COVID vaccine materials at J&J Baltimore facility to be disposed of over contamination concerns
FDA allowed two more batches of Johnson & Johnson 's COVID-19 vaccine to dispatch but said because of the possibility of contamination, other batches should not be released. Additional batches are still under review.
A possible contamination at Johnson & Johnson's Baltimore factory required the company to toss out materials used to make the vaccine, the Associated Press reported.The Food and Drug Administration approved for 10 million doses to be dispatched but several other batches are not suitable for use, additional batches are still under review.
The factory used to make the vaccines was shut down in April due to the contamination. Investigators were sent in and reported unsanitary conditions, poorly trained employees and other problems.For more reporting from the Associated Press, see below.Registered nurse Tiffany Karschamroon draws a dose from a vial of the Johnson & Johnson COVID-19 vaccine, at an event put on by the Thornton Fire Department on March 6, in Thornton, Colorado. A possible contamination at Johnson & Johnson's Baltimore factory required the company to toss out materials used to make the vaccine
Michael Ciaglo/Getty ImagesA 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. headtopics.com
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 byFDAstaff after factory employees accidentally contaminated a batch.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. headtopics.com
A file photo shows vials of Johnson & Johnson COVID-19 vaccine at a pharmacy in Denver on March 6. 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.Read more: Newsweek »
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wow they're still pumping out the covid19 virus vaccine you would think they would at least attempt for the covid 21 virus
Johnson & Johnson says FDA has extended shelf life of single-dose COVID vaccine by six weeksOriginal three-month expiration dates loomed at end of June. It’s better to get sick and trust drugs that have been around for years. These Vaccines are experimental. These vaccines are more dangerous than getting covid and getting Hydroxychoroquine also it is more effective against Covid-19 than the vaccines.
FDA tells Johnson & Johnson to toss 60 million Covid vaccine dosesThe doses were produced at a plant in Baltimore that was previously found to have contamination issues. Just letting you know they're busting you on facebook Just what in Baltimore isn't contaminated? Q: What do you call 60 million tossed doses of an experimental vaccine? A: A good start.
FDA tells Johnson & Johnson to toss 60 million Covid vaccine dosesThe FDA has told Johnson & Johnson to discard about 60,000,000 doses of its Covid-19 vaccine that were produced at a troubled plant in Baltimore, according to 2 people familiar with the matter. matteroffacttv 60 million people waiting longer for vax.
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Moderna files for FDA authorization of Covid vaccine for 12 to 17-year-oldsModerna has filed for FDA emergency use authorization of its Covid-19 vaccine for kids ages 12 to 17, which could expand the number of shots available to middle and high school students across the country. NBC News ’ Dr. John Torres has the latest. Is it an emergency for this age group range to be trying a vaccine that has no longitudinal study? nice A lot of pressure
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