 11 billion doses that the World Health Organization has said are needed globally to stamp out the pandemic.

Dr. Luciana Borio, who oversaw public health preparedness for the National Security Council under President Donald J. Trump and was acting chief scientist at the F.D.A. under President Barack Obama, said that the discarding of the Johnson & Johnson doses should emphasize to the Biden administration the risks of leaning on Emergent.

“It’s a company that we have relied on for making biodefense products,” she said. “It’s important to go back now and ask what we know about their ability to manufacture.”

Experts characterized the F.D.A.’s plan to allow 10 million doses to be used in the United States or abroad with a warning about manufacturing as unusual for a product that is authorized only for emergency use. The agency has typically taken that action for fully approved drugs that are in short supply, they said. The agency’s guidance for vaccines under emergency use authorization makes it clear that regulators expect sites that produce shots to operate with standard manufacturing practices.

In its statement, the F.D.A. said that Johnson & Johnson doses from Emergent might be exported only on the condition that both companies divulge how the doses were manufactured “under an appropriate confidentiality agreement, with the regulatory authorities of the countries in which the vaccine may be used.” Experts said that effectively amounted to a warning from the agency that it had concerns about whether workers had adhered to proper manufacturing standards.

“The fact that they can’t say with certainty that they’re fine contributes to the perception that this is not the best,” Dr. Limaye, the Johns Hopkins vaccine researcher, said of the Johnson & Johnson shot.

The F.D.A. said that before regulators had decided what to do with the Johnson & Johnson doses, they “conducted a thorough review of facility records and the results of quality testing performed.” They also considered the ongoing public health emergency.

The agency also said it was continuing to “work through issues” at the Baltimore plant with both Johnson & Johnson and Emergent.

Sheryl Gay Stolberg contributed reporting.

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