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J&J Vaccine Data

We have more data on the J&J/Janssen coronavirus vaccine, which those keeping score at home will remember is an adenovirus vector candidate. It uses an obscure member of that virus family (Ad26) that very few people have ever been exposed to, as opposed to the ones where significant parts of the population might have pre-existing antibodies to the vaccine vector itself. And it’s also significant because it’s the only vaccine that’s in late-stage efficacy trials where the dosing schedule is a single shot, as opposed to a two-dose booster regimen.

So how does it look? The results in this preprint cover several trial arms – groups of volunteers 18 to 55 years old (Cohorts 1a and 1b) and those >65 years old (Cohort 3), at two different viral particle loading levels (one twice as high as the other). All of this was done in late July and early August. The first thing to note is that safety looks fine, so far – the usual site-of-injection reactions, along with some fever and fatigue in some patients. This was more noticeable in the younger cohort, which fits with the general trend of older patients having less reactive immune systems in general. Safety for all of the vaccine candidates is going to have to be established in the larger Phase III trials, of course, but I don’t think there’s anything to be worried about in these Phase I/II data (which feature about 400 people in each group). One patient was hospitalized overnight with fever, which was later determined to be vaccine-related, so we’ll keep an eye out for that.

As for antibody responses, it looks like one shot of the higher vaccine load leads to a higher response than the half-sized lower one in the 18-55 year old groups, but both of the doses showed strong seroconversion by day 29. And even that difference was not as apparent when neutralizing antibodies were measured, as opposed to total antibody titers: the two doses really look basically identical in that measurement. This paper has data from only 15 patients in the 65-and-over cohort, unfortunately, so it’s going to be risky to draw conclusions. But from what I can see (Figure 2 in the paper), their responses are broadly similar, but there’s a possible trend towards the higher dose actually being less effective. I’m not going to get worked up about that until more than fifteen data points are available, though.

What I do wonder about, though, is the comparison to convalescent plasma antibody levels. The total antibody measurements look quite similar, but frankly, the neutralizing antibody titers look higher in the recovered-patient panel than they do for the vaccinated cohorts (Figure 2B). I’m not sure what to make of this. The paper notes, however, that the 95% confidence interval overlaps between the convalescent plasma comparison group and both vaccine groups, though, and also goes out of its way to mention that some of the vaccine patients hit the upper limit of the assay and are being re-analyzed, which will raise the numbers there. So you can tell that the authors most certainly noticed this trend in the numbers, a feeling that’s reinforced by the discussion section of the paper where the lack of standardization of convalescent plasma samples is noted in detail.

We do have T-cell data, however, and this shows that both CD4+ and CD8+ cells are produced, with the former very strongly biased towards the Th1 response. The earlier experience with SARS and MERS suggest that a Th2-biased response runs the risk for vaccine-associated enhanced respiratory disease, so this is likely a good profile.

This is necessarily an incomplete report. As mentioned, there are only fifteen data points in the older patients, and there are several assays mentioned (such as a pseudovirus neutralization one) whose results will only be available later. But overall, this single-dose vaccination continues to look pretty strong, although we find ourselves right back where we always land at this point: waiting for efficacy data. Antibody titers and T-cell counts are useful and necessary (if they weren’t where they are in this report, that would be trouble). But they’re not enough, and we don’t know what “enough” might be. That can’t be overemphasized – at this point, all of these earlier-stage data are increasingly in the “Great, great, that’s nice” category (well, when they work!) because they’re going to be totally overshadowed by the real-world protection data that we’re all waiting on.

70 comments on “J&J Vaccine Data”

  1. Reader 2 says:

    Quite expected results, which correlate with data on adverse events and immunogenicity of component I (Ad26-S) of the heterologous prime-boost COVID-19 vaccine developed by Gamaleya

  2. ScientistSailor says:

    Derek, Have you commented on what the confirmed re-infections mean for the potential efficacy of a vaccine?

    1. Patrick says:

      Well, it seems to be extremely rare. So, at a population level: Nothing.

      1. Chuck Choi says:

        I don’t think you can safely conclude that yet. Re-infections have been rare possibly because community levels of virus have diminished since the original outbreak–opportunity to get re-infected is small. If it did exists you might see more re-infections. In any event, it’s been conclusively proved that re-infection is possible.

        1. Marko says:

          The main reason reinfections appear to be so rare is the stringency of the criteria defining a “confirmed reinfection” , i.e. , PCR+ plus genomic sequencing of the strain involved in both infections.

          What effect could this have on the number confirmed vs. the actual number ? Let’s say the odds of your viral strain being sequenced in the early ( first 3 months ) part of the outbreak was 1 in 500. Now , once reinfected , what are the odds that you’ll both seek a PCR test ( i.e. symptomatic disease ) and that your viral strain will be subjected to genomic sequencing. Probably 1 in 100 or less. Multiplying the odds , you get a 1 in 50,000 chance that both infections would have viral sequencing.

