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Vaccine Side Effects Q and A

So what’s the side effect that caused the J&J vaccine pause?

Blood clotting – but not the usual kind. This appears to be the same (or very similar) to the problem seem with the Oxford/AstraZeneca vaccine in Europe, and both are very similar to a known syndrome called heparin-induced thrombocytopenia. That involves unusual binding to a blood protein, platelet factor 4, and it occurs in rare patients when the blood thinner heparin is administered (leading to blood clots instead, the opposite of what it’s supposed to do). Something about the vaccine (again, in rare patients) is leading to the same kind of PF4 effect.

Is there treatment for this once it happens?

Definitely. There are  a lot of blood-thinning compounds out there that work through several different mechanisms. Most of the people who have shown this syndrome recover, but the key is recognizing it and treating it the right way. When a patient presents with symptom of a blood clot, one of the first-line therapies is to give them heparin, but if they have this syndrome going on, heparin will do nothing but make the clotting worse. A signature of the condition is that blood clots are forming when the patient has low platelet counts (thrombocytopenia). Most of the time when a patient presents with that in their blood work, they’re at increased risk of throwing blood clots, because their platelet count is low for some other reason. But in these cases of heparin-induced (or vaccine-induced) thrombocytopenia, it’s different – the platelets are getting tangled up in this odd protein binding event involving PF4, making their count artificially low.

So the key for people getting these vaccines is to be aware of the symptoms of this blood clotting problem, and for physicians to know how to treat it appropriately (not heparin!) It seems to take several days to come on, so people need to keep an eye out, but on the other hand, if someone has had the J&J or AstraZeneca/Oxford vaccine weeks ago and shown no problems, they should be fine.

How many people are getting this? What are the odds?

A key question, but one that’s still coming into focus. It’s complicated by the fact that we have surely missed some incidences of the syndrome, and by whether or not some people are more at risk than others. It’s possible that younger women have a higher incidence rate, for example, but that could change as we learn more. Likewise, older patients don’t seem to be at higher risk, from what we’ve seen. Roughly, the incidence might be around the case-per-hundred-thousand-patients level, but that’s a real back-of-the-envelope number, and it will change. Obviously, this incidence rate is going to be a major factor in figuring out how to manage the whole problem and its effect on the vaccination plans. Reports from various European countries on the AZ/Oxford side effects have not always lined up, so we don’t know yet how the J&J ones fit into the picture.

Why didn’t we see this during the clinical trials? Doesn’t it mean that things were rushed too much?

We didn’t see this because no one has ever run a clinical trial large enough to get any good statistical read on such rare events. Remember, the Phase III trials (the largest ones) involved about 20,000 patients getting vaccinated versus another cohort of thousands as controls. Now, for a clinical trial that’s a huge number, but it’s still not going to be powered to catch the per-hundred-thousand (or per-million) levels of side effects. As I wrote here the other day, that goes for all drugs, not just vaccines (and there are a lot of drugs that never hit those 20,000-patient clinical trial levels, either). This is why there’s a whole field called “pharmacovigilance” (PV), which involves watching closely to see what happens after a drug is approved and goes out to a far larger number of people than it has ever seen before.

As for the idea of rushed trials, they were indeed fast, but some of that speed was because we immediately ramped up to the high levels of patients right after Phase II. A development program over several years might have picked up hints of this clotting problem, but on the other hand it might well not have – and if you’d seen one case of blood clotting it would likely not have been enough to stop things. Recall that there was a case of transverse myelitis in the AstraZeneca vaccine trial that stopped it for a while in several countries, but there has been no increase in that since the vaccine was rolled out. Single rare instances of things like this are a real headache in a trial, because many of them are indeed “just one of those things” and not necessarily related to your drug candidate. All kinds of odd stuff just happens to people out of the blue at a very low level, which is something that I don’t think enough people outside of the clinical sciences realize.

It’s worth remembering, though, that all drugs can have very low-incidence side effects in people and that these can be difficult-to-impossible to predict. Most people, for example, can take penicillin antibiotics without incidence, but some people have strong anaphylactic reactions (all the way up to death). Similarly, a few people are people are allergic to aspirin, and this holds for many other drugs. You’ll notice a common thread of immunology here, which also ties in with rare events like Reye syndrome and Guillain-Barré. In that context, it’s worth remembering that the seasonal flu vaccine itself probably leads to about one case of G-B syndrome per million people vaccinated, but that’s on top of several thousand cases that just happen anyway.

Is there any way to tell up front who might be at higher risk?

You’d hope so, but we don’t know yet. No one’s ever been able to pick out who might be at higher risk of the heparin-induced thrombocytopenia that this resembles, for example. Knowing which patient groups might be at higher risk in general would be even more helpful – you could just recommend a different type of vaccine for them without having to give every single person a blood test or something.

Did the CDC and other authorities make the right call here?

