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Vaccine Manufacturing Woes at Emergent

The New York Times has a good story on the problems at the Emergent vaccine plant in Baltimore, following up on this one. They’ve uncovered a report from last summer that warned that the facility had quality control problems:

A copy of the official’s assessment, obtained by The New York Times, cited “key risks” in relying on Emergent to handle the production of vaccines developed by both Johnson & Johnson and AstraZeneca at Emergent’s Bayview plant in Baltimore.

The assessment, which has not been released publicly, was based in part on a visit to the plant just days after the government awarded Emergent a contract worth up to $628 million, mostly to prepare its factories to make coronavirus vaccines as part of Operation Warp Speed.

Addressing the problems “will require significant effort,” and the company “will have to be monitored closely,” said the report, which was written by Carlo de Notaristefani, a manufacturing expert who has overseen production of Covid-19 vaccines for the federal government since last May. Though marked as a draft, federal officials said the report was considered to be final.

You’d think that this visit might have been even more useful before the contract was awarded, but Emergent has been contracting with the government for vaccine production since 2013. But apparently the problems are longstanding as well – here’s a bit from the earlier Times story:

An audit conducted for AstraZeneca specifically highlighted the risks of viral cross-contamination, which experts believe was responsible for tainting the millions of Johnson & Johnson doses, according to a review of the confidential document by The Times. The audits and investigations also flagged a persistent problem with mold in areas required to be kept clean, poor disinfection of some plant equipment leading to growth of bacteria, the repeated approval of raw materials that had not been fully tested, and inadequate training of some employees.

The current theory is that the recent J&J production run was lost because an employee did not adequately disinfect while moving from the AstraZeneca section of the plant into the J&J section. That would most certainly do it. Anyone who’s done biologics production (or who has just worked in a busy cell culture lab) will be able to tell you stories about contaminations of this sort, some disastrous and some narrowly avoided. It’s even worse than mistaking the sugar for the salt in a kitchen, because you’re dealing with things that grow and reproduce – cells and viruses. A mixup can spread catastrophically, and that’s just what seems to have happened here.

And if the hygiene at this plant is as depicted above, they’re asking for other kinds of contamination as well. Things like adventitious yeast can rip up your cell cultures, too. In research labs, people are warned about doing any home baking or brewing, and to be sure to take serious showers before setting foot in the cell culture room after anything like that. There are mycoplasma out there ready to drop in and mess with your cells, there are viruses that you haven’t even heard of before that can ruin everything (ask Genzyme people about that). . .no, cell culture work is pretty unforgiving, and the larger the scale, the larger the worries. There is only one way around this problem, and that is rigorous cleanliness. No shortcuts, no exceptions. And walking from a part of a production plant that is dealing with one kind of cell/virus combination into a part that’s dealing with a completely different one without even taking a shower is not rigorous cleanliness.

The Times reports that Emergent’s own auditors had repeatedly detected mold in a cell culture room, repeatedly had problems with bacterial growth on equipment surfaces, and so on. This stuff will happen anywhere if you are not a complete hardass about disinfection, and if you’re running a vaccine production facility there is no excuse not to be. Fungi and bacteria never take breaks and they are the living, metabolizing definition of “opportunistic”. This attitude does not help:

But four former company officials, speaking on the condition of anonymity because they had signed nondisclosure agreements or feared retaliation, described an environment where top Emergent leadership tolerated and even encouraged the flouting of federal standards for manufacturing and marketing products.

One of the former officials said that as the company scrambled to meet the heavy demands of vaccine production, a senior manufacturing supervisor often responded to reports of quality errors by asking: “Do you want me to make drugs or fix issues? I don’t have time to do both.”

The cure for this is to stop telling your partners and clients that you can deliver on these demanding schedules when you actually can’t. That’s how you get a culture of sweeping things under the rug, because you end up having to lie (and to make others lie) in order to meet the targets you’ve publicly agreed to. You see it in industry when a toxic environment sets in over in sales and marketing: “Make your numbers or I’ll find someone who will” and all that. But trying this tough-guy business when you’re up against the constraints of science and engineering is particularly idiotic. This is the “take off your engineer hat and put on your management hat” attitude that helped blow up the Challenger space shuttle, and it’s helping to blow up vaccine production in Baltimore.

I see that J&J has taken over management of the facility, and I wish them good luck fixing these problems. We – the US and the world – need this production facility running the right way, but having it full of corner-cutting managers and overworked employees is not that way. Better to scale down the production targets and get them right, at least for now, than to run on the edge of disaster.

 

82 comments on “Vaccine Manufacturing Woes at Emergent”

  1. Jason says:

    “stop telling your partners and clients that you can deliver on these demanding schedules when you actually can’t. That’s how you get a culture of sweeping things under the rug, because you end up having to lie (and to make others lie) in order to meet the targets you’ve publicly agreed to. You see it in industry when a toxic environment sets in over in sales and marketing: Make your numbers or I’ll find someone who will and all that”

    Nothing new in this story’s conclusion. It happens all the time, everywhere, every day.