          So far , about 20 reinfections have been confirmed , so the actual number could be 20 x 50,000 = 1 million. If you take the earliest 20 million of the 34 million global confirmed COV2 infections as the pool from which you’d expect most of the reinfections to arise , that gives you 1 out of 20 primary infections resulting in reinfection.

          I don’t know if the odds I’ve suggested above are correct , but I’d guess they’re within a factor of ten. I pose these calculations only to illustrate that we simply don’t know how numerous reinfections are. They might be rare , or they might be much more common than we think.

        2. Marko says:

          In the first weeks of the outbreak in the US , the actual number of infections was probably hundreds to thousands of times higher than the reported infections , due to grossly insufficient testing. The same applies to reinfection. Due to the requirement for PCR-positivity and genomic sequencing of both the primary infection and the reinfection to declare a case a “confirmed reinfection” , the actual number of such cases could easily be thousands of times higher than the 20 or so reported to date.

          1. aviators99 says:

            In my opinion, thousands of times greater than reported is still the statistically equivalent of zero.

        3. Anon says:

          Have there been any peer-reviewed scientific studies proving that re-infections are possible with this particular virus that you can point me to?

          I hear about reinfections on the news but I don’t trust anything unless it’s peer-reviewed.

          1. chemist says:

            It’s just more bull-sh!te to keep people in fear of COVID. We were told “don’t wear masks,” “no wait, everyone wear a mask,” “it spreads on surfaces,” “no wait it doesn’t spread on surfaces.” Nothing about the public messaging on COVID has been consistent, by design. It’s a giant farce.

          2. Hopeful Layman says:

            We know that it can and does happen. What we don’t know is the frequency; what we also don’t know is whether a vaccine may bring about a more robust and lasting immunity. My own (uneducated) guess is that the vaccine, if truly effective, will mimick (or, if we’re lucky, exceed) the antibody load experienced by someone who has had a severe case rather than a mild or asymptomatic case. The optimistic conclusion would be that the immunity broght about by a good vaccine would be somewhere in the high end. We’ll no doubt still need a booster shot (hopefully no more than annually), but it should be enough to stem the outbreak, at least during the first vaccine rollout. (We’ll have to see what happens a year later, when people have relaxed a bit and might decide that since the crisis is over, they don’t have to go through the inconvenience of getting a booster, especially if the side effects are uncomfortable.)

            Also — let’s hope the promises to keep a vaccine affordable (“free”?) are borne out, and let’s hope they extend to the booster, as well. On my physician’s advice, I just took the first of my two shingles vaccines, and I was hit with a nearly $200 bill — and I have Medicare! I’m hoping the next one won’t be another $200 . . . we’ll see . . .

          3. DataWatcher says:

            C’mon, Chemist — if you’re really a “chemist,” you know that science is an iterative process; knowledge proceeds in stages. We’ve learned a lot about COVID, and we’re still learning. Those admonitions you’re talking about represented the “best estimate” at the time, given what was known.

  3. confused says:

    A probably very stupid question… why aren’t antibody and T-cell results enough?* Are there cases where a candidate vaccine had these results and still did nothing (barring diseases like HIV which specifically affect the immune system, maybe)?

    Or is the concern not ineffectiveness but safety (e.g. antibody-dependent enhancement)?

    *From a theoretical/biological mechanism perspective, not a “regulatory process leading to approval” perspective.

    1. Jacky says:

      Some experts (including some well-known ones) even insisted that first batch of vaccines will only reduce the severity of getting covid-19, so we STILL need to wear masks afterwards.

      Really feel desperate after reading what such experts like Eric Topol had suggested or agreed…(and who will be willing to get covid vaccine if they have to keep social distance afterwards?!)

      1. Matthew says:

        Of course you’ll still ha e to wear a mask after getting a vaccine.
        The vaccines are designed to prevent disease, not infections or infectiousness.
        You can get infected and spread the virus to your teachers, relatives, anyone you get within ten feet of, and potentially kill them because you didn’t want to wear a mask after you partied at the bar last weekend.

        1. Patrick says:

          Err, that’s not quite correct?

          The vaccines are designed to prepare the native immune system against SARS-COV-2.

          A less efficacious vaccine may only prevent disease rather than prevent infection – and there’s a good chance that’s what we get, especially at first – but they’re not *designed* for that. They’re designed to wham the damn thing as hard as can be done, modulo other safety concerns. They just may not reach that goal.

          1. Matthew says:

            All of the vaccines currently in phase 3 trials have “preventing disease” as the primary outcome. Not preventing infection.
            You can get infected and not be sick, and still transmit virus.

          2. Bertram Lee says:

            The vaccines dosage were determined to generate a measured immune response comparable to recovering covid-19 victims. This is may or may not be able to prevent infection or disease. Preventing disease is easier to measure than preventing infection. To measure disease prevention trial participants would have to be tested nearly every day for infection, and the number of people who would volunteer for such a trial would be much smaller.