We’re not going to be able to settle that question very easily. They were put in a more or less impossible position, one that happens pretty often in drug regulatory matters. You either end up looking like you’re killing patients by letting unsafe therapies through, or looking like you’re killing patients by denying them useful ones. “Unsafe” and “useful” are both words with a lot of sliding scales hiding inside them. For now, I think I can safely scorn the two far ends of the response to this issue, that is “Disband the FDA and the regulatory state!” and the “Ban everything that causes any level of harm!” position. There’s a hell of a lot of territory between those two.

Is this blood clotting happening with the mRNA vaccines, too?

No. That seems quite clear – to the best of my knowledge, there have been no reports like this at all with either the Moderna or the Pfizer/BioNTech vaccine. That’s good news, and it tells us a lot. For one thing, this blood clotting problem is not a general feature of trying to vaccinate people against the coronavirus. It also means that it apparently has nothing to do with inducing the coronavirus Spike protein in people, since that’s what both the adenovirus vectors and the mRNA vaccines are doing, in the end.

The version of that protein brought on by the AZ/Oxford vaccine is slightly different from the others (it doesn’t have a key set of protein-stabilizing mutations), and when the clotting problems showed up in Europe some people were wondering if that had anything to do with it. But the appearance of such side effects with the J&J vaccine would seem to rule that out. Instead, what those two have in common is that they’re both adenovirus vector vaccines. Oxford used a chimpanzee adenovirus, and J&J picked a less-common human one. Which means that if this is a side effect shared by adenovirus vectors, it’s shared at a pretty basic level, isn’t it? I’m not enough of an adenovirus jock to tell you in detail about the similarities between the proteins in the ChAdOx vector versus Ad26, and at any rate it’s probably more about the antibody response to these things (and why, in a small number of people, that goes awry with the PF4 protein).

What does that mean for adenovirus vectors, then?

It complicates things, for sure. As with all side effects, it depends on what disease you’re treating and in which population. Vaccines are in an unusual category here, since they’re being given to a vast population of people who are not sick yet – pretty much the opposite of a normal drug rollout! At the other end of that scale, as mentioned here the other day, no one would think twice about this level of side effect for treating an otherwise incurable disease with a high death rate (pancreatic cancer or the like).

J&J, for one, has been hoping to leverage their Ad26 platform into a number of other vaccines and therapies, and I believe that Oxford has similar hopes for their adenovirus vector as well. There’s always been a cloud on that horizon, in that you wonder if people who are treated with such vectors for one condition will have too high an antibody response to the adenovirus itself to be easily treated again. The mRNA platform doesn’t have as much to worry about in that regard – the lipids involved in the formulation don’t seem to set off an immune response of their own (from what I’ve seen, although there could always be some rare exceptions), and they don’t have the rest of the viral-vector machinery as immunological baggage.

This potential clotting effect is another cloud. One of the features of the vaccine response to this pandemic has been that we were finally going to see large-scale human dosing of these two platform technologies, head to head, and at least at the moment, it looks like mRNA is winning out. In this case, it looks like it’s (1) faster to deploy, (2) has manufacturing that is not dependent on the vagaries of cell culture in its crucial steps, (3) may be somewhat more efficacious, at least in this case, and (4) so far has a better safety profile. The competition is just beginning, but so far the mRNA tech looks to be ahead.

What does this mean for vaccinating the world?

More complications, unfortunately. One of the weak points of the mRNA vaccines is that the current ones, anyway, can have more demanding cold chain storage requirements. The logistics have been working out well here in the US, but they’re not going to work out so well in many other regions of the world, and the adenovirus vector vaccines have been more promising for wide distribution. We definitely could have done without something that slows down their rollout and adds to the uncertainties about who should be dosed – or adds to the uncertainties that many people might be feeling about getting vaccinated at all.

There are several ways out of this. One could plow ahead and just vaccinate away, side effects be damned, but since there are cleaner alternatives that doesn’t seem like it’s going to be as popular a strategy. As I mentioned in the previous post linked above, if there were no other vaccine alternatives that’s exactly what we would be doing right now – but that’s not our situation. It doesn’t help that the regions of the world that would have the most difficulty with the mRNA cold chain distribution are generally the ones that would have the most difficulty doing the pharmacovigilance for blood clotting problems and subsequent treatment.

If we can narrow down the at-risk patient groups for the adenovirus vaccines, that would help a lot. If there are other ways to store and distribute the mRNA vaccines, that would similarly help. And we could also use more vaccines – I would particularly point to Novavax’s recombinant-protein candidate as another one that apparently has easier storage and distribution requirements and already has some clinical efficacy data to make its case. There are plenty of other interesting and potentially very useful candidates in the works (more on this in a coming vaccine roundup post), but they’re further behind and time is tight.

256 comments on “Vaccine Side Effects Q and A”

  1. Anon says:

    Vaccines were developed in less than a year and were declared safe for emergency use..governments and scientists(!) all around the world pushed people to get vaccinated. Turns out there are some serious side effects and suddenly everyone is expected to be more cautious. A lot of people here were called all sorts of insults here for saying that they are not interested in getting vaccinated by a 6 month old experimental medicine. Fo a healthy and young person with no underlying problems, the choice is simple. It is a calculated risk and the odds are in your favor in my opinion.

