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Repeated Issues

Some 15 million SARS-CoV-2 vaccine doses manufactured by Emergent BioSolutions have had to be destroyed recently because of contamination, and the New York Times reports that this appears to reflect a corporate culture where errors are dismissed.

It reports that the US government contracted with the biotech firm eight years ago to be primed to produce vaccines should a pandemic arise. But, according to the Times, Emergent struggled to show that it was at the ready even before the COVID-19 pandemic. Despite this, the Times writes that the US had little choice but to turn to Emergent to manufacture SARS-CoV-2 vaccines, as it was one of the few US companies that could make the vaccines developed by Johnson & Johnson and AstraZeneca.

Now, audits by regulators, J&J, and AstraZeneca, as well as internally, have uncovered a number of lapses at the manufacturing facility in Baltimore, including deviations from manufacturing standards, errors that killed cells growing the vaccine, and persistent mold concerns, and inadequate employee training, the Times says.

The Times adds that the 15 million J&J vaccine doses that had to be destroyed were contaminated with the AstraZeneca vaccine, and that another 62 million J&J vaccine doses and possibly about 70 million AstraZeneca doses need to be tested to ensure they weren't also contaminated. It further reports that previous lots of AstraZeneca's vaccine had to be discarded due to contamination.

The Biden Administration last weekend instructed J&J to take over manufacturing at the plant, which is to be restricted to that vaccine, the Times notes.