            So it would be prudent to still wear masks after having the vaccine, and wait for post vaccine data.

          3. Patrick says:

            “All of the vaccines currently in phase 3 trials have “preventing disease” as the primary outcome. Not preventing infection.
            You can get infected and not be sick, and still transmit virus.”

            Right, as *primary outcome*. Because we want to have anything that works well enough to help. If the primary trial outcome were preventing infection, then we wouldn’t be set up to approve something that only prevented disease.

            “Primary outcome” is set for the lowest bar that regulatory bodies have deemed acceptable. And so it’s a goal for the vaccines, but they hope to do better.

            “The vaccines dosage were determined to generate a measured immune response comparable to recovering covid-19 victims.”
            OK, that makes sense, and obviously we do not know exactly what will happen. We actually don’t really know about reinfection in the general case – yes, a few people appear to have been reinfected (with I think even at least one reocurrence of disease), but we don’t really know how common reinfection is. (We are pretty sure reocurrence of disease is quite rare.)

            So yes of course, until your local population is broadly vaccinated with a vaccine known to be highl efficacious, you keep masking. No argument here.

        2. Hopeful Layman says:

          It’s universally agreed that masking and “distancing” will remain essential for some time after a vaccine is rolled out. I think it’s also universally agreed that, all else being equal, this won’t last forever (Fauci and others are still sticking to their “normalcy toward the end of 2021” prediction, altough it wouldn’t surprise me if that were a couple of months too optimistic). And there could well be variations on the theme — masking requirements eased for most outdoor activities, for instance. It will be a step-by-step, gradual process. And even then, it will not surprise me at all if the masks make reappearance during subsequent flu seasons, and/or if people who feel as if they’re “coming down with something” will continue to mask up (as they’ve been doing in Asia for years). At the very least, as someone with allergies, hay fever, and post-nasal-drip-related chronic coughs, I fully (and sadly) expect to be “shamed” and shunned a lot in the coming years!

          1. Dark Day says:

            It’s all about uptake — the best vaccine in the world won’t succeed if a significant majority of people don’t use it. My main fear is two-fold: (1) Too many Americans will continue to ignore safey measures during the time the vaccine is being rolled out, thus prolonging the problem; and (2) too many (probably a lot of the same people) will refuse to take it. A nightmare scenario would be a situation where millions of doses of vaccine are sitting on the shelves unused, while unmaksed anti-vaxxers run rampant through our cities and towns, continuing to spread the damn thing without compunction. It’s especially worrying to consider that a lot of younger folks are apprently mollified by the belief that they’re at relatively low risk of dying, and (at least thus far) they don’t seem to care whether they’re infecting anyone else with their behavior.

            THIS — what public health folks call “compliance” — rather than the mere existence / availability of a reasonably effective vaccine, will no doubt be the make-or-break (or mask-or-unmask) element of this saga. And given what we’re seeing right now in states like Florida, one is not overcome by optimism.

          2. Steven says:

            These things are very far from universally agreed. There are large numbers of people even now who think the masks and distancing restrictions are futile and not worthwhile given that Covid is essentially only a severe disease for the elderly. Once people are vaccinated, it is difficult to imagine that there would be many people willing to continue to tolerate masks and distancing.

          3. DroveTheWheelsOff says:

            I have no credential or expertise to mark this comment with, but all of the evidence and some simple observations point to the risk being dramatically different indoors vs out, especially during the day, when the air is unlikely to be stagnant. As best I can tell, wearing masks outdoors is symbolic (of no practical value) unless you are within a large crowd.

            Masks appear to be more likely to work indoors, especially when among many strangers or if in the same building for a number of hours.

          4. chemist says:

            “It’s universally agreed…” by whom? We can stop all this mask and social distancing madness right this second, without any consequences.

          5. Dark Day says:

            “There are large numbers of people even now who think the masks and distancing restrictions are futile and not worthwhile, given that Covid is essentially only a severe disease for the elderly.”

            Meaning . . . because it’s only “those people” (over 15% of the population) who are at risk of getting seriously ill and dying, the rest of “us” shouldn’t care if we put them at greater risk? Or maybe they shoud all just shut up and keep their fossilized old a$$es quarantined at home where they belong?

        3. confused says:

          Compliance with a mask mandate seems pretty poor *now* (at least here in TX). I really can’t see mask mandates persisting past a vaccine, except maybe in a few places like NYC where things were *exceptionally* bad so there’s more fear of it, even if they would be useful.

          1. Dark Day says:

            (To quote Matthew above): “You can get infected and spread the virus to your teachers, relatives, anyone you get within ten feet of, and potentially kill them because you didn’t want to wear a mask after you partied at the bar last weekend.”

            And this will slow down the pandmic . . . HOW?

          2. confused says:

            I didn’t say anything about slowing down the pandemic. I meant that I think once people get a vaccine they will stop being afraid of it.