    1. Gianfranco says:

      Did you even bother reading the post? Do you understand the concept of relative risk? I don’t think you do.

    2. Marcus Theory says:

      I agree tempers have been unusually high in the In The Pipeline comments. However, I think the choice is indeed simple, but in the other direction.

      The headline risk with COVID-19 is hospitalization and death, but there are a lot of unknowns about long-term health effects — and what we do know about “long-haul” covid is also unpleasant. One recent U. Washington study shows that 30% of non-hospitalized patients experienced persistent symptoms up to 9 months later, including 2% with the dreaded “brain fog.” There is also evidence of myocardial damage following infection.

      https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2776560
      https://jamanetwork.com/journals/jama/fullarticle/2776538

      I’m a young and relatively healthy person who hasn’t seen my parents in well over a year. I also have small children who will be unable to get the vaccine for some time (and I am not at all comforted by children being “less” affected — they also have more to lose from long-lasting damage). I jumped at the chance to get my first shot (Moderna) and I’m keenly looking forward to shot #2.

    3. georgeofthejungle says:

      If you calculate the odds, they might still swing in favor of getting vaccinated, even when you’re young and don’t have underlying health issues. A chance of ~1 in 100.000 of getting thromboses if you are a young female, likely less in men, and maybe a ~1 in 1.000.000 of dying from thromboses. What is the chance of getting sever covid, or long covid for the same age groups, given that there is a high likelihood that sooner or later they will contract the virus if they’re not vaccinated?
      In The Netherlands, 17 million inhabitants, about half of those <50, there have been 124 Covid deaths last year of people under 50. So 124 deaths in 8,5 million people, about 3000 have been hospitalised in that age group, and likely a multitude are suffering from long Covid.
      I think you suffer from what many people suffer from, they underestimate the probability of a passive action (take no vaccine), while they overestimate the probability of a active decision (take a vaccine).

      1. sPh says:

        If a person is susceptible to the clotting syndrome what is the probability it will manifest if they are infected with live SARS-COV-2 and develop active COVID19? If nonzero that would have to be factored out of the ultimate risk.

        1. Patrick says:

          I don’t know about any interaction with existing clotting propensities, but COVID itself causes blood clotting in some (many?) cases.

        2. Michael Turner says:

          The useful unit to do comparisons is known as the micromort. One micromort is a 1:1,000,000 chance of dying. https://en.wikipedia.org/wiki/Micromort

          There are some comparisons there like driving 250 miles by car is 1 micromort. Sky diving is 8 micromorts per jump. Skiing is 0.7 micromorts per day. Giving birth is 120 micromorts.

          If we put the chance of dying from the vaccine at 1:1,000,000 then that’s a 1 micromort. If it is 1:100,000 – that’s 10 micromorts.

          Living in NYC in May 2020 was 50 micromorts per day. ( https://www.nytimes.com/2020/05/22/well/live/putting-the-risk-of-covid-19-in-perspective.html )

          If we put the chance of dying from Covid 19 with an infection at 1% (648k cases, 7402 deaths – also in line with https://www.medrxiv.org/content/10.1101/2020.08.12.20173690v2.full.pdf ), that’s 10,000 micromorts.

          1. ThanosJr says:

            ‘Micromort’ should be the key concept in a sci-fi dystopia.

    4. Rock says:

      Another factor vaccine skeptics fail to realize is that it does not matter if the vaccines were developed in one year or five years. Clinical trials, no matter how long you run them will never pick up extremely rare adverse events. For non-chronic medicines, it is the number of patients not the length of the trial that is most important. And no company is going to have a million patients in their trial.

    5. Martin says:

      How are you supposed to detect 1 in 100000 or 1000000 adverse reaction that happens shortly after administration with LONGER and less rushed trial?
      The only way such thing could have been detected is via LARGER trials, administering the unapproved vaccine to million or millions of people.

      1. Terry says:

        This is true of short term effects. But you do know that deadly long term
        effects can appear with vaccines? Hence the need for long term safety trials. I also recall media reported cases with mRNA vaccines and sudden deaths and even involving thrombocytopenia (doctor in Fl). How was the vaccine ruled out in that case?

        1. Todd Knarr says:

          It really wasn’t. It’s pretty much impossible to rule out the vaccine. What they did was looked at the case and decided that between known factors that correlate with the same problem and the lack of other incidents the rate was about what you’d expect to see absent the vaccine. So, no particular reason to think the vaccine was the cause rather than it just being one of those things you expect to happen about that often anyway. That’s how all safety testing works: it’s never about the rate at which adverse events happen, it’s about whether that rate’s significantly above what you’d expect normally. I can’t tell you whether a set of dice is loaded or not from one single roll either, I have to watch a lot of rolls and see if there’s a pattern that deviates significantly from what I’d expect from an honest set (the fewer rolls, the larger the deviation has to be to be significant).

