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Canada has rejected 300,000 doses of the Johnson & Johnson vaccine from the U.S. after it was made at a Baltimore facility riddled with contamination issues.
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the FDA report reads like an episode of kitchen nightmares https://www.fda.gov/media/147762/download
That reads like they made that batch in a crackhouse. Peeling paint? Cross contamination with unsealed medical waste? Employees crossing between zones and bumping into stuff in crowded spaces.
Just to quote a few incidents.
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I got fired from a QC job for finding too many defects in neurovascular catheters. Apparently it was upsetting the production team.
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The medical industry just likes to whine about how there are too many rules in place to make sure that they don't oopsie people to death.
America doesn't invest in infrastructure and change unless it has a pure entertainment value or military value.
Hollywood computers phones entertainment comsetic surgery. Why change the crumbling bricks when you can just paint over it. Sure it will look cheap and shitty but atleast it will look clean from afar and hide the cracks.
But the arteries of this country are decaying. All the really important things in our infrastructure are being held by ductape and billions are spent each year just to keep it from collapsing because our country leaders don't want to spend a more billions to upgrade and do it right.
I mean in America you litterally have to go through PayPal or cash app, zelle or some other 3rd party app to transfer funds from two of your own accounts in different banks even though all banks use the same clearing house system .
There is so much more to list. •decaying middle class •union are on life support all of the country • health infrastructure is horrible. Americans don't go for preventing care, just go when the pain is too much to tolerate. • living is unaffordable for a large percentage of the population now. Like people with 2 income no kids are now treading water.
We literally still have lead water mains in the country . • for a large part of the country both storm water and sewage get tied into the same pipe and basically overloads the sewage treatment plants during storms. All that combined water cost more to treat . Would cost more upfront to separate them but less to treat as rain water doesn't need much in terms of treatment before they dump it back .
You have large swaths of the country on cesspools and heating oil still rather than their local government investing their tax dollars into natural gas and sewer lines and pumping stations.
America is failing and the only ones with blind loyalty to the country are the masses. We are the only ones who truly believe in it regardless of political affiliation.
The politicians and rich have no loyalty to their own constitution or constituents. They give zero fucks and turn a blind eye to the deteriotion
Place I worked in when I lived a California 7-8yr ago was the same. IV bags and medical packaging. Supposedly “sterile” lol. They lost a class action suit for counting dress/in dress/out time on a 10min break and 20min lunch. Was more like a 5min break and a 10min lunch.
Place was absolutely disgusting as well. Rats on the loading area outside the “clean rooms”. Almost everyone who worked there was Filipino or Pacific Islander (definitely exploiting).
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That’s basically exactly why they got fucked with a class action lol. Department of labor? actually takes meal/bathroom breaks pretty seriously
As someone who uses film in medical applications, ugh, which company?😅
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and suddenly they came to their senses after 30+ years. doubtful. Thanks, avoid Winpak.
This is why I didn't want a J and J right from the get go. They also have a shitty track record for shipping contaminated blood, contaminated baby products that they knew were contaminated, all for the sake of profit.
Wait, is this the same asbestos baby power Johnson & Johnson, now making vaccines?!
I thought it was a coincidence as who in their right mind would let them near anything medical?
No.
J&J doesn't make the vaccine themselves.
Basically, they make/patent the recipe, then sell it to a manufacturer to build.
That's how there was that whole "pfizer in J&J bottles" issue. Both companies were using the same manufacturer, and the manufacturer is actually what is total shit.
In this case its Emergent BioSolutions.
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thank you for clearing that up.
J&J is a massive multi-faceted corporation. They make everything from medical devices and pharmaceuticals to consumer goods and baby products.
They don't actually make a lot of that.
They create the patent, then sell the right/licensing to manufacturing firms, in this case Emergent BioSolutions.
J&J has a very large pharmaceutical wing called Janssen. They've been around for decades and produce a ton of important medications. You may not recognize a lot of them but they make some of the most commonly used anti-psychotics, powerful injectable anti-inflammatories used to treat rheumatoid arthritis, a number of oncology meds, HIV meds, and others. I think they make tramacet (edit: and Tylenol 3/4) which many people might recognize.
The issues in this case are with the manufacturer they sourced production from.
It's because they use the formula for ensuring dynastic wealth. Jamie Johnson, one of the heirs, went rogue and made a documentary sometimes secretly filming. But even when they knew he was filming they're just pure psychopaths living in a different reality than us.
