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HHS Closes WarpSpeed AZ Manufacturing Plant

by Oui Sun Apr 4th, 2021 at 08:25:51 AM EST

FDA has not approved manufacturing of vaccines by Emergent BioSolutions Inc. and has yet to approve the Oxford AstraZeneca vaccine. It is BARDA, a division of the U.S. HHS which took steps and intervened in the manufacturing of Johnson & Johnson to reach standards of quality at the plant.


The AstraZeneca Factory in Baltimore

Emergent BioSolutions has a factory in Baltimore that operates under an innovative long-term private-partnership agreement with BARDA. Essentially BARDA subsidized the factory in return for an option to use it in an emergency-Operation Warp Speed exercised that option and in June-July AstraZeneca signed a licensing agreement with Emergent for large-scale manufacturing of its vaccine.

Emergent BioSolutions Hosts Biopreparedness Roundtable for NATO
Parliamentarians | Press Release - July 2010 |

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A long history of poor compliance and governance of quality standards and a number of violations were recorded by the FDA.

Maryland company whose Baltimore factory compromised Johnson & Johnson COVID vaccine doses had history of violations

Emergent's revenues skyrocketed during the Trump administration, from about $523 million in 2015 to more than $1.5 billion in 2020. Emergent has invested heavily in lobbying the federal government, according to disclosure records that show the company spent $3.6 million on lobbying in 2020 alone.

Emergent is one of about 10 compagnies that Johnson & Johnson is using to speed up manufacturing of its recently approved coronavirus vaccine, the company said. The Bayview factory where the tainted vaccine ingredient was found had not yet been approved by the FDA, so no vaccine in circulation is affected. Emergent declined to comment.

Emergent BioSolutions plant that ruined Johnson & Johnson vaccine doses had prior FDA violations | Seattle Times |

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 joining the Trump administration, Kadlec was paid as a consultant to Emergent and formed a startup company with Emergent's chairperson.

Kadlec did not mention either role in a questionnaire about his career that he completed for the Senate when it considered his nomination by Trump in 2017.

Robert Kadlec consultant to Emergent BioSolutions ...

BARDA: Rick Bright's complaint points to the influence of industry over the Trump administration's coronavirus response

How One Firm Put an `Extraordinary Burden' on the U.S.'s Troubled Stockpile | NY Times |

But even as he fretted over the stockpile's lack of preparedness for a pandemic, Dr. Kadlec said, he felt compelled to continue preparing for anthrax and other bioterrorism threats. His office awarded roughly $3 billion in long-term contracts to Emergent in the months before the Covid-19 crisis, and last year decided to buy the company's unlicensed anthrax vaccine -- relying on the same emergency authority that has allowed the use of unlicensed coronavirus vaccines and treatments.

[Update-1]

AstraZeneca, Emergent BioSolutions sign $87M deal to produce U.S. supply of COVID-19 vaccine | Fierce Pharma – June 11, 2020 |

AstraZeneca made waves last week when it signed a massive $750 million deal to ramp production of a University of Oxford COVID-19 vaccine up to 2 billion doses per year. Now, as part of a Trump administration effort to get shots into U.S. hands as soon as possible, AstraZeneca has agreed to another major manufacturing tie-up.

AstraZeneca and Emergent BioSolutions have inked an $87 million deal to manufacture doses of the University of Oxford's adenovirus-based COVID-19 shot for U.S. supply, the companies said.

The manufacturing accord is part of the Trump administration's Operation Warp Speed initiative to develop and rapidly scale production of targeted vaccines before the end of 2020.

As part of the agreement, Emergent will reserve large-scale manufacturing capacity for Oxford's vaccine candidate, AZD1222, at its Baltimore Bayview facility through 2020. The company will also provide contract development manufacturing services to aid AstraZeneca's goal of producing more than 2 billion shots per year by 2021, Emergent said.

AstraZeneca pledges $174M to ramp up coronavirus vaccine supply deal with Emergent | Fierce Pharma – July 27, 2020 |

Despite signing massive deals around the world to produce the University of Oxford's COVID-19 vaccine, AstraZeneca has been relatively quiet stateside. Now, the British drug maker will expand its partnership with a Maryland CDMO to get its U.S. shot manufacturing up and running at full steam.