    1. Someone else says:

      Classic american culture. “Fake it until you make it”

      1. Jason says:

        I like this story about a Silicon Valley company (Verkada) about Bro culture pushing sales:

        “current and former employees said that the inattention to data protection was emblematic of a larger bro culture that was sophomoric and sales obsessed, and which tolerated the harassment of women, frequent partying and misleading marketing claims. Video footage of female employees was passed among male colleagues, who offered graphic comments, and in-office parties — even during the pandemic — were prone to excessive drinking and occasional drug use, according to the employees. Verkada gives frat boys a bad name, one former sales employee said.”

        Reminds me of Uber in Travis’ days. And you can’t get “better” than having a culture that gives frat boys a bad name.

      2. David Cockburn says:

        It’s not only America, it happens everywhere. I’ve personally seen it in Morocco, Belgium, South Africa, Iceland, Portugal, Canada.

    2. Tom A says:

      I’ve witnessed this type of cavalier attitude, supported by senior management “ethical agnosticism” while working for aerospace and chemical manufacturing companies. For a vaccine manufacturer to roll the dice like this is really reprehensible. It just adds to arguments by anti-vaccine proponents.
      We’ve experienced these type of corporate lapses before. The Boeing 737 MAX is our most recent example.

  2. Hap says:

    They probably couldn’t have gotten the money they did, though, if they’d been honest about their limitations. Pretending they could and then doing whatever they needed to make the numbers was the most lucrative option. Like with insider trading, unless the expected cost to the deciding individuals and companies is higher than the expected gains, people and companies will keep faking it until they don’t make it.

    1. Anon says:

      This is a common problem in a lot of different endeavors. It’s a sort of prisoner’s dilemma, in which your bidding competition is going to overpromise, so you feel like you have to as well to get the contract.

    2. Brian Slesinsky says:

      I suspect they would have gotten the job anyway due to the emergency. What alternatives were there?

      And they did make a lot of vaccine before screwing up, so in this sense it was well worth taking the risk.

      1. Mammalian scale-up person says:

        Uh ,well, off the top of my head: Patheon/Thermo, Catalent, Fujifilm Diosynth, Lonza, WuXi Apptec who just bought a huge Pfizer facility, Biogen, AbbVie, Boehringer, MassBiologics in Derek’s neighborhood…

        I like Patheon/Thermo for viral vector myself. Good people, quite competent.

        1. wubbles says:

          Why didn’t we contract them all to produce vaccines to hedge against these issues?

          1. Mammalian scale-up person says:

            Some did, including JnJ – Catalent is producing most of their material, with some also produced at Grand River Aseptic and Merck is offering use of their facility as well.

      2. Chemjobber says:

        “And they did make a lot of vaccine before screwing up, so in this sense it was well worth taking the risk.”

        No doses from Emergent have been released to the public (I don’t think).

  3. SP123 says:

    And so a thousand HBR and consulting case studies were launched… and bad managers will continue to use the same “motivational” practices.

  4. Richard Feynman says:

    ditto on the Challenger analogy

    1. Jason says:

      Intel failed to deploy their 10 nn fab production due to bad leadership starting right at the top with the CEO, Brian Krzanich. Insiders said he ignored his top engineers, flat out told people he likes to work alone, and told people “f–ing [you]” when he heard things he did not like.

      He was finally ousted when it was revealed that he had an affair with a subordinate. This affair ended long before he became CEO. Speculation is that the board had enough and used this as an excuse to get rid of him. That’s good, but it took way too long. This story plays out everywhere.

  5. Dr. Wood says:

    As an engineering student I was advised by several people I respected that I should always keep financial reserves available so that I could look my boss in the eye and simply say “no, I will not do that”, regardless of if it might get me fired. Looks like some people at Emergent should have been taught that too.

    1. Anon says:

      That’s good advice on the individual level, but there will always be someone willing to follow orders, no matter how obviously unethical they are.

      The only real way to address this is to remove corporate liability protections for the private sector and qualified immunity in the public sector for individuals who do something illegal. My concern with this is that the higher ups will find avenues of plausible deniability, and the sword will fall on the rank and file (i.e. Abu Ghraib is the first example that comes to mind). But I think removing some liability shielding is a worthwhile discussion to have.

      1. Mammalian scale-up person says:

        I have seen successful pharmaceutical companies deal with such findings with the “nuke it from orbit, it’s the only way to be sure” method: Get a warning letter or god forbid a Consent Decree, just shut it all down. Fire everyone, in some cases with extreme prejudice. If you let it happen without notifying Compliance, you’re as guilty as the rest.

        I have seen less-successful companies try to pick and choose and fire only the bad eggs, and then limp along with all the people who learned bad habits and struggle to un-learn them.

        I favor the first method. You can have your facility retrofitted with the best automated CIP/SIP/automated room decontamination in the world, but you can’t fix stupid.

        1. x says:

          Unfortunately, this kind of “burn it and start over” measure is sometimes the only thing that will fix a rotten work culture.

