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2 Vaccines Collided at Plant Flagged by FDA

15M doses of Johnson & Johnson's vaccine were ruined as a result
By Arden Dier,  Newser Staff
Posted Apr 2, 2021 8:23 AM CDT

(Newser) – The plant that lost up to 15 million doses of Johnson & Johnson's one-dose vaccine had something of a history of prior FDA violations. That's according to the AP and Washington Post, which obtained a copy of the FDA investigator's report from a year ago. It found a variety of issues at one of Emergent BioSolutions' Baltimore plants, known as Bayview, including that containment areas meant to "prevent contamination or mix-ups" were deficient, established testing procedures weren't followed, employees weren't properly trained, and records weren't adequately secured. Less than six weeks later, Emergent received $628 million from the government through Operation Warp Speed and began producing vaccines for J&J and AstraZeneca at Bayview. Federal officials tell the Post that a batch of J&J's vaccine was ultimately contaminated with AstraZeneca ingredients, ruining 15 million doses.

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A rep for the Department of Health and Human Services says it worked with Emergent to resolve the earlier issues before vaccine production began. An Emergent rep, who notes the mix-up was found during routine quality checks, says the company hosted two onsite FDA visits that addressed the items flagged. But the Post uncovered other allegations of Emergent's "multiple internal failings" during development of a vaccine against ricin poisoning. Emergent allegedly supplied a partner with drugs that were "out of specification" and only realized the error in January 2020 after two study participants were given doses. The FDA has yet to certify Emergent's coronavirus vaccine production line, forcing J&J to import vaccine made in the Netherlands. The company, which still plans to deliver 100 million doses to the US by the end of June, says it will directly monitor production at Bayview moving forward. (Read more coronavirus vaccine stories.)

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