Thread by @DrEricDing

JUST IN—FDA decided that ~60 million doses of the Johnson & Johnson #COVID19 vaccine produced at Emergent (Baltimore factory) must be discarded because of possible contamination. But 10 million doses can be used with a disclosure warning. 🧵
nytimes.com/2021/06/11/us/…

2) FDA cannot guarantee that Emergent BioSciences, 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

3) 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 site.

4) More than 100 million doses of Johnson & Johnson and at least 70 million doses of AstraZeneca were put on hold after Emergent discovered in March that its workers had contaminated a batch of Johnson & Johnson’s vaccine with a key ingredient used to produce AstraZeneca’s.

5) Federal officials then ordered the plant to pause production, stripped Emergent of its responsibility to produce AstraZeneca’s vaccine and instructed Johnson & Johnson to assert direct control over the manufacturing of its vaccine there.

6) the loss of 60 million J&Jdoses puts a dent in the Biden plan to distribute vaccines to other countries. Biden WH had been counting on sharing doses of both Johnson & Johnson and AstraZeneca but had to delay its plan while the F.D.A. completed a review of the facility.

7) The World Health Organization estimates that 11 billion doses are needed globally to stamp out the epidemic.
The F.D.A.’s action is disappointing news for Emergent and Johnson & Johnson, which hired the firm as a subcontractor.

8) Inspectors are still reviewing the plant and are not expected to decide whether the company can reopen it until later this month. Regulators are also continuing to cast doubt on whether the company, paid hundreds of millions of dollars, adhered to manufacturing standards.