        2. lapsed chemist says:

          I’m speculating, but another challenge is staff turnover. I guess it is pretty high as the “good ones” leave for better opportunities leaving less capable/ less well trained staff behind. The process is the product, so any nuances are lost and it is back to square one. Rather than any individual, it is the system that has failed, so that should be gutted and any “square pegs” removed. Brutal, but the only way forward.

      2. Jane says:

        Even if liability shielding isn’t removed (not likely given the influence these guys have over both parties in DC), claw back of bonuses is a worthwhile consideration. Most of the guys at the top derive the majority of their income from bonuses (usually paid in stock) and somehow they always seem to keep it even when it turns out that the numbers were smoke and mirrors.

        1. eyesoars says:

          Even when it’s not even smoke and mirrors.
          Many years ago, I worked for a no-longer-extant company, with three major facilities in my division of the company. VP in charge of the division sees he won’t make his revenue numbers, and closes his smallest site (which also happens to be his most profitable). He expected to lose 1/3 of his employees, and make his numbers by attrition, assuming most employees will relocate. Instead, he (predictably and predicted) lost 80%, engineering continuity on many of his products, and cost the company something more than US$200M. CEO/president/board/… all know he’s screwed the company — as soon as he announced the site closure — but he got his bonus ($250k). Two years later, after the company closed on a couple of other companies to make up the talent/product loss, he was let go.

      3. Vader says:

        IANAL.

        But qualified immunity certainly does not protect a government official who does something actually criminal, and I doubt corporate liability protections protect a corporate officer who does something actually criminal.

        Corporate liability protection is supposed to protect the personal assets of corporate officers if the company goes bankrupt. That’s not the situation here.

    2. John Wayne says:

      That was some good advice. There are at least two reasons why:
      1. Sometimes the management of an organization decides to engage in dubious behavior. If they get caught, they will definitely try and pin the blame on their employees. Outside of the ethics, it is safer for you to create a record of what they asked you to do and then get a new job.
      2. Not having any savings makes you poorer. A lot of Americans cannot financially handle unexpected expenses. If you don’t have the money, it will cost you even more money to deal with the situation (credit cards, payday loans, etc.) If you take a long view, many of these ‘unexpected’ expenses should be expected. Examples: your car will eventually break, your house will need work, your kids will do something dumb, etc.

      1. Vader says:

        This.

  6. John Wayne says:

    The very common “fake it ’till you make it” strategy doesn’t tend to work when you have to perform iterative sterility and endotoxin testing. You are going to have some failures even if you are ruthlessly competent.

  7. li zhi says:

    OCD, me. “That would most certainly do it.” wrong. “That could do it.” right. Or “That would most certainly do it if done routinely.” maybe or probably given the inadequacies of their clean procedures.

  8. electrochemist says:

    Let’s not forget about MMV (Minute Mouse Virus). That one cropped up a number of times a decade or so ago (see PDA J Pharm Sci Technol Nov-Dec 2011;65(6):580-8).

    Ironically, MMV outbreaks may be having a resurgence due to the infatuation of Pharma companies with doing away with trash cans in individual desk areas in favor of having scientists accumulate garbage (lunch remnants) at their desks and then hand carry the stuff to a Recycling Center of Excellence (Trashercize, as Dilbert named it). Guess who comes to check on the trash at night if said scientists forget to do a garbage run? Chuck-E-Cheeeeeez!

  9. Wilhelm Cody says:

    Part of the issue is lack of training in fundamentals, often information out the field of expertise of the staff. I had once had an intense discussion with some biochemists who were wondering how endotoxins got into the product. The new knowledge was that protein isolation columns were also potential continuous fermenters: put protein rich salt solutions in the top and run it slowly past huge surface area to maximize the potential of producing organisms.

    Some key microbiological principles were ultimately inculcated. Only then did people understand why change was needed and do what was needed .
    -Yes, many microorganisms grow at temperatures down to and even below 0 deg C.
    -Yes, microorganisms LOVE being on surfaces-most even prefer it.
    -Yes, many microorganisms can grow in high salt concentrations.
    -Yes, microorganisms are everywhere and hard to get rid of completely: start clean because you probably cannot clean it up later.
    -No, it is not worth trying to recover the column. Trash it, change your protocols to use sterile technique, and make new columns.

    As Demming pointed out, the issue is usually not poor operators but poor processes. The solution to poor performance is first to change the management philosophy since they design and run the processes. If management does not or will not change then get new management. You can often retrain all but the most recalcitrant staff once they understand the issues and how following new protocols will help the company survive so they can keep their jobs in, likely, a better environment. In this case, set aside Emergent managers and put in J&J ones to revamp the system and train everyone else, including managers willing to learn.

    1. A Nonny Mouse says:

      I find it very hard to understand; we we making a small molecule injectable in a clean area and we had to have cleaning protocols for the DMF/FDA inspection which amounted to a complete washdown of walls and roof every 2 weeks with 4% peroxide.

      I did work summers as a student at a soft drinks bottling plant and a couple of times I had to steam blast the mould from above the tanks prior to a Coca Cola inspection (didn’t want to see the state of the sugar loft! Plant was owned by Beecham).

