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FDA tells Johnson & Johnson 60 million doses of vaccine cannot be used

WASHINGTON – Federal regulators said on Friday that millions of doses of Johnson & Johnson’s coronavirus vaccine produced at a struggling Baltimore plant could not be used, the latest in a series of setbacks for a company whose vaccine Single injection was once considered crucial for the nation’s immunization campaign.

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

The agency has yet to decide whether Emergent can reopen the plant, which closed two months ago over fears of cross-contamination with another vaccine made at the same site. That verdict is most likely in a few weeks, according to people familiar with the situation.

The 21 million doses of Johnson & Johnson vaccine distributed in the United States so far have been manufactured at Johnson & Johnson’s factories in the Netherlands, not by Emergent. Still, the coup waned in popularity after the government investigated its possible link to a rare bleeding disorder. And in recent weeks, state health officials have rushed to use the Johnson & Johnson doses before they expire.

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

The federal government has agreed to pay Emergent around $ 200 million so far to manufacture coronavirus vaccines, but until Friday, regulators had not authorized a single dose produced by Emergent for use in the states. -United.

In a statement, Johnson & Johnson called Friday’s decision “progress in our continued efforts to make a difference in this pandemic on a global scale.” And Robert G. Kramer, President and CEO of Emergent, said in a statement, “We are delighted that these first doses of the Johnson & Johnson Covid-19 vaccine are available to protect millions of people from this deadly disease. . “

But the two companies were hoping the FDA would agree not only to release tens of millions of doses but to let the plant reopen, according to people familiar with the operations of the companies who did not want to be identified because they were not authorized to. comment. publicly.

While the United States is now teeming with vaccines from other suppliers, the 60 million doses discarded may have been recovered by other countries that have been asking the United States for weeks to share their surpluses. Johnson & Johnson’s vaccine is used in 24 countries, including Africa.

The FDA move brings the total number of doses Johnson & Johnson had to phase out due to manufacturing delays to 75 million. The fate of the more than 100 million other doses of the Johnson & Johnson and AstraZeneca vaccines that Emergent produced remains to be decided.

Regulators go through the files to determine if they can be released safely. “The agency will keep the public informed as these reviews are completed,” the FDA said in a statement.

Emergent’s troubles became a serious problem for the Biden administration, which planned to export tens of millions of Johnson & Johnson and AstraZeneca doses produced at the plant. Federal authorities cracked down on Emergent in April, suspending operations at the plant, stripping Emergent of its responsibility to manufacture AstraZeneca’s vaccine and asking Johnson & Johnson to take control of manufacturing at the site.

Due to Emerg’s issues, Johnson & Johnson has fallen far behind on its pledge to deliver 100 million doses to the US government by the end of June. Johnson & Johnson also suffered a major setback in April when federal health officials recommended states temporarily stop using its vaccine while the FDA and the Centers for Disease Control and Prevention investigated possible links to a disorder. rare blood clotting.

Although officials rescinded that recommendation around 10 days later, the hiatus appears to have helped undermine interest in the Johnson & Johnson shooting. Dr Rupali J. Limaye, a researcher at Johns Hopkins University who studies vaccine use, said Emergent’s failures could further diminish public confidence in Johnson & Johnson’s shot and could lead to suspicion other coronavirus vaccines.

“It’s a great product – it’s safe, effective and allows us to reach people who are more on the move,” she said. “But it undermines confidence in the product more generally.”

President Biden announced in late April that the United States would send up to 60 million doses of AstraZeneca vaccine overseas once it obtains FDA clearance, even though the emerging plant was already under close scrutiny from regulators. The agency continues to assess the safety of at least 70 million doses of AstraZeneca produced there, people familiar with the matter said.

After arriving in Britain for the Group of 7 summit this week, Mr Biden announced another donation plan: 500 million doses of Pfizer which the company sells the administration for at cost for a donation of around 100 country over the next year. While important, it is still a long way from the 11 billion doses that the World Health Organization says are needed around the world to eradicate the pandemic.

Dr Luciana Borio, who oversaw public health readiness for the National Security Council under President Donald J. Trump and was acting chief scientist at the FDA under President Barack Obama, said the rejection of the doses Johnson & Johnson should focus on the Biden administration. the risks of looking into Emergent.

“This is a company that we rely on to make biodefense products,” she said. “It’s important to go back now and ask what we know about their manufacturing capacity. “

Experts have called the FDA’s plan to allow 10 million doses to be used in the United States or overseas with a warning about making a product that is only allowed in the event of emergency. The agency has generally taken this step for fully approved drugs that are in short supply, they said. The agency’s guidelines for vaccines under emergency use authorization make it clear that regulators expect sites that produce vaccines to operate with standard manufacturing practices.

In its statement, the FDA said that Emergent’s Johnson & Johnson doses could only be exported on condition that the two companies disclose how the doses were manufactured “under an appropriate confidentiality agreement, with regulatory authorities in countries where the vaccine can be used. ” Experts said it actually amounted to a warning from the agency that it was concerned about whether workers had adhered to the proper manufacturing standards.

“The fact that they can’t say for sure that they’re okay contributes to the perception that it’s not the best,” Johns Hopkins vaccine researcher Dr Limaye said of the Johnson vaccine. & Johnson.

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

The agency also said it was continuing to “fix the problems” at the Baltimore plant with Johnson & Johnson and Emergent.

Sheryl Gay Stolberg contributed reports.

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