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US Supplies of J&J Covid-19 Vaccine Dry up

17.05.2021 - Problems at CDMO Emergent BioSolutions in the US state of Maryland and the resulting Food and Drug Administration shutdown of its Baltimore vaccine production facility continue to cloud the rollout of Johnson & Johnson’s Covid-19 shot. The newspaper Washington Post said the US federal government will not send any supplies of the healthcare group’s single-dose vaccine to states over the coming week, citing the weekly shipment allocation of the Centers for Disease Control (CDC).

Due to ongoing supply issues, this week’s canceled allocation of only 600,000 doses, was the last the government had scheduled for J&J, the paper said. The company’s vaccine has seen strong demand from state and local authorities as it requires only one dose and is easy to store, but the rollout has been beset by difficulties. The CDC’s weekly allocations of the vaccines made by Pfizer/BioNTech and Moderna are said to be still on track.

The troubles in Baltimore – where Emergent workers reportedly mixed up ingredients of the J&J vaccine with others from AstraZeneca – is only one cause contributing to the sluggishness of the J&J rollout. The plant has never been approved by the Food and Drug Administration, due to questions about safety and hygiene. The FDA’s inspection report, published after the incident, pointed to unsanitary conditions and a lack of training and procedures to prevent contamination of vaccine batches.

Up to now, ingredients for the vaccines in J&J’s US rollout are said to have all come from the company’s CDMO partner in the Netherlands. But even the certification of the Dutch facility was only recently completed, after being delayed due to unspecifed issues. German vaccine centers late last week said they had received no J&J doses and nothing from AstraZeneca. Catalent last year said it was expanding an Italian plant to produce the J&J shot.

Emergent officials have a date with Congress

Meanwhile, Emergent's top officials, including company founder and executive chairman Fuad El-Hibri and CEO Robert Kramer, are headed to Washington for a hearing with the US Congress. The legislators will not only seek to shed light on the production glitches and sanitary conditions but also ask for more information on pandemic manufacturing contracts with the Defense Department.

Kramer’s divestment of Emergent stock in January and February 2021, shortly before the shares began a downhill slide, will also be a topic. The newspaper New York Times reported that Kramer sold altogether $10 million worth of stock. The company has said the sales were part of a pre-established trading plan.

Author: Dede Williams, Freelance Journalist