With a $174 million manufacturing pact signed, Maryland-based Emergent BioSolutions will help produce bulk drug substance for AstraZeneca and Oxford's adenovirus-based COVID-19 shot starting this year.

There goes a large part of the AstraZeneca vaccine manufacturing success story literally … down the drain.

Johnson & Johnson Has Emergency FDA Approval, AstraZeneca Still In Pipeline

In addition, the FDA argument is rational, as a one-shot Covid-19 vaccine is preferred over the two-shot from the British Oxford AstraZeneca …

Covid-19: Johnson & Johnson Put in Charge of Plant That Ruined Millions of Vaccine Doses | NY Times |

The extraordinary move by the Department of Health and Human Services will leave the Emergent BioSolutions facility solely devoted to making the Johnson & Johnson single-dose vaccine and is meant to avoid future mix-ups, according to two senior federal health officials. Johnson & Johnson confirmed the changes, saying it was “assuming full responsibility” for the vaccine made by Emergent.

The change came in response to the recent disclosure that Emergent, a manufacturing partner to both AstraZeneca and Johnson & Johnson, accidentally mixed up the ingredients from the two different vaccines, which forced regulators to delay authorization of the plant’s production lines.

It’s Easter Sunday … how will Tory boss Boris Johnson, his acolytes and his British boulevard media react??

A bad week for Conservatives after Mark Rutte’s headache, dropping Baseball’s All Star Game venue at Atlanta and the Yellow Card issues of the AZ vaccine across Europe.

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Not people's health concerns ... continues year in, year out ... whether Democrats of Republicans running lobbyists in U.S. Congress and the White House. So much still to do as the Planet and its resources are pilfered by unregulated multinationals, oligarchs and money flows unlimited into the pockets of lobbyists and parliamentarians - revolving door benefits are astounding.

US panel backs trial for anthrax vaccine on children

A US presidential commission has paved the way for testing an anthrax vaccine on children, prompting criticism that participants would be "guinea pigs".

But the bioethical issues report said researchers would have to overcome many hurdles before conducting any trial. Health and Human Services Secretary Kathleen Sebelius must decide whether to act on the paper's recommendations.

An earlier biodefence commission said in 2011 that a vaccine should be developed for children. The National Biodefense Science Board said at the time that any such study would need approval from a bioethics panel first.

One anthrax vaccine, BioThrax, is available for sale in the US. Drug-maker Emergent BioSolutions reported $215.9m (£142.8m) in sales of the vaccine in 2012.  

Emergent BioSolutions Completes Deliveries of BioThrax to Allied Foreign Governments | June 2010 |

The Anthrax scare mongering, Al Qaeda terror and the profits of the Biodefense Industry ... yet the NHS nurses are left with a marginal 1% salary raise that doesn't compensate inflation. The generation of greed and capitalism.

TLR sensing of bacterial spore-associated RNA triggers host immune responses with detrimental effects

Does science know what they are dealing with?

by Oui on Sun Apr 4th, 2021 at 10:04:09 AM EST
British vaccine company Microscience forced to sell out | June 2005 |

British vaccine company Microscience yesterday sold out to anthrax specialist Emergent Biosolutions at a knock-down price - another victim of a funding drought in the biotechnology sector.

The Berkshire-based company tried to raise £40m last year in a flotation but scrapped its plans after investors failed to support a valuation of £140m for the meningitis vaccine developer.

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Emergent finance director Mr Pocksonsaid private companies needing to raise cash will increasingly look to well-funded private businesses like Emergent as buyers due to the stock market conditions. "They need too much to get to the stage to be sustainable, investors see that there is a downward spiral in price and new money becomes extremely expensive," he said. "This is an exceptionally good deal for Emergent."

He added that the merged firm would be profitable, and that in turn would be attractive to investors at the time of its float on Nasdaq.

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Emergent BioSolutions sells an anthrax vaccine to the US military, its primary customer. However, Mr Pockson said it plans to expand in Europe and the far east and that the US government is considering buying the vaccine for workers in the emergency services.

by Oui on Sun Apr 4th, 2021 at 11:28:03 AM EST
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Military contractors' epic overcharging | The Guardian - Oct. 20, 2010 |

An anthrax vaccine of contested quality has paid out over $1bn in profit to a small company in Maryland, despite the fact that the company neither invented the product nor built the production facilities. A new report by Scott Lilly, my colleague at the Centre for American Progress in Washington, has the details: Emergent BioSolutions has billed the Pentagon $1.3bn for BioThrax, which he calculates cost the company roughly just $250m to manufacture. Lilly comments:

    "It is hard to imagine that any attempt to reduce federal outlays and shrink the size of the budget deficit will be credible if it does not address the issue of government contracts that pay extraordinary profit margins."

