After ruining 75M J&J doses, Emergent gets FDA clearance for 25M doses

The US Food and Drug Administration is making progress in its efforts to sort out the fiasco at Emergent BioSolutions’ Baltimore facility, which, at this point, has ruined more than 75 million doses of COVID-19 vaccines stemming from what the regulator identified as significant quality control failures.In March, news leaked that Emergent ruined 15 million doses of Johnson & Johnson’s vaccine as well as millions more doses of AstraZeneca’s vaccine. The spoilage happened when Emergent cross-contaminated batches of the two vaccines with ingredients from the other.Last week, the FDA told Emergent to trash about 60 million more doses of Johnson & Johnson’s vaccine due to similar contamination concerns, The New York Times reported.But at the same time, the agency cleared 10 million doses of Johnson & Johnson’s vaccine for use—with the catch that the doses must carry a warning saying that the FDA cannot guarantee Emergent followed good manufacturing practices while making them. All of the doses at the facility were made prior to April 16, when the FDA shut down production after an investigation found sweeping and significant quality control failures and manufacturing violations.Some lawmakers say the issues were clear before the investigation; Emergent has a long track record of such problems, as well as trouble fulfilling contracts.In spite of the prior issues, the manufacturer was contracted during the pandemic to produce both the Johnson & Johnson one-dose vaccine and the AstraZeneca vaccine.