De­spite FDA go-ahead, Emer­gent still sits on mil­lions of J&J vac­cine dos­es — re­port

In Sep­tem­ber, the FDA cleared the twelfth batch of quar­an­tined Covid-19 vac­cine from Emer­gent BioSo­lu­tions, fol­low­ing a con­t­a­m­i­na­tion mishap that led to the dis­card­ing of mil­lions of dos­es. Nine of those batch­es be­longed to J&J — but now, even af­ter the site has got­ten the go-ahead to con­tin­ue man­u­fac­tur­ing, be­tween 30 mil­lion and 50 mil­lion ad­di­tion­al dos­es are still in lim­bo.

The CD­MO is await­ing FDA ap­proval to re­lease these dos­es, and the plant must be in­spect­ed and au­tho­rized be­fore the drug sub­stance can be shipped, Reuters re­ports.

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