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Another Vaccine Trial Halt

The first advice is “Don’t panic”. You will have heard that last night J&J announced that their coronavirus vaccine dosing has been paused while they investigate an adverse event in the trial. And while you never like to hear that, considering the size of their effort, this sort of thing is likely to happen even if the vaccine turns out to have no real safety issues. Just this morning, the company’s CEO told analysts on a conference call that they don’t even know yet if the affected patient is in the treatment group or the controls: that’s how early this is. Now, there are definitely ways that this could go that would be concerning, but we’re not there yet.

Update: now it appears that a trial of their monoclonal antibody plus remdesivir has also been paused after an adverse event “out of an abundance of caution”. I’m still not panicking.

In the larger picture, this (and the AstraZeneca vaccine halt, which continues here in their US trial) are why we have been developing so many candidates. The central fact of the biopharma industry is that most things we try don’t work. That means that (1) we have to keep trying a lot of things, and (2) since that costs a lot of money, we generally charge a lot for the things that actually do work. I expect the coronavirus vaccine success rate to be higher than the industry average, though, because (thanks to the work on the earlier SARS and MERS outbreaks) we already had a lot of information about how these coronaviruses are organized, how they attack cells, where the best choices might be to produce antigens against them, and some of the potential problems we would need to look out for. All that has been an invaluable leg up.

It will be a good thing if we don’t do the industry average, though, because that’s around a 90% failure rate from a standing start. Here’s the good news about that: what we’ve been able to see from the Phase I/II data on the various candidates is very encouraging. We can indeed stimulate antibody and T-cell responses, and every single vaccine that has reported data at this level has shown this. The uncertainty is that we don’t know (yet) what responses we need for a given level of protection, how well such vaccines will work across different populations groups (ages, risk factors), nor how long such protection will last. The only way to get those numbers is to go out there and get them, which is what’s going on right now.

And the other big uncertainty, which we’re also dealing with now, is safety. Again, the only way to find out about this is to go find out about it – we have no ways to really predict what might happen when a new vaccine is dosed in a large population. Showstopping holy-crap level tox effects are extremely rare (fortunately), but that means that you’re then looking for unlikely adverse events across a large trial population, and trying to figure out what will happen when you expand to a much larger one. It ain’t easy.

So this latest J&J headline has not changed my views. They’re still overall positive. I still think we’re going to have at least one (and likely more than one) useful vaccine in the next few months. It’s just that I have no idea of which ones those will be. And I also think that we will have even better choices in the longer term, once we’ve broken the back of the current pandemic: there are a lot of other interesting candidates that are just getting towards human trials.

But this doesn’t mean that things will go smoothly, which is why I wrote this earlier post. This is what drug development is like all the time; all we’ve done is hit the fast-forward button and put the spotlights on it. I completely understand if it’s nerve-wracking to watch, believe me. Remember, it’s extremely likely that there will be more dips and swerves coming, and it’s a good idea to try to be psychologically ready for them. When they come, it doesn’t mean that everything’s failed. We have too many things going for one piece of news to mean that. I’ll end where I started: don’t panic.

93 comments on “Another Vaccine Trial Halt”

  1. Philip says:

    Typo: they they

    Please delete this post.

  2. Matthew says:

    Not uncommon.
    Good writeup Derek.

  3. Some idiot says:

    Indeed. Doug last Adams has not lived in vain….!

    😊

    Incidentally, I have seen a face mask one can buy with that on it… I think I need to buy one…!

    1. Some idiot says:

      *Douglas Adams…

  4. steve says:

    Sure would be nice to know if this was a case of transverse myelitis like the AstraZenica patients. If so there may be some problem with these adeno-based vaccines.

    1. Thomas says:

      I would be more worried that it was a problem with the antigen used.

    2. Chris Phillips says:

      In March J and J said that 50,000 people had received their vaccines based on the same vector, Ad26, so if it’s a problem related purely to the vector it seems it must be a pretty rare one:
      https://www.sciencemag.org/news/2020/03/1-billion-bet-pharma-giant-and-us-government-team-all-out-coronavirus-vaccine-push

  5. In Vivo Veritas says:

    I have non-pharma friends and family actually tell me I’m dead wrong when I cite the 90% failure rate in our industry. If only I were…..

