Wednesday, March 3, 2021

FDA's EUA for Johnson and Johnson's vaccine *excluded* authorization for the anthrax vaccine company's Covid vaccine/ WaPo

"Most of Johnson & Johnson’s partners disclosed to date are contract manufacturing companies, but now it is moving to team with larger drug companies that have seen their own vaccine projects delayed or fizzled.

The manufacturing process is time-consuming: Johnson and Johnson ferments large batches of its vaccine in vats at a contract manufacturing facility in Baltimore operated by Emergent [the anthrax vaccine manufacturer, Emergent BioSolutions], as well as locations in the Netherlands and India. That brewing step takes two months.

Emergent received commitments of $628 million from the Trump administration in June to expand capacity at its Baltimore plant for coronavirus vaccine production. It then received contracts worth $615 from Johnson & Johnson in July." [Yes, readers, this company received $1.243 Billion dollars to produce J and J's vaccine, but it hasn't produced yet.]

"But eight months later, the undisclosed number of J&J vaccine doses produced at Emergent are not available for public distribution. Emergent still has not been authorized to produce Johnson & Johnson’s vaccine under the FDA emergency use authorization, the New York Times first reported Tuesday. An administration official said Emergent’s Baltimore production line is expected to be approved in the next few weeks..."

Emergent Biosolutions has made billions of dollars over the past 22 years by producing sole source products and failing to deliver them, pleading and receiving extra dollars to get their factories up to speed. It seems they decided to try that trick again. Will Biden and J and J fold?

And from the NYT:

"The F.D.A.’s authorization for emergency use, granted late Saturday, covered the Dutch production lines and the Grand Rapids bottling operation. In about two weeks, federal regulators are expected to decide whether to amend that authorization to include the other plants, according to the two people familiar with Johnson and Johnson’s operations. Until then, they said, supply will be uneven and limited."

1 comment:

Anonymous said...

Sorry, I should have read more of your blog before complaining about no links to the NYT source about Emergent BioSolutions. I have to wonder if the FDA can be buffaloed into OKing a substandard factory in the US, they actually visit and inspect them before allowing production.