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Tue May 10, 2022, 09:22 AM

A company with an early contract to produce coronavirus vaccine hid evidence of problems.

Source: New York Times

WASHINGTON — Emergent BioSolutions, a longtime government contractor hired to produce hundreds of millions of coronavirus vaccine doses, hid evidence of quality control problems from Food and Drug Administration inspectors in February 2021 — six weeks before it alerted federal officials that 15 million doses had been contaminated.

The disclosure came in a new report by the Democratic-led House Committee on Oversight and Reform. The report, based on internal company emails, documents and interviews, sheds new light on Emergent executives’ own worries about deficiencies in the company’s quality control systems at its troubled Bayview plant in Baltimore.

The report, released Tuesday morning by the House and the Select Subcommittee on the Coronavirus Crisis, said that all told, nearly 400 million doses of coronavirus vaccine manufactured by Emergent had to be destroyed “due to poor quality control,” including about 240 million doses in late 2020 and early 2021. Previous estimates of lost vaccine were far lower; no contaminated doses were ever released to the public.

“These doses were squandered despite repeated warnings from employees, outside consultants, pharmaceutical companies and F.D.A. regulators that the company’s manufacturing practices were unsafe,” Representative James E. Clyburn, Democrat of South Carolina and the chairman of the House subcommittee on the pandemic, said in a statement.

Read more: https://www.nytimes.com/2022/05/10/us/politics/emergent-fda-vaccine-covid-contaminated.html?smid=tw-nytimes&smtyp=cur



House Oversight Committee released their report investigating what happened.

Edit - have been getting "Forbidden" errors (no code) to edit but am trying to find a link to their report. So far Committee members have been retweeting the NYT and ABC stories mentioning the report (it's not up on the Committee websites yet).




Select Subcommittee on the Coronavirus Crisis
@COVIDOversight
·
May 10, 2022
NEW | A manufacturer awarded $628M by the Trump Admin botched nearly 400M #COVID19 vaccines—more than previously revealed—due to poor quality control, per a joint @COVIDOversight and @OversightDems report.
abcnews.go.com
Emergent BioSolutions discarded ingredients for 400 million COVID-19 vaccines, probe finds
Emergent BioSolutions was forced to discard up to 400 million coronavirus vaccine doses due to the contamination of ingredients, according to a congressional report.
Select Subcommittee on the Coronavirus Crisis
@COVIDOversight
New evidence reveals the Trump Admin and executives at Emergent BioSolutions were aware of serious deficiencies before production of Johnson & Johnson and AstraZeneca vaccines began at Emergent’s Bayview facility.
9:09 AM · May 10, 2022





Select Subcommittee on the Coronavirus Crisis
@COVIDOversight
·
May 10, 2022
Replying to @COVIDOversight
Before signing agreements with Johnson & Johnson and AstraZeneca, one former Emergent executive had warned senior executives “for a few years” about the company’s deficient quality systems, including that “room to improve is a huge understatement.”
Select Subcommittee on the Coronavirus Crisis
@COVIDOversight
Emergent failed to address these warnings and even hid evidence of contamination from government regulators.

Before a Feb 2021 FDA site visit, Emergent removed tags showing that vaccine batches had a potential quality issue “to avoid drawing attention” from inspectors.
9:09 AM · May 10, 2022





Select Subcommittee on the Coronavirus Crisis
@COVIDOversight
·
May 10, 2022
Replying to @COVIDOversight
Emergent failed to address these warnings and even hid evidence of contamination from government regulators.

Before a Feb 2021 FDA site visit, Emergent removed tags showing that vaccine batches had a potential quality issue “to avoid drawing attention” from inspectors.
Select Subcommittee on the Coronavirus Crisis
@COVIDOversight
Emergent received $330M in taxpayer funds before the Biden Admin terminated the Trump-era contract in November 2021—saving taxpayers hundreds of millions of dollars remaining on the contract.
Millions of doses of the Johnson & Johnson coronavirus vaccine were ruined in the Baltimore manufacturing facility of Emergent BioSolutions.
nytimes.com
A company with an early contract to produce coronavirus vaccine hid evidence of problems.
A report sheds new light on Emergent executives’ own worries about deficiencies in the company’s quality control systems at its troubled Baltimore plant.
9:09 AM · May 10, 2022


(retweeted by Coronavirus Subcommittee of the House Oversight Committee) -




ABC News
@ABC
NEW: Between March 2020 and February 2022, vaccine-maker Emergent BioSolutions was forced to discard or destroy up to 400 million coronavirus vaccine doses due to the contamination of ingredients, according to a congressional report.
abcnews.go.com
Emergent BioSolutions discarded ingredients for 400 million COVID-19 vaccines, probe finds
Emergent BioSolutions was forced to discard up to 400 million coronavirus vaccine doses due to the contamination of ingredients, according to a congressional report.
9:03 AM · May 10, 2022