  6. dearieme says:

    “The central fact of the biopharma industry is that most things we try don’t work. That means that (1) we have to keep trying a lot of things, and (2) since that costs a lot of money, we generally charge a lot for the things that actually do work.”

    Pithy summary: thank you for that.

  7. SirWired says:

    If only your publishing platform allowed you to state that in large, friendly, pink letters, right there in the headline.

    1. Wes says:

      I’m still waiting for the Derek Lowe commemorative towels.

  8. Tom says:

    It doesn’t matter. We’re going to have social restrictions and rolling lockdowns no matter what.

    1. zero says:

      We’ll have them until prevalence drops enough for cautious reopenings.
      We still have them now because we’ve only had criminally reckless reopenings.

  9. Andy says:

    Failure rate is 90% for all drugs, but only 67% for vaccines, and 15% for vaccines that make it to phase 3 (according to Chi Heem Wong, Kien Wei Siah, Andrew W Lo, “Estimation of clinical trial success rates and related parameters,” Biostatistics, April 2019).

    1. PTRS says:

      Asked specifically about Covid-19, 16 vaccines expert estimated Phase III probability of success around 50%, plus or minus 10% depending on the platform: https://www.cgdev.org/publication/covid-19-vaccine-predictions

    2. Dark Day says:

      I had beern under the impression that the failure rate for vaccines that made it to Phase III was closer to 60 – 70%. But that would still mean we’d see two or three successes among the so-called “Warp Speed” candidates.

      Actually, believe it or not, that’s just about what I’m hoping for. As much as I admire Dr. Fauci, some of his recent predictions about large-scale availability by April or so have assumed that almost ALL of the current candidates get approved. With all respect, not only do I think that’s overly optimistic; I think if something like that were to happen, it would further exacerbate vaccine hesitancy among the American peope, who already distrust what they see as a “rushed” research/development/approval process. If “all” the vaccine candidates won approval, I think that would look like a “rubber stamp” to skeptical Americans. If, on the other hand, three or four out of the current seven candidates did NOT make it through, people might interpret that as a sign of rigor in the evaluation process, and hence be more inclined to trust the “survivors” when they do get rolled out.

      I realize this is a contrarian opinion, because we all want as many good and reliable vaccines as possible, but given the way this process has been politicized and de-legitimized in many people’s minds, I honestly think it would be the best-case scenario. If it means we have to wait a litte longer for the rollouts to be complete, then so be it. At least they’ll be trusted more.

  10. Patrick says:

    A general question:
    Why is the trial blinded in such a way that an adverse event in the placebo arm would stop the trial? That seems unnecessary. What is it about structure/who is blinded vs not, etc, that requires stopping the trial for an AE in the placebo arm?

    I’m not saying they’re wrong to do this – This is a very carefully developed set of protocols… I’d just like to understand…?

    1. Carl says:

      Caution. I would assume both to protect against perceptual bias, and possibly also to protect the readout info from potential leaking, (i don’t know if all the safety people belong to J&J, but i’d assume they don’t for reasons of impartiality), the safety team is kept in the dark. So when an adverse event happens they call the halt first, then they go and find the people who do know which arm the patient was in and ask them for that info

    2. Ken Jackson says:

      Normally there isn’t the same level of urgency that you’re seeing with this particular vaccine. Most aren’t big deals but for these vaccines everyone is watching every single minutiae.

  11. Grebs says:

    Wonder what the risk of and adverse event with this vaccine compared to the fatality rate of covid is in say healthy adult or god forbid, a child.

    Throw in what some people where advocating for last week – forced vaccinations – i think trouble is brewing. i think our industry needs to proceed carefully under this media spotlight and what seems to be a complete loss of perspective within public health systems.

    1. Jose Blo says:

      Well, risk of critical COVID events in children <10yr is ~1/20k while in 10-20yr it's ~1/10k so actually, if there's only 1 event in 30k and it's representative (not much statistics on single events really) then you're actually better off even for the very young. That of course assumes that adverse events are evenly distributed among ages, which also seems like a stretch.

