J&J Takes Control of Problematic Emergent Plant

06.04.2021 - With the backing of the US government, Johnson & Johnson has taken over “full responsibility" for manufacturing at the Bayview plant operated by its Baltimore, Maryland-based vaccine ingredients supplier, US biotech Emergent BioSolutions.

According to the newspaper New York Times, the CDMO ruined close to 15 million Covid-19 vaccine doses by mixing ingredients for AstraZenca’s shot with J&J’s at the Baltimore plant. In an interview with business broadcaster CNBC, however, Emergent CEO Robert Kramer said doses had not been mixed together. "It was more simply the fact that one production run, one batch of product, was determined to be inconsistent with our quality specifications."

The incident is said to have occurred several weeks ago at the Bayview facility in Baltimore that was contracted to supply both J&J and AstraZeneca. J&J said Emergent itself reported the mistake at the plant, which is not yet authorized by the US Food & Drug Administration. None of the tainted doses had been delivered.

US health authorities said the decision to have the facility make only the single-dose J&J vaccine is a precaution to avoid future problems. The healthcare giant has said it is on track to deliver 100 million doses to the US government by the end of May.

Emergent reported on Apr. 5 that the US Biomedical Advanced Research and Development Authority (BARDA) has agreed to pay it an additional $23 million to purchase new manufacturing equipment to boost production of the main ingredient for the J&J shot.

AstraZeneca said it will work with BARDA to find another US vaccine production site. The Anglo-Swedish drugmaker, which is planning to apply to the FDA for emergency use authorization, recently encountered negative publicity after the independent data safety monitoring board (DSMB) reviewing its US trial said its efficacy figures were confusing. The company later updated them.

Before the Baltimore incident became known, US president Joe Biden tentatively agreed to provisionally supply around 4 million AstraZeneca doses from the government’s stockpile to neighboring Mexico and China. The president’s pandemic advisor, top US virologist Anthony Fauci, said recently that the country may have sufficient vaccine supply without AstraZeneca, even though both it and J&J reportedly have fallen behind delivery commitments pledged earlier.

The Times said the Emergent plant’s output has been under FDA scrutiny several times in the past, with recent issues allegedly concerning improper training, record keeping and testing procedures. While waiting for the health agency’s green light, the CDMO had already been producing at Bayview and shipping doses to J&J's fill & finish partner Catalent. The New Jersey CDMO’s plant itself only received federal authorization in late March.

In June 2020, Reuters reported that Emergent had signed a $628 million contract with BARDA to build up capacity for a potential Covid-19 vaccine. The bulk of the payment was to go toward scaling up capacity at Bayview. The Strategic National Stockpile, the country’s emergency medical reserve, is one of the CDMO’s clients.

According to the Times, the government last year paid Emergent $626 million for products that included vaccines against anthrax and smallpox. Throughout most of the past decade, the paper added, the government has spent “nearly half of the stockpile’s half-billion-dollar annual budget” on Emergent’s anthrax vaccines.

Emergent may upgrade Canadian plant

The CDMO is reportedly now in talks with the government of Canada about upgrading its vaccine fill & finish facility in Winnipeg with financial support from the national budget. The facility, which employs around 350 people, is said to be equipped to handle the final manufacturing stages for mRNA, mammalian and microbial drugs, including the mRNA-based Covid-19 vaccines of Pfizer/BioNTech and Moderna.

Author: Dede Williams, Freelance Journalist