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Up to 15 million J & J coronavirus vaccine doses are ruined due to factory mix-up

Washington — Workers manufacturing two at a Baltimore factory Coronavirus vaccine A few weeks ago I accidentally confused the ingredients, causing up to 15 million doses of contamination. Johnson & Johnson Vaccine Forces regulators to delay the approval of factory production lines.

The plant is operated by Emergent BioSolutions, a manufacturing partner of both Johnson & Johnson and AstraZeneca, a UK and Swedish company whose use of the vaccine in the United States has not yet been licensed. Federal officials have attributed this mistake to human error.

While the Food and Drug Administration was investigating what happened, the turmoil delayed future shipments of Johnson & Johnson doses in the United States. Johnson & Johnson has moved to strengthen control over the work of Emergent BioSolutions to avoid additional quality lapses.

This mistake is a great embarrassment for both Johnson & Johnson, who is allegedly speeding up the country’s vaccination program, and its subcontractor, Emergent. Fierce criticism of fierce lobbying against federal contracts, Especially for government emergency medical stockpiles.

This error does not affect Johnson & Johnson doses currently being shipped and used nationwide, including shipments that the state is counting next week. All of these doses are manufactured in the Netherlands, where operations are fully approved by federal regulators.

Further shipments of the Johnson & Johnson vaccine (a total of 24 million doses expected next month) were expected to come from a huge factory in Baltimore. According to people familiar with the matter, their delivery is currently a problem while quality control issues are being sorted out.

Federal officials expect to still have enough doses to meet from Johnson & Johnson and two other approved coronavirus vaccine makers. President Biden’s Commitment Provide sufficient vaccine to vaccinate all adults by the end of May.

Pfizer is shipping its dose earlier than planned, and Moderna is on the verge of winning approval to provide vials of vaccine. Packed up to 15 times Instead of 10, further strengthen the country’s inventory.

The problem arose at a new factory where the federal government joined last year to produce vaccines from Johnson & Johnson and AstraZeneca. The two vaccines use the same technique, which uses a harmless version of the virus called a vector, which is transmitted to cells to produce proteins and stimulate the immune system to produce antibodies.But Johnson & Johnson And AstraZeneca Vectors are biologically different and incompatible.

In late February, one or more workers confused the two during the manufacturing process and questioned training and supervision. Last year, Emergent hired and trained hundreds of new workers to produce millions of times both vaccines, which should be ready to show in clinical trials whether the vaccines actually work. Did.

Vaccine production is a notorious whimsical science, and it is often expected that errors will occur and ruin the batch. However, according to people familiar with the situation, Emergent’s mistakes were not discovered for days until they were discovered by Johnson & Johnson’s quality control checks. By that time, people said up to 15 million doses had been contaminated.

Neither dose left the plant and the lot was quarantined. There is no indication that it affected the production of AstraZeneca’s vaccine, which has not yet been approved for emergency use by the Food and Drug Administration.

Johnson & Johnson reported the accident to federal regulators, who began an investigation, delaying the approval of the plant’s production line. The company has launched a variety of new checks aimed at increasing the number of its staff monitoring Emergent’s work and protecting it from future revocations.

Johnson & Johnson is already facing manufacturing delays, lagging behind its commitment to the federal government, but seems to be on track to catch up. We promised to provide 20 million doses by the end of March and an additional 75 million doses by the end of May.

White House officials hedged their forecasts on a phone call with the governor on Tuesday, predicting certain deliveries from Pfizer and Moderna, but warned that Johnson & Johnson shipments would fluctuate.

The company said in a statement late Wednesday that it expects the current steps at Emergent to provide 24 million doses, or the amount expected by the federal government, by the end of April. But that depends on whether Johnson & Johnson meets the Food and Drug Administration’s regulatory authorities.

The agency removed the bottling facility used by Johnson & Johnson in Indiana last week, allowing more doses to be released in the Netherlands. However, the facility cannot send doses produced by the emergency plant until approved by the Food and Drug Administration.

So far, nearly 7 million vaccines have been given, about half of which have been given. According to the Centers for Disease Control and Prevention..

Carl Zimmer Contribution report.

Up to 15 million J & J coronavirus vaccine doses are ruined due to factory mix-up

Source link Up to 15 million J & J coronavirus vaccine doses are ruined due to factory mix-up

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