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10 million Johnson & Johnson vaccines from troubled factory to be released for use

Many more will be discarded, regulators say

10 million Johnson & Johnson vaccines from troubled factory to be released for use

Many more will be discarded, regulators say

SO, YEP YOU GOD I DO AFTER TAKING AN OATH EMERGENT BIOSOLUTIONS CEO OWNED THE PRODUCTION PROBLEMS. IN CORONAVIRUS VACCINE BACK IN MARCH AS CEO, I TAKE FULL RESPONSIBILITY FOR THAT EXECUTIVES FROM THE BALTIMORE BASED BIOTECH FIRM GRILLED BY HOUSE DEMOCRATS WEDNESDAY AS NEW DETAILS EMERGED IN CONGRESSIONAL DOCUMENTS RELEASED JUST BEFORE THE HEARING BEGAN THESE DOCUMENTS PROV. AT INSIGHT INTO THE DYSFUNCTION AT EMERGENT THAT CAUSED SO MANY LIFE-SAVING VACCINES TO BE RUINED ACCORDING TO A COMMITTEE STAFF MEMO. THE FEDS HAVE BEEN PAYING EMERGENT 27 MILLION DOLLARS A MONTH JUST TO RESERVE SPACE TO HOLD A SPOT AT BAYVIE AND TWO OTHER SITES IN MARYLAND THE COMPANY TOOK TAXPAYERS MONEY AT LEAST 271 MILLION SO FAR THAT THEY’VE SPENT BUT FAILED TO DELIVER ACCORDING TO DOCUMENTS. URGENT PAID OUT MILLIONS IN BONUSES TO TOP EXECUTIVES AMID PRODUCTION FAILURES AND ALL THOSE RUINED VACCINE DOSES AND AS EARLY AS JUNE 2020 EMERGENT HAD BEEN WARNED REPEATEDLY ABOUT PROBLEMS INCLUDING CONTAMINATION RISKS AND UNSANITARY CONDITIONS EMERGENT IS COMMITTED TO ADDRESSING ALL QUALITY AND MANUFACTURING ISSUES AT THE BAYVIEW FACILITY WITH DILIGENCE. CORONAVIRUS AND URGENCY AS THE EXACT VOWED THAT CORRECTIVE ACTION IS BEING TAKEN REPUBLICAN MEMBERS WORK TO MAKE THE ARGUMENT ABOUT INTELLECTUAL PROPERTY THE ORIGINS OF THE PANDEMIC AND MASKING MANDATES MR. SPEAKER. WHY ISN’T THE COMMITTEE CHARGED WITH UPHOLDING PUBLIC HEALTH CDC GUIDELINES ON MASKS? INSTEAD OF PUTTING SHOTS IN ARMS THE BIDEN ADMINISTRATION IS PUTTING US IP IN CHINA’S HANDS. THAT IS INSANE. EMERGENT EXECUTIVES FLATLY DENIED ANYTHING IN PROPER IN THE WAY THAT THEY WERE AWARDED THE NO-BID CONTRACT AND THEY ALSO DENIED THAT THE FEDS RECENTLY STOPPED PAYING THE FULL 27 MILLION. MONTHLY BILL DESPITE CONGRESSIONAL DOCUMENTS AND CONGRESSIONAL DEMOCRATS SAYING OTHERWISE REPORTING L
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10 million Johnson & Johnson vaccines from troubled factory to be released for use