          1. Foxy says:

            Young otherwise healthy guys gets sick with a rare clotting disorder very soon after getting vaccinated. Take your loaded dice theory and stick it where the sun don’t shine!
            Knowing what we know now, this case should be revisited. Along with others reported to VAERS. Signal is evident with mRNA if anyone’s bothered to look. See other comments here. There’s a loaded dice alright…. loaded against the truth.

          2. Polite disgreement says:

            I’d say Foxy makes a great case – for active moderation of this column. There’s no need for such hostility and abuse, even if the conspiracy theory is acceptable, which it isn’t in my view. As to your main point, most of us are scientists here, Foxy. You might not like statistics but this is how we decide between cause and effect vs just bad luck.

          3. albegadeep says:

            Perhaps, rather than moderation, a way of verifying a user (like actually checking the email address exists and is owned by the poster). Then if a particular poster repeatedly (that’s important) posts messages with “hostility and abuse”, they can be removed. But NOT just for disagreeing. Polite discourse, including with people we disagree with, is how we all learn, and it can change opinions.

          4. Michael R James says:

            Young, otherwise healthy guys get blood clots randomly at a low baseline rate, even without the vaccine. The fact that regulators picked up on an extremely rare type of blood clot, even while the rate of blood clots in general was the same as in the unvaccinated population makes me more confident in the safety process.

    6. Todd says:

      The alternative to a one in hundred-thousand chance at death from an experimental medicine is a one in 85 chance of dying. For the young and healthy, the odds improve to…one in a thousand. So to avoid dying due to human hands, you’re going to up your odds a hundred fold in dying. And you forgot about the disability risks of Long Covid. GTFOHWTBS

        1. georgeofthejungle says:

          1.1 million suffering from Long Covid in the UK, with a population of about 63 million and so far 4.3 million diagnosed with Covid. So almost 1 in 4 seems to suffer from Long Covid. I personally know several cases. Scar tissue on lungs, heart issues (8 months after infection still a sky rocketing heart rate, ~150, when sitting at a desk, fatigue) and that with people 20-40 years old with bmi’s <25 and no known illnesses otherwise. Somebody with a light infection in december, triathlete, still can't train properly again. Can all be avoided with one or two vaccine shots.

          1. Craken says:

            The way to estimate number infected in the UK is to find the mortality rate and the number of dead. In the UK, IFR is ~1%, ~125,000 are dead = 12.5 million infected. That means long Covid would be closer to 1 in 11 infectees if these numbers were time-matched to the survey of long Covid, which they’re not. Using time-matched numbers 112,000 were dead 4 weeks before the March 6 survey in the Guardian article = 11.2 million infected. That is a 10:1 ratio of infected to Long Covid. Also: they define “long Covid” as any symptoms beyond 4 weeks. Four weeks is not a very useful time-frame to consider. But, they go on to say 700,000 have had symptoms for over 3 months; that’s more useful. It turns out that the time-matched numbers for that definition of long Covid also deliver a 10:1 ratio.

            This problem is potentially bad enough without exaggerating its prevalence.

            I noticed an oddity in the official ONS report on long Covid: 70,000 claimed symptoms for over a year as of March 6, 2021. Yet, the UK reported its first Covid death on March 5, 2020. This shows up a major problem with self-reporting, on which the ONS survey is based: people are careless and inaccurate.

          2. theasdgamer says:

            Or with early treatment with any number of antivirals.

        2. Not-an-epidemiologist says:

          Re. long covid — there was a recent (and excellent) prospective study in Nature Medicine that finally puts some firm numbers on this.

          Take home is that — while long covid is clearly a thing — it’s doesn’t appear as prevalent as people first feared. In the study, 13% had symptoms lasting longer than 4 weeks, 4.5% had symptoms longer than 8 weeks, and 2.3% longer than 12 weeks. The response was very much age-dependent, with a greater proportion experiencing long covid over the age of 50 (but never exceeding 21% of individuals with symptoms lasting 4 weeks or longer, for the 70+ age bracket).

          Ultimately, while there’s a reasonable chance that recovery will be longer and less pleasant than a cold or flu (not unsurprisingly, given that this a significantly more deadly disease), your chances of suffering long-term disability appear reasonably low.

          However … if you agree that those chances are low, then you shouldn’t be remotely concerned about being vaccinated with AZ or J&J, because the risks from those vaccines are three orders of magnitude lower.

    7. Eric says:

      It doesn’t matter if it took 10 years to develop–these extremely rare 1 in 100,000 to 1 in a million cases still would not have been picked up in a clinical study.

  2. A Nonny Mouse says:

    …… may be somewhat more efficacious, at least in this case…..

    The recent study of over 80s in the UK indicates that the AZ vaccine produces 3 times more T-cells than the P-B vaccine, which may be better for the longer term protection.

    1. Alan White says:

      That was only in the context of the first dose, was it not? From what I recall, and I may be wrong in this, the trials showed the 2nd dose of mRNA vaccines as having a much more significant impact in the overall immune response.