They have psychiatrists who run family meetings and coerce any family members into doing what's best for the business. The kids are groomed and controlled to ensure they can run things and continue the dynasty. If they rock the boat at all they often get cut off financially and emotionally.
It's called Born Rich and is a decent watch. Really sad its like a cycle of abuse as his father also wanted to make documentary films when he was young but was discouraged by his father, the family / company. He's now the psychopath discouraging his son from doing...anything remotely positive lol.
Edit: if you're interested in this sort of thing, some of the recent ProPublica pieces about the mega rich avoiding taxes touch on this. Explains how they protect their wealth and ensure it continues to do their bidding even after they die while avoiding estate tax.
https://www.propublica.org/article/the-secret-irs-files-trove-of-never-before-seen-records-reveal-how-the-wealthiest-avoid-income-tax
There's a short form with some key takeaways here:
https://www.propublica.org/article/the-secret-irs-files-short-form-a-quick-guide-to-what-we-uncovered
YouTube video if you prefer: https://youtu.be/jWRlkGcc4Yw
And instead of reform the government's response is to prosecute the whistle-blower. They don't even hide it anymore they exist to protect the wealthy at the expense of the public.
Edward Snowden would like word with you. Whistleblowers are celebrated in America for their acts of courage! /s
Fantastic documentary in terms of providing some insight into the try psychopathy of these people and the shitty offspring they tend to bring into this world to continue their legacies.
Bonus for Ivanka Trump being one of the subjects and being just as shitty as we always knew her to be.
They’re one of the largest medical companies in the world. You won’t get rid of them.
My family believes my grandmother’s cancer was due to lifelong use of Johnson & Johnson’s Baby Powder. Scum company, but they all are.
I'm curious what makes you think it was the baby powder. My grandma grew up near some government testing area and got a disease that destroyed her lungs that had only been found in people in that area. This was about 15 years ago when I was still a teenager so I don't remember what it was called.
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There you go. Givin' a fuck when it ain't your turn to give a fuck.
"fuck"
It's Baltimore, gentlemen. The gods will not save you. 😔
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shhheeeeeeeeiit
"The fuck did I do?"
You set fire to everything you touch and walk away while it burns.
"Dying is the only way to get out of Baltimore."
From MD, can confirm. Baltimore is a perpetual shit show but we love it nonetheless
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Say "Aaron earned an iron urn".
It’s all in the game
The game is the game
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Walter White: are you expecting me to cook in those conditions?
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Pharmaceutical facilities should have the right controls and maintenance, that's the point. People's lives are on the line when it comes to manufacturing drugs.
I have no idea how this passed FDA or EU-GMP certification.
This 483 needs to be higher up and people should have a quick read of it. These issues are fundamental and basic in any medical manufacturing plant. No written procedures for certain activities, no routine QC to verify product meets specification, poor handling of contaminated material, unacceptable environment for production area (eg point peeling off the wall, and probably what sounds like damp or mold) amongst other similar issues. Frightening.
This plant was dormant prior to covid.
They get government money to basically be on standby and produce anthrax vaccines. The anthrax vaccines have a long shelf life so they were just doing batches every few years
How did it happen, though? Or does Johnson & Johnson use the same factory for our toothpaste and baby shampoo?
That would be nearly impossible. I work in vaccine production and the equipment/building design is very unique. It's more likely that they quickly retrofitted an existing vaccine production building on the cheap just to get it done in time to be one of the firsts. Most likely it was a flu vaccine production building, if j&j is using a protein based vaccine.
so how do folks continue trusting the j&j family of products or vaccines? this shit is a PR nightmare and as a mod removing vaccine misinfo daily i find it harder to argue with folks that are being thruthful about how they feel about these kinds of things. what good is the FDA if they aren't going to practice what they preach about standards for making meds? is there some kind of process where a rep from the FDA comes and looks over a facility to vet it and make sure it qualifies as a safe place to manufacture things people are going to put in their bodies?
It’s not a J&J facility. It’s a company called Emergent that is a contract manufacturer for J&J. Emergent doesn’t make all the J&J vaccine.
There are tons of processes where that happens. We get audits annually from the FDA, USDA (we use chicken eggs in vaccines), internally, and once in a while other international organizations. But we only get them annually because we're already established and don't get any outstanding records. But new production needs to meet a more stringent process before the FDA clears them to go.
