so they QC sample check every 15 millionth vile?
Posted on 04/02/2021 9:08:59 AM PDT by SeekAndFind
Human errors at a manufacturing plant forced Johnson & Johnson to throw out 15 million doses of its COVID-19 vaccine – enough to vaccinate 7% of the U.S. adult population.
The New York Times, which first reported the loss on March 31, 2021, called it “a major embarrassment” for the vaccine-maker and its subcontractor, Emergent BioSolutions.
But while errors with an impact of that magnitude sound shocking, they’re also a reminder that the U.S. vaccine manufacturing process has strict quality control measures designed to catch these problems before they reach the public.
Vaccine manufacturing is complex, with many potential points for errors. As an expert in health care operations and the COVID-19 vaccine rollout, I closely follow vaccine manufacturing and approval processes. The multiple layers of quality checks by the producer and external inspectors throughout the process are essential to protect public health.
Checking the vaccines, and checking them again
After authorizing a vaccine, the U.S. Food and Drug Administration must approve and regularly inspect each vaccine manufacturing facility.
Before each batch of vaccines is released by the FDA, it undergoes rigorous and extensive testing to ensure vaccine safety. In the case of COVID-19 vaccines, manufacturers are required to submit the results of each quality control test for each batch of vaccines 48 hours prior to its distribution. This stringent quality control process has led to what the FDA describes as the safest vaccine supply in U.S. history.
The quality control process is also how Johnson & Johnson discovered defects within the batch of 15 million doses at the Emergent BioSolutions facility.
(Excerpt) Read more at chron.com ...
It doesn’t.
I wonder what KIND of workers worked at the J&J Baltimore factory....
The Baltimore plant was one of several contracted by the federal government in 2020 to help vaccine-makers ramp up production. The facility was still awaiting authorization from the FDA to deliver the vaccines for U.S. use when the problems were discovered.
As standard practice, Johnson & Johnson said it had specialists at the facility to check safety and quality. The Washington Post reported that workers at the facility in late February mixed up the ingredients for the AstraZeneca and Johnson & Johnson vaccines both being produced there, throwing the entire batch into question.
The FDA had previously flagged quality control concerns at Emergent’s Baltimore plant related to its testing of a potential treatment for anthrax, according to the records obtained by the Associated Press.
All vaccine manufacturing plants – domestic and international – require authorization from the FDA before they can supply vaccines to the U.S. population. The Johnson & Johnson vaccines currently used in the U.S. were manufactured in Johnson & Johnson’s own facility in the Netherlands.
“No no no no no no no no no...” she explained
Most drugs are made overseas, no that should scare you.
so they QC sample check every 15 millionth vile?
The whole article is damage control.
They are doing their damnedest to convince people that this was a rare occurrence and there’s nothing to worry about.
When you hire workers who cannot SPEAK English-—Write English-—READ English-—this is the result.
HOW MUCH $$$ did that cost?
They made 15 million bad doses before they caught it?
I am really impressed by their quality control.
FWIW and everything is anecdotal given the distrust we correctly have for the “experts” and the media, I am getting my J&J today. Several co-workers have had it from the same place with minimal problems (one had a headache and another a day of fatigue and fever - 4 of them had no adverse reaction) and half of them already had Covid.
Your mileage may vary, but I am generally confident about getting this particular vaccine. Given that we have passed the 100 million mark, the statistical data still supports the vaccine for those at higher risk despite the very small number of adverse reactions. My children WILL NOT be getting the vaccine any time soon as it is not warranted in my opinion.
QC as in animal studies. All the vaccines have gone thru extensive animal testing, so they are safe...
Oh wait, why are they considered experimental?
I think you are missing something: it could be that they were making ONE batch of 15M doses, and someone made a mistake. It’s not like they make a vial (with 5 doses, as I recall) one by one.
Botching 15M doses is a good thing.
Like Oscar Schindler’s factory botching shells and bombs so that they cannot explode.
It was a bad batch (too strong) from one subcontractor among many making the same vaccine.
RE: Like Oscar Schindler’s factory botching shells and bombs so that they cannot explode.
So, you are equating Covid-19 vaccines to bombs?
Had my J&J two weeks ago through the VA. Would they tell me if there was anything wrong?
I got J&J on Tuesday. No side effects other than a sore arm. (It’s pretty sore though—more sore than the flu shot.)
You may be right but:
If one batch is 15M then they only need 14 batches to have enough for the whole of the USA.
If each shot is $10 each batch is worth $150 million.
How about hired sabotage by those, who hate vaccines?
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