6 replies, 1311 views

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Reply A company with an early contract to produce coronavirus vaccine hid evidence of problems. (Original post)
BumRushDaShow May 10 OP
AZLD4Candidate May 10 #1
BumRushDaShow May 10 #3
womanofthehills May 10 #5
BumRushDaShow May 10 #6
llashram May 10 #2
BumRushDaShow May 10 #4

Response to BumRushDaShow (Original post)

Tue May 10, 2022, 11:53 AM

1. Big businesses have shady practices and are mostly corrupt and dishonest?

Shocked, shocked I tells ya.

There's a reason, most of the time, when talking about a big businesses, I can't not use the POS adjective in front of businessman.

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Response to AZLD4Candidate (Reply #1)

Tue May 10, 2022, 01:00 PM

3. Oddly enough

Emergent isnt really a "big pharma" place - sortof more a medium-sized one that was "in the right place at the right time" but messed up anyway.

One of the bigger problems with them is that they were due to also make AstroZeneca's similar vaccine (for export) and that was messed up as well.

The whole shebang was basically transferred over to Merck (a "big pharma" ) to pick up the slack.

Of course now, Janssen's (J&J) vaccine is being moved away from so not sure what Merck is going to do now outside of maybe picking up the AstraZeneca stuff that Emergent was doing.

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Response to BumRushDaShow (Reply #3)

Tue May 10, 2022, 03:55 PM

5. Emergent was the main supplier of the anthrax vaxx

Not good - this sloppy company made all the anthrax vaccines for our military.

Before the pandemic, top contractor received billions from government to help prepare the nation for biowarfare


A growth spurt
By 2010, the company had more than a quarter-billion dollars in annual revenue but only one product and one main customer: the U.S. government.



https://www.washingtonpost.com/investigations/before-the-pandemic-top-contractor-received-billions-from-government-to-help-prepare-the-nation-for-biowarfare/2020/06/17/38d9ad3a-a41b-11ea-8681-7d471bf20207_story.html

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Response to womanofthehills (Reply #5)

Tue May 10, 2022, 04:31 PM

6. Yes I know all about them

But they are not Merck or Pfizer (who also owns Warner-Lambert and Wyeth) or Glaxo-SmithKline, etc.

As an example, the proposed budget for my city (Philadelphia) for their upcoming fiscal year, is almost $6 billion.



Emergent is a small-medium sized company.

(ETA to note that I expect their business with the federal government is probably going to come to an end)

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Response to BumRushDaShow (Original post)

Tue May 10, 2022, 12:54 PM

2. pure unadulterated greed

cause this... Millions more at risk because of trump administration malfeasance...

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Response to llashram (Reply #2)

Tue May 10, 2022, 01:03 PM

4. You also had this ditty happen along with this last year

Emergent CEO sold more than $10M in stock before scrapping J&J COVID-19 vaccine doses: report

By Noah Higgins-Dunn
Apr 26, 2021 11:30am


Emergent BioSolutions has faced a number of back-to-back PR crises since production issues at its Baltimore facility placed the company under intense scrutiny. The CDMO's stock price has tumbled as a result, but it appears CEO Robert Kramer cashed out some of his shares just in time. Citing Securities and Exchange Commission filings, Kramer sold more than $10 million worth of Emergent stock in January and early February, right before the company’s shares began to tumble following its quarterly earnings reported on Feb. 19, The Washington Post reports.

That was also before The New York Times reported in late March that the company had to dump up to 15 million doses of Johnson & Johnson’s COVID-19 vaccine over an ingredient mix-up at its Baltimore plant. J&J has since taken control over the facility and AstraZeneca, which was also making its vaccine there, was forced to move out.

Shares of the contract manufacturer have fallen from roughly $125 in mid-February to a low of $62 per share, a more than 50% decline. If Kramer were to have sold his shares at Emergent's current market price, they would fetch about $5.5 million, the Post reports. The transactions mark his first substantive sale of the company’s stock since 2016.

The sales were part of Kramer’s compensation package and were made under a trading plan—designed to protect executives and their sales from insider trading probes—first adopted in November, the Post reports. Under the plan, Kramer purchased the shares for about $2.5 million to sell at market price. The executive's remaining stake in the company is worth roughly $10.1 million, according to the report.

https://www.fiercepharma.com/pharma/emergent-ceo-sold-more-than-10-million-stock-before-j-j-doses-were-scrapped-report

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