      It seems to me like forced vaccinations are likely to be in "essential workers", which almost by definition are over 18… people with state licenses. Also people over 50 would pretty much be insane not to take a 1/10k risk on a vaccine, but then people are nuts.

      1. Charles H. says:

        I think you’re very optimistic in your estimate on the rate of adverse effects in children. You’re probably relying on something like “rate of hospitalization”. Many of the effects, however, are not readily detectable. It’s still not clear how much permanent heart damage is done, or micro-strokes (etc.). Those are permanently damaging, but not severe or obvious enough to usually be noticed.

        1. confused says:

          Is there decent evidence of these things happening in younger populations at a meaningful frequency?

          1. Riah says:

            I would rather opt for vitamin D, zinc, magnesium, especially after the Ben-Gurion Uni (Israel) study, Boston (Holick) study and the Cordoba RCT:
            Adverse events from all vaccines may be a staggering 1 in 39 according to a 3 year follow up of 45 vaccines (well over million doses)for 30 days following vaccination (so that does not include adverse effects after 30 days which would exclude many neurological and autoimmune conditions). “Lazurus” study commissioned in 2010: U.S. Health and Human Services (HHS) pilot study by the Federal Agency for Health Care Research (AHCR) to test the efficiency of a state-of-the-art machine counting (AI) system on data records from the Harvard Pilgrim HMO, prior to them updating the entire reporting system but that was all ditched quickly on discovering this and the contract terminated. Now who knew that?
            There was a also a 2016 HHS survey in JAMA – 19.5% of children under 5 admitted to emergency for drug reactions were suffering vaccine injury (again an underestimate as the study excluded the main paedeatric hospitals where most of the serious cases were seen).
            Finally, transverse myelitis is not an uncommon vaccine injury – in the last two decades, the Vaccine Injury Compensation Program has awarded compensation on 266 post-vaccination cases of transverse myelitis. 55 pending. That is probably not anywhere near all cases as most probably could not be proved or were too far removed in time to link with the vaccine.

          2. Riah says:

            sorry forgot to say, yes many of the TM and Guillain Barre cases have been in younger people

  12. I can’t imagine the pressure on a patient in one of these trials right now. You know the world is counting on you, and something like this happens. That has just got to suck hard.

    Most of all, regardless of what happens with this particular vaccine candidate, I hope the patient will be as well as possible.

  13. Alyssa Vance says:

    Undertaking the delay and massive logistical headache of pausing a 60,000 person trial across dozens of different sites, before you’ve even looked up whether the adverse event was in the vaccine group or not, seems like an insane level of risk aversion compared to letting the trial continue for a day or two (while the lookup happens) and then pausing it if it was. This feels like scrubbing all of D-Day because a single soldier might have sprained their ankle getting into the landing craft.

    1. debinski says:

      I find it hard to believe they paused the trial before knowing if it was placebo or not. Perhaps the spokesman didn’t know, but someone who paused the trial must have known. The blind can be broken almost immediately if an SAE occurs. As a trial participant (and someone who has run clinical trials) I know there is a phone number you can call to get the study treatment unblinded in the case of an emergency.

    2. One possible scenario is that this AE was indeed in the placebo group, and it was possibly an effect of COVID-19 infection. From what we’ve learned about COVID-19, that might be almost any AE at all.

      The DSMB might now be relieved that the trial has been paused, and intensively discussing whether this is the 4th or 5th similar AE, all in the placebo group, and that perhaps the trial should be stopped, not because of a bad safety outcome, but rather because of a surprisingly favorable efficacy outcome.

      As Derek has continually pointed out, drug development is more complex than it appears. The work of DSMBs is a hairball within that hairball.

    3. Chris Hawkins says:

      Thank you for this comment. I was floored by this and actually thought of the same analogy. Absolutely horrifying they would stop the trial for this.

      Although I don’t really think “risk aversion” is the exact term I would use (at least at the society level). It is that “we act in a way with higher expected death and damage because we have done things this way for so long.”

