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Baltimore plant ruins 15M Johnson and Johnson coronavirus vaccines
- hn8788 6y agoI wonder if those vaccines were primarily going to be distributed locally. I live nearby, and my county's weekly covid update said they expect to have most people 16+ vaccinated by the end of April because we're supposed start getting an increased number of vaccine doses every week.
- finolex1 6y ago"The error should not affect Johnson & Johnson doses currently being delivered and administered nationwide, as they were produced in the Netherlands. ... The Times says the accident won't stop the U.S. from reaching President Biden's goal of having enough vaccine by the end of May for every adult, but in the global race against the virus, every dose counts." Won't affect vaccine delivery for Americans. Difficult to say for the rest of the world.
- markdown 6y agoYou could vaccinate two dozen countries to 100% with 15M doses.
- sp332 6y agoIt's good that it won't hurt the current schedule, but we could have had 15 million doses sooner.
- deleted 6y ago[deleted]
- drawfloat 6y agoProbably won't affect rest of the world given the US export ban is going to be around until second half of the year.
- Throwawayaerlei 6y agoIf by locally you mean anywhere near the factory, no, for it just makes raw vaccine, which gets shipped to specialist firms that do "fill and finish." 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.
- briefcomment 6y agoHow do you make 15 million of anything without realizing there's an issue, let alone the most scrutinized thing on the planet right now?
- endisneigh 6y ago> Context: Workers at the plant, which had been producing Johnson & Johnson and AstraZeneca vaccines, conflated the ingredients between the two different types of vaccines, destroying 15 million doses of Johnson & Johnson vaccine, according to the Times.
- markdown 6y agoJesus Christ, this shouldn't happen in a certified cGMP (food) facility let alone a pharmaceutical plant. HACCP would prevent this in any number of ways.
- eric-hu 6y agoCan you describe in more detail how that process would prevent such an error?
- markdown 6y agoHard to do without knowing anything about this facility, but maybe just not store the ingredients for two different vaccines in the same place. Basically restrict the set of ingredients available to the person making the batch. 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.
- epistasis 6y ago
- abacadaba 6y agoWell, thanks EU for all the good doses!
- rurban 6y agoYou can have all our 30m Italian doses of AZ, as long as you don't insist on liability. We don't want them
- jebeng 6y agoProposition Joe had the connect on lockdown with the eastside and westside working together pumping out 15 million doses. Until young Marlo came in and put a stop to that. The game is the game, vaccines or not.
- eyelidlessness 6y agoWell, I stopped looking at news for one week and the frothy right has entirely new sentences I don't understand. Edit: folks stop upvoting this I was missing a cultural reference I didn’t remember.
- slillibri 6y agoIt’s a reference to the HBO series The Wire.
- eyelidlessness 6y agoWell now I just feel old.
- optimalsolver 6y agoThe Wire came out almost 20 years ago.
- eyelidlessness 6y agoYes, and I watched it about 15 years ago and didn’t remember enough to recognize the reference.
- isignal 6y agoThis probably explains why only 5M doses of J&J vaccine were allocated for the week of April 5 as opposed to the 11+M that were anticipated. Emergent was also supposed to be approved to ramp up the full supply chain but that hasn’t happened yet, could be related.
- jschwartzi 6y agoIn the article it says that these doses were produced in a facility that wasn't approved by the FDA yet, so this has no impact on the availability of doses now. It might have an impact on the availability of doses in the future though.
- bitcharmer 6y agoHonest question: if the facility wasn't approved by the FDA then why was it manufacturing the vaccines at all? And how could such vaccines be used anywhere if they were produced by an unapproved facility?
- maxerickson 6y agoFDA is likely reviewing their processes and controls more than running a white glove inside of anything. So those things would be the same for a batch that was in production as they would be for a batch started tomorrow.
- hn8788 6y agoMaybe the approval process includes a "must have met X criteria for the past Y months", so once you get approved, everything you've done in the past Y months counts as having been created in an approved facility. I'm just guessing though, I have no idea what the process is.
- markus92 6y agoBasically this. You need four consecutive batches with consistent quality in a row for approval.
- anitil 6y agoIt bothers me that people have expectations of perfection. Of course there will be breaks in the chain the lead to doses being wasted. There are thousands or millions of ways for it to go wrong, and only a few ways for it to go right. It is an astounding miracle of human progress that we can get to this point.