I'm guessing some strings were pulled to overlook a few small issues that they most definitely, 100% were going to fix on their own before they even thought of starting production.
The FDA are literally the ones who initiated and enforce this recall based on their standard.
Considering they knowingly sold baby powder with asbestos in it, you already shouldnt be trusting them. Or any of the other companies for that matter
Edit: Crime of the Century on HBO will have you calling for the heads of the fda, the senate, and will jade you from trusting anybody in a pharmeceutical position. Liars and theives, unfortunately
Someone else mentioned below that J&J may not have had a choice in using the facility.
https://www.reddit.com/r/worldnews/comments/nymkld/canada_has_rejected_300000_doses_of_the_johnson/h1kz0ed/?utm_source=share&utm_medium=ios_app&utm_name=iossmf&context=3
This 100% plays into the narrative of the vaccine being a rush job and damn the consequences, and now the antis will latch into it. But at the same time, it has to make you wonder. Was the shot I got made in some ramshackle warehouse?
The factory is owned/operated by Emergent BioSolutions, not Johnson & Johnson. So they're probably not making shampoo there.
how have the vaccines been released for use from a plant with these ridiculous observations? Are normal quality standards just thrown out the window because it's for emergency use?
I work in qa in the medical device field, can say that these observations are likely due to systemic company issues and poor quality culture. Unrelated to the product being for emergency use authorization, the company has likely always operated poorly and never caught during an audit or something, now only caught because of the issues reported followed by a thorough audit as a result. Unfortunately it does happen I have worked for some truly bad companies and it is not a fun position to be in when you're in qa trying to do the right thing but have no support from management otherwise. In those cases I don't sign off on anything I don't agree with and try to get out of the job asap.
its hard to have a job where you are in charge of being the companys conscience when the brain is committed to short term profit over everything.
Thank you for having moral courage and Im sorry that it might cost you something in this world
As a QC technician (not in medical - asphalt paving) this is absolutely true. While quality is one of my company's 3 'core priorities' and profit is not, profit is always the main driver. Thankfully the decisions I make (and arguments I have) only impact money, not risk to human life.
Yes it can be hard honestly. I have worked at some bad places where I was able to change some things in small baby steps, you take the small wins when you get them. Thankfully working somewhere good at the moment. Unfortunately I think general public doesn't have a good understanding of all the checks and balances that go into device or pharma operations. Yes, things go wrong but systems can break down too. Fda is not all knowing and usually inspections are driven by reported issues, or at least deep drive ones. Most people who work in the industry want to do the right things and aren't doing something malicious but I see most issues driven by ignorance and lacking the big picture of issues that could arise from a poor decision, in most cases people aren't doing something terrible on purpose.
I posted in response to another comment:
This plant was essentially dormant prior to covid.
They get government money to basically be on standby and produce anthrax vaccines. The anthrax vaccines have a long shelf life so they were just doing batches every few years
Money
jesus that's a pretty bad read, it sounds like they are operating like a wallmart loading dock, not a place that's making something that will be injected into people.
What is (b)(4)?
Redaction I believe.
This vaccine is so contaminated it needs a vaccine itself!
read with Gordon Ramsay voice
How was this discovered in the first place? Did Canada simply perform quality controls? Or the fda?
According to the report it was discovered when J&J complained that their vaccines were contaminated with AZ.
This would make a great Gordon Ramsay reality show.
"THIS SERUM IS FUCKING RAW!!!"
Emergent BioSolutions factory Has a long track record of failing quality checks.
It has a long consistent track record of failing.
It fails and fails and fails.
Want to know why it still keeps getting contracts from the federal government? Hmm…
Proof:
https://www.fda.gov/media/147762/download
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Not saying what Emergent did was ethical, but our government officials should hold the blame for making bad decisions and being swayed by lobbyists.
...I'm sorry, what? It's hard to hear you as I'm munching on lobster while on my fully paid trip to a Caribbean resort, courtesy of this very nice anthrax vaccine maker whose lawyers are explaining why it's legal for them to take over the payments on my yacht. Speaking of anthrax vaccines, it's always good to be prepared, right? And I know just the company that's qualified to make those. That'll fly with my voting base.
you just hit the nail on the fucking head
Company I used to work for contracted emergent for some of our old sample storage (vials of blood plasma needing to be kept at -80°c), so I had to do weekly drives from Bethesda to Baltimore to pick them up. The front side of the facility was always empty, with no one at the desk, and right behind the first door it went to looking like an absolutely decrepit lab, worse than the basement of any college teaching lab. Staff was perfectly fine in all my experience, but that facility was....lacking.
