The US FDA has authorized an emergency use authorization (EUA) for one additional batch of the Janssen COVID-19 vaccine manufactured at Emergent’ Bayview facility. Contamination issues stemming from Emergent BioSolutions marred rollout of J&J’s ‘Janssen’ single dose COVID-19 vaccine earlier this year. The contract development and manufacturing organization’s (CDMO) Bayview, Maryland facility had been contracted by both J&J and AstraZeneca, but an ingredient mix up rendered 15 million doses unusable and landed the plant with an FDA Form 483 and a…

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…