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COVID NEWS AND COMMENTARY* from Jeff Childers
On May 10th, the New York Times published what may be the most important story that you didn’t hear about, a story immediately swept off into the news maelstrom, headlined “Emergent Hid Evidence of Covid Vaccine Problems at Plant, Report Says.”
Uh oh.
The NYT reported that House Democrats “released” — gave to reporters — a report on a Congressional investigation into a covid vaccine manufacturing plant that started having problems in February 2021. In April 2021, the manufacturer admitted to federal officials that 25 million safe and effective doses had been contaminated. It was finally ordered closed in November and 400 million more safe and effective doses of Johnson & Johnson were ordered destroyed “due to poor quality control.”
Bet you didn’t hear much about this story, did you?

The timing of the report’s release is also quite interesting. It was “released” on Tuesday, May 10th. Just a few days earlier, on Thursday, May 5th, the CDC “strictly limited” the Johnson & Johnson vaccine to people at highest risk, allegedly because of months-old reports of a half dozen non-fatal blood clots, which the CDC cleared after a short pause at the time.

Back in 2020, Emergent, a well-established biodefense manufacturer, got a $628 MILLION DOLLAR contract to make J&J and AstraZeneca jabs. But problems at Emergent’s Baltimore plant were well known even before it got the contract to make the safe and effective covid drugs. The Times obtained an email between federal Operation Warp Speed officials from as early as June 2020 noting that reliance on the Baltimore plant would raise “key risks” and the site would “have to be monitored closely.”

Spoiler: it WASN’T monitored closely.
A different June 2020 email between Emergent executives expressed internal concerns about the plant’s problems. Emergent’s top manufacturing manager wrote the company’s CEO saying, “Of all the things we have to deliver on [Operation Warp Speed] the thing that keeps me up at night is overall perception of state of quality systems at Bayview…room to improve is a huge understatement.”

The House report noted that Trump OWS officials even told the FDA in 2020 about their concerns about Emergent. So, the FDA had plenty of warning.

Later, a November 2020 email from an outside quality consultant told Emergent that there were SERIOUS problems at the plant, stating plainly, “Ultimately Emergent will have to decide what level of risk they are willing to accept, but this is one of those where you really better listen to me and do exactly what I tell you to. I am stating very loudly that this work is NON-CGMP compliant. And a direct regulatory risk.”
Then — this is so insane — in February 2021, employees at the plant yanked yellow warning tags stuck to contaminated batches and re-labeled vials right before an FDA inspection. Then after the inspection was finished, they allegedly put the tags back on after federal officials left. The House report says that senior Emergent executives knew about the switcharoo, so it wasn’t just some awful idea the plant workers came up with.

House investigators wrote that “despite this apparent attempt to impede oversight,” and despite the FDA noting OTHER serious quality concerns, the FDA still “granted Emergent some leniency” and allowed the badly-run plant to continue making millions of doses of the safe and effective vaccines.

Then in March 2021, Emergent officially notified HHS about what it described as “mass contamination.” Yet it still continued making doses until its contract was terminated months later in November. A November 4th report in the Times describes Emergent as a “centerpiece of Operation Warp Speed” and the SOLE domestic manufacturer of J&J.
Emergent got about $450 million before its contract was terminated. Then, according to Yahoo News, it received another $320 million-dollar “severance payment” when its contract was ended for cause in November. It actually made more money by screwing up, since only $180 million more was to be paid under the terminated deal.

The House report stresses that “no contaminated doses were released to the public.” As if they could possibly know that. I’ll bet they are relying on Emergent for that conclusion.

In testimony before Congress, Dr. Peter Marks, the FDA’s director for Biologics Evaluation and Research, explained “Shame on us for thinking that [Emergent’s] experience in manufacturing would mean they would be able to move ahead and make the vaccines in a high-quality manner that we would expect for an experienced vaccine manufacturer.”
Representative Carolyn Maloney (D-NY), chairwoman of the Committee on Oversight and Reform, announced “inexperienced staff and high staff turnover contributed to vaccine contamination… Emergent’s business practices are simply unacceptable, and I urge the federal government to carefully consider future contracts in light of Emergent’s failures.”

Representative James E. Clyburn, chairman of the Select Subcommittee on the Coronavirus Crisis, admitted in a statement there were numerous red flags at the plant, but blamed the snafu on “Emergent executives [who] prioritized profits over producing vaccines in a responsible manner that complied with FDA requirements.”

It’s definitely NOT the government’s fault.

BDair 8 May 18
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