BioThrax may just be the tip of the iceberg. Richard C Loeb, a former deputy administrator of the Office of Federal Procurement Policy, whose tenure in that office extended across four presidents, says that he has seen government contracts with even higher gross margins. (By contrast, a 2009 study (pdf) of 6,000 Army and Air Force contracts by the Institute for Defence Analysis found that normal margins on such contracts were typically around 10% of production costs.)

No Choice, No benefits: Missouri veteran injured by vaccine ineligible for benefit. More ...

by Oui on Sun Apr 4th, 2021 at 11:29:31 AM EST
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U.S. puts J&J in charge of plant that botched COVID vaccine, removes AstraZeneca | Reuters |

The United States has put Johnson and Johnson in charge of a plant that ruined 15 million doses of its COVID-19 vaccine and has stopped British drugmaker AstraZeneca Plc from using the facility, a senior health official said on Saturday.

White House Moves Vaccine Event After Critical Emergent Report | Bloomberg - March 8, 2021 |

The White House moved an event celebrating Johnson & Johnson and Merck & Co.'s collaboration on a coronavirus vaccine after the original host -- Emergent BioSolutions Inc. -- came under fire for anthrax vaccine contracts that the federal government prioritized over medical and protective supplies ahead of the pandemic.

My recent posts ...

Biden's Vaccine Stockpile: AmericaFirst!

U.S. not planning to share AstraZeneca vaccine stockpile with other countries | NBC News |

U.S. secures 300 million doses of potential AstraZeneca COVID-19 vaccine | Reuters |

by Oui on Sun Apr 4th, 2021 at 12:35:51 PM EST
Emergent BioSolutions says it can make 1 billion Covid vaccine doses annually | CNBC - March 3, 2021 |

The Gaithersburg, Maryland-based contractor last year landed a multi-year deal to be the domestic producer of the Covid-19 vaccine from Johnson & Johnson, whose single-dose shot was cleared for use in the U.S. over the weekend. It also has a multi-year contract production contract for a vaccine developed by a British-Swedish biopharmaceutical company, AstraZeneca.

"We're now at the point where we have this infrastructure in place and we're producing on a daily basis, 24/7, both AZ and the J&J products," Kramer told Jim Cramer in a "Mad Money" interview. "We are operating at a level where our capacity is well in access of 1 billion doses annually for those products."

Emergent BioSolutions got started on the massive project last summer when it signed the five-year J&J contract, which is valued at about $480 million for the first two years.

The partnership with AstraZeneca's Covid-19 vaccine lasts three years. The value of the contract is $174 million through 2021, in addition to an $87 million deal that was struck to secure production space.

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President Joe Biden announced that he expects the U.S. to have a vaccine supply of 300 million within the next few months, which he says is substantial enough to reach all adults. He also moved the projected timeline for building up that supply to May from the end of July.

Not messing around, the Biden administration acted! The EU and VDL could take such policy as example. Room for improvement.

by Oui on Sun Apr 4th, 2021 at 02:36:43 PM EST
US government moves AstraZeneca out of vaccine plant that suffered contamination | CNN |

AstraZeneca confirmed it would stop manufacturing it vaccine, called AZD1222, at the Emergent Baltimore plant.

"AstraZeneca is working with the Biomedical Advanced Research and Development Authority (BARDA) to assist in the effort to maximize and accelerate US production of COVID-19 vaccines. As part of that effort, and in full cooperation with the US Government, AstraZeneca will relocate production of AZD1222 vaccine drug substance from the Emergent facility in Baltimore, Maryland," the company said in a statement posted online.

BARDA is a division of HHS that helps develop medical countermeasures for pandemics and biological attacks.

"The company will work with the US Government to identify an alternative location for domestic drug substance production of AZD1222," it added.

"AstraZeneca and the US Government continue to work closely together to support agreed upon plans for the development, production and full delivery of the vaccine."

