HOUSE OVERSIGHT-Expand Emergent BioSolutions Investigation After More than 85 Million Doses of Coronavirus Vaccine are Destroyed

Millions More Remain Quarantined - how many actual vaccines have been administered using material from Emergent BioSolutions? Zero. Zip. Nada. None

Emergent $628,000,000.00 in Tax Payer Funds

Thanks to Trump…

By way of background — in May 2021 I wrote about Emergent BioSolutions - at the time I wasn’t being factious when I said - buckle up - things are about to get bumpy and verybad.

• May 19, 2021 Emergent CEO confirms $271M of $638M obligated funds - NOT A SINGLE VACCINE ADMINISTERED (updated with the FDA Inspection Reports)

• May 18, 2021 Article - Dear Jared et al - the Attorney General Announces Task Force to Combat COVID-19 Fraud 

  • “The Department of Justice will use every available federal tool - including criminal, civil, and administrative actions - to combat and prevent COVID-19 related fraud”

• April 20, 2021 Emergent BioSolutions, Inc, Operation Warp Speed - $628M TCV Dr Kadlec should hire an attorney FORTHWITH

• April 13, 2021 Article —The Select Subommittee on the Coronavirus Crisis - it is worse than most of us knew. Paging Drs Atlas, Alexander and Hatfill -your depositions awaiting

• March 31, 2021 Article: Trump Pence Kushner & Azar covid-19 supply chain failures far deeper than previously known and it’s maddening

It’s an IDIQ Contract - that noise you hear? That’s me slamming my head on my desk - FFS an IDIQ Contract a freaking I-D-I-Q contract

And yes I get it that you might not like FPDS.gov (I ran a global search and converted the FPDS report to a pdf) as much as I do so here’s a peace offering USASpending.gov —as tax payers it is absolutely nonsensical to me that we are on the hook for a multi billion dollar contract

Meanwhile @emergentbiosolu is using their twitter account to re-shape the narrative that they aren’t completely incompetent, complicit and their senior management did not violate the Securities Exchange Act by selling a metric phuckton of stocks before the horrible news that their filthy and I mean filthy Bayview plant -

June 2020 FDA Report 

The FDA documented numerous breaches of manufacturing and sanitary standards at the Emergent Biosolutions facility.

The report was made public (June 2020) showed;

• mishandled waste, 

• peeling paint in hallways and rooms, 

• and piled-up equipment.

but this is Emergent’s pinned tweet 👇🏻

EmergentBioSolutions @emergentbiosolu

At Emergent, our people make the things you never thought you’d need - until you do. Our latest video tells the story of when “What If . . .?” becomes “What now?”

To be clear the letters to Johnson & Johnson and AstraZeneca Pharmaceuticals LP. are in NO WAY meant to directly or indirectly say either pharmaceutical giants have done anything wrong. To date there is no public reporting that these companies have done anything unethical or impermissible. What the significance of the House OverSight’s June 22, 2021 letters mean — Congress is properly investigating and by asking Johnson & Johnson and AstraZeneca Pharmaceuticals LP —to produce a bunch of documents. This largely means that Emergent and HHS and more broadly the Biden Administration have provided Congress with documents but asking Emergent’s customers for documents is a way to cross check previous document production fulfillment.

Emergent TVC is north of: $1,500,000,000,000.00

I shouldn’t say this out loud or put it in writing but Johnson & Johnson and AstraZeneca should Sue Emergent into financial insolvency because their errors their failure to ameliorate the known substandard plant hygiene and these failures would contaminate the end product - that being vaccines - I sure hope Emergent has an up to date D-and-O policy because - welp the letter reads in part —

…Combined with its federal contracts, Emergent’s coronavirus vaccine manufacturing deals with Johnson & Johnson and AstraZeneca are reportedly worth up to $1.5 billion

The Committee has collected and released substantial evidence which indicates Emergent was warned multiple times;

• serious manufacturing problems and deficient controls at the Bayview facility

• could lead to contamination but that Emergent failed to act

• Emergent’s Bayview facility had persistent problems with mold, poor disinfection of plant equipment, and inadequate training of employees.

Those previous warnings came in internal inspections as well as inspections and audits by the Food and Drug Administration (FDA), the Biomedical Advanced Research and Development Authority, Operation Warp Speed, Johnson & Johnson, and AstraZeneca.