            I was referring to what I *expect* to happen (without any statement as to whether it’s a desirable outcome or not).

            However, I don’t expect the pandemic to last all that much longer, even if people do give up. Respiratory pandemics rarely do; the last five (1890, 1918, 1957, 1968, 2009) were 1-2 years, and we’re already ~7 to ~11 months in, depending on whether you count from the declaration of a pandemic in March or the probable first cases in Oct-Nov 2019).

        4. Paul says:

          Hardly ‘universal’. Not for me.

          What is it with all this ‘we’ll have to wear a mask’ stuff? I’m tired of it. The body of evidence leans on the side masks are largely ineffective. You want to wear one be my guest. I got nothing against it. But mandating them is specious in my view. CEBM, NEJM, BMJ, OSHA and a host of other studies going back decades back this claim up. It’s the least effective of the NPIs. And quite frankly, the handling of masks simply make it futile. And that’s a fact. In hospital settings already it’s hard to practice proper handling. Plus we don’t even dispose of them right.

          This is a habit we should have never embarked on. It provides marginal benefits while having potential harmful effects on people. And spare me these artisanal cotton masks. Get real. Talk to real PPE experts. They’ll give you a nice lesson on masks. N95s, at the end of the day, are construction masks. I wore them when I worked in the industry. They are NOT meant for long-term, every day use. The valve may protect me but it sure ain’t protecting you.

          Hazmat suits. That’s it. That’s what works.

          And why are people dumb for not taking a vaccine? I’ve never taken a flu shot in my life and I’m pushing 50. Not against vaccines at all and my daughter has all the necessary ones. Just don’t feel the need and my doctor feels it’s a choice.

          Let’s please stop it with shaming people for their rational choices. Anti-maskers aren’t anti-vaxxers. I oppose masks based on the data. At best voluntary action is warranted not mandates. For most places in North America, you look from the point of mandates infection rates go up so spare me this talk. Again. Fed up with this. We can live with this.

          I’m seriously tired of all this. Covid this, Covid that. It’s serious, but it smells like hysteria.

          And this ‘proof of vaccination’. For the love of God. We’ve lived around viruses all the time. Why go this far? There are virologists who even think a vaccine may not be necessary. This is still a virus with, what, a 99.8% survival rate? Influenza kills across all age groups more than this virus. Let’s chill a little. We’re living for a vaccine. It’s nuts. I refuse to live this way.

          Outbreaks in restaurants are over-stated and we’ve scapegoated them. Now there’s a lot of politics in this. I find medical professionals are guilty of a little bit of fear mongering.

          I really have a problem with ‘vaccination papers.’ If you’re afraid, stay home. Let the rest of us get on with it already.

          Vaccination papers, masks with the vaccines….this tramples on personal choice. Liberty.

          What kind of live is this?

          Thank God for Sweden. Seriously. They’re back to normal. It’s like everyone ignores them.

          Cheers.

          1. WST says:

            “Thank God for Sweden. Seriously. ”

            Sweden quietly changed policy and starting week 34 did a lot of testing, actually doubled, recommends to stay at home if you are positive and..a new one, allows for family members of infected to self quarantine for a week. Sick children are not supposed to go to school any more. The chief epidemiologist stopped mocking masks and even said that “they may be useful in some circumstances”.
            So, no longer controlling the infection rate in a march to illusory “flock immunity”.

            “back to normal” – hardly, the new trend seen in FHM weekly report is a steady increase in weekly infections since 4 weeks, week for week increase is 1.1, 1.2, 1.2, 1.4 and preliminary 1.5 for the current week. The authorities are warning of a new wave of infections, all looks like a beginning of an exponential growth.
            Analysis of age of infections shows also increase in the group of young adults and children, followed by an increase in their parents age groups.

            have a look at :
            http://www.folkhalsomyndigheten.se/globalassets/statistik-uppfoljning/smittsamma-sjukdomar/veckorapporter-covid-19/2020/covid-19-veckorapport-vecka-39-final.pdf

          2. mzchem says:

            A German I know asked, “Have you ever been to Sweden?” when the social distance subject came up.
            “This,” pointing to the required 6 feet between us, “is about as close as they getin normal circumstances.”
            Customs, co-morbidity prevalence and countless other factors all contribute to a society’s or county’s experience.

          3. chemist says:

            This is all an unconstitutional power grab. The petty tyrants are having a field day bossing the general public around, telling them where they can or can’t go, forcing them to wear face diapers, threatening fines for not “quarantining” while perfectly healthy. These people need to swing from ropes, mainly Democratic governors and their lackeys. So now the “new normal” is that we shred the Constitution every time there’s a virus. No thanks.

          4. Dark Day says:

            I do continue to see predictions from public health policy experts that masks will remain with us indefinitely, as they have in many Asian countries. I’m not sure whether this means that they’ll be mandated, highly recommended, or simply used by people as just another everyday clothing accessory. Personally, I hope this is not the case; I find it incredibly alienating and depressing to not be able to see people’s faces. But I am also hearing, anecdotally, from a lot of people who say they’ve accepted the masks as the “new normal” and they feel no speical urgency about them one way or the other.