I applied for a job at Emergent last year. Looks like I dodged a bullet.
Lowest bid wins.
Several people should be fired from the Emergent BioSolutions factory, including at least the plant manager, operations manager, and QA manager. J&J should be firing people too, including whoever was involved with approving them as a CoMan. What a clusterfuck.
Emergent is a contract manufacturer for the federal government. More than likely with Project Warp Speed, JnJ were forced into using them. Not clearing them of wrong doing, but, i blame the tech transfer teams. As it clearly a cluster fuck, and something they should have caught and raised as issues.
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Here in Canada I inspect buildings for a living. Buildings on a farm built just to clean and bulk package carrots straight from the field have no painted surfaces as all walls and ceilings must be stainless steel and must be washed frequently. Recreational cannabis facilities are at the carrot cleaning building level and medical cannabis grow operations require that I double bunny suit to enter. I can't understand how a facility making vaccines wouldn't be well beyond a farm building.
One bunny suit to inspect carrots.
Two bunny suits to inspect grass.
I expect you'd be in three bunny suits to inspect hops...?
bravo
Joke's on you, I only allow my carrot to be inspected by half bunny suited people! (The top half)
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Now there's something that I never want to hear in regards to safety regulations
You mean the same FDA that just approved the controversial new Alzheimer's drug?
The one that had not been shown to be effective?
That was unanimously voted against by their advisory committee?
The approved it because... reasons?
Oh right, they approved it because it is going to cost $56,000 a year!
Yeah, the FDA fucking sucks
I work in big pharma and FDA is no joke. every time FDA comes knocking every single person is scared shitless.
Being in Canada I don't really have any faith in them.
Also because Health Canada went super overkill for cannabis, which was* previously illegal. It's pretty dumb actually that cannabis is more strict than food, even if it is to be combusted and not ingested.
Curious, have you gotten the chance to visit Organigram? I was flown out a couple years back and it absolutely blew me away. Canada's legal weed is lightyears ahead of the states when it comes to production standards. The laws to get products in store kinda sucked but that's a small price to pay.
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Lol, the building across the street from my lab produces mushroom spawn, and they have similarly strict QA rules. I get contams regularly so they can be ID'd and the sources can be traced.
In a facility that makes food that grows in horse shit.
so which administration is responsible for approving that manufacturer then? cause then those people need to get into some shit.
Which one do you think?
Even based on the preliminary site reports from the FDA they should have never been granted the contract.
Edit:
Pre-inspection: https://www.fda.gov/media/147884/download
After incident inspection: https://www.fda.gov/media/147762/download
They should have never even been up for consideration for anything health related.
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"leadership"
That's not a word that applies to someone that says "I don't take responsibility at all".
Yes.
https://abcnews.go.com/US/emergent-biosolutions-officials-facing-questions-lawmakers-part-vaccine/story?id=77777242
Like some sort of pillow magnate?
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Just throw it on the lawsuit pile.
Emergent has been making the anthrax vaccine and purchased for stockpiling across Bush/Obama/Trump administrations for over a decade + so it probably would have gotten awarded to them regardless of the administration.
Apparently we live in a time when no one is responsible for their actions
Unless you're poor. And then you should know better.
Or minority.. Then you're somehow responsible for everyone else's problems..
Assuming you survive the initial arrest
Nah man, CEO got like a 5 mil bonus instead.
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Why should it be those positions rather than the executives who put them there?
Emergent claimed to be capable of something they weren't capable of.
It's on them, not the employees.
When I was working in industry I can't remember the amount of times the higher ups gave us unreasonable tasks to complete with not enough staff.
I would've never signed off on anything improper though as part of the QA team. It's literally the job. Unless falsified data was given to them by the production them, either they ignored massive issues and approved the product for sale regardless or they were missing documents that would've shown it wasn't appropriate for sale.
Either way, it sounds like this facility is a mess from lackluster SOPs, training, accountability, regulatory compliance, and everything else you can think of.
