Wednesday, March 31, 2021

Newest Emergent BioSolutions excuse on its Covid vaccine delay

This article does not make sense to me, but I am reproducing tonight's NYT story below.  If the quality control issues are still being sorted out, then the "conflation" of two vaccine ingredients is not the whole story of the plant's problems.

FDA knew there were problems a month ago, when it withheld the EUA for vaccine made here.  I guess this story perhaps came out now, the night of March 31, because until just  a few days ago, J and J had promised to meet its 20 million dose quota by the end of the month.

But there is another unanswered question.  How did FDA allow Emergent to ship its vaccine out to Indiana in bulk for bottling, when it knew there were problems at the plant? Based on what happened at the time of the Gulf War, once unauthorized product is allowed to be shipped off premises, it could wind up in the arms of the unsuspecting. All vaccine product made by Emergent needs to be accounted for, immediately, both bulk and bottled.

I could have predicted there would be delays.  Emergent's Modus Operandi is to plead manufacturing problems and demand extra money to fix them, which as a sole source supplier, it always got.  Read the old Congressional hearings on the anthrax vaccine.  Here's one. A commitment to quality would lose them money. And when you are making vaccines under an EUA, you have no liability.

And don't forgot, Emergent has contracts to product 9 different medical products in response to Covid.  Nine.  Lobbying pays.

UPDATE:  The 4/1/21 Associated Press article on Emergent.

Workers at a Baltimore plant manufacturing two coronavirus vaccines accidentally conflated the vaccines’ ingredients several weeks ago, ruining up to 15 million doses of Johnson & Johnson’s vaccine and forcing regulators to delay authorization of the plant’s production lines.

The plant is run by Emergent BioSolutions, a manufacturing partner to both Johnson & Johnson and AstraZeneca. Federal officials attributed the mistake to human error.

The mixup has delayed future shipments of Johnson & Johnson doses in the United States while the Food and Drug Administration investigates. Johnson & Johnson has moved to strengthen its control over Emergent BioSolutions’ work to avoid further quality lapses.

The mistake is a major embarrassment for Johnson & Johnson, whose one-dose vaccine has been credited with speeding up the national immunization program.

It does not affect Johnson & Johnson doses that are currently being delivered and used nationwide. All those doses were produced in the Netherlands, where operations have been fully approved by federal regulators.

But all further shipments of the Johnson & Johnson vaccine — projected to total tens of millions of doses in the next month — were supposed to come from the massive Baltimore plant.

Those shipments are now in question while the quality control issues are sorted out, according to people familiar with the matter..Federal officials still expect to have enough doses to meet President Biden’s commitment to provide enough vaccine by the end of May to immunize every adult. The two other federally authorized manufacturers, Pfizer-BioNTech and Moderna, are continuing to deliver as expected.

Pfizer is shipping its doses ahead of schedule, and Moderna is on the verge of winning approval to deliver vials of vaccine packed with up to 15 doses instead of 10, further boosting the nation’s stock.


Dr Chris King said...

"conflated"? Who wrote that article? And why?

Conflation is the combining of two separate things (e.g., ideas, concepts, information) into one. Isn't that what's supposed to happen with vaccine ingredients during manufacture?


Yvette said...

Your knowledge of Emergent's history is finally getting dug up by the media a little bit more - it's coming through the Associated Press so it's on multiple outlets today.