          5. Dark Day says:

            Here’s Dr. Fauci’s latest prediction, as quoted in the Philadelphia Inquirer today (10/15) — it continues to look as if we’re in this for the long haul.

            “Sandra E. Brooks, chief medical officer at Jefferson University Hospital, asked Fauci to predict how long masks and social-distancing will be needed. Fauci said that if the vaccine is 70% effective, and if some people resist taking it, many months will elapse before society reaches herd immunity.

            ” ‘You’re not going to have a profound degree of herd immunity for a considerable period of time, maybe toward the end of 2021, into 2022,’ he said. ‘I feel very strongly that we’re going to need to have some degree of public-health measures to continue. Maybe not as stringent as they are right now.’

            “He added: ‘It’s not going to be the way it was with polio and measles, where you get a vaccine, case closed, it’s done. It’s going to be public-health measures that linger for months and months.’ “

          6. confused says:

            Maybe in some states. These sorts of public health mandatory measures are basically state level.

            Some states — and it’s not all tiny rural ones, FL is one of them! – don’t have mask mandates *now*. So I see very little to no chance that masks will be broadly mandated after a vaccine becomes available to the public.

            In a few places that were hit hard, maybe, but not in general.

            I respect Dr Fauci, but I think he underestimates how quickly public fear (and therefore support for any kind of mandatory public health measures) will decline once a vaccine is available.

          7. Dark Day says:

            I don’t think Fauci underestimates people’s unwillingness to face facts at all. He’s been pretty forthright about expressing his frustration with it.

            As long as case positivity levels are at anything above diminishing levels, we’re all still at risk. That’s simply a fact. Even if a vaccine is upwards of 75% effective there’s still a good chance of contracting the virus (all the more so, given the apparentl reluctance of anywhere from 25 – 50% of Americans to take it). And I know I sound like the CEO of the Dept. of Redundancy Dept. here, but it’s not “only” senior citizens who’ll be at risk of serious illness and/or death. There are people of all ages with pre-existing condions, and there are plenty of examples of young, healthy people suffering serious morbidities for extended lenghts of time.

            Public “fear” may go down, but that’s called “denial.” (See: Donald J. Trump rallies) The data, not anyone’s “feelings” or “needs,” will determine what’s safe to do and when it’s safe to do it. And if people insist on ignoring this, well . . . I have one word for them: Sturgis.

          8. confused says:

            >>I don’t think Fauci underestimates people’s unwillingness to face facts at all. He’s been pretty forthright about expressing his frustration with it.

            Maybe, but then how does he expect widespread mandates to survive that long?

            >> As long as case positivity levels are at anything above diminishing levels, we’re all still at risk. That’s simply a fact.

            Sure, but there are levels of risk, and the political will to continue mandates depends on *perception of risk* not just *actual risk*.

            >> Even if a vaccine is upwards of 75% effective there’s still a good chance of contracting the virus

            Yes, but if it’s like the flu vaccine and reduces *severity* as well as *chance of infection* then it might not matter. Reducing COVID to a regular upper respiratory infection is still a win.

            >>all the more so, given the apparentl reluctance of anywhere from 25 – 50% of Americans to take it

            I am *exceptionally* skeptical this reluctance will survive to the time the general public gets a chance.

            >>The data, not anyone’s “feelings” or “needs,” will determine what’s safe to do and when it’s safe to do it.

            Yes, but it won’t determine what people do (either governments or individuals). If you are talking about being above or below an objective standard of risk, fine, but that’s not what will determine either the persistence of mask mandates, or the persistence of mask use.

            >> And if people insist on ignoring this, well . . . I have one word for them: Sturgis.

            See I think that exactly supports my point… in many parts of the US people will do stuff anyway regardless, and the authorities won’t impose public health measures to stop them.

            What % of the people who attended Sturgis do you think would now say it was a mistake? I’d imagine it’s a pretty small fraction…

          9. Dark Day says:

            I really don’t want to prolong this, but — with all respect, I care little for whether the Sturgis attendees regret having been there. The fact is that the cases from Sturgis spiraled out and infected people in many parts of the country — estimates vary, but one study estimated that upwards 200,000 cases can be traced back to Sturgis, That’s probably a bit extreme, but there’s no denying that it was a superspreader event, whether the people who went there think it was a “mistake” to go or not.

            Also, at least in states like Ilinois, I can guarantee 100% that regardless of what people are or are not afraid of, public gatherings such as festivals, performances in theaters and auditoriums, full-capacity bars and nightclubs, sports arenas and stadiums, etc. will NOT return to “normal” until a vaccine is widely available AND the numbers have gone down to diminishing levels. Some places might re-open, but methods will be found to keep attendees “distant” from one another (most likely by limiting capacity), and — at least for indoor venues — masks will still be required. That’s better than what we have now, but it won’t mean much of a payday for the performing artists or the venue owners, and it will still most likely feel pretty tense and stressful for all concerned. And people will NOT feel comfortable talking face-to-face, hugging/handshaking, etc. (which in the performing arts world is basically as natural as breathing). For that matter, a lot of folks won’t feel safe/comfortable attending the events, either.