- DarknessFalls 6y agoI was ready for the knee-jerk response to pounce and heap damnation on the plant for messing it up. But you have a very valid and insightful point.
- BLanen 6y agoI was ready for the knee-jerk hackernews response where people complain about deserved criticism. I don't know how you people expect things to get better if this wouldn't happen.
- kodah 6y agoThere's a big difference between complaining and curiosity. Really, there's a whole host of ways to think and vocalize improving a system without complaining.
- Guthur 6y agoThis is a failure of leadership to ensure that a quality product is being delivered by the system they're responsible for. 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.
- mulmen 6y agoScenario: 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.
- outside1234 6y agoIn other news, a developer had a test fail in CI/CD and the build wasn’t, therefore, pushed to production.
- hetspookjee 6y agoIt's funny to read it as J&J vaccine, while here in the Netherlands where the institute we all call it Janssen because that is the name of the institute. Im also in favor if the title reflected Janssen as well but I guess it's what it is as the article and the rest of America also calls it J&J vaccine. It's just a bit weird that it now gets the American name while they're just the parent company and didn't were involved so much in the R&D.
- sebmellen 6y agoSame deal with the Pfizer vaccine, really. My family in Germany lives near where BioNTech is located, and everyone is very proud to call it the BioNTech vaccine.
- adventured 6y agoEntirely different in fact. Pfizer doesn't own BioNTech, they're business partners. J&J owns Janssen (for 60 years now), the vaccine belongs specifically to J&J.
- epistasis 6y agoI'm not in Germany, but I also get very frustrated when the Pfizer name is applied to what BioNTech created. BioNTech is going to be doing amazing things later on too, with their great tech platform. 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).
- fermienrico 6y agoMay be its just easier to pronounce Pfizer than BioNTech? 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.
- Yhippa 6y agoI'm glad this was identified before people got injected with these and thought they were safe.
- duckfang 6y ago"He"?
- Guthur 6y agoYes, a common and accepted genderless pronoun.
- duckfang 6y ago"He" is 'a common and accepted genderless pronoun.' ? Uh, no. And continuing to propagate damaging falsehoods make it very tough for many of us. "He" is a male pronoun. He/Him/His "She" is a female pronoun. She/Her/Hers "They" is a neutral pronoun. They/Them/Theirs
- NeutronStar 6y agohttps://www.merriam-webster.com/dictionary/he https://www.merriam-webster.com/dictionary/he 2nd definition.
- herewulf 6y ago"They" is a plural pronoun. Obviously.
- BrandoElFollito 6y agoDominique (a non-gendered name) goes to school everyday. They take the bus. Is this a proper English sentence? (question from a non native speaker)
- mulmen 6y agoAs a native english speaker I consider that valid. The possible confusion is the fact that “they” could be singular or plural. AKA “singular they” [1]. Your second sentence could be referring to some other group of people who are not Dominique who instead of going to school take the bus. [1]: https://en.m.wikipedia.org/wiki/Singular_they https://en.m.wikipedia.org/wiki/Singular_they
- markvdb 6y agoThis should make some people sleep badly. 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 https://epistat.wiv-isp.be/covid/covid-19.html
- EveYoung 6y agoSure it's not great and the incident needs to be investigated but mistakes happen. We shouldn't expect perfection as a baseline. If nobody is willing to take risks, we wouldn't have any vaccines right now.
- HenryBemis 6y agoOh how I would like this to be an april fool's joke... 15M doses? We definitely could have used them (if they weren't messed up).
- DoingIsLearning 6y agoAlternate title: 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.
- sbehlasp 6y agoAgree with you Quality assurance guys saved and stopped the batch before it was out for general public for use, could have adverse effect on patients, if it was rolled out.
- Throwawayaerlei 6y agoOr the people who went to add ingredients to a AZ/Oxford batch found they were missing.
- Throwawayaerlei 6y agoThis is a bigger thing than anyone here realizes, for Emergent BioSolutions is a notorious company who's core competency is politics, not production, see one or more recent New York Times articles on them. This is a minor fowl-up compared to the sorts of things many of us have been expecting from this factory of their's.