I work in a QC/QA role. One of the biggest problems in a manufacturing/production industry is that it is littered with problems on a daily basis. Typically, those problems are discovered by the QC dept. Sometimes a line(s) have to be shut down to have maintenance or manufacturing address it. But, the manufacture techs and supervisors are given metrics, or quotas, to meet in order to collect their bonuses - Eg. yield, waste, runtimes, etc.... Shutting down a line interferes with meeting those metrics. So, a lot times there is a shit show between QC and manufacturing. It sucks. I hate my fucking job for it. It's the executives who create those metrics which are sometimes unrealistic goals. Especially when there are dept. budget constraints so we wind up with very old equipment creating new technology.
It should obviously be both.
I’m sad to see stuff like this, but the silver lining is it’s out in the open for people to see. Transparency on missteps and holding things to a higher standard gives conspiracy theorists less to stand on.
Kinda happy to see J&J called down for their corner cutting. My father worked for them for 40 years and died of a chemical exposure disease last year.
You cant defeat a conspiracy theorist, they just twist it to create a new conspiracy. Its how they survive
That's sad for all those doses to go to waste, but as a silver lining it's nice for once to see "Baltimore" and "riddled with" in a news headline that doesn't involve bullets.
Still involved shots though
and hopefully getting fired.
and people possibly dying.
They won't be wasted, they'll go to a 3rd world country who will pretend to administer then sell on the black market
Canada will likely destroy them.
Yea, highly doubt we would let these go anywhere. I'm Canadian and I'm sure they're just getting destroyed.
Thank you, Canada!
I don't blame them... the Baltimore facility has had NOTHING but problems.... Speaking as a person living in Baltimore.
What sort of issues?
they mixed ingredients for two different vaccines i believe. rendering hundreds of thousands of doses unusable. because of this the plant was closed for a while as well, causing Janssen to be behind on deliveries world wide
Hundreds of thousands? Wasn't it like 60 million?
Its 60 Million, its just the part supposed to go to Canada is only a couple 100k - most of that was suppssed to be the Q2 delivery for the EU (thats going to be missed by 70% or so).
oh very possibly, i typed this comment from memory of what i've read in the news!
Sounds like a clown show. I'd understand if some pipe or boilder decayed and added residue, or an ingrediant was stored at -10° instead of -20° during transportation, but they're just too stupid to follow the recipee?
I wouldn't understand those mistakes either.
Right? Preventive maintenance exists for a reason, and so do transport agreements that stipulate transport conditions.
Freak mechanical breakdowns do happen but decay just means improper maintenance.
Most of my career is in diagnostic development but I've worked in biopharma. Making these drugs is a very long and complicated process that involves a lot more than just mixing things together, especially when you're dealing with therapeutics made from biological agents like in J&J's case with adenoviruses. But we also have sophisticated QC assays at every step of the process with strict parameters to assess purity and efficacy so that clusterfucks like these don't happen.
Due diligence.
Due negligence
Massive news that Canada rejects 300,000
Not news at all that South Africa has to destroy 2,000,000
This. It took my very minimal Dutch to cobble together a small idea of the shit show going on from afrikkans headlines from the cape. That was easier than finding English articles actually talking about it
https://mybroadband.co.za/news/trending/401515-2-million-of-south-africas-covid-19-vaccines-to-be-destroyed.html
Granted, r/worldnews is generally reserved for stuff that happens in and around America (Specifically the USA / Canada) - Actual world news is generally over at r/anime_titties (And yes - That's the actual subreddit)
I'm pretty sure world news specifically exludes US internal news... but it is definitely western-centric (America, Europe, Australia, NZ)
McNulty is on the case! Likely another scheme by Bubs.
Bubs: "We got some big time drug dealers in this one McNulty, are you in?"
McNulty after getting to the scene and finding out its not the type of drug dealers he thought: 😩
SHEEEEEIIIIIITTTTT
This is 100% the The Wire reboot I’d buy in to
Everyone's mad he didn't bring in the big case they thought.
Mcnulty - "the fuck did I do?!"
McNutty
Canada won't take them. South Africa is checking into potential issues. But I'm betting J&J try to pass these off to some third world country so they can get paid. It shouldn't be this way. It should be the best of us.
Canada already took them. We're not distributing them.
South Africa also has 2 million doses that are potentially contaminated. If they're found to be contaminated they won't be distributed either and will be destroyed. J&J will have to replace the doses if they are destroyed according to their contract signed with SA, since the contact requires safe doses to be delivered.
Why was J&J even allowed to distribute these? They should have been required to destroy them once the FDA found out what was going down
Source? Not saying you’re wrong, Just interested
They were "quarantined" in Canada according to the article.