  10. Nathan Williams says:

    This all sounds bad, but much like restaurant inspections, I wonder what the baseline is. Is this crazy-bad outside the norm, or does every commercial-scale cell culture facility have messes they need to clean up now and then? Would we – outside of the industry – even have heard about this if they weren’t critical-path for something that’s very important right now?

    1. Derek Lowe says:

      As I understand it, batches do fail QC, of course (and the Times article mentions five AZ batches that had to be discarded over the last few months). But this last one was a rather large and especially avoidable error. Given the importance and critical-path nature, as you mention, it’s especially unpardonable to mess it up in this way (cross-contamination via employee, from one zone of the factory to another).

      1. lapsed chemist says:

        I’ve worked in multi product manufacturing facilities and a major focus from regulators are safeguards to minimise cross contamination. If any equipment is shared then the control measures required are especially stringent. If, as speculated, a cleaning step was missed and resulted in cross contamination then this is a catastrophic failure of internal systems and it is no wonder that the FDA stopped them from making any other viral vectors.

        1. Derek Lowe says:

          Agreed – this is not a bolt from the blue like the Genzyme virus – this one is preventable and inexcusable.

    2. Mammalian scale-up person says:

      In cell culture generally – it’s a huge range. For regular cell culture production, most large scale facilities actually run far, far better than small scale ones, for the simple reason that they’ve automated most of their processes and put inline sensors to ensure cleanliness and sterility because robots are cheaper than humans. Small scale companies aren’t big enough to invest in DeltaV or Siemens distributed control systems and the full SAP suite of bar-coded inventory control, and often get really weird about consumables (ie disposable plastics, necessary for viral control) use, insist on re-using things until they break instead of disposing as intended.

      Viral vector production is comparatively new. Most viral vector production facilities are still working out growing pains to some extent…but Emergent has been working with pathogens a long, long time and has had government contracts to handle up to BSL-3 materials. They really, REALLY should have no excuse for this sloppiness, and, well, as soon as you say your root cause analysis was “operator error” you might as well go ahead and put up a sign that says “abandon hope all ye who enter here” to prepare the auditors for the disappointment and war stories to come. I can forgive them for working people hard, we have all been working hard to try and find something to end the pandemic, right? I want to go back to indoor restaurant meals and live music myself. But if they can’t handle relatively harmless viruses properly, no way should they retain their license to handle select agents and BSL-3 stuff for the Defense Department either. There are other viral CMOs who can handle this, pick one and get them ramped up.

      1. stewart says:

        Am I missing something, or should they have had passkey-implemented need to access controls that would have prevented staff traffic between the two zones?

        1. Mammalian scale-up person says:

          You are not missing anything. Ideally there would be a maglock system integrated to the building management system that simply only gives access to limited staff.

  11. Derek Freyberg says:

    Well before this fiasco, there were reports about Emergent and its dealings with the federal government, particularly with regard to anthrax and Ebola vaccines. They seem to have established themselves as the chief supplier of the anthrax vaccine and been incredibly pushy about making sure the feds continued to restock from them whether or not more supplies were needed.
    If J&J can make their COVID-19 vaccine safely at Emergent – notice that I do not say “if Emergent can safely make the J&J COVID-19 vaccine”, as we know that just ain’t so – then they should until there are other facilities elsewhere that can take up the task; but after that a major look at the company and its operating practices seems long overdue.

    1. John M says:

      Last month the NY Times reported on Emergent gaming the Strategic National Stockpile program, eating up more than half of its budget for anthrax vaccine. Link in my name.

  12. Insilicoconsulting says:

    This Baltimore thingie not in Chindia? It also happens elsewhere? Colour me surprised!

  13. Brussels bureaucrat says:

    In the US as in the EU it all comes down to production facilities. Next time some governments are hopefully going to be better prepared. They should know which factories will produce what, how much and how fast, and, not least, who will get the vaccines first:

    “The commissioner added that the performance of the 27 member states’ vaccine rollout would have been superior to that of the UK if they had not had issues with AstraZeneca, which was only able to produce 29.8m doses in the first quarter of this year – less than 25% of its initial commitment.”

    https://www.theguardian.com/world/2021/apr/08/almost-all-dutch-made-astrazeneca-doses-will-stay-in-eu-says-brussels

    1. A Nonny Mouse says:

      The issues are not with AZ, but with their sub-contractors who seem unable to perform the required operations to the same level as seen in the UK. I believe that some UK personnel have been drafted into Leiden in order to help with production there (though, if the government there had put in the extra 10m Euro that was requested to top up the 25m already put in by the UK government then the production would be five times higher. They refused and were warned that this would severely limit supplies).

      1. WST says:

        ….hmmm and not with technology transfer, training, management and quality control of subcontractors ?

      2. Brussels bureaucrat says:

        Interesting. I was not aware of AZ asking the EU for 10 million Euro? Do have you have a link?
        I guess from the EU perspective, a contract was made with AZ to deliver the vaccines at a certain time to the EU. So the issue is with AZ (and not with sub-contractors).