Many more will be discarded, regulators say

Video above: Emergent BioSolutions executives grilled at Capitol Hill hearingU.S. regulators are allowing for the release of 10 million doses of Johnson & Johnson's COVID-19 vaccine from a troubled Baltimore factory, but material to make many more must be thrown out because of possible contamination, a person familiar with the decision told The Associated Press on Friday.The Food and Drug Administration announced that it had determined that two batches from the plant could be released. But it said several other batches are not suitable for use and additional batches are still under review.A second person familiar with the decision confirmed that it would allow for 10 million doses to be released. Both people spoke to the AP on condition of anonymity because they weren’t authorized to release details about it.The doses originated at an Emergent BioSolutions factory, known as Bayview, that is making the vaccine for J&J. Those doses would be the first from the factory approved for use. J&J doses that had been administered came from other plants.Emergent is one of several contractors for J&J that produces its one-shot vaccine in bulk. The concentrated vaccine then is shipped to other factories for final steps, including diluting them to the correct strength, putting them in vials and packaging them up.Roughly 100 million doses made from bulk vaccine produced at Emergent’s factory had been set aside for additional testing by FDA staff after factory employees accidentally contaminated a batch.That contamination led the FDA to shut down the factory in mid-April and send in a team of inspectors. They spent a week going through the factory and reviewing security camera footage that showed employees carelessly handling vaccine materials. The inspectors reported unsanitary conditions, poorly trained employees and other problems.The lapses have hampered J&J's efforts to be a major player in vaccinating people, particularly in remote areas and poor countries, given that it’s the only drugmaker with an authorized vaccine that only requires one dose and standard refrigeration.The problems forced J&J to import millions of doses from its factory in the Netherlands and to miss supply commitments.Emergent's factory had a history of FDA citations for problems including mold, dirty walls and floors, poorly trained employees and an inadequate strategy to prevent contamination, yet it was given a huge role in COVID-19 vaccine production by the Trump administration. Emergent was handed a lucrative contract to make many millions of COVID-19 vaccines for both J&J and AstraZeneca at the Bayview factory.Emergent's chief executive has blamed the contamination and other problems on the complexity of scaling up the factory in just months to make two different vaccines.The Biden administration is working to find a different American manufacturing partner for the British drugmaker, which has yet to request authorization to distribute it in the U.S.

Video above: Emergent BioSolutions executives grilled at Capitol Hill hearing

U.S. regulators are allowing for the release of 10 million doses of Johnson & Johnson's COVID-19 vaccine from a troubled Baltimore factory, but material to make many more must be thrown out because of possible contamination, a person familiar with the decision told The Associated Press on Friday.

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The Food and Drug Administration announced that it had determined that two batches from the plant could be released. But it said several other batches are not suitable for use and additional batches are still under review.

A second person familiar with the decision confirmed that it would allow for 10 million doses to be released. Both people spoke to the AP on condition of anonymity because they weren’t authorized to release details about it.

The doses originated at an Emergent BioSolutions factory, known as Bayview, that is making the vaccine for J&J. Those doses would be the first from the factory approved for use. J&J doses that had been administered came from other plants.

Emergent is one of several contractors for J&J that produces its one-shot vaccine in bulk. The concentrated vaccine then is shipped to other factories for final steps, including diluting them to the correct strength, putting them in vials and packaging them up.

Roughly 100 million doses made from bulk vaccine produced at Emergent’s factory had been set aside for additional testing by FDA staff after factory employees accidentally contaminated a batch.

That contamination led the FDA to shut down the factory in mid-April and send in a team of inspectors. They spent a week going through the factory and reviewing security camera footage that showed employees carelessly handling vaccine materials. The inspectors reported unsanitary conditions, poorly trained employees and other problems.

The lapses have hampered J&J's efforts to be a major player in vaccinating people, particularly in remote areas and poor countries, given that it’s the only drugmaker with an authorized vaccine that only requires one dose and standard refrigeration.

The problems forced J&J to import millions of doses from its factory in the Netherlands and to miss supply commitments.

Emergent's factory had a history of FDA citations for problems including mold, dirty walls and floors, poorly trained employees and an inadequate strategy to prevent contamination, yet it was given a huge role in COVID-19 vaccine production by the Trump administration. Emergent was handed a lucrative contract to make many millions of COVID-19 vaccines for both J&J and AstraZeneca at the Bayview factory.

Emergent's chief executive has blamed the contamination and other problems on the complexity of scaling up the factory in just months to make two different vaccines.

The Biden administration is working to find a different American manufacturing partner for the British drugmaker, which has yet to request authorization to distribute it in the U.S.