Friday, September 24, 2021 Daily Archives

AstraZeneca vaccines: Further problems at Emergent but FDA okays exports

The US FDA has determined several lots of a COVID-19 vaccine are acceptable to use despite AstraZeneca identifying further manufacturing deviations at CDMO partner Emergent.  Efforts to scale up COVID-19 vaccines in the wake of the pandemic have been exceptional, but in April Emergent BioSolution fell afoul of the US Food and Drug Administration (FDA).  The contract development and manufacturing organization (CDMO) had been contracted by both Johnson & Johnson and AstraZeneca (AZ) to make their respective COVID-19 vaccines, but an ingredient mix up rendered 15 million doses unusable and landed the…