          10. confused says:

            Yeah this conversation is probably reaching diminishing returns. And I think our different opinions of public response are driven by different locations/cultures – I can’t speak to Illinois as I’ve never been there except to change planes, but the public attitude here in TX is a lot different.

      2. Michael says:

        Jacky, I have seen Eric Topol interviewed in which he says that we will prevail over the pandemic — it will take tests, treatments and vaccines but he is sure it will happen. This isn’t forever and the disease will ultimately be attenuated for most people once their immune system isn’t naive due to vaccination or previous infection.

        As for post-vaccine restrictions, you would need to be very careful around unvaccinated people but, assuming high efficacy in preventing disease, you should be able to socialize with other vaccinated people once enough time has passed (for all of you) post-injection that the immune response kicks in. I agree with you that if it’s not an immediate easing for the vaccinated, there at least has to be a benchmark (tied to transmission rates or population percentage vaccinated) for easing social distancing for the vaccinated if they want to encourage vaccine uptake from lower-risk groups.

        And don’t give up on positive effects on transmission rates. Not all, but many animal challenge trials have seen lower viral replication, and for a shorter time, in the upper respiratory tract while protecting the lower respiratory tract. And two animal trials — one with Novavax’s vaccine and another with a Novavax-style vaccine — led to no viral replication.

        1. Hopeful Layman says:

          “. . .As for post-vaccine restrictions, you would need to be very careful around unvaccinated people but, assuming high efficacy in preventing disease, you should be able to socialize with other vaccinated people once enough time has passed (for all of you) post-injection that the immune response kicks in.”

          For this reason (and yes, I know this will be controversial) , in the absence of a governmental mandate (which apparently would be Constitutional, but would be politically infeasible in the U.S.), at least some private entities — restaurants, bars, performance/entertainment venues such as nightclubs, show lounges, auditoriums, gambling casinos, etc. — could have an impact by mandating that proof of vaccination would be required for entry (not unlike having show an ID to purchase alcohol). It might mean fewer patrons for a while, but it couldn’t be much fewer than the current “25% – 50% capacity” restrictions that a lot of places are being held to right now — and, in the long run, it would attract more patrons who otherwise might not feel safe going out. I’m sure there are plenty of other people like me, so hungry for normal human contact again that we would revel in the opportunity to gather safely together with other “vaxxers” in normal social settings.

          Such policies would also, one hopes, encourage vaccine “fence-sitters” to get vaccinated, just so they can join the fun. Let the vaxxers be the “in-group,” and the anti-vaxxers be the “other.” In other words, a “carrot” approach rather than a “stick” approach might be the most feasible, and the most likely to produce good results. (A significant piece of that “carrot,” I think would be the opportunity to spend time in the company of other “safe” people without fear, which is a feeling that I think many of us miss very deeply.) It’s possible, also, that this could lead to a kind of positive, proactive social “shaming” of people who refused vaccination (I could actually envision “Vax Parties” springing up around the country, making it “cool” to be vaccinated).

          1. Duncan says:

            OK – to play devil’s advocate back at you, where does that stop? When is this getting reversed? Are we going to shut down the world on a regular basis? Are we going to have daily screening for covid, and if so then why not a raft of other things too? Am I supposed to sever all my friendships and family relationships over this by act of government?

            For example I never had chicken pox as a child, yet I didn’t expect every child in my little girl’s nursery to be screened daily. Shingles is a nasty illness and I have an eye condition that potentially could be aggravated by shingles – and indeed ‘long shingles’ is very real.

            Here in the UK we’ve gone from a 3 week shut down to protect the hospitals to a 3 month shut down to flatten the curve to ‘it’s only a mask’ to it’s only an app that follows us around, tracking our movements to you have to have the app to get into buildings to laws to split up families. It is hard to shake the nagging suspicion that this stuff won’t be reversed. I get the sense that tempers are starting now to fray the more this starts to turn into a Margaret Atwood novel.

            One does not have to be a staunch anti-vaxer to see the problem with where we are headed with stuff like this – https://www.nejm.org/doi/full/10.1056/NEJMp2020926. It’s getting messianic now, this is the doctor playing God and a line has to be drawn. Health services are meant to exist to protect me, not the other way around.

            My favourite bit is, ‘Neither fines nor criminal penalties should be used, however; fines disadvantage the poor, and criminal penalties invite legal challenges on procedural due-process grounds.’ It is very literally breathtaking to read a statement like that in the NEJM.

            My Auntie was a nurse who finished her training during the 1969/70 Hong Kong Flu. She thinks we’re all mad, I’m inclined to agree.

