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

LewisBraham

https://nytimes.com/2021/03/31/us/politics/johnson-johnson-coronavirus-vaccine.html

The mistake is a major embarrassment both for Johnson & Johnson, whose one-dose vaccine has been credited with speeding up the national immunization program, and for Emergent, its subcontractor, which has faced fierce criticism for its heavy lobbying for federal contracts, especially for the government’s emergency health stockpile.

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

Crash

Mistakes get made. Some are more costly and vital than others. Remember the employee who left some vaccines OUT of the fridge deliberately? Asshole. A few days later, some official, or maybe the CEO, posited that maybe those vaccines would still be valid and effective... Maybe he was proved right. I think so. But I'd not want to be the beta-tester on that one. In other news, I see in the past few days that MA and HI opened up vaccine eligibility to everyone down to 16 years old.

Old_Joe

I believe that this unfortunate incident actually took place several weeks ago, and that it has led to J&J taking direct control over the manufacturing of it's vaccine at the Emergent facility in Baltimore.

Mark

I believe that OJ is correct unless this is another new batch. I sincerely hope not.

Meanwhile back on the front lines I read a story today that said that only 75% of seniors have been vaccinated. That's disconcerting.

carew388

NYT article dated 3/31/2021 .

Old_Joe

Here's more on this, in excerpts from a current NY Times article:

A congressional panel has opened an investigation into Emergent BioSolutions, the company whose Baltimore factory ruined millions of doses of the Johnson & Johnson Covid-19 vaccine, focusing on whether it was improperly awarded a $628 million federal contract to manufacture vaccines.

The inquiry will look into whether a Trump administration official steered the work to the company despite questions about its qualifications, according to a statement released late Monday.

“Specifically, we are investigating reports that Emergent received multimillion-dollar contracts to manufacture coronavirus vaccines despite a long, documented history of inadequately trained staff and quality control issues,” the statement said.

The congressional inquiry is the latest in a series of problems for Emergent, a longtime federal contractor that has a reputation for aggressive lobbying tactics. This month, the Food and Drug Administration began an audit of its factory in southeastern Baltimore after workers contaminated a batch of Johnson & Johnson’s vaccine with an ingredient for AstraZeneca’s vaccine, another product manufactured at the plant.

Emergent said on Monday that it had suspended operations at the plant and acknowledged that it needed to make improvements to “restore confidence” in its work. It also said it was quarantining the vaccine substance already produced at the plant until after the inspection ends and the company has had a chance to fix any problems highlighted in the review.

Biden administration officials have said that AstraZeneca’s vaccine will no longer be manufactured at the plant, and Johnson & Johnson has vowed to exert stronger control over Emergent, its subcontractor. The F.D.A. has not certified the facility to distribute any vaccine to the public; all Johnson & Johnson doses that have been administered were manufactured overseas. AstraZeneca’s vaccine is not yet authorized in the United States.

The New York Times reported this month that confidential audits and internal documents showed that Emergent had failed to follow some basic industry standards and identified repeated shortcomings in efforts to prevent contamination. Those records were among the documents that congressional investigators are now seeking.

The inspections flagged a persistent problem with mold in areas required to be kept clean, poor disinfection of some plant equipment, repeated use of raw materials that were not fully tested and inadequate training of employees. In one month, they indicate, workers making AstraZeneca’s vaccine deviated from manufacturing standards an average of over three times a day.

Note: if you do follow the link to the NY Times article you will have to scroll down a fair amount, as that link contains a number of articles regarding Covid-19.

Crash

Acccchhh. Just goes to show: you can't FORCE people to be conscientious. Not only the front-line workers, but the "leadership" which tolerates (encourages?) such lax oversight and quality-control. The trait NOT to be conscientious shows up in such people in every aspect of their lives. It's difficult to define, but either you have it or you don't. I'll not ever understand the "have-nots" when it comes to this stuff.

LewisBraham

It just keeps getting worse with this Emergent Biosolutions subcontractor for J&J: https://reuters.com/business/healthcare-pharmaceuticals/us-fda-finds-peeling-paint-debris-us-plant-making-jjs-covid-19-vaccine-2021-04-21/

Crash

beyond words. Abominable.

LewisBraham

It found failure to train personnel to avoid cross contamination of COVID-19 vaccines from Johnson & Johnson (JNJ.N) and AstraZeneca (AZN.L), which had also been produced at the site. The agency also cited staff carrying unsealed bags of medical waste in the facility, bringing it in contact with containers of material used in manufacturing.

Earlier this week, the U.S. House Representatives launched an investigation into whether Emergent used its relationship with a Trump administration official to get a vaccine manufacturing contract despite a record of not delivering on contracts.

It sounds a bit like the Three Stooges were running this plant.

Crash

You mean, besides the Orange Abortion's influence. Ya. Pigs at the trough.

Observant1

"A U.S. plant that was making Johnson & Johnson’s (JNJ.N) COVID-19 vaccine must fix a long list of problems including peeling paint, shoddy cleanups, and poorly-trained staff to resume operation, according to a highly critical report by the Food and Drug Administration."

The many issues reported by the FDA should preclude Emergent Biosolutions from producing any vaccines in the US. The company's malfeasance will provide another reason for the vaccine-hesitant to forgo vaccination.


"Earlier this week, the U.S. House Representatives launched an investigation into whether Emergent used its relationship with a Trump administration official to get a vaccine manufacturing contract despite a record of not delivering on contracts."

It shocks me that such a company may have received a vaccine manufacturing contract based on political connections!

Sven

Something is smelling fishy for such company to stay in business. They are NOT clean enough for fast food business let alone fine pharmaceutical products.