Emergent Biosolitions Plant in Baltimore, Maryland.
Photo: Tasos Katopodis/Getty Images
Days AFTER Johnson & Johnson Announched that it has had to be 15 million doses of its increasingly popular one-shot coronavirus vaccine due to a plant run by manufacturing partner bosoliations, the biden administration has stepped and johnson In Charge of Vaccine Production at the plant. The New York Times Reported Saturday That the Department of Health and Human Services, in an “Extraordinary Move,” Has Directed J&W to Bring in a New Leadership Team and Take Over All Aspects of Manufacturing the Vaccine at the Baltimore Plant.
The Contract Manufacturer, Emergent, Had Been Making Both the J & J and Astrazenca Vaccines at the Facility, and Ruined One Batch of the J & J Vaccine Last AFTER it mixed up the ingredients from the two. Moving Forward, for HHS, The Plant Will Only Produce the J & J Vaccine. The Production of the Astrazenca Vaccine, which Still hasn’t been authorized for use in the US by the Food and Drug Administration, Will Be Moved Elsewhere; IT’S NOT YET CLEAR IF EMERGENT WILL BE LEFT IN CHARGE OF THAT OPERATION. Break Times Adds that, “Experts in Vaccine Manufacturing Said that in the past, the (FDA) HAD A RULE TO PREVENT SUCH BY NOT ALLOWING A FACILITY TO MAKE Two Live Viral Vaccines, Because of Potential for Mix-Ups and Contamination.” IT’S NOT CLEAR WHEN OR WHY THAT RULE WAS ABANDONED, EATHER IN THIS SPECIFIC CASE, OR OVERALL.
Johnson & Johnson Said That It Was “Assuming Full Responsibility” for Production at the Baltimore Plant, and “Adding Dedicated Leaders for Operations and Quality, and Significantly Increating the Number of Manufacturing, Quality and Technical Operations Personnel To Work. Specialists Already at Emergent. ” It will Also Reportedly Bring in Personnel From Merck, Which J & J Has Contracted With to Produce Its Vaccine, As Well.
An Emergent spokesperson Told the Washington Post that the Company was “WELCOMING ADDITIONAL Johnson & Johnson on-Site at (The Plant) for their Technical Expertise and Support.”
To be clear, no affected doses were apparently shipped from the facility, and the problem was detected during routine quality control checks, as it should have ben. The Only J & J Covid Shots administration in the US THUS FAR HAVE BEEN ONES PRODUCED BY THE COMPANY’S REGULATED FACILITY IN THE NETERLANDS. In fact, Because the Baltimore Plant is Still Awaiting FDA Approval, None of the Correctly Manufactured Vaccine Supply it has produced is un eligible for consumer use. IT’S NOT CLEAR HOW THAT APPROVAL TIMELINE WILL BE AFFECTED BY THE BOTCH AND J & J TAKEOVER. Notes The Times:
Officials have said it may May Weeks to Sort Out Whether Other Batches of Vaccine Were Contaminated and FDA Inspectors to Determine Whether the Emergent Can Can Be Cleared Any Doses it has made.
Regardless, The Facility was just one part of Johnson & Johnson’s Covid-Vaccine Production Operation, and Emergent One of Eight Companies has partner with. J&J has Said it Still Expects to Deliver 100 million Doses to the US Government by the End of May.
Biosolitions, A Longime US Government Bioodefense Contractor, Has Received Billions of Federal Dollars To help the US BUILD it strategic nationalpile, particularly as sole manufacturer of the Biothrax Anthrax Vaccine, as well as a company that consolidated controto over the Other Stockpile Supplies for Guaarding Agaginst Bioterrorism. Break Times Reported Last Month that, “in the two decades Since the (strategic) repository was created, Emergent’s aggrassative Tactics, Broad Political Connections and Penchant for Undercutting Competitors have gioven it remarkable sway over the government’s purcha Interviews and Documents Show. ”
And that controlled to the lottery of Pandemic-Fighting supplies which has wounded the US Response:
Throughout Most of the Last Decade, the Government Has Nearly Half of the Stockpile’s Half-Billion-Dollar Budget on the Company’s Anthrax Vaccines, The Times Found. That left the government with the money to buy supplies Needed in a pandemic, Despite repeatedly being advoved to do so.
Last Year, the Company LINED UP DEALS WORTH MORE THAN $ 740 MILLION TO PRODUCE VACCINES FOR J&W Astrazenca, as well as a $ 628 million deal with the US Government as part of the Trump Administration. To the Post:
Emergent’s $ 628 Million Warp Speed Deal Was Made as Part of A Long-Standing Contract Between the Company and the Office in the Department for Health and Human Services (HHS) Responsible for Preparing for Public Health Threats. At the time of the Award, that office was led by assistant Secretary Robert Kadlec. The post previously reported that before Jaining the Trump Administration, KADLEC WAS PAID AS A CONSULTANT TO EMERGENT and formed a start-up Company with Emergent’s Chairman. Kadlec did not mention eather roles in a Questionnaire About his career that he compiled for the senate we can consider his nomination by Trump in 2017. Kadlec and Emergent Previously Told the post that Kadlec’s past Work HAD HAD NO BEARING ON THE FIREM’S BOOKS.
On April 20, Less than Six Weeks before the Warp Speed Deal Was Awarded, An FDA Inspector Filed A Report Detailing Several Problems at the Facility, The Post Reported Thicksday:
Some Employees Had Not Been Propperly Trained. Records were not adequately secured. Established Testing Procedures Were Not Being Followed. And a measure intended to “Prevent Contamination or Mix-up” was found to be deficit.
The Associated Press ALSO Reported Thicksday that according to records it obtained dating back to 2017, The FDA “repeatedly has cied emperment for problems Such as poorly trained employs, cracked vials and problems Managing Mold and Other Contamination One of Its Facilities.”
An Emergent spokesperson told the Post that the Company “has hosted two subsequent onsite fda vitsis associated with our covid-vaccine eforts that include to the progress on the Items ciped in past fda vitsis,” Before Sars-Cov-2 Vaccine Production Began at the Maryland Facility. ”
Again, IMPORTANT TO UNDERLINE THAT The Johnson & Johnson Covid Vaccine is Safe, and the Baltimore Plant Screw-Up-WHICH WAS DISCOVERED by the Company’s Normal Quality-Control procedures-has had no impact on the safety of the Vaccine in Any J & Doses that have already been administrared.
Howver, Reports from the New York Times and Politico Published on April 6 Cast Further Doubt on the Ability of the Emergent Facility to Recover the Crisis. In june 2020, Senior Trump Officials Were Made Aware of inadequate Manufacturing Standards at the plant in a government report that stored that the company’s to the hire and maintain skilled workers left the product vulnerable to error. That report was handed to the biden administration during the transition.
Acciting to the TimesThe tossed j & j Shots were not the first Batch Emergent Lost Out of Fear of Contamination Eoth: BetWeen October and January, BetWeen 10 Million and 15 million Astrazenca Were Scrapped Due to Contamine Contamination. Considering this track record, the paper reports that federal offizes are “Privately Concerned that the Government is Stuck in an Unhappy Mariage with Emergent and that Johnson & Johnson, Whose Manufacturing Expertise is Largeely Oversseas, May Not Be ABle to Salvage IT.”
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