April 6, 2021
BARDA to give Emergent Biosolutions an extra $23 million for new tech after plant mix up ruined millions of doses of J&J’s single-shot COVID vaccine.
The facility in question is Emergent’s plant in Baltimore, Maryland which made the news after it emerged the contract development and manufacturing organization (CDMO) had mistakenly mixed ingredients of the J&J jab with those of the AstraZeneca shot, rendering 15 million doses unusable.
The incident prompted the Biden administration to place Johnson & Johnson in charge of the plant and move to stop it making the AstraZeneca vaccine according to the New York Times.
Image: iStock/Christian Horz
In an official response J&J said it identified one batch of drug substance that did not meet quality standards adding that the batch was never advanced to the filling and finishing stages of the process.
It wrote “As we continue to work with FDA and Emergent toward the Emergency Use Authorization of the Emergent Bayview Facility, Johnson & Johnson is providing additional experts in manufacturing, technical operations and quality to be on-site at Emergent to supervise, direct and support all manufacturing of the Johnson & Johnson COVID-19 vaccine.”
J&J said the measures will allow it to deliver an extra 24 million vaccine doses through April.
Emergent’s statement focused on the resulting $23 million increase on the original task order from the US Biomedical Advanced Research and Development Authority (BARDA).
“The $23 million will be used for the purchase of biologics manufacturing equipment specific to Johnson & Johnson’s COVID-19 vaccine for the potential expansion of manufacturing of that bulk drug substance into a third suite of Emergent’s Baltimore Bayview facility.”
The CDMO also said it “expects to align with the U.S. government and AstraZeneca on a mutually agreed ramp down of manufacturing for AstraZeneca’s COVID-19 vaccine bulk drug substance.”
In a separate statement AstraZeneca said it “will relocate production of AZD1222 vaccine drug substance from the Emergent facility in Baltimore, Maryland.
“The company will work with the US Government to identify an alternative location for domestic drug substance production of AZD1222.”
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