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Among documents made public by congressional investigators are those pertaining to the government’s contracts with Emergent BioSolutions, a two-decades-old concern that has enjoyed extremely lucrative agreements for producing and packaging COVID-19 vaccines, despite what those documents reveal are serious shortcomings in safety and quality control.
We first wrote about those shortcomings on 4 May, in “UPDATE: BAD & UGLY, UPS & DOWN.”
As reported by The New York Times last Thursday, the company, with headquarters in Gaithersburg, MD, has long enjoyed federal contracts; over the past 20 years it’s been a major supplier of anthrax vaccines to the nation’s emergency stockpiles. That history may be behind the government awarding Emergent a 2020 contract to produce and package COVID-19 vaccines without requiring any competitive bidding process.
Production Lines Kept on Standby
That contract essentially reserved three of the company’s factories — two in the Baltimore area and one in Rockville, MD — for COVID drug production, keeping the production lines on standby for between 3 and 20 months, and paying Emergent whether any drugs were actually produced there or not, because, according to the NYT article, in that early phase of the COVID War the government was in a “panic buying” mode and needed to ensure adequate future vaccine production capability.
The amount to be paid to reserve those factories was based on what they would have taken in for other, non-government work, and amounted to some $542 million. But the recently-released documents show that, according to Emergent’s filings with the Securities and Exchange Commission, that figure far exceeds the company’s combined revenue, from all its contracts, for the previous three years combined.
Money for Nothing?
And, the NYT reports, the factories have, until last week, mostly sat idle. Furthermore, the government committed $78 million to build a new production line at the factory in Baltimore’s Camden section and another $10 million to reserve its use once completed.
Under those agreements Emergent would have been bottling and packaging vaccines for the government at a cost of around $9.03 to $18.40 per vial. But then the government provided for additional production by awarding an additional contract, this time based on competitive bidding, to a Florida company that performed essentially the same services for $6.83 per vial.
The NYT also reports that the Trump administration official who oversaw the agency that awarded Emergent that contract—a contract that enabled the company to have the best year, financially, in its history and to pay bonuses of almost $8 million in cash and stocks to five of its leaders—had previously worked for Emergent as a consultant. That official claims he did not negotiate the contract, but did approve it.
But Wait, There’s More!
Inspectors from the Food and Drug Administration have documented a pattern of serious quality concerns at Emergent facilities, including failure to reject materials or product that didn’t meet specifications for purity, identity, strength or quality; failure to follow procedures designed to prevent contamination and maintain sterility; and broken and cracked vials, particulates in vials, and obsolete equipment. In one case, a batch of Johnson & Johnson vaccine was corrupted with an ingredient meant for AstraZeneca vaccine.
On 11 June the FDA ruled that the equivalent of 60 million doses of Johnson & Johnson vaccine produced by Emergent were unusable, bringing to 75 million the total number of J&J vaccine doses “ruined” by Emergent’s poor manufacturing processes. Another 25 million are awaiting distribution, but will include a warning that the FDA could not guarantee that standards had been adhered to. And the equivalent of 100 million more doses are being held until testing and review of records can determine if they are safe.
Through it all, Emergent’s management has been said to have downplayed such concerns so as to take only the minimum required corrective measures.
And in spite of all of this, the company still projects another record-setting year. Emergent has told its investors that, despite revenues falling from $50 million to $200 million below projections, the company expects that shortfall to be made up for next year.
TRENDPOST: We note this article to again emphasize that, as the late comedian George Carlin noted, “It’s one big club, and you’re not in it”… and to also illustrate not only the outlandish revolving door corruption the pervades governments, but also the high levels of incompetency.
No-bid contracts based on inflated numbers, approved by “officials” with questionable connections, and paying for production lines whether they moved or not has long become the American way… and is, in fact, a trend of government piracy across the globe.