Sumary of The FDA reportedly forces J&J to scrap about 60 million doses of its Covid vaccine:
- Johnson to scrap about 60 million doses of Covid-19 vaccine produced at a troubled Baltimore plant run by Emergent BioSolutions due to possible contamination, the New York Times reported Friday, citing people familiar with the matter..
- The plant was shuttered in April after an inspection revealed several violations, including possible contamination of J&J’s vaccines with a key ingredient from AstraZeneca’s Covid vaccine..
- It said it was clearing two batches of vaccine materials manufactured at the plant for use, according to an emailed statement..
- The salvaged doses will come with a warning stating federal regulators could not guarantee that the manufacturing plant’s operator, Emergent BioSolutions, followed good manufacturing practices, the Times reported..
- “While the FDA is not yet ready to include the Emergent BioSolutions plant in the Janssen EUA as an authorized manufacturing facility, the agency continues to work through issues there with Janssen and Emergent BioSolutions management.”…