15 MILLION doses of J&J’s one dose Covid vaccine halted after ingredient mix-up

Mito

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Some 15 million doses of Johnson & Johnson's one-shot coronavirus vaccine have been ruined after employees at a Baltimore manufacturing plant accidentally swapped two ingredients, the New York Times reported Wednesday.

The gaff occurred two weeks ago and will delay tens of millions doses slated to ship next month while the FDA investigates.

J&J blamed the mix-up on human error and says that 11 million doses that shipped this week were not affected.

White House officials told the Times that the J&J fiasco will not prevent the U.S. from reaching President Biden's goal of having enough COVID-19 vaccine doses in the national stockpile to inoculate every American adult by the end of May.

 

tankasnowgod

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Some 15 million doses of Johnson & Johnson's one-shot coronavirus vaccine have been ruined after employees at a Baltimore manufacturing plant accidentally swapped two ingredients, the New York Times reported Wednesday.

The gaff occurred two weeks ago and will delay tens of millions doses slated to ship next month while the FDA investigates.

J&J blamed the mix-up on human error and says that 11 million doses that shipped this week were not affected.

White House officials told the Times that the J&J fiasco will not prevent the U.S. from reaching President Biden's goal of having enough COVID-19 vaccine doses in the national stockpile to inoculate every American adult by the end of May.


Why didn't they just ship them out and use them anyway? It's not like J&J or the manufacturer has any liability anyway.
 

Giraffe

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From that article linked in the original post:

'It was no secret that Emergent [J&J's contractor] did not have a deep bench of pharmaceutical manufacturing experts,' that official told Politico.

The Emergent BioSolutions plant is also manufacturing doses for AstraZeneca, and apparently used an ingredient for the UK firm's vaccine in a batch of J&J's.

The FDA inspected Emergent´s Bayview plant in April 2020, just as the agreement with J&J was being announced. The federal agency criticized the company for problems with its testing of a potential treatment for anthrax, according to the records obtained by the AP. The FDA´s lead investigator cited the company for failing to train employees 'in the particular operations they perform as part of their function and current good manufacturing practices.'

Other problems cited by the FDA during the April 2020 inspection included failures by the Bayview plant 'to ensure that electronically held data generated during analytical testing' of material 'was protected from deletion or manipulation.' The FDA´s lead investigator, Marcellinus Dordunoo, wrote that Emergent hadn´t investigated what he described as 'data integrity concerns.'

The inspection was the most recent in a series of critical reports from the FDA about Emergent, including one following a December 2017 inspection at a plant in Canton, Massachusetts, in which the FDA said the company hadn´t corrected 'continued low level mold and yeast isolates' found in the facility. Nearly a year later, agency investigators questioned why Emergent had 'an unwritten policy of not conducting routine compliance audits' at a separate plant in Baltimore, known as Camden, where an anthrax vaccine is filled into vials.

Mold problems in the past? Employees that are not trained? Falsified data? Routine compliance audits not conducted?

Why is this company still up and running?
 

tankasnowgod

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I hope that they are liable if they deliver something else than what was ordered.

Agree, but I don't know how anyone would prove it in the real world, after it's been administered. I don't think amounts are listed on the vaccine boxes or inserts, and some ingredients are hidden behind proprietary names, anyway. I don't know all the details of the EUA immunity from liability, but it does seem like some "manufacturing errors" would be included, since they are ramping up mass scale production in a limited time.

The quotes you linked from the article should be setting off massive alarm bells for anyone considering either the J&J or AZ shot. Same with the Moderna or Pfizer shots, as those companies wouldn't be immune from this sort of problem.
 

Giraffe

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Agree, but I don't know how anyone would prove it in the real world, after it's been administered. I don't think amounts are listed on the vaccine boxes or inserts, and some ingredients are hidden behind proprietary names, anyway. I don't know all the details of the EUA immunity from liability, but it does seem like some "manufacturing errors" would be included, since they are ramping up mass scale production in a limited time.
Worried people with expertise and access to labs are provided with samples, and they check what is in there. Where to go from there is a different question.

The quotes you linked from the article should be setting off massive alarm bells for anyone considering either the J&J or AZ shot. Same with the Moderna or Pfizer shots, as those companies wouldn't be immune from this sort of problem.
There were quality problems (too little mRNA) with the Pfizer stuff in Europe. The EMA knew it, but the stuff was administered anyway. It was revealed later thanks to hackers.
 

Mito

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U.S. Bet Big on Covid Vaccine Manufacturer Even as Problems Mounted​

The Baltimore plant that recently had to scrap up to 15 million ruined doses had flouted rules and downplayed errors, according to internal audits, ex-employees and clients. Other doses had to be scrapped last year.

 

tankasnowgod

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U.S. Bet Big on Covid Vaccine Manufacturer Even as Problems Mounted​

The Baltimore plant that recently had to scrap up to 15 million ruined doses had flouted rules and downplayed errors, according to internal audits, ex-employees and clients. Other doses had to be scrapped last year.


Well they bet even bigger on a company that had never even brought one single product to market or even past Phase 2 clinical trials in Moderna.
 
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