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FDA gives Emergent BioSolutions a consolation prize: it must throw out 60 million vaccine doses but can sell 10 million, which will be labeled as failing GMP standards

By Meryl Nass, MD | June 11, 2021

Now this is a really odd FDA decision. FDA is acknowledging that the 10 million doses it is authorizing is adulterated. But adulterated doses can’t be sold. But EUA products don’t generally get sold, except to the US government. I am scratching my head. I thought all these doses were already bought and paid for, by the taxpayer.

And there seem to be another 100 million doses about which FDA has not made up its mind.

This echoes FDA’s decision last week to license a very expensive but ineffective Alzheimer’s drug, after its advisory committee unanimously voted against it.

We always knew FDA was a political organization. But now, without Biden having appointed anyone to its helm, its decisions are wilder than ever.

From the NY Times today:

WASHINGTON — Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation.

The Food and Drug Administration plans to allow about 10 million doses to be distributed in the United States or sent to other countries, but with a warning that regulators cannot guarantee that Emergent BioSolutions, the company that operates the plant, followed good manufacturing practices.

The agency has not yet decided whether Emergent can reopen the factory, which has been closed for two months because of regulatory concerns, the people said.

The Johnson & Johnson doses administered in the United States so far were manufactured at the firm’s plant in the Netherlands, not by Emergent. For weeks the F.D.A. has been trying to figure out what to do about at least 170 million doses of vaccine that were left in limbo after the discovery of a major production mishap involving two vaccines manufactured at the Baltimore factory.

June 12, 2021 - Posted by | Aletho News | , , , ,

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