FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Fri­day re­leased about 10 mil­lion dos­es of J&J’s vac­cine for use, and dis­posed of an­oth­er 60 mil­lion dos­es that were man­u­fac­tured at the now-shut­tered Emer­gent BioSo­lu­tions fa­cil­i­ty in Bal­ti­more where cross-con­t­a­m­i­na­tion oc­curred.

The agency said it’s not yet ready to al­low the Emer­gent plant to be in­clud­ed in the J&J EUA, but that may oc­cur soon. FDA came to the de­ci­sion to au­tho­rize some of the dos­es af­ter re­view­ing fa­cil­i­ty records and qual­i­ty test­ing re­sults.

Pe­ter Marks, FDA

“This re­view has been tak­ing place while Emer­gent BioSo­lu­tions pre­pares to re­sume man­u­fac­tur­ing op­er­a­tions with cor­rec­tive ac­tions to en­sure com­pli­ance with the FDA’s cur­rent good man­u­fac­tur­ing prac­tice re­quire­ments,” said CBER di­rec­tor Pe­ter Marks.

Emer­gent pre­vi­ous­ly ru­ined 15 mil­lion dos­es of J&J’s Covid-19 vac­cine in March due to the cross-con­t­a­m­i­na­tion with the As­traZeneca vac­cine, which was pre­vi­ous­ly made at the same Bal­ti­more site. In April, Emer­gent slammed the brakes on all pro­duc­tion there, at the FDA’s be­hest, and J&J took con­trol of the plant.

Now, the 10 mil­lion dos­es that are OK to be used may al­so be ex­port­ed, but the FDA said Fri­day that will come with con­di­tions. For in­stance, for any ex­port of these two batch­es OKed for use, or of vac­cine man­u­fac­tured from these batch­es, J&J and Emer­gent agreed that the FDA may share rel­e­vant in­for­ma­tion, un­der an ap­pro­pri­ate con­fi­den­tial­i­ty agree­ment, with the reg­u­la­to­ry au­thor­i­ties of the coun­tries in which the vac­cine may be used.

Ad­di­tion­al batch­es are still un­der re­view, FDA said, but the agency de­clined to say how many or even how many dos­es are in one batch. The New York Times first re­port­ed on Fri­day that the FDA would not al­low the use of the 60 mil­lion dos­es. J&J did not re­spond to a re­quest for com­ment.

The Eu­ro­pean Med­i­cines Agency al­so re­leased a state­ment on Fri­day, say­ing that based on avail­able in­for­ma­tion, batch­es of the vac­cine re­leased in the EU are not af­fect­ed by the cross-con­t­a­m­i­na­tion that oc­curred at the Emer­gent fa­cil­i­ty.

“How­ev­er, as a pre­cau­tion and to safe­guard the qual­i­ty of vac­cines, the su­per­vi­so­ry au­thor­i­ties [the med­i­cines au­thor­i­ties in Bel­gium and the Nether­lands who are re­spon­si­ble for batch re­lease in the EU] have rec­om­mend­ed not re­leas­ing vac­cine batch­es con­tain­ing the ac­tive sub­stance made at around the same time that the con­t­a­m­i­na­tion oc­curred,” the EMA said.

Ad­di­tion­al­ly, the FDA has ex­tend­ed the ex­pi­ra­tion dat­ing for the re­frig­er­at­ed J&J dos­es, af­ter re­view­ing in­for­ma­tion and de­ter­min­ing that the vac­cine can be stored at 2-8 de­grees Cel­sius for 4.5 months, in­stead of 3 months.

More than 10 mil­lion peo­ple in the US have now re­ceived the J&J vac­cine, all of whom re­ceived vac­cines made at the com­pa­ny’s plant in the Nether­lands. An­oth­er 10 mil­lion more dos­es have been de­liv­ered across the coun­try but not ad­min­is­tered yet, ac­cord­ing to the CDC.

As of the end of May, 2 mil­lion dos­es of the J&J vac­cine have been ad­min­is­tered in the EU, EMA said.

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