      In 2020, society seemed to agree the answer to the trolley problem is “definitely better to kill 5 people than 1 person”. https://en.wikipedia.org/wiki/Trolley_problem

  14. Jeff C says:

    And now Lilly’s antibody study is reporting a pause. Sigh. I’m not panicking, but I am a little stressed!

    1. confused says:

      What’s the mechanism for adverse effects for monoclonal antibodies? Is it an immune reaction against the antibody itself?

  15. MTK says:

    The public at large is beginning to see how the sausage is made.

  16. John Wayne says:

    Welcome to every day in modern pharma. I hope that study goes well, or my department is going to get fired (again)

  17. Dark Day says:

    I’m not panicking about the vaccine development overall — I am getting pretty panicky about what this will do to the already-shattering public trust in vaccines. Most of us here know that this kind of thing is an example of good science doing what it’s supposed to do; the majority of Americans, who don’t know a lot about the scientific process, will no doubt see it as “evidence” that the vaccines currently under development can’t be trusted. Result: Woefully insufficient uptake of whatever vaccine[s] finally might make it through Phase III and get approved.

    Meanwhile, a Dutch woman has died from COVID reinfection — so much for our hoping that reinfection, while rare, might result in relatively mild cases.
    https://www.cnn.com/2020/10/13/europe/covid-19-dutch-woman-reinfection-death-intl/index.html

    1. Marko says:

      “Meanwhile, a Dutch woman has died from COVID reinfection — so much for our hoping that reinfection, while rare, might result in relatively mild cases”

      Probably not a good example from which to draw that conclusion. She was an 89 yr-old woman with bone marrow cancer. A reinfection with a common cold virus may have been sufficient to push her over the edge.

      Still , this global reinfection tracker does show several cases where the second case was worse than the first :

      https://bnonews.com/index.php/2020/08/covid-19-reinfection-tracker/

      1. confused says:

        Also, given the number of COVID infections (tens of millions confirmed; probably hundreds of millions actually have occurred), no useful conclusion can be drawn from *anything* happening once or a few times.

        I never thought reinfection was impossible. I had chickenpox twice – once after the vaccine, because my family was told we didn’t need the vaccine as I was immune since I’d already had it. So reinfection is possible – though rare – even for diseases conventionally thought of as providing good immunity.

        I did, and still do, doubt that reinfection is common enough to be *a significant factor in the course of the pandemic* (later it may become more common as immunity wanes, but the pandemic phase should be over by then).

        The fact that something has happened a few times worldwide doesn’t mean it’s common enough to be worth considering in practice.

        1. Michael says:

          Published today – durable neutralizing antibodies:

          https://www.cell.com/immunity/fulltext/S1074-7613(20)30445-3

          The authors suggest that reinfections are very rare, and that it is not durability but rather rare viral variants that are the culprit when it happens.

          Cover article here: https://uahs.arizona.edu/tomorrow/antibodies-shown-provide-long-term-immunity-against-covid-19

          And a comprehensive, encouraging thread from one of the authors:

          https://mobile.twitter.com/deeptabhattacha/status/1316137612466241536

    2. Dark Day says:

      I don’t recall now — has it been suggested that in fact the immunity from a vaccine might, in fact, be stronger than the immunity resulting from having contracted, and recovered from, COVID? That sounds like an awful lot to ask from a first-generation vaccine developed at “warp speed” . . .

      1. Marko says:

        I think the expectation is that , on average , vaccine-acquired immunity will be more robust and durable than that acquired from natural infection :

        https://www.abc.net.au/news/2020-09-16/why-coronavirus-vaccine-better-immunity-infection-covid-19/12668050

    3. Michael says:

      This paper is out today — immunity looks very durable, and reinfections appear to be extremely rare and likely tied to specific “selection of rare viral variants”;

      https://www.cell.com/action/showPdf?pii=S1074-7613%2820%2930445-3

      https://www.cell.com/immunity/fulltext/S1074-7613(20)30445-3

      1. Riah says:

        Ah yes, I’ve been looking through that paper too but I had already been fairly convinced from pre-existing knowledge that there is long term immunity (of course there will be rare exceptions). We have known this is true for SARS-CoV-1 and MERS for years:

        William J.Liuabc et al. T-cell immunity of SARS-CoV: Implications for vaccine development against MERS-CoV.Antiviral Research. Volume 137, January 2017, Pages 82-92 https://doi.org/10.1016/j.antiviral.2016.11.006

        And both Beda M Stadler, the former Director of the Institute for Immunology at the University of Bern, a biologist and Professor Emeritus, and Professor Dunn-Walters in the UK (who was reviewing the research on B cells/B memory cells in a BSI immunology webinar), are pretty certain there is long term immunity to SARS-CoV-2.

    4. confused says:

      I think that by Jan-Feb this will have been largely forgotten due to how chaotic & fast the media cycle is right now.

      Even if the Pfizer vaccine has a readout in early November and we get an EUA in November or December, I can’t see it being available to *the general public* immediately.

      Since it won’t go straight from approval to general-public vaccinations the next day, I think current uncertainty will be *much* reduced by the time most people are actually offered the chance to be vaccinated.

      1. Dark Day says:

        . . . and again, as you’ve suggested, a Trumpless public discssion about COVID, — masks, vaccines, possibilities/probabilities for the future, etc.etc.etc. — could become unrecognizably sane and ratinonal in a relatively short time after January 20 (Inauguration Day). Assuming the Biden/Harris ticket wins, I believe strongly that they’ll appoint Dr. Fauci as the public spokesperson for the ongoing COVID struggle (he’s widely admired and respected), and I’m guesing they’ll also rapidly enlist other respected medical and scientific experts (of diverse racial / gender /ethnic backgrounds) to help speahead a national vaccine awareness/educationn campaign.

        Given all that, though, if current positivity rates and death rates continue along their current trajectory, by January 2021 things could look almost as dire as they did in April or May 2020. Not a pleasant or reassuring thought.

        1. SteveM says:

          The Sputnik V vaccine from the Russian Gamaleya Institute is testing nicely. Positive immunogenicity in all subjects in the Phase 1/2 clinical trials. Minimal side effects. Currently engaged in a 40,000 subject Phase 3 clinical trial.

          It would be perversely ironic if the Sputnik V vaccine provides the best proven clinical response at an attractive price, but the Biden regime then rejects it out of simple Russia Hate.

        2. confused says:

          >>by January 2021 things could look almost as dire as they did in April or May 2020

          No way. April-like death rates are pretty much impossible IMO given better treatments now. June/July/August probably saw more infections than the March/April spike (certainly CA TX FL AZ etc. have more population than the Northeast) but the death rate was about half (peaked at maybe 1050-1100/day 7-day average vs maybe 2200 in April).

          I know IHME model predicts some crazy things but that one seems pretty baseless & has been consistently far wrong.

          More likely is continuing spike in Great Plains + smaller uptick in some other places. But the former won’t have that dramatic an effect on national numbers due to relatively low population, and will be over well before January.

          We might hit 1000 deaths/day 7-day average again, though I rather doubt it. But not much higher.

          The IHME model daily-deaths numbers for relaxed measures just don’t seem to make any sense without an implausibly high IFR.

  18. Alan Goldhammer says:

    I don’t know which medicinal chemist coined the phrase, but I remember hearing it first when I sat in on BR Baker’s course at UC Santa Barbara way back in 1969. He was talking about looking at modified side chains and out of nowhere said, “methyl, ethyl, propyl, butyl, futile.”

    1. MeddyChem says:

      sounds better with a british accent, have heard this line in every medchem position I’ve had (and repeated it myself)

  19. AppleButter for Brains says:

    I’m tired of all of this! When is the next “Chicken Pox” party. Get me exposed, let my immune system do it’s thing and let’s get back to normal.

      1. AppleButter Brains says:

        From your first referenced article….

        >>>As we look backwards, we can tell that people who have been in the hospital tend to have more of those long-term symptoms, just because of the severity of the illness.<<<<

        The second appears to be just a recitation of anecdotals by "long haulers."