AstraZeneca has not yet asked the FDA for emergency use authorization of its vaccine, but, like other coronavirus vaccine makers, has been making it ahead of time in anticipation of winning EUA.

by Oui on Sun Apr 4th, 2021 at 06:31:25 PM EST
[ Parent ]
Source of Delivery for J&J Vaccines in the U.S.?

None of the contaminated Johnson & Johnson vaccine had been packaged or shipped, and the plant's operation making it had not been approved. All J&J vaccine used in the US was made at a plant in The Netherlands.

Government officials have stressed that the discovery of the contamination shows the meticulous inspection and quality control systems in place at vaccine manufacturing plants worked the way they are designed to. They characterized moves to strengthen oversight at the Emergent plant as standard for such an occurrence, and noted that contamination, while uncommon and undesirable, is not an extraordinary event.

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J&J's vaccine is made using a common cold virus called an adenovirus that has been genetically engineered to produce a small part of the coronavirus's spike protein -- the knob-like part it uses to infect cells. This genetically engineered virus is grown in large vats called bioreactors. AstraZeneca's vaccine also uses a so-called viral vector -- an adenovirus that infects chimpanzees. It, similarly, is grown in bioreactors.

by Oui on Sun Apr 4th, 2021 at 06:32:11 PM EST
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Pharmacovigilance Risk Assessment Committee (PRAC):

PRAC investigating thromboembolic events after vaccination with COVID-19 Vaccine Janssen

by Oui on Fri Apr 9th, 2021 at 05:09:48 PM EST
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Emergent's Immunoglobulin Fails COVID-19 Trial Day | BioSpace - April 2, 2021 |

Gaithersburg, Md.-based Emergent BioSolutions offered an update on its Phase III trial of SARS-CoV-2 Immune Globulin Intravenous (Human) (COVID-HIG) to treat hospitalized patients with COVID-19. Unfortunately, the ITAC trial showed that the addition of the treatment to Gilead Sciences' remdesivir, did not provide clinical benefit compared to standard of care plus placebo in hospitalized adult COVID-19 patients with symptoms for less than 12 days. No safety issues were raised.

"While we are disappointed by these data in hospitalized patients where there remains a high unmet need, we recognize that similar to other antibody-based therapies, intervention with COVID-HIG earlier in the disease course may be necessary to impact COVID-19 in patients," said Laura Saward, senior vice president and therapeutics business unit head at Emergent.

Saward went on to say, "Emergent will continue to explore COVID-HIG as a treatment in ongoing clinical trials. The public-private partnership with NIAID and the Biomedical Advanced Research and Development Authority (BARDA) has been important to generate data on the COVID-HIG investigational product. We also would like to thank all study participants, sites, and investigators across the globe who contributed to this effort."

The therapy is also being investigated for outpatients at high risk of progression to severe disease. That program is funded by BARDA and from the U.S. Department of Defense.

by Oui on Sun Apr 4th, 2021 at 06:05:32 PM EST
Army Radio reported that Pfizer called Israel a "banana republic."

A shipment of 700,000 doses was expected to arrive in Israel on Sunday but was halted until further notice.

by Oui on Mon Apr 5th, 2021 at 11:14:31 AM EST
Thanks for confirming my suspicions, Oui. I'd idly been wondering who was underwriting Joe's "loan" to Mexico, given the difficulty Baltimore has had securing tests, beds, vaccine, etc. over the past year.

6 March photo op

Baltimore is a magnate for unscrupulous local and state politicians--I might have mentioned--chief among them, cruising the "Capitol Corridor" between DC and Annapolis, being Gov Larry "Maglev" Hogan who was the Washington Post's favorite to win back in '14. These past 4 years of mine within the city limits has left a deep, derogatory impression of chicanery in play regardless of party controlling Maryland's legislature. This port city has been cheated by mercantile interests for 400 years, it's no wonder Baltimore can't shake its "mob town" reputation in fact or fiction.