        1. A Nonny Mouse says:

          They didn’t; Oxford did very early on as the extra 10m would have allowed them to go from 200 litre production to 1000 litres.

          This information was released by a whistle blower to the Dutch press a few weeks ago.

          ….The broadcaster bases its claims on ‘background talks’ and a letter to prime minister Mark Rutte. It says that Oxford asked the Dutch government to invest €10m in Halix, around the same time as the British government put in €25m. The British investment allowed production to be increased to 200 litre drums, but Oxford wanted a further scale-up to 1,000 litre drums in order to ensure sufficient capacity, the broadcaster said. However, despite the involvement of CDA MP Pieter Omtzigt and meetings in the prime minister’s office, the talks petered out. Sources in the UK told NOS that the Netherlands would have been able to participate if it had taken a more proactive role in the negotiations……

          1. Brussels bureaucrat says:

            Thank you. I have never heard this story before and would very much like to see a link?
            Anyway, even if this rumor is true then it still does not justify AZ signing up to a contract they could not live up to and nor its general behavior in this matter, in my opinion.
            What makes matters even worse is that not only did AZ suddenly announce that they could only deliver 25% of the vaccines without warning, but they did so only shortly before expected delivery time leaving no time sort things out for the EU. This came as big surprise to the EU. Also, the EU was not aware that the deal between AZ and the UK included a nationalistic/protectionist clause saying that all AZ vaccines must first go the UK, and that no vaccines must leave the UK. As you are probably aware, 20 million Biontech/Pfizer vaccines that were developed in Germany and produced in the EU went to the UK.

            Hopefully the EU has learned from this mistake that has likely caused deaths among old people the EU. On a personal note, my parents are in their late 70’ies and are still waiting to get vaccinated and meanwhile younger people are being vaccinated in the UK. I guess you can spin this as a story about how the UK was simply being smarter that the EU…

    2. Jane says:

      Part of the problem with having massive ready to go vaccine capacity available is that we’d have been sitting on chicken farms producing a billion eggs a year.

  14. Hólmsteinn Jónasson says:

    Interesting stuff. “Global trends in clinical studies of ivermectin
    in COVID-19” http://jja-contents.wdc-jp.com/pdf/JJA74/74-1-open/74-1_44-95.pdf?fbclid=IwAR1H4ECCpCy9TZLD5lmLA3AvmsNo511g3acc0VPxgInIQsA1ZJsR-_nkz4c

  15. Job at Emergent says:

    I applied to a job posting in manufacturing at Emergent a few times. I saw that they dropped the job position, then put it back on, then dropped it… only to emerge 1 year and 2 years later.

    It either says high turnover or indecisiveness or both.

  16. Marcus Theory says:

    “In research labs, people are warned about doing any home baking or brewing”

    I’d never heard this/thought about it before, but it makes sense! Another reason to be happy to be a synthetic organic chemist — though I guess the analogy here would be tiny seed crystals of novel crystal forms hitching a ride on your lab coat and then screwing up the existing process….

  17. DV Henkel-Wallace says:

    I was surprised neither NYT article mentioned GMP. These failures described are in pretty basic areas of GMP which suggests that their SOPs were either ignored or nonexistant in *other* parts of the process as well.

    It’s been years since I’ve had to worry about that part of the business but I remember the agency being quite interested in our process maturity.

    Also: The government is holding on to a lot of anthrax vaccine from Emergent: how can we trust it?

  18. Brussels bureaucrat says:

    This makes me proud to be an EU citizen. The EU now shows how to be a good neighbour and promise to help out the UK with their vaccine challenge:
    “Our objective is to meet our target, and to help our friends meet theirs.”

    https://www.theguardian.com/world/2021/apr/08/almost-all-dutch-made-astrazeneca-doses-will-stay-in-eu-says-brussels

    1. sgcox says:

      Pity that all those doses will be sitting in the fridge and than discarded after expiry day.
      Thanks to EU countries politicians (not EU itself) who basically made sure that almost no one there will take it. Why not send to UK and other countries who will use it to save thousands and thousands lives ?
      Oh, the humanity..

      1. Brussels bureaucrat says:

        … not to mention the 20 million Biontech/Pfizer vaccines that were developed in Germany and produced in the EU and went to the UK (meanwhile the UK were of cause free to chose a more nationalistic/protectionist approach that so far has prevented a single vaccine from leaving the UK…).
        So sure, I am proud of the EU. The question is why does this upset you?!
        You should be proud of the UKs fast roll out, among other things. The UK is a great nation for sure.

        1. sgcox says:

          Ever heard about Croda for example?
          Anyway, the question was why hoarding quasi-ineffective and deadly medicine which will not be used and likely go to waste ?