          2. Hopeful Layman says:

            Duncan, I’m not suggesting an “act of government” — I’m suggesting volutnary policies on the part of venues that no doubt want their patrons to feel as safe and free to interact as possible. I’m cetainly not suggesting “shut[ting] down the world on a regular basis” or requiring daily screenings for covid or for “a raft of other things too.” No one has to sever any friendships or family relationshps, either. In fact, I’m hoping that if enough places where people like to congregate initiated policies like this, a lot of people would feel a lot more comfortable assocaiting with their friends in these places, knowing that they’d all been vaccinated as well.

            My suggestion has nothing to do with government mandates or with anything people do in private with their families. It’s an idea that I think could be both good for the pulblic health and profitable for the businesses. If youre keeping up with the news articles in cities where restaurants are re-opening, you’ll see that a lot of them are still in danger of going out of business because people are still fearful of going there. With a “proof of vaccination” policy, their patrons could know that the folks sitting at the other tables had been vaccinated, also, and so they could all feel a lot safer. I’m guessing that the result would be more — and more relaxed– diners.

          3. Kaleberg says:

            For example, airlines are considering requiring testing and a negative result before boarding. It’s as much about safety as the perception of safety. People stopped going to restaurants and other crowded venues before the official shutdowns. Those people are the ones more concerned with their own health and most likely to have taken health related measures in the past, something that correlates with higher disposable income.

          4. chemist says:

            If you’re so hungry for normal human contact why don’t you just go interact with people? The Covid hysteria has really rotted your brain huh?

          5. Hopeful Layman says:

            When I say “normal” human contact, I mean no longer having to mask our faces and stay at least six feet away from one another. I’m looking forward to that day, as most of us are.

    2. confused says:

      I was asking about why that data isn’t ‘enough’ in the sense of ‘enough to start vaccinating people’ (as an emergency measure, separate from trials) not anything about mask mandates or whatever.

      1. Dude says:

        Yeah you got zero decent response to your actual question, heh.

        To answer: it probably is “good enough.”

        However, drug approvals are now designed to let perfect be the enemy of “good enough,” because people have psychotic, irrational, System One reaction to anything to do with medicines in their body, and if something gets approved that has even the teensiest eensiest bit chance of some off reaction or illness, people freak out.

      2. cynical1 says:

        What I know about antibody dependent enhancement is all I need to know to want to see some clinical data in a whole bunch of people before I roll up my sleeve rather than trusting the Phase 1/2 data.

  4. Barry says:

    The BCG vaccine which protects against (rare) miliary tuberculosis, but fails against (common) tuberculosis infection on the surfaces of the respiratory tract is the prime example of why “antibody and T-cell results” may not be enough.

  5. Faust says:

    Not a big fan of any of the Ad virus vaccines.

    1. Oudeis says:

      Out of curiosity, why?

      1. Hoot says:

        1. Prexisting antibodies, sometimes highly prevalent in certain populations eg Africa
        2. One shot deal, so anyone vaccinated for COVID with a certain viral vectored vaccine cannot have a different vaccine based on the same vector
        3. Febrile reactions, obviously a problem

        1. Juan Escobar says:

          J&J is using an adenovirus to which very few people have been exposed. They are are only giving 2 doses using the same Ad vector t some people. Oxford/AZ also give 2 doses (immunogenicity has in the past been shown to be mainly against the antigen being carried by the vector rather than to the vector).
          The Russian vaccine used 2 different Ad for prime and boost.

          1. Steve Scott says:

            It is not really accurate to say that few people have been previously exposed to AD26. One study, involving the HIV and Ebola vaccines that used AD26, found that half the adults in sub-Saharan Africa and Southeast Asia had pre-existing antibodies against AD26. Another study claimed that 80-90% of Africans had been exposed to it, but only 10-20% of the population in the U.S. and Europe. That’s still a substantial number of people. Note that Johnson and Johnson’s previous AD26 vaccines used a booster shot of a different adenovirus.
            J&J expects one dose of its Covid-19 vaccine will suffice. But getting very little publicity is the fact that they are running a parallel Phase III trial with two doses, to see the difference.
            In any case, suppose the vaccine is only good for a year. Would a booster shot with AD26 work, or would the recipients have built up such a degree of immunity from the first shot that it would be rendered ineffective? However….here’s the response from a J&J collaborator.

            ” “Ad26 vaccine responses do not appear to be suppressed by the baseline Ad26 antibodies found in these populations,” because the titres are low, (Dan) Barouch writes in an email to The Scientist. Barouch has long experience with Ad26-based vaccines and collaborates with J&J on their COVID-19 vaccine.”

            https://www.the-scientist.com/news-opinion/vector-based-vaccines-come-to-the-fore-in-the-covid-19-pandemic-67915

  6. seth says:

    Will these Adenovirus vaccines be a problem for people with MS who should not take live or attenuated vaccines?