I'd been waiting for some kind of "scandal" to drop (on top of the latest: State's Atty fed investigation), and when it did--thanks to a national syndicate of NY Yella Cake and Politico's calibre, no less!--local journalists' duly feigned surprise. I expect, they'll never get to the bottom of this caper. For one, they've been trained to gloss "ethical" lapses of established figure heads. Second, Americans, in general, are parochial animals who are unable or unwilling to perceive the world beyond their commuter boundaries, much less anticipate calumny, orchestrated by opportunists who transit the misery and mysteries of the "largest transfer of wealth" ever. Again.

by Cat on Mon Apr 5th, 2021 at 02:11:25 PM EST
by Oui on Tue Apr 6th, 2021 at 06:46:22 PM EST
by Oui on Wed Apr 7th, 2021 at 01:52:59 PM EST
by Oui on Wed Apr 7th, 2021 at 01:54:54 PM EST
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IPO for Oxford COVID-19 vaccine startup in peril | MarketWatch - March 7, 2021 |

The university owns about 10% of the startup. Vaccitech, its bankers and lawyers have sought access, so far unsuccessfully, to Oxford's exclusive Covid-19 vaccine contract with AstraZeneca, according to these people. The pact was struck last spring when the drugmaker agreed to make and distribute the Oxford vaccine. Vaccitech and its advisers have argued the document spells out financial and legal obligations that are key to valuing the company fairly and for regulatory disclosures.

Oxford and Vaccitech are separately sparring over the narrative of the company's role in the vaccine's development, these people say. Vaccitech wants Oxford's imprimatur to market its scientists' early work alongside Oxford in inventing the vaccine and its assistance in speeding up manufacturing for early clinical trials and providing safety data for regulators, according to people familiar with the matter and related correspondence viewed by the Journal.

by Oui on Wed Apr 7th, 2021 at 02:04:35 PM EST
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by Oui on Wed Apr 7th, 2021 at 02:10:28 PM EST
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by Oui on Wed Apr 7th, 2021 at 02:29:11 PM EST
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by Oui on Wed Apr 7th, 2021 at 06:45:39 PM EST


by Oui on Thu Apr 8th, 2021 at 10:07:30 PM EST
by Oui on Fri Apr 9th, 2021 at 02:20:19 PM EST
by Oui on Fri Apr 9th, 2021 at 02:30:32 PM EST
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by Oui on Tue Apr 13th, 2021 at 10:51:51 AM EST
by Oui on Tue Apr 13th, 2021 at 12:41:37 PM EST
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by Oui on Wed Apr 14th, 2021 at 02:45:09 PM EST
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by Oui on Wed Apr 14th, 2021 at 08:56:51 PM EST
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by Oui on Tue Apr 13th, 2021 at 07:12:54 PM EST
Dutch won't use ["]Johnson & Johnson["] vaccine pending EMA review, 80K doses in stock
The Netherlands will not start using the Leiden-developed Johnson & Johnson coronavirus vaccine until the European Medicines Agency has completed its safety review, health minister Hugo de Jonge said on Wednesday evening.
[...]
The Netherlands has ordered 11.3 million doses of the Janssen vaccine in total.... Nevertheless, Pfizer said on Wednesday it would be able to deliver some two million doses of vaccines earlier than planned, news which De Jonge described as `fantastic'.
sarcasm?
by Cat on Wed Apr 14th, 2021 at 04:50:18 PM EST
I have no idea why Rutte got so many votes in election. His party VVD was losing seats, but populace considered his leading the war on COVUD-19 essential. In latest zig-zag course on promises and timetable for relaxing rules, his trust has tanked. From high rating of >70% a year ago, today it has dropped to 39% in polls. Falsehoods have been present for a decade ... people are basically uninformed or just plain stupid.

From a low number of people vaccinated 10 days ago, and a high number of "unused" doses, overnight the number was adjusted by nearly a million. Indeed besides the central location of GGD, the GPs started their campaign last two weeks. These numbers were not yet picked up in national stats. The Netherlands was ranked 22nd in Europe. Great going Mark!  😠

by Oui on Wed Apr 14th, 2021 at 05:54:09 PM EST
[ Parent ]
Full manufacturing of all ingredients and bottling inside the EU-27.

by Oui on Wed Apr 14th, 2021 at 07:11:14 PM EST
by Oui on Wed Apr 14th, 2021 at 07:14:02 PM EST
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The economics of Wall Street, Fascism and cut throat Capitalism ...

by Oui on Fri Apr 16th, 2021 at 06:42:36 AM EST
Negligence and complacency ...

by Oui on Fri Apr 16th, 2021 at 09:01:58 PM EST


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