For example, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, conducted an audit of Emergent’s Bayview facility from June 9 through June 18, 2020. On July 24, 2020, Janssen sent Emergent a report with its audit findings, which concluded that Emergent’s “quality systems may have weaknesses or gaps that require CAPA [Corrective and Preventive Actions].”

The audit report included numerous findings related to deficient virus contamination practices, noting,

“There is not a formal Bayview contamination control strategy for the site.”

I feel like bears repeating- Johnson & Johnson and AstraZeneca are the immediate injured party . But the audacity and temerity of Emergents Leadership to quickly blame their customers - strains credulity and frankly think J&J and AstraZeneca have a Torts claim and possibly concrete and particularized injury as to reputational damage too because Emergent’s CEO said this:

“There were a number of contaminations while we were starting up the AstraZeneca manufacturing process, which you would normally find... That was not the case with the AstraZeneca product. And, in fact, we ended up making 80 different process changes alone in the first 60 to 90 days of trying to stand that manufacturing process up. So it was very difficult, very complicated, and it did result in a number of lost production runs.

Which contradicts Mr Kramer’s April 1, 2021 CNBC interview

Now let’s look at his May 19, 2021 House OverSight Testimony which begins around the the 1:21 minute marker and Chairwoman Maloney pounded Emergents CEO - so was Mr Kramer lying in April or May or both?

Emergent BioSolutions-Vaccine Contamination FUBAR

• June 21, 2021, manufacturing at the Bayview facility remains on hold.

• June 11, 2021, FDA ordered an additional 60 million doses of Johnson & Johnson vaccine that were manufactured at the Bayview facility to be destroyed because they were not suitable for use due to possible contamination

• more than 85 million total doses destroyed and tens of millions more held back for testing…

Because the House OverSight Committee is right to call attention to how Emergent has emerged as the ground zero for some to be vaccine-hesitant and that’s an injury way too complicated to enumerate…

We are troubled by the impact Emergent’s manufacturing errors have had on the availability of coronavirus vaccine doses, as well as the potential effect on public perceptions regarding the safety and efficacy of these vaccines. We are also concerned about the circumstances that led AstraZeneca and Johnson & Johnson to sign contracts with Emergent to produce their respective coronavirus vaccines.

To be clear and not to belabor the point Johnson & Johnson and AstraZeneca are the injured party here - as is the Federal Government and by secondary extension so are the American tax payers - the documents the House OverSight committee is requesting - it seems rather broad but I do not think the pharmaceutical companies are the target - it’s Emergent. And if you understand how investigations work this secondary request makes a ton of sense. Again you can read the letters to Johnson & Johnson and AstraZeneca Pharmaceuticals LP.

Should you be inclined to read more about the Emergent Fubar - I highly recommend reading the following

• April 19, 2021, Chairwoman Maloney and Chairman Clyburn launched an investigation into Emergent’s profits and performance under federal vaccine contracts.

• May 19, 2021, Chairwoman Maloney and Chairman Clyburn released initial findings from their investigation into Emergent, indicating that the failure to address serious deficiencies at Emergent’s Bayview facility led to the destruction of millions of doses due to contamination. 

That 14 page initial findings are beyond worrisome - and this is why Congress is vested by our Constitution to conduct oversight

So for now I think you’re caught up - for now - but this isn’t the end of this - I suspect it’s about to get a lot worse for Emergent but if you read their April 29, 2021 Twitter thread -

EmergentBioSolutions @emergentbiosolu

CEO Bob Kramer outlines “Herculean task of progressing Bayview in months from facility designed to develop/manufacture 50 million doses of single influenza vaccine to one capable of producing 100s of millions of bulk drug product for COVID-19 vaccines”

then you read the 14th page of the House OverSight Preliminary Report - I have so many questions - don’t you?

I mean I guess I should triple check their recent SEC filings too?

Form 8-K

Filing Date May 25, 2021 or you can read their SEC filings here

Guess who exercised more stock options….
And lastly if you think this is the end - I can assure you that Congress is just getting warmed up and the next area they are going to scrutinize are the Ts & Cs of the IDIQ contract because it’s insane that we the tax payers are still paying hundreds of millions to Emergent and they have yet to produce a single vaccine that’s been administered. Whereas tens of millions of doses are being thrown out because their plant contaminated an enumerable amount of doses. Alas I think I’ve said too much.