          1. Brussels bureaucrat says:

            Well, I did post the original entry to this sub-thread and then you derailed the discussion. But, sure, lets follow your lead and I will try to answer our question then.
            Yes! Several individual EU countries have been too slow in roll out, for example France. Nobody in France, or in the EU, in denying this. But the MAJOR reason for the slow roll out in France is lack of vaccines.
            The UK itself is now also adding to skepticim about the AZ vaccine, but how many lives have been lost due to this? Do we know? Vaccine skepticism was quite prevalent even before the AZ stories came out.
            It seem to me that you are quite biased in your view – basically the UK can only do good and the EU is plain evil and for this reason you cannot admit that the UK got roughly half of its vaccines from the EU so far, and will get even more in the future. For example, the UK has not gotten a single vaccine from the US.
            In one year from now, when hopefully the pandemic is under control we will look back at this mess and judge who protected their populations best and who treated other countries most fairly, etc.
            I wish the UK all the best, but I believe there is a need to counter some of the more radical Brexit lies that seem to dominate on the web and in UK media.

        2. Rtah100 says:

          Look either it is wrong for the UK to obtained written contractual exclusivity on UK production or it is not. But if it is wrong, then it is wrong for the EU to do likewise. Hypocritical European “what-abouttery” is unbecoming: what is sauce for the goose is sauce for the gander….

          Except if course that is not how the EU works. A democracy where nations which rejected treaties were told to vote again until they got it right or the vote was simply ignored. The UK left for good reasons.

          The real irony is that the AZ vaccine is not even wanted by many EU members!

          1. Brussels bureaucrat says:

            Couldn’t agree more. Just because the UK is acting in a nationalistic/protectionist fashion the EU should not do the same.

            As for your comments about the EU in general – this site is probably not the place for that discussion (and I totally disagree with your view)

          2. Stroodle says:

            Just some quick points to the ‘Brussles beurocrat’, whom I hope is playing devil’s advocate to some degree…

            It’s a bit rich to refer to the German developed Biotech vaccine when most of the world believe it’s the US developed Pfizer. Sure, it’s a collaboration, and I’m uncertain of the contribution of each party. Regardless, who developed the not for profit vaccine to be distributed to billions?

            Secondly, the UK clearly hasn’t stopped exports, as they actually sent vaccines to Australia, whereas the EU completely ignored their contracts and shafted Australia, letting the intended exports to sit around and expire (I’m Australian btw).

            Finally, you can’t claim that the UK added to vaccine scepticism. Their consistent message has been that the Oxford AZ is safe. Rather than making bad medical decisions in opposition to their experts, they made a careful assesment and issued advice for risk/benefit for age ranges. Certainly not comparable to Macron confusing efficacy on over 65s to enrolment rate of over 65s, something which an undergrad wouldn’t be capable of.

          3. Rtah says:

            But that’s just the point – the EU accuses the UK of vaccine nationalism and then passes laws to restrict the export of vaccines to the UK!

            But the EU accusation was false and has been admitted as such by the Commission.
            – There is no UK law banning exports. AZ or the UK (not sure if title had passed) has exported vaccines to Australia, as noted below.
            – The UK has a contract prioritizing UK funded domestic production by AZ for the UK, of a vaccine developed with UK public research grants.
            – the UK has provided funding to the EU Halix plant to increase its production capacity.

            The EU chose to negotiate a contract with AZ with looser performance conditions at a cheaper price. Because German Ordoliberals know the price of everything and the value of nothing and refuse to countenance fiscal expansion.

            The EU position is insane. A few weeks ago they proposed to detonate the Withdrawal treaty themselves over this fix they got themselves in, without consulting Ireland, their own member state, or the UK. Having preached about not weaponising the NI border, they weaponised it!

            Now Thierry Breton, pandering to a domestic French audience, is doing the Eurocrat version of the Mafia speech: nice vaccination programme you’ve got there, shame if anything happened to it….

            All this while the US has an export ban and is making millions of doses and keeping them all at home but nobody says a peep.

            These are not irrelevant geopolitical topics. They are medical life and death. It is reasonable to draw attention to Brexit – it is a far better demonstration of the bullying incompetence of the EU than years of arcane disputes would have provided (e.g. the sneak protectionism of making impossible import of UK live shellfish requiring purification by deleting the relevant forms!). I don’t propose to relitigate here but I do think it should be acknowledged that the EU’s behaviour here is swaying a lot of people who voted remain….

            I hope the EU gets better at governing its member populations for their sake, or they break it up.

  19. John M says:

    One of the largest cross-contamination cases ever, perhaps, is by HeLa cells as recounted in “The Immortal Life of Henrietta Lacks”. There’s an accessible telling of the story in the Berkeley Science Review (link in my name) – scroll down to “Life in the lab: as a hearty contaminant”.

    Essentially it was discovered in the mid-60s that a huge number of purportedly different cell lines in a huge number of labs were actually all HeLa. The Berkeley articles estimates at least 500 research papers were invalidated (although not retracted).

  20. Smokerr says:

    Back when I was in high school we did the Fruit fly thing (no I never could tell the sex differences)

    My single egg tubes got a mold and covered the egg before it hatched and no fruit flies.

    I spent the whole semester (quarter) trying to kill it off and grow eggs to do my breeding experiment in. I had just got it overcome when the semester ended.

    Even at that level it was almost impossible to sanitize, boiled water , alcohol, dish detergent, I tired it all.