        I wonder if the virus affects the ACE receptors in blood vessels and resultant inflammation leads to an increase of Von Willebrand Factor leading to transient micro thrombosis and thus longer term damage for some?

    1. Barry says:

      You may get your wish for a protective mild (or asymptomatic) case willy-nilly. It’s proposed that wearing masks permits some (many?) to take on a small viral load and gear up an immune response w/o manifesting frank disease
      https://www.nejm.org/doi/full/10.1056/NEJMp2026913

      1. Hopeful Layman says:

        That could also be good news for vaccine efficacy, since it would mean more people among the general population with at least some immunty. As far as I know, though, this is still a minority opinion among most researchers (NEJM publication notwithstanding). Am I mistaken?

        1. Marko says:

          If this paper is any indication , Tokyo may be at or near herd immunity , while suffering very few deaths , relatively speaking. Mask wearing is virtually universal in Japan , indoors and out , although there are no doubt other factors at play ( fish consumption = healthy Vit. D status ? ):

          https://www.medrxiv.org/content/10.1101/2020.09.21.20198796v1.full.pdf

          1. Drive! says:

            Japan employed their Samurai Warrior Spirit.
            The soul of the virus is defeated, it shrinks away.

          2. Chris Phillips says:

            Given that that Japanese study found a far higher degree of seroprevalence (46.8%) than studies elsewhere, it would be interesting to know what kind of work they did (in the preprint I can see only that they worked for a “large Japanese company” and commuted to work, but had little contact with one another because of the way the company was organised). One would hope the reviewers ask for this information before the paper is accepted for publication!

          3. Riah says:

            Talking of vitamin D, Marko, you might be interested to know we have had a big U-turn from the UK’s Health Secretary who has now at long last ordered a new review of vitamin D and is talking about bolstering the message to the public:

            https://www.dailymail.co.uk/news/article-8844255/amp/Now-Matt-Hancock-says-vitamin-D-amid-mounting-evidence-protects-against-Covid-19.html
            https://www.telegraph.co.uk/news/2020/10/15/matt-hancock-ready-review-health-benefits-vitamin-d-fight-against/
            The articles mention various studies they will be looking at

  20. wilhelm Cody says:

    What is it about the SAE in the Astra Zeneca trial that the trial could be resumed in the United Kingdom (where the event happened), South Africa, India, Japan, and Brazil but not the USA? The delay may interfere with a significant proportion of participants getting a second shot in a timely fashion even if it is resumed.

    1. Diver Dude says:

      Each of those countries has their own regulations about how such things are handled. FDA is notoriously slow to address such issues, especially if the study in question is not being run by a US pharma co.

  21. Hopeful Layman says:

    Not sure whether this belongs here, but I think it’s encouraging news. It would be wonderful if schools could reopen next fall with more or less “normal” conditions for the students.

    https://www.npr.org/sections/health-shots/2020/10/13/923248377/will-kids-get-a-covid-19-vaccine-pfizer-to-expand-trial-to-ages-12-and-up

  22. DataWatcher says:

    I wonder if “Vaccine Resistance” should be an entire topic in and of itself. I admit I don’t understand some things about it. A recent poll in Texas showed that only 27%, of Texans said they are “living normally” — meaning, presumably, that they’re not very satisfied with their lives at the moment . Only 50% said they felt safe attending church;; 45% felt safe sending their child to school; 41% felt safe attending a sporting event at an outdoor stadium (Texans without football??!); 29% felt safe attending a sporting event or concert in an indoor arena, 28% fetl safe going to a bar or club, etc.etc.etc.

    Yet 42% said they would take a vaccine, and 36% said they wouldn’t

    If being dissatisfied or unhappy with having to live an “abnormal” life, and feeling unsafe doing everyday things that used to be cherished in our lives, aren’t enough to motivate people to want to take a vaccine, what could be?

    1. confused says:

      I think it’s *not* really consistent, but that’s because of when & how the question is being asked.

      Much of the skepticism/hesitancy is likely related to fears of President Trump pushing the FDA to approve a vaccine before the election regardless of the data… that will be irrelevant after Election Day (which is only 3 weeks away).