    1. cynical1 says:

      Vaccination in MS with live or attenuated vaccines are only not recommended for patients who are taking disease modifying therapies. That is more about what the drugs are doing to their immune system and much less about any issues with the immune system of the MS patient interacting with the vaccine. They also don’t recommend vaccination during a relapse but that is sort of self explanatory.

  7. exGlaxoid says:

    I think people are thinking too much. There will be limited supplies of whatever vaccine is approved first, which should likely go to high risk groups like medical, elderly, and teachers. Once they are done, we can prioritize by some more factors, but a desire to be vaccinated should be a big part of it. Once a substantial number of people are vacccinated, we should see a reduction in new disease cases and hopefully deaths, which will quickly show if the vacccine works in the real world. If it does, then schools, employers, assited living centers, etc and certain groups can require vaccination to enter, and I think we will find that the demand for the vaccine will be meet pretty well as manufactures ramp up. And if you use a Adenovirus vaccine, there will be likely a dozen or more other vaccines eventually available to use in the future. SO much of the worries are unneeded.

    And if people don;t want to get the vaccine (as 50% do now for the flu vaccine), then that is their right to be dumb. that saves more vaccine for the smarter people. Eventually people will either get a vaccine, get sick, die or the thing will fade out to a small risk. This has happened for every other disease in the history oif the world, and I see no reason to think Coovid will be different. No one lives forever, and that will continue. This to shall pass.

    1. chemist says:

      Or you could just stop being a baby, get the coronavirus and get it over with.

  8. Juan Escobar says:

    Did you notice that the dosing that is being carried forward for the next phase of the clinical trials in the lower, and exactly the same number of viral particles as Oxford/AZ? In the animal experiments J&J had used a much higher dose.
    The antibody count/neutralizing antibody data vs the range of convalescent plasma seems rather weaker than I would have expected for a single shot vaccine. In fact, given that data is only available to day 29 and not beyond -and that part of the cohort is on a 2 dose regime makes me think that the booster has not yet been ruled out. May depend on preliminary efficacy data.

  9. Noni says:

    This single dose regimen was requested by BARDA. early data suggested a booster may be required so now there are two phase 3 trials with the JnJ vaccine, one single dose and another, done mostly in Europe with two doses. Look them up on clinicaltrials.gov

  10. JasonP says:

    Speaking of vaccines….just a reminder…the 2020 – 2021 Flu Season has begun and the new Flu Vaccine is is available.

    I got my injection today, hope everyone reading this makes firm plans to get one too!

  11. Rudolf says:

    Now that Trump has received two experimental treatments not yet fully appoved by regulators. What should our attitude be to vaccines currently at a similar stage.
    Trumps medical team presumably judge the statistical risk to him from his Covid is much greater than any risk from the treatments.

    For vulnerable and priority groups the same is surely true for several of the vaccines already in P3 trials.
    No one is suggesting early or forced universal use, but surely those who would benefit most should have the option.

    This policy is already pursued in China and elsewhere with Sinovac and perhaps less responsibly in Russia. Treatments running in parallel with formal P3 trials.
    Shouldn’t we do looking at doing something similar?

    Every months delay costs thousands of deaths.

    1. chemist says:

      The HCQ prophylaxis, widely used in Asian countries like India, Singapore, Malaysia, etc. most likely contributed to DJT’s rapid recovery.

    2. Hopeful Layman says:

      Isn’t that more or less what EUA amounts to?

  12. Frank Smith says:

    This is such a great resource that you are providing and you give it away for free

    1. Chris Phillips says:

      It’s perhaps worth noting that in March Johnson and Johnson’s chief scientific officer commented about the safety of the adenovirus vector being used:
      “We have 50,000 people so far in the vaccine projects against different diseases who have received our Ad26-based vaccines and we have a very, very solid safety profile.”
      https://www.sciencemag.org/news/2020/03/1-billion-bet-pharma-giant-and-us-government-team-all-out-coronavirus-vaccine-push

  13. DataWatcher says:

    Maybe a topic for an entirely new thread (not sure if it belongs here, but this is as close as I can come) — We’re increasingly seeing predictions that a rollout of one or more “decent but not optimal” vaccines could inhibit the research and development of better second-/third-generation vaccines in the future. Basically, the argument is that if we have decent uptake of the first-generation vaccines, it will be difficult (and ethically questionable) to find enough unvaccinated people willing to participate in a study in which they have a 50% chance of getting a placebo, when they could simply go to the local pharmacy and take an already-existing vaccine that would provide at least some protection.

    One possible solution that’s been proposed has been to use an already-existing vaccine, instead of a placebo, as the “control” — in other words, the new trials would test efficacy of what have, against potential efficacy of what’s being developed.

    What do people here think about this? If we do get one or more safe and reasonably effective vaccines over the next few months, might this have dire unintended consequences for future research and development?

  14. DataWatcher says:

    “. . . test the efficacy of what WE have,” not “what have.” Typo — sorry!

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