Thursday, July 8, 2021

Johnson & Johnson takes control at troubled Emergent vaccine plant after major production snafu

Johnson & Johnson is in. Emergent BioSolutions is out—at least when it comes to managing its own plant in Baltimore.

After a manufacturing mix-up forced J&J to discard up to 15,000 doses of its vaccine made there—and after news emerged of Emergent’s history of violations there—the U.S. government stepped in, handing control of the plant to the pharma giant.

J&J over the weekend said it’s “assuming full responsibility” for drug substance manufacturing at Emergent’s troubled plant in Baltimore. The Biden administration forced the change—and it’s calling a halt to production of AstraZeneca’s shot there as well, The New York Times reports.

J&J is “adding dedicated leaders for operations and quality” and is “significantly increasing” the number of manufacturing experts who will work at the site, the company said.

The news comes after workers at the plant mixed up ingredients of the two vaccines and ruined a batch of J&J drug substance that could have yielded 15 million doses, the Times reported. None of the doses was finished and distributed, but the episode created a public relations crisis for Emergent, which had scored contracts to produce J&J and AZ shots. 

RELATED: Up to 15M Johnson & Johnson coronavirus vaccine doses ruined due to human error: NYT 

As for AZ, it’s now looking elsewhere for space to produce its vaccine, the company said in a statement.

Meanwhile, J&J said it still expects to deliver 100 million vaccine doses to the U.S. by the end of next month. So far, CDC data show that 8.7 million doses of the single-shot vaccine have been distributed to states, and more than 4 million have been administered. 

After news broke that the doses were discarded, J&J said it was providing additional experts to supervise and help with manufacturing at the plant. 

Last year, long before the vaccine mix-up, an FDA investigator flagged improper training, record keeping, testing procedures and more at the site, the Washington Post reports

RELATED: Emergent BioSolutions’ plant behind the lost J&J vaccine batch hit with several FDA red flags last year: report 

Meanwhile, AstraZeneca plans to seek an emergency use authorization for its vaccine, but it isn’t clear whether the U.S. will need those doses. Between the Pfizer, Moderna and J&J vaccines, the U.S. will have more than enough supply to vaccinate the entire population.

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