      Also, it’s an “unknown” now. Whereas by the time it’s actually made available to most of the general public it will be a known quantity, and presumably e.g. healthcare workers will have been getting it for a while.

      If you asked the question a week after the election, and again a month after FDA approval, you’d probably get very different answers.

  23. Lenny Wintfeld says:

    If everyone watched sausage being made, no one would eat it. They’re developing this vaccine with everyone watching.

    1. Hopeful Layman says:

      But isn’t that what “transparency” is supposed to be all about? We want this, don’t we?

      1. confused says:

        Ideally, yeah.

        Transparency is important to avoid the appearance of things being ‘swept under the rug’ for political benefit – certainly now in this highly charged environment.

        But the problem is that the “general” media (as opposed to science/medicine specific sources) tends to be pretty terrible on scientific topics.

  24. Good guy says:

    Of course another trial got halted. Everyone who is done virology knows that all the big pharma is in the pocket of trump. Now that the data is finally getting to ” deep state ” regulators its a forgone conclusion that the ” data ” is going to look like crayon colored picture books to real scientists at our good and upright agencies.

  25. Brian says:

    Does anyone know what sorts of things the FDA is investigating with the AstraZeneca pause? I’m neither impatient nor critical, but I’m curious to know what a month-long investigation into these two cases consists of. What sort of avenues might they be pursuing day by day over the course of the last month, and how specifically is it different from the investigations of the equivalent agencies in the countries that quickly resumed?

    1. confused says:

      Yeah, I’d like to know this too. Is there a sort of “not invented here” issue where the ‘okay’ from those other nations’ regulators isn’t considered to have any weight?

      If so, this probably isn’t the best time for that…

      Of course, I am not unbiased either – I tend to find the FDA rather overcautious, especially in emergency situations. (I would have been willing to take the Moderna vaccine in June, if not May…)

    2. Chris Phillips says:

      According to this Reuters report a fortnight ago, the investigation had been widened to look at earlier Oxford vaccines using the same vector. Reuters had found there was a serious adverse event in one of those too, which had been deemed unrelated to the vaccine:
      https://uk.reuters.com/article/health-coronavirus-vaccine-astrazeneca/exclusive-fda-widens-us-safety-inquiry-into-astrazeneca-coronavirus-vaccine-sources-idUKL1N2GR1SK

  26. donorcure says:

    In a small village, there are a lot of medical events that happen. I hope we can find a vaccine that truly cures this virus.

    1. Metaphysician says:

      So, how do you report a comment as spam?

  27. Jorge says:

    Clear article about what has happen in this vaccine race, many bumps but it is normal, we expect to be closer know having so many Pharma companies and governments investing and supporting global trials, lets be positive and meanwhile use the mask, wash hands and maintain social distancing.

    1. Jim Van Zandt says:

      > mask, wash hands and maintain social distancing

      Does this generic advice need tweaking? Nowadays, I would say (in decreasing order of priority) “meet outside with a crosswind, wear a mask, wear glasses, maintain social distancing”, with “wash hands” a distant 5th. (There was a Chinese study suggesting glasses help: https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2770872.)

      1. Bill says:

        Doesn’t matter how you tweak it or repeat it. People either do or don’t. It’s an attitude issue, not that nobody ever told them. This whole thing says a lot about our country and it’s people. And it’s not good.

      2. Irene says:

        Washing hands is something we don’t usually do enough of anyway. It’s some help against COVID-19, and a lot of help against many other illnesses. Really hoping for a much reduced incidence of colds, flu, and gastric disorders this year, due to hand-washing as well as social distancing, etc. I really don’t want to have to worry about even a minor cold this year, as every symptom would convince me that I had COVID-19. Not to mention that anything we do to reduce general disease spread also reduces the number of severe cases of any infectious disease that require medical attention, freeing up medical resources.

  28. Barry says:

    I do worry that a vaccine candidate that would provoke effective immunity in the elderly might be discarded because it sometimes provokes adverse effects in younger subjects with “better” immune systems.