No word on whether or not Canada paid full value for them but there probably was a percentage paid up front.
Didn't we and all other countries who pre-ordered pay upfront for all vaccines without guarantee they'll be approved or even pass stage 3 testings? I thought that was the main issue with the vaccines pre-orders which gave a huge advantage to rich countries to order enough doses to vaccinate its whole population 9 times (Canada) over poorer ones who can't afford to waste money on an unapproved vaccine.
The South African DoH announced this morning that we can't use about 2 million doses of the Baltimore made vaccines that were affected.
A total disaster considering the setback from the AstraZeneca rollout being inefficient for our strain, global vaccine hoarding, and our incapable leadership.
Edit: SAPHRA - South African Products Regulatory Authority, announced it.
wow principles exist
Like… yes, but this decision was probably helped by the fact Canada leads the G20 nations in % of eligible population that has received a first dose. And the fact the federal gov’t has spent a shit-ton of $$ to secure a huge supply of Pfizer, especially this month.
It’s the right call, but I do wonder how much “no worries, we don’t need that J&J shit, we’ve got 2 doses of Pfizer for every Canadian already” played a part in it.
I haven’t read enough about this facility’s problems to say for sure whether the risk was very real or if this is just precautionary… but, tough to watch 60 million doses be tossed when 4 billion people in developing nations are still months away from having a chance at a first dose. Hopefully that was thoroughly considered when the FDA and now Canada / South Africa made this decision.
Cant blame Canada or South Africa for not using potentially tainted vaccines that the USA itself wont even use.
This is the best tl;dr I could make, original reduced by 53%. (I'm a bot)
Extended Summary | FAQ | Feedback | Top keywords: facility#1 Canada#2 doses#3 Health#4 vaccine#5
this the same company that gave people cancer with baby powder or some shit?
Yes
Here's a weird and interesting story that starts in the 1800s about how Belgian colonialism led to tropical disease research, which led to Janssen's know-how, which led to J&J having the capability to make the covid19 vaccine
The video isn't making a negative point about the company or anything, it's just an interesting story. (the colonial part of the story is terrible but that's on Belgium, not J&J)
Hey I got a J&J! Chuckles, I'm in danger.
From another article linked in this article
Does this apply internationally? I got my dose in Europe 3 days ago, no chance it was from Baltimore, right? Probably Netherlands, if that's the case.
However, is it true that the factory is still not approved? The article you mention is from April.
As far as I can tell they were never approved after April.
I literally opened up Reddit 1 minute after getting the J&J to read this, woohoo!
Maybe this will ease your mind, linked in the article
I got my J&J shot the day before news broke about their "pause" in manufacturing. That was fun.
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The initial batches were made in Europe
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You didn't receive a dose that was manufactured from this specific plant.
Is there a way to find out where the j&j shot you got was manufactured?
Yeah, you call the provider who did it.
These weren't distributed in the US though
cool cool cool cool
Coming up next: Johnson & Johnson donates 300,000 doses of vaccines to poor countries of Africa.✨
Smart move Canada
New donations for latinamerica!
"FUCK YOU, BALTIMORE!"
This scumbag company - Emergent Biosolutions - also paid its execs millions in bonuses (on top of a very generous compensation package), for a fantastic job at criminal negligence.
Fucking thundercunts.
We're getting J&J here in Brazil, but news outlets are saying that the FDA approved the batch that's being sent here. Alleging it was produced before those issues happened. Now I'm scared.
I predict this will be used by covidiots as disinformation fuel. 🙁
remember when everyone was mad at Bill Gates cuz he said that he didn't think waiving IP rights on the vaccine would help. this is what he meant. if you get subpar vaccine produced by some rando facility without the proper quality controls, then it's going to make it even more difficult to get people to take the vaccine they already dont trust.
Being a generic doesn’t just magically waive FDA safety regulations.
FDA regulations appear not to have done so much, since the Canadian government had to reject this batch.
Regulators are usually overstretched in normal times. In these times especially it’s important for manufacturers to be hand held by the people who designed the vaccines.
Not every country has a reliable FDA-equivalent
Literally happened without them being waived
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So the IP rights weren't waived and somehow this is the fault of the IP rights being waived?
Does anyone know if this factory produced the same vaccines donated for Mexico? I will likely get the J&J vaccine in the following days/weeks and I wanted to make sure if maybe our vaccines could also be contaminated.