Sumary of U.S. FDA asks J&J to discard millions of COVID-19 vaccine doses:
- The agency said it was not yet ready to authorize Emergent BioSolutions Inc plant for manufacturing the J&J vaccine..
- The agency said the drugmaker and Emergent must agree that the FDA can share relevant information about the manufacturing of the doses with regulators where the vaccine is shipped..
- Last month, Emergent Chief Executive Robert Kramer said it was his understanding that there are 100 million doses of J&J vaccine ready for FDA review and that regulators had begun the review process..
- An FDA inspection also turned up a long list of sanitary problems and bad manufacturing practices at the Emergent plant….