  29. Hopeful Layman says:

    RE: The discussion about whether we’re too “risk averse” in the U.S.: Moderna has gotten permission to submit their vaccine candidate for fast-track approval in Europe. Good idea? Too rash? If it get approved, and rollout starts, will that put more pressure on U.S. officlas to speed up the process here?

    https://www.fool.com/investing/2020/10/14/moderna-wins-permission-to-submit-coronavirus-vacc/

    1. confused says:

      Interesting.

      *Personally* I think the US is being too risk-averse… in the sense that I would absolutely take the vaccines in phase III trials today if I were allowed to, and am pretty annoyed that I am not able to. Even the 1970s swine flu vaccine fiasco actually had a really, really low incidence of problems – much too small to offset even a 50% reduction in COVID risk even for a relatively low-risk person like myself.

      But in terms of *public acceptance* I think caution is appropriate.

      Canada and the EU may not have as much difficulty in terms of public acceptance, and therefore moving faster makes sense…

  30. Marko says:

    I would have bet money that Trump would find a way to push thru a vaccine EUA before the election , and Pfizer seemed to be the company pushing hardest in the same direction , so it’s surprising to me that things worked out this way , but encouraging :

    Pfizer says could apply for U.S. emergency use approval for vaccine in late November

    https://www.reuters.com/article/idUSL4N2H72KT

    1. confused says:

      I think what Trump wants is becoming less and less relevant to what actually happens. Even early on there were plenty of cases where things were ‘decreed by Twitter’ but never actually done, but more so now, I think.

  31. Digibom says:

    good article thanks

  32. debinski says:

    Here we are a week later and still no info at all from Johnson and Johnson as to why their trial remains on hold. Obviously this was not a placebo event, although they are not even admitting to that yet. Doesn’t bode well for trust and transparency with these vaccines.
    https://www.cnn.com/2020/10/19/health/johnson-and-johnson-vaccine-trial-transparency/index.html

    1. DataWatcher says:

      Still no word from AstraZeneca in the U.S., either . . .

        1. DataWatcher says:

          Okay — but will we get a full and open disclosure of exactly what happened? “It was unclear how the FDA would characterize the illness, they said” doesn’t exactly inspire confidence.

  33. Dark Day says:

    RE: Lancet article on potential link beteen some COVID vaccines and heighened risk for HIV infection: What does everyone think about this? Does it look viable? Will this news further vaccine hesitancy (especially, perhaps, among people of color)? How serious might this be?
    If it is not likely or purely hypothetical, would this count as irresponsible journalism?

    https://www.forbes.com/sites/roberthart/2020/10/20/researchers-warn-some-covid-19-vaccines-could-increase-risk-of-hiv-infection/#455717cb3740

    1. Dark Day says:

      Also, I guess, while I’m in the doubt-casting business, what’s the general concensus on the fear that the virus might be less than effective for the obese? That’s a LOT of Americans, esp. poor and low-income Americans (people at some of the highest risk). Might this be a serious stumbling block?

    2. Michael says:

      This only applies to CanSino and perhaps the Russian vaccine, among the current candidates.

    3. confused says:

      Frankly, even if were certain, it might be a bit irresponsible to publish *now* when uncertainty is so high (esp as Forbes is an US outlet so should know about vaccine concerns related to the current administration & election is 2 weeks away!) and the vaccine isn’t being distributed yet.

      And nothing about COVID vaccines can really be certain since there are several different mechanisms being pursued.

  34. DataWatcher says:

    UPDATE: J&J Trials To Resume — “An independent committee investigated the case of a man in the trial who suffered a stroke and concluded it was not related to the vaccine.”

    https://www.msn.com/en-us/news/us/johnson-and-johnson-coronavirus-vaccine-trial-will-resume-soon/ar-BB1akWKb?li=BBnbfcL

    1. Marko says:

      Also AstraZeneca :

      https://www.businessinsider.com/astrazeneca-oxford-coronavirus-vaccine-trial-can-continue-in-the-us-2020-10

      “…The FDA plans to require AstraZeneca researchers to tell participants of the suspected adverse reaction, and monitor them for “neurological events,” the Wall Street Journal reported.”

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