Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson

WASHINGTON – Two Coronavirus vaccine workers at a plant in Baltimore accidentally seized the material several weeks ago, contaminating Johnson & Johnson’s 15 million doses of the vaccine and authorizing the plant’s production lines Forced the regulators to delay.

The plant is run by Emergent Biosolutions, a manufacturing partner of both the British and Swedish companies Johnson & Johnson and AstraZeneca, whose vaccine is not yet authorized for use in the United States. Federal officials attributed the mistake to human error.

The mix-up has delayed future shipments of Johnson & Johnson supplements to the United States while the Food and Drug Administration investigates what happened. Johnson & Johnson has gone on to strengthen its control over the work of Emergent Biosolutions to avoid additional quality deficiencies.

The mistake is a major embarrassment for both Johnson & Johnson, whose one-dose vaccine has been credited with accelerating the national immunization program, and for Emergent, its subcontractor, which has suffered. Fierce criticism for heavy lobbying of federal contracts, Especially for the emergency health reserves of the government.

The error does not affect any Johnson & Johnson supplements that are currently being delivered and used, including shipments that are counted next week in the states. All those doses were produced in the Netherlands, where operations have been fully approved by federal regulators.

Further shipments of the Johnson & Johnson vaccine – estimated to total tens of millions of doses in the following month – were to come from a large plant in Baltimore. According to people familiar with the case, those deliveries are questioned when solving quality control issues.

Federal officials still expect adequate doses to meet three approved coronavirus vaccine manufacturers President Biden’s Commitment Providing enough vaccines for every adult to be vaccinated by the end of May. Two other condensed authorized manufacturers, Pfizer-Bayonet and Moderna, are working as expected.

Pfizer is shipping its supplements ahead of schedule, and is on the verge of winning approval to deliver modern vaccine vials. Packed with 15 doses Instead of 10, taking the stock of the country further.

The federal government raised problems last year at a new plant to produce both Johnson & Johnson and AstraZeneca vaccines. Both use similar technology in which genes unique to coronovirus are harbored in human cells, where they cause the immune system to produce antibodies.

In less than a year, Amergent hired and trained hundreds of new workers to produce millions of doses of both vaccines, which were about to be ready by the time the clinical trial revealed whether He did indeed work. In late February, one or more workers for AstraZeneca’s vaccine with Johnson & Johnson somehow confused a key component, raising questions about training and supervision.

Vaccine production is a notoriously fickle science, and errors are often expected to occur and ruin batches. Johnson & Johnson’s quality control investigations ignored Emergent’s mistake, according to people familiar with the situation. By then, up to 15 million doses had been contaminated, people said.

None of the doses ever left the plant, and a lot fell apart. There are no indications that the production of AstraZeneca vaccine, which has so far been authorized for emergency use by the Food and Drug Administration, was affected.

Johnson & Johnson reported the accident to federal regulators, who then launched an investigation, which delayed authorization of that plant’s production lines. The company has increased the number of its own staff members who supervise the work of Emergent and install a variety of new checks to protect against future losses.

Johnson & Johnson is already experiencing a hiatus in its construction, causing the company to collapse due to its commitments to the federal government, but it seemed on track to catch up. It delivered 20 million doses by the end of March, and has promised to deliver around 75 million by the end of May.

White House officials rejected their estimates in a phone call with governors on Tuesday, speculating some of Pfizer and Moderna’s episodes but warned that Johnson & Johnson’s shipments would fluctuate.

In a statement late Wednesday, the company said it hoped the actions it was taking with Emergent now would be able to deliver 24 million doses by the end of April, or what the federal government would expect from it. But it depends on whether Johnson & Johnson satisfies the Food and Drug Administration regulators.

The agency last week approved a bottling facility that Johnson & Johnson uses in Indiana, allowing more doses to be released in the Netherlands. Unless the Food and Drug Administration authorizes it, the facility cannot ship out the doses produced at the Amergent plant.

Approximately seven million doses of the vaccine have been delivered so far, and about half of them have been administered, According to the Centers for Disease Control and Prevention.

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