    The biology teacher was impressed at my efforts and and I was done in by the mold, so I got a B for trying!

    1. Marko says:

      If I was in the next semester’s lab class, I’d have paid you good money for some of that mold.

      1. eyesoars says:

        You and half the premeds I went to school with.

    2. Derek Lowe says:

      I once saw (during my first pharma job in NJ) a vigorous dark gray mold floating happily in a plastic bottle of saturated sodium bicarbonate solution (half an inch of solid bicarb on the bottom). I could not believe my eyes. My labmate Bill looked at it and said “That’s a *Jersey* mold”. My wife saw some stuff living in 5N NaCl one time. She was impressed, too – this stuff is pretty hardy.

      1. gippgig says:

        Reminds me of halobacteria (which of course they weren’t). Anyone bother to identify these things? Might find some interesting or useful extremophiles.

  21. Rob McMillin says:

    So, a question for Derek: given all the troubles that AstraZeneca, Johnson & Johnson, and Gamaleya have had with manufacturing, is it reasonable to assert that vectored virus vaccines are simply too complicated to manufacture at scale and rapidly? Because at this point, it sure looks like the mRNA boys are lapping everyone else. The mRNA manufacturing process may be much more complicated — but from 50,000 feet (i.e. the number of vaccines getting into arms), it sure looks like they’re also more deterministic.

  22. wubbles says:

    How did this plant not only get the contract, but become the sole plant producing? Why didn’t we spend the money to build 100 just like it? And who exactly is going to to blackball Emergent and all its managers from federal business? At this point the Emergent managers responsible should be shot for sabotage.

    The US Navy has since WWII implemented a quality control program for submarines. Only two hull losses have happened since then, both when the requirements of the program was waived. Apparently this knowledge has not permeated the rest of the government.

  23. Brussels bureaucrat says:

    Stroodle,
    I find it quite strange to have defend the EUs actions here. The EU is by far the biggest exporter of vaccines and has exported at least 80 million vaccines to the world, including the Biontech/Pfizer vaccines used in Israel and the UK. Now that the US and UK has vaccinated its own populations, they will begin to export vaccines also. So will India at some point.

    The BioNTech vaccine surely was developed by a German company and then Pfizer bought it developed/produced the early vaccines in EU sites. Had the UK&AZ been honest about their secret nationalistic scheme then you could well imagine that the EU would have retaliated and blocked the 20 mill Biontech/pfizer vaccines that went to the UK (with a population of 50 mill). However, only just before expected delivery did AZ announce that they could only provide 25% of the vaccines. And only then did the world understand that AZ had made a secret deal with the UK. This came as big surprise to the EU. In other words, the UK fooled the EU and life were lost in the EU instead of the UK…

    As for vaccine skepticism, and as I am sure you know, the UK has u-turned and does not recommend AZ vaccination for people under 30 years of age. In other countries the cut off is presently 50, 55 and 60 years, I believe. The exact age hardly determines the degree of vaccine skepticism caused, right? But Macron made a mistake early on. I agree. Are you claiming that it is the EU fault that the UK decided to make their vaccines with AZ with very little experience in vaccines? The UK Brexit government did this because AZ is partly British as they were free to do. But there have been consequences to this and this decision has created vaccine skepticism and other problems.

    The story about the vaccines in Italy that were blocked from going to Australia is more complicated. I dont think we have all the details. I think it is worth noting that when the vaccines were “discovered” hundreds of people died every day in Italy, whereas not a single person died daily in Australia. So, the Italians blocked the batch. I was not aware that the vaccines were left to expire? If they were then clearly that was disgrace!

    1. A Nonny Mouse says:

      Let’s summarise this:

      The EU has not supplied any vaccines to the rest of the world. Companies based in the EU have been fulfilling (or trying to) contacts which were negotiated with various parties.

      Prior to the Covid outbreak ALL of the UK’s vaccines were sourced from the EU and USA with the exception of a plant in Liverpool which made the annual flu vaccine. This problem had been recognised a few years ago and a national vaccine production site is being constructed in Oxfordshire (and at an accelerated pace now).

      The UK government (not companies) put the money into various plants (including in the EU as already shown to you) in order to manufacture these vaccines for UK use as there was no alternative. A-Z was approached as a partner as the government did not want Merck to be involved due to the “US first” policy of the Trump administration.

      The UK government signed contracts well before the EU who were debating price and liability on a “not for profit” vaccine. It is clearly stated in the EU contact that pre-existing contracts (ie, the UK’s) take priority. Had the Dutch government put that money into the Lieden plant, then there might have been enough for everyone. Indeed, the UK government has funded the Austrian/French company Valneva who were not able to get money from the EU or their own governments (and supplied a manufacturing base in Scotland).

      The good thing that the UK did was to put a venture capitalist in charge of the vaccine task force rather than any bureaucrat. In that way, bets were hedged by spending a vast amount of money on the options (some 10bn Euro for 65m while the EU spent 3.5bn for 400m).

      As for Italy, the plant that was raided had 13m vaccines for the EU and 16m for the Covax programme (which the UK gave £550m to). There was none for the UK.