  3. Lane Simonian says:

    This is an excellent article, but I would add one point: there are indications that these rare blood clotting problems may also be caused by the Pfizer and Moderna vaccines.

    https://www.bmj.com/content/372/bmj.n699/rr-6

    1. Lane Simonian says:

      This commentary is somewhat more detailed and more specific.

      https://onlinelibrary.wiley.com/doi/10.1002/ajh.26132

      1. John Wayne says:

        Very rare side effects are probably associated with all therapies. We are finding them with Covid vaccines due the large number of patients combined with the overwhelming attention being placed on potential side effects.

        Below is an excerpt from the second article you posted. It’s all about relative risks.

        “Notwithstanding these concerns, the incidence of symptomatic thrombocytopenia post vaccination is well below the risk of death and morbidity from SARS‐CoV‐2 infection as also described on the Platelet Disorder Support Association (PDSA) website in the statement from the Medical Advisory Board.”

      2. Blaine White, M.D. says:

        I’m no anti-vaxer and have encouraged folks to get these vaccines. But these authors give every reason but Spike and Spike-immune complexes interactions with platelets. At the end of that article, look at the Conflicts Declarations. That’s why journals have started putting those in.

    2. Gus says:

      Then logically the only thing the viral vector and Mrna vaccines have in common is the spike protein – that’s the only common denominator right?

  4. KingPyrin says:

    You left out that they did see this in the trial. Quite a few cases of blood clotting, way more than the placebo group, and in people who you wouldn’t expect to see it in.

    You really should update the article to include that very important information.

    1. Gianfranco says:

      Source? This is not true.

    2. Derek Lowe says:

      You’re going to have to back that up with some figures – thanks.

      1. Marko says:

        Don’t hold your breath.

      2. thjread says:

        Don’t know about quite a few, but there was a single case of CVST with thrombocytopenia in the trial: https://www.nejm.org/doi/full/10.1056/NEJMc2106075

    3. Christian Weisgerber says:

      For actual figures, see the EMA’s Risk Management Plan, pp. 55-57.
      “Important Potential Risk: Venous thromboembolism”
      https://www.ema.europa.eu/en/documents/rmp-summary/covid-19-vaccine-janssen-epar-risk-management-plan_en.pdf

      1. Marko says:

        It took 33 minutes to get an answer to Derek’s request, so it turns out that my advice to him was sound. If he’d held his breath for that long, he’d be dead now.

      2. FoodScientist says:

        From the link you posted

        ” Natural infection with SARS-COV-2 has shown to be associated with
        hypercoagulability, pulmonary intravascular coagulation,
        microangiopathy, and VTE or arterial thrombosis. The occurrence of
        thrombotic and thromboembolic events in context of COVID-19 is
        associated with a poor outcome. The hypercoagulable state observed in
        patients with severe COVID-19 is thought to be related to the high-grade
        systemic inflammatory response, although other mechanisms such as the
        higher incidence of severe COVID-19 in individuals with risk factors for
        thrombotic and thromboembolic events have been proposed.
        It is unknown whether these proposed mechanisms linking COVID-19
        and thromboembolic events could also be applicable for vaccines against
        COVID-19.
        The available evidence from the clinical trial development program does
        not suggest that VTE is an important identified risk in participants
        vaccinated with Ad26.COV2.S. Nevertheless, due to the observed
        numerical imbalance and its potential life-threatening nature, the risk of
        VTE resulting from vaccination with Ad26.COV2.S, especially in
        participants with comorbidities associated with DVT and PE, cannot be
        entirely ruled out. Therefore, venous thromboembolism is considered an
        important potential risk.”

        1. Theo says:

          Id bet a dime to a dollar that whole inactivated vaccines will cause worse effects.. antibodies against epitopes and antigens are likely attacking the platelet bound proteins in these cases? When more epitopes present in the vaccine I think this is likely to lead to ADE and many other unknown autoimmune problems… just a theory

    4. Philip says:

      From the Pfizer FDA briefing document:
      https://www.fda.gov/media/144245/download
      “There were no other notable patterns or numerical imbalances between treatment groups for specific categories (system organ class or preferred term) of non-serious adverse events, including other neurologic, neuro-inflammatory, and thrombotic events, that would suggest a causal relationship to BNT162b2 vaccine.”

      From the Moderna FDA Briefing document (Table 27):
      https://www.fda.gov/media/144452/download
      Deep vein thrombosis from November 25 data set: 0 Placebo, 2 mRNA-1273

      From the J&J FDA Briefing document:
      Page 7: “Numerical imbalances were observed between vaccine and placebo recipients for thromboembolic events (15 versus 10)…”
      Also look at table 29.

      Keep in mind we are not talking about Deep Vain Thrombosis for what went wrong for the 6 young women.

      The FDA Briefing documents are a great, authoritative source of information about the vaccines. If you cannot back up your statements with the FDA documents or peer reviewed journal articles then head on over to some conspiracy web site.

  5. Some idiot says:

    For info: here in Denmark the authorities have estimated the incidence of AZ-related blood clots to 1:40 000. And completely halted use of the AZ in Denmark. Use of J&J suspended until word comes in from the FDA.

    I put a longer summary of the press conference on the end of the AZ calculations post.

