FDA tells Johnson & Johnson that 60 million vaccine doses are not available

Washington — Federal regulators said Friday that millions of Johnson & Johnson coronavirus vaccines produced at the troubled Baltimore plant would not be available. Inoculation campaign.

The Food and Drug Administration allows about 10 million doses from the factory to be distributed in the United States or sent to other countries, but regulators say Emergent BioSolutions, the company that runs the factory, is appropriate. It is conditional that we cannot guarantee that we have followed proper manufacturing. Practice, according to those familiar with agency decisions. Approximately 60 million doses cannot be used due to possible contamination.

The agency has not yet decided if Emergent can reopen the factory. Closed Two months ago due to concerns about mutual contamination with another vaccine manufactured in the same location. According to people familiar with the situation, the verdict is probably a few weeks away.

All 21 million Johnson & Johnson vaccine doses distributed in the United States to date were manufactured at the Johnson & Johnson plant in the Netherlands, not by Emergency. Still, the shot suffers from popularity after the government has investigated possible associations with rare coagulopathy.And state health officials have said in the last few weeks Scramble to use Johnson & Johnson is taken before it expires.

Regulators have kept the Baltimore facility under a microscope since March, when they discovered that a major production accident resulted in contamination of a batch of Johnson & Johnson vaccines. After that, Emergent discarded the equivalent of 15 million doses.The New York Times Documented months of issues In the factory, including failures to properly disinfect equipment and protect it from viral and bacterial contamination.

The federal government has so far agreed to pay Emerging about $ 200 million to produce the coronavirus vaccine, but until Friday, regulators will use a single dose manufactured by Emagent for use in the United States. I didn’t allow it.

In a statement, Johnson & Johnson described Friday’s decision as “an ongoing effort to make a difference in this pandemic on a global scale.” 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 can be used to protect millions of people from this deadly disease.”

However, the two companies not only released tens of millions of doses, but also restarted the plant, according to people familiar with their businesses who did not want to be identified because they were not allowed to comment. I wanted to agree to let you. publicly.

The United States is currently flooded with vaccines from other suppliers, but 60 million discarded doses could have been surged by other countries that have asked the United States to share surplus supplies over the course of several weeks. There is sex.Johnson & Johnson Vaccine Used in 24 countries, Including Africa.

The FDA’s move brings Johnson & Johnson to a total dose of 75 million that had to be discarded due to manufacturing expiration. The fate of more than 100 million other doses of the Johnson & Johnson and AstraZeneca vaccines produced by Emergent has not yet been determined.

Regulators are examining the records to determine if they can be safely released. “Once these reviews are complete, the authorities will continue to inform the general public,” the FDA said in a statement.

The Emergent problem has become a serious problem for the Biden administration, which was hoping to export tens of millions of Johnson & Johnson and AstraZeneca doses produced at the factory. Federal officials cracked down on Emergent in April, suspending factory operations, taking responsibility for AstraZeneca’s vaccine production from Emergent, and instructing Johnson & Johnson to control on-site production.

Due to an emergency issue, Johnson & Johnson is far behind its promise to provide the US government with 100 million doses by the end of June. Johnson & Johnson also faced a significant setback in April. Recommended by federal health authorities The state will temporarily suspend the use of the vaccine while the FDA and the US Centers for Disease Control and Prevention are investigating possible associations with rare blood coagulation disorders.

Officials Overturned that recommendation Approximately 10 days later, the pause increased interest in Johnson & Johnson’s shots. Dr. Rupari J. Limei, a researcher at Johns Hopkins University who is studying the use of vaccines, said that the expiration of Emergent further reduced public confidence in Johnson & Johnson’s injections and warned against other coronavirus vaccines. He said it could be connected.

“This is a great product. It’s safe and effective, and it can reach more temporary people,” she said. “But this more generally undermines confidence in the product.”

In late April, President Biden announced that once the United States obtained FDA approval, the United States would send 60 million AstraZeneca vaccines abroad, even under strict regulatory scrutiny. 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 the UK for this week’s Group 7 Summit, Biden announced another donation plan. With 500 million doses from Pfizer, the company will sell its administration to about 100 countries next year at the cost of donations. Importantly, it is still far below the 11 billion doses that the World Health Organization has stated globally needed to eradicate a pandemic.

Dr. Luciana Borio, who oversaw the preparations for public health at the National Security Council under President Donald J. Trump and was the FDA’s chief scientist under President Barack Obama, is a member of Johnson & Johnson. Risk of relying on Emergent, who said dose disposal should be emphasized to the Obama administration.

“It’s the company we’ve come to 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 characterized the FDA’s plan to allow 10 million doses in the United States or abroad, with manufacturing warnings that are unusual for products that are only allowed for emergency use. Authorities usually took that action against a fully approved drug that was in short supply, they said.Of the agency Vaccine guidance Under an emergency use authorization, regulators have made it clear that they expect shot-producing sites to work with standard manufacturing practices.

In that statement, the FDA revealed that Johnson & Johnson doses from Emergent will be manufactured by both companies under a “proper nondisclosure agreement” with regulators in countries where the vaccine may be present. It may only be exported on condition that it is done. ” second hand. “Experts said it effectively corresponded to a warning from the agency that workers were concerned about their compliance with proper manufacturing standards.

Dr. Limei, a Johns Hopkins vaccine researcher, said of the Johnson & Johnson injection, “The fact that they can’t be confident that they’re fine contributes to the perception that this isn’t the best. “.

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

The agency also said it continues to “solve problems” at both Johnson & Johnson and Emergency at its Baltimore plant.

Cheryl Gay Stolberg Contribution report.

FDA tells Johnson & Johnson that 60 million vaccine doses are not available

Source link FDA tells Johnson & Johnson that 60 million vaccine doses are not available

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