      The UK has supplied 770K doses of AZ vaccine to Australia after the 250K doses were blocked by Italy. As we can only produce 2m doses per week, then this is quite a significant amount. Australia will shortly be producing their own AZ vaccine due to the licensing agreement that they have all around the world (Brazil, India etc) as part of the not for profit agreement with Oxford/AZ.

      While the UK may not see supplying vaccine to many places due to lack of capacity, they have ensured that the rest of the developing world can get a decent vaccine at the cheapest price possible. I’m certainly not seeing this from Pfizer who seem to have taken the technology from Biontech and are dumping them heavily.

      1. WST says:

        Amazing, maybe you should contact and inform von der Leyen about the true state of the European vaccine exports .

        17 March 2021, Brussels
        Statement by President von der Leyen
        “We have this export authorisation scheme since 1 February – so it is six weeks – and since then, in these six weeks, we have received hundreds of requests for exports – in numbers, more than 300 requests for export – 314 have been granted, only one has been refused. If you put that in numbers of doses: In that time – these six last weeks – 41 million doses have been exported to 33 countries.”
        https://ec.europa.eu/commission/presscorner/detail/en/STATEMENT_21_1222

        1. sgcox says:

          EU does not make vaccines. Neither is UK or US. It is made by private companies fulfilling their contractual obligations. This is a linchpin of our civilization. Infringing on it threatens to relearn of last century history which unfortunately edges closer.
          The desire of countries to secure vaccine supply is in fact fully understandable as the first obligation of any responsible government is protection of the realm and its citizens. I really hope it will not go to far.
          EU itself is not a source of any problems despite what you may think from my comments. EMA report last week was very balanced, measured and down to facts. In concluded that AZ vaccine is likely to be linked to very rare serious adverse effects but its effectiveness outweighs any potential risks.
          It is the EU country politicians who irks me. The kneejerk hostility to AZ vaccine started well before first side effect reports came in. It was branded inefficient and not recommended for people over 60. Now it is labelled across EU as deadly dangerous and not be used in people under 60.
          No wonder the vaccine hesitancy in EU skyrocketed. I am not sure but believe this smearing complain spilled to over to all vaccines.
          I really struggle to see how all this politicizing led to thousands of preventable deaths.

          1. sgcox says:

            Typing too fast again and not reading. Damn.

          2. Brussels bureaucrat says:

            I believe the first country to report side effects with AZ vaccine was Austria. Soon after Denmark and Norway and the several other countries reported similar side effects. Then Canada also put the AZ vaccine on pause and finally the UK itself decided to follow suit and also limited the use of the AZ to older people.

            As for the initial concern, there were very few old people in the early clinical trails of more than 60 years of age. This raised concern in several countries (including Garmany, but also in Canada and the US). Macron misunderstood this and confused “lack evidence” with “lack of efficacy”. Pretty stupid mistake, everybody agrees.

            But are you suggesting that all this was an evil plot dictated by the evil people in Brussels? To this I can only say, that your view of the EU is wrong. People in the EU are not like you say they are. What else can I say? It is honestly kind of sad that the Brexit movement managed to create such hatred for the EU. I guess the only way this can change is if people like myself, in the EU, try to correct the lies, but I am clearly not doing a very good job.
            Have a nice Saturday. Spring is here and summer is coming!

          3. sgcox says:

            🙂
            There is almost certainly no malice involved, just total lack of understanding that words of people of authority really matter, it is not for tomorrow headlines. BoJo is especially guilty here.

  24. Barry says:

    This is where”biologics” diverge from traditional pharmaceuticals. Small-molecule chemists know well that many reactions that work well on the kill it larger scale are desperately hard on the milligram scale. Anaerobic technique is easier at scale; chemical contaminants don’t multiply.

    1. sgcox says:

      I remember a post by Derek few(many) years ago about polymorgh which spread like a virus and ruined the production in the whole factory.. No idea how to find it – search option goes to Science franchise, not the forum.

      1. sgcox says:

        From November 2019…
        And somehow I thought it was ages ago in some bygone era. The current events really messed up minds.

  25. HeyOh_billy says:

    Chemistry is essentially the new mathematics. Its old, its established, it has a ton of literature and authority, it has a bunch of people working on it, it makes a lot of internal sense. But it doesn’t explain too much in the end. There are a ton of inside problems that mathematicians love to work on that no one else cares about. And it probably wont help humanity in the end absent more groundbreaking discoveries.

    1. Drive away, far says:

      “ nobody needs that fancy abstract math“

      Posted on a device which relies on knowledge of Maxwell’s equations, imaginary numbers, probability and statistics, quantum mechanics and the strange math it uses, laser driven fiber optics, and Sometimes nuclear reactors to generate the electricity for it.

      Yep, you can do all that with just readiin ritin’ n rithmatic!

  26. Alex says:

    Do you think J&J can solve all the problems and allow children to be vaccinated, as Pfizer and BioNTech did? https://freenews.live/pfizer-and-biontech-ready-to-vaccinate-12-year-olds/

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