    1. georgeofthejungle says:

      In The Netherlands the population under 50 is about 8,5 million.
      124 deaths –> ~ 1 in 70.000
      ~3000 hospitalisations –> 1 in 2800
      Cases of long Covid unknown

      But how high is the probability somebody will contract the virus? I’d say that’s quite high in the long term, currently it is at least 1 in 13 (1.3 million infections on a population of 17 million).

      1. Bubba says:

        Not everyone is susceptible to catching the virus or also catching it and showing symptoms … we still don’t know.

      2. theasdgamer says:

        Well, looks like we have achieved herd immunity in my county. Deaths started dropping long before hospitalizations and are down to 0.1/day. This occurred before vaccine rollouts. Cases are around what they were in June. Seasonal. But many people want the vax.

        Nurses appear to be 50/50 in my town.

        Covid mortality for the under 40 cohort looks to be far less than influenza. Vaccines may actually be more dangerous than covid if you’re under 40.

        1. Chris Phoenix says:

          No, COVID is more dangerous than adenovirus vaccines even if you’re just looking at severe effects. When you factor in brain fog, long COVID, and organ damage, the choice is obvious: get the shot.

          And that’s not counting the people you may kill by passing on the virus.

          And then there’s the newish variant that puts 3% of teenagers in the hospital.

          This is too important to be wrong about. Get the actual numbers. If you choose to go with emotion rather than actual risk… two healthy people close to me have died of COVID, and if you kill people by running your mouth or by spreading COVID, then damn you for a dangerous fool.

          1. theasdgamer says:

            One of the biggest problems with covid is the response. Admitted panic mongering by SPI-B in the UK has caused a lot of excessive fear over covid. People have become neurotic and dangerous. They have become afraid of other people and unreasonably afraid of microbes so much so that they are willing to restrict freedoms and support authoritarianism.

          2. theasdgamer says:

            There is no evidence that long covid is a serious problem for many people. You are merely latching on to anything in order to justify your fear.

          3. albegadeep says:

            theadsgamer,

            A relative of mine, who was otherwise healthy, died of COVID. A member of our church died from it as well. I know two different families that got it, and months later still have problems. And I’m an introvert – I don’t know that many people!

            That’s not “latching on to anything”, that’s personal experience – COVID is, in fact, dangerous, it’s killing people, and causing long-lasting health problems. My second shot is scheduled for a couple weeks from now, and I’m glad to have it.

          4. theasdgamer says:

            Fear inhibits optimum decision making. I lost a sweet sister in law, supposedly to covid. But we don’t really know what killed her. We haven’t had an autopsy done on her body.

            Covid PCR tests have been overcycled for a loooong time. The WHO a few months ago recommended drastically reducing the cycles. Cases are now dropping. Shock!

            You may have heard of OODA…Observe…Orientate…Decide…Act. This method doesn’t work when your emotions are being manipulated and the data is being fudged. You have to add Recognize and Deal and Filter.

            Recognize the game being played to manipulate your emotions. The UK’s SPI-B didn’t try to hide it. And the media certainly saw covid as an opportunity to generate clicks and add revenue.

            Deal with your emotions so that they don’t undermine your decision making. People don’t generally make optimal decisions when they are in a highly emotional state.

            Filter. You have to filter incoming data in order to separate signal from noise.

            So, instead of OODA, you need RDOFODA.

            Recognize…Deal…Observe…Filter…Orientate…Decide…Act

            Fear and Delegate are mind killers. Trust, but verify. Never delegate information gathering.

        2. Brit not abroad says:

          I assume from your followup posts that you live in the UK. If so then we hadn’t reached herd immunity before vaccination, nowhere even close. Antibody positive rates were between 10-15%. Our cases have come way down because we’ve been in lockdown for the last 3 months. Vaccination might have had a small additional effect so far.

          The Covid infection fatality rate for 30-39s is in the region of one in 2500, and for 20-29s is one in 10000, not remotely close to influenza.

          1. Charles H says:

            I’m not really sure that you can trust antibody tests as more than an indication of immunity. Several reports have antibody levels falling fairly quickly. And there’s also indications that recurrent infections are possible (though so far rare, and usually among immunocompromised people in the reports I’ve seen). Some argue that mucosal immunity is necessary. Unfortunately, it’s quite hard to test TCell based immunity. However *some* corona viruses have a very short period of immunity. IIUC, not all of them, and I don’t know whether reinfection yields a significantly milder disease. They generally just give one a cold, so nobody bothered to do a really careful study that I’ve heard of.

            Any assertion that “we’re nearly over the pandemic” is grossly overoptimistic. It *could* be true, but the evidence doesn’t appear to warrant anything approaching certainty. (Actually, in the areas I’m aware if, it would be grossly ignoring the data even with the most optimistic assumptions.)

        3. theasdgamer says:

          Brit,

          Not in UK. My county in the US publishes covid stats daily, along with a 7 day moving average. Our covid deaths peaked 12-23 and vaccines weren’t being given to the public until Jan.

          When the public health authorities won’t publish the cycle thresholds used for testing, you should be aware that something funny is going on. And the cycle thresholds have likely been lowered since the WHO recommended lowering them. So you have case data based on multiple different PCR cycle thresholds.

          This, of course, inflates covid death statistics, although it is not the only factor that inflates those statistics. So I am not too concerned with “covid” death statistics. (Conveniently, flu is now at phenomenally record low case and mortality rates. The stock answer for that is that nontherapeutic interventions work in the case of the flu, but not in the case of covid. Unless it helps the narrative. Or something.)

          People who have at least a little sense put little trust in public health data because public health officials are _uniformly_ hiding their PCR cycle threshold data. How can that be due to anything except a conspiracy?

          There is another big signal of bad faith on the part of public health officials. They were saying back in March to restrict the use of hydroxychloroquine, an antiviral, for hospital use. And at the same time we were supposed to smooth the curve to prevent overcrowding in hospitals. But antivirals keep patients _out_ of the hospital. And, oh by the way, back in Jan. 2020, the CDC was saying to give flu antivirals _early_ to high risk patients. This shows that the issue isn’t a lack of competence. What is left? Bad faith.

          1. TheRandomNameGuy says:

            I think asdgamer has a point here. Offhand, I’d say anyone who doesn’t have a contra-indicating condition is better off with the vax, and the public in general will be much better off after some critical % has had it. I also think it’s not at all unreasonable to think that politicians and the ph officials they choose to speak for them are up to some games. The PCR cycle # adjustment looks significant, and the use of a high-cycle test during times/places of low WCV prevalence makes it highly prone to producing inflated numbers.

          2. theasdgamer says:

            Random Name,

            Because there will be variants that avoid the vaxxes, antivirals will still be important.

    2. J says:

      https://www.bbc.co.uk/news/world-europe-56744474

      I put this report on another article.

      Thank you Derek for your comprehensive analysis.

  6. bewd says:

    I think Derek was referring to the unusual rare cases of low platelets accompanied with blood clots. I believe there has been case reports of Immune thrombocytopenia (ITP) with the mRNA vaccines.

    1. Blaine White, M.D. says:

      SICK Covid-19 patients often have below-normal platelet counts and clots.

      1. theasdgamer says:

        Isn’t coagulopathy a standard feature of covid?

        1. Joseph Scherzer MD says:

          You are absolutely correct. Among all these questions and best-guess answers so far I have only seen HCQ mentioned once, and Ivermectin not at all. There are ever-increasing reports about the efficacy of these therapeutics. Physicians NEVER suggest avoiding a safe, potential therapeutic until you are so ill that you require hospitalization. As a retired MD I was aghast to find governors and medical societies prohibiting off-label use of medications proven safe over half a century of use.

          1. theasdgamer says:

            I noticed early on that the people who said that they tried HCQ and found it didn’t work were ICU and ED doctors. Never a family med physician who said it didn’t reduce hospitalization. I saw the hunt for even one such person as a hunt for a black swan that could prove the null hypothesis.

            It has been over a year and no black swans sighted.

            Other evidence: 1. the generation of several high quality early treatment HCQ retrospective cohort studies on high risk patients (Derwand and Procter showing about 80% reduction in hospitalization), 2. Mokhtari’s retrospective report on 29,000 patients in Iran (probably 20% are high risk…6,000 high risk patients) showing death reduction of 70%, Brian Tyson’s report of having treated 2,000 patients early with his antiviral protocol (Includes HCQ, Ivermectin, zinc, vit. D, vit. C, etc.) with ZERO deaths and two hospitalizations and Tyson emphasizes the importance of aggressive followup, so there’s reason to believe that his loss to followup is very low, Robin Armstrong’s report of treating 39 nursing home residents with Zelenko’s protocol, resulting in only a single death (assume half are 80+ and should suffer 20% mortality with no early treatment…we’d expect about five deaths in that group, so it’s an 80% reduction in mortality)

            These reports have included some checking, so these are stronger than mere anecdotal evidence. Derwand had 100% followup (likely due to selecting for that characteristic from his data) on sequential patients.

            There’s nothing absolutely conclusive, but we believe that water is wet and that the sun rises in the east without conclusive research having been done.

          2. theasdgamer says:

            I should have written, “Never a family physician _who had tried HCQ for a few weeks_ and said it didn’t reduce hospitalization.

  7. jpo234 says:

    > If there are other ways to store and distribute the mRNA vaccines, that would similarly help

    The CureVac mRNA vaccine should complete it’s trial any day now. It just needs standard refrigeration (+5 °C for 3 months).

  8. Eugene says:

    The largest phase IV trial in history.

  9. Robin Schlinger says:

    Can KingPyrin (or someone) please advise whether there was any gender correlation in the “[q]uite a few cases” in the trial? With the J&J cases all pre-menopausal women and the medical director at Cedars-Sinai Women’s Heart Center (Dr. Noel Bairey Merz) apparently having stated “The ‘gold standard’ test to detect artery blockage…often doesn’t reveal plaque in women, as it is more diffuse and harder to see [and]…because aortic aneurysms are more prevalent in men, screening guidelines only applied to them, even though aneurysms grow faster and are more likely to rupture in women….”.

    If indeed “female subjects are ‘woefully underrepresented’ in cardiovascular research, even though heart disease is the number-one killer of women [and this heart center director cannot] overstate the need for sex-specific diagnostic testing…’”

  10. Ric C says:

    Decisions we make are ALWAYS about comparative risk. In the US, 6 cases of blood clotting in the month following 6 million shots is 1 case per million. European numbers are 1-2 per million, although somehow Denmark recently estimated 25 per million. Being reversible with treatment, fatalities should approach zero. Compare to auto accidents: 10 deaths per million, per month, in the US. Not reversible. If you refuse a J&J or AZ vaccine, you are being logical if you also refuse to ever ride in a car. If you refuse the vaccine, but routinely ride in cars, then you are being hysterical. The ultimate comparison is to COVID-19: the 2% death rate is 20,000 per million. Not reversible, either.

    1. CET says:

      “If you refuse a J&J or AZ vaccine, you are being logical if you also refuse to ever ride in a car.”

      This. It never ceases to amaze me how much energy people spend worrying about risks that are rounding errors compared to their daily commute or their diet.

      1. Charles H says:

        That can actually be quite reasonable when you factor in utility (for an individual interpretation of utility). If many low risks with low utility can be avoided, then you’ve decreased your risk exposure with minimal effect on your perceived utility.

        OTOH, it’s quite common for people to disagree about how they assess utility. So don’t expect this to yield a consistent decision making.

    2. Kaleberg says:

      Given 5.579e12 highway passenger miles in the US in 2019 [BTS] and 36,096 fatalities [NHTSA], a one in a million risk of dying is equivalent to driving about 155 miles. That means if your vaccination site is more than 39 miles and you need two doses, you are just as likely to die from the vaccine as the drive to and from. Of course, most Americans drive to a lot more places than just COVID vaccine sites.

    3. theasdgamer says:

      What are the risks of the various vaccines three years out?

      What is the risk of covid to someone U40?

      1. bewick says:

        depends where you live
        So far this month, according to government data, about 2,030 Brazilians aged 30 to 39 have died from Covid, more than double the number recorded in January. Among those in their 40s, there have been 4,150 fatalities in March, up from 1,823 in January, and for those 20-29, deaths jumped to 505 from 242.

        “Before, the risk factor to dying from Covid-19 was being older, having some co-morbidity,” said Domingos Alves, a professor of medicine who’s part of the national monitoring group. “Now, the risk is being Brazilian.”

        1. theasdgamer says:

          So what is the new infection fatality rate for people U40 in Brazil?

    4. Craken says:

      There is no evidence that the IFR for Covid is 2% in any country. In older countries, like Spain, the IFR was found to be ~1% with the variant circulating there 10 months ago.

      1. theasdgamer says:

        The numbers I have seen are estimates between 0.1% and 0.35%.

  11. John says:

    So correct me if I’m wrong here. From what I can gather, just about every single case of this has happened in younger women. Even the European AZ thrombocytopenia cases were almost exclusively in young women. So my question is, how does this not point to a bad combination with some birth control along with adenovirus vector vaccines?

    1. bewd says:

      uk data
      With more than 20m doses of the AstraZeneca vaccine administered in the UK, 79 cases of clots have been reported and 19 people have died, the MHRA chief executive said.
      Blood clot risk
      Of the 79 cases, 51 occurred in women and 28 in men – aged from 18 to 79 years of age. Of the 19 deaths, three were in people aged under 30, with 14 of these cases involving cerebral venous sinus thrombosis (CVST), and five ‘other types of thrombosis’ in major veins.
      don’t have the EU data to hand

    2. Martin says:

      EMA said there is no connection between birth control and AZ induced blood clots. The mechanism is probably different.

    3. bewick says:

      birth control along with adenovirus vector vaccines?

      if it was wouldn’t you expect the numbers of these clots to be much higher??

  12. J Curwen says:

    Could someone please explain me why the residual DNA amount of 10 µg in the mRNA jab is of no concern? That corresponds to 3.1 x 10^10 300 bp fragments. Nobody has ever looked at possible genomic integration events in combination with the new LNP carriers.

    1. J Curwen says:

      Sorry, obviously its 10 ng/jab…

    2. Omar Stradella says:

      Because there is no DNA in an mRNA vaccine

      1. J Curwen says:

        This just propaganda, 300 ng DNA/mg mRNA are allowed.
        30 µg mRNA/jab > 10 ng DNA.
        Reference:
        Quality rolling review CHMP overview and list of questions
        EMA/CHMP/641856/2020
        page 19/67: residual template < 330 ng DNA/mg RNA
        https://www.slideshare.net/enave2609/ss-242999249

        1. Omar Stradella says:

          <= 330 ng DNA/mg RNA is just the acceptance criteria, it doesn't mean that you should expect those quantities. In fact, the report says:

          "Residual DNA template is a process-related impurity derived from the linearised DNA template added to the in-vitro transcription reaction. Residual