Workers at a Baltimore plant that manufacture two coronavirus vaccines accidentally combined the drug’s ingredients several weeks ago, ruining about 15 million doses of Johnson & Johnson and forcing regulators to delay authorization of the plant’s production lines, reported The New York Times.La plant owned by Emergent BioSolutions , a partner of Johnson & Johnson and AstraZeneca, and federal officials attributed the fact to a human error. The accident forced discontinuation of the pharmaceutical drug’s dose distribution in the United States, while the Food and Drug Administration (FDA) investigates the case. Johnson & Johnson has taken care of strengthening its quality control over Emergent BioSolutions’ work to prevent further failure.
The vaccine, which does not require reinforcement, demonstrated 85% effectiveness for the prevention of serious diseases, according to the results of the Phase 3 trial.
The mistake is a major backing line for the company, whose single-dose vaccine is credited with accelerating the national immunization program. However, it does not affect the doses of that laboratory that are already being administered and which were produced in the Netherlands, where operations were approved by federal regulators. But all subsequent shipments of the vaccine, a total of tens of millions of doses in the coming month, were expected to come from the huge Baltimore plant. These shipments are now on suspense as quality control issues are resolved, according to people familiar with the case. However, federal officials expect sufficient doses to fulfill President Joe Biden’s commitment to providing enough vaccines by the end of May for the entire adult population to be immunized. The other two federally authorized manufacturers, Pfizer-BioNTech and Moderna, continue their deliveries as scheduled. Pfizer is even sending its doses earlier than scheduled, and Moderna is about to get approval to deliver vials of packaged vaccine with up to 15 doses instead of 10, further boosting the presence of immunizers in that country.
