Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines
axios.com
axios.com
Quality Control and Safety procedures (put in place to meet medical manufacturing regulations) prevent a bad batch of vaccines from entering the market and potentially harming patients.
It'd be like the difference between burning dinner 7 nights in a row, versus making a single mistake during Meal Prep Sunday and ruining a weeks worth of dinners all at once. The latter is much more understandable.
Microbrewers often use fermenters larger than that.
This is akin to me using a large 64 core server for an app, instead of say 4x16 . Sure, the larger server can easily handle the load, however the 4x16 setup is more redundant and avoids many scenarios where all users will be out of service
Just because there are high capacity machines capable of doing that much does not mean it should be used especially a With a new process trying to scale up
(If you're using a 4x16 server, whatever that is, to provide isolation in your system, you may want to talk to additional devops folks for other options.)
Yes fuck ups happen at plant and in planning, and yes we are not experts in the field to comment in detail on what is best approach. However if you are looking at it as an admin, clearly risk was not well managed.
Obviously, the mistake is bad. But this is something with a very high fan out. And the smaller number just doesn't get the clicks. :(
And it's put other production from the facility into question.
Obviously, it should be investigated such that were can reduce the chance is mistakes in the future. But piling on with blame will just convince folks not to try.
And then there's the much greater value of the doses once they have been administered.
HACCP would prevent this in any number of ways.
What makes them different is 1) there are ample checks in place to prevent mistakes from ever leaving the facility, and 2) there is process that reduces the chances of having it happen in the first place.
But all of these places will have incident logs of mistakes like this, along with corrective actions that change the procedures and make it less likely to happen a second time.
They shouldn't happen in a 150yr old, multi-billion dollar pharmaceutical company.
How hard is it to restrict the ingredients available to the "chef" to the ones needed for the current product? Not hard at all unless you want to save a few dollars cutting corners.
Some other comments have already pointed out that 15M doses is probably only one or a few batches. Combined with the fact that the procedure documents for this particular line are probably still warm from the laser printer, I'd say let them iterate a bit more to get the kinks out.
[ Procedures are not (should not be) engraved on stone tablets handed down from on high. If you try it that way, you are just as guaranteed to fail as when you had no procedures at all. ]
As to what went wrong at this facility (besides overpromising?); we'll have to see. I wish there was such a thing as open source procedures!
In a situation where maximizing vaccine production sooner saves lives, pinning this on saving a few dollars doesn't make sense. Whatever they were doing cost them quite a few dollars in addition to the lives lost from slower vaccination.
I don't know their process, but suppose the "restricting the ingredients" phase happens. What if the ingredients were swapped at the time of restriction? Same problem happens.
Chef goes to find eggs as required by the recipe for his cake, and finds that there are none. Instead there is pepper, an ingredient not required by the recipe.
Or have the employee log what he is doing in real time BEFORE he does it. I am adding sugar, I am adding eggs, I am adding wheat flour. Then an alert is triggered when the system (which knows what product is being made) recognises that the ingredient doesn't belong.
This is a multi-billion dollar company... they could have the process live-streamed to 30 independent chemists each one watching the "chef's" every move (this is not a serious proposal).
This stuff is all hashed out when one writes up a HACCP process.
Assuming somewhat efficient allocation, a 30 day delay delivering 15 * 10^6 one-shot vaccines equals ~1100 deaths[0], plus many long term health issues for survivors.
Fingers crossed this f*ckup won't delay the lifting of the US vaccine export restrictions. Many people objectively need the vaccine much more urgently than the healthy young adults currently starting to be vaccinated in the US.
[0] rough extrapolation based upon current covid-19 mortality rates in Belgium, available at https://epistat.wiv-isp.be/covid/covid-19.html
It is an astounding miracle of human progress that we can get to this point.
I don't know how you people expect things to get better if this wouldn't happen.
We don’t know, but you seem to be assuming it wasn’t as the result of negligence.
I'd usually be pretty forgiving especially when there is a high degree of novelty.
Maybe this particular vaccine is novel and that benefit of the doubt should be extended in this case, I'm not sure though.
It's also possible this is common variation but we never hear about it.
An engineer who you pay $200,000.00/yr in salary pushes code to prod which brings your totally unique SaaS product down. Accounting says the incident cost $2,000,000.00.
Do you:
A) Fire the engineer on the spot.
B) Conduct a thorough investigation of your testing and deployment practices and implement changes to avoid such a mistake in the future.
Was the engineer wilfully negligent of checks and balances put in place. Was he wilfully negligent because of undue pressure to deliver more in the same time and without any system changes. Did his mother recently die and he couldn't take time off to grieve properly.
There are many aspects that make up the analysis of a failure in quality, and that is the job of leadership.
C) Fire the engineer's manager.
D) Resign.
What i was trying to imply is that there's something to be reviewed here and it's leaderships responsibility to do so.
I'm feeling that potentially with covid and all it's a little too emotive and the whole comment was misplaced and doomed to degenerate into a slinging match.
Also there is a lack of detailed knowledge that precludes me from making more detailed statements.
Edit: folks stop upvoting this I was missing a cultural reference I didn’t remember.
Won't affect vaccine delivery for Americans. Difficult to say for the rest of the world.
A paper, pretty sure it was The Washington Post ran a hit piece on the company and how Baltimore was behind on getting vaccines or something, and they replied pointing out they're just doing this under contract, they have no say in the disposition of doses. Which of course is several levels above them.
Emergent was also supposed to be approved to ramp up the full supply chain but that hasn’t happened yet, could be related.
And how could such vaccines be used anywhere if they were produced by an unapproved facility?
It's actually an incredible achievement.
You get approved? Great - We can immediately ship these 30 million doses while we start the next 30 million.
We don't get approved? Write off the produced doses, fix your process, and try again.
So those things would be the same for a batch that was in production as they would be for a batch started tomorrow.
See also Pfizer vs. BioNTech
The world knows the Johnson & Johnson brand. It's one of the top brands on the planet and has been for decades. Most of the world doesn't know Janssen. It's logical to call it the J&J vaccine accordingly, for marketing purposes it makes a lot more sense.
If the Berkeley West Lab subsidiary of J&J produced the vaccine, nobody would call it the Berkeley West Lab vaccine.
I have a feeling that news sources are very guarded about introducing new names to the public, especially ones as difficult to pronounce as BioNTech (I've heard some great butchering of the pronunciation too).
Not everything needs to be distilled down to nationalistic undertones.
I am getting sick of this kind of discussion permeating on HN - It is extremely juvenile and damaging to the spirit of HN. In this regard, Reddit seems to be a lot better. Go on any vaccine related thread and there is absolutely none of this. There is so much more global cooperation observed on Reddit than on HN.
My complaint, beyond just the media, is that large pharma, like Pfizer, being fundamentally uninnovative companies that grow by acquisition rather than invention. And about small companies being denied the potential to grow because of an oligopoly of control.
Name brand recognition drives dollars, and in biotech the ability to raise money is just as much a hurdle as the chances of your trial failing.
15M doses? We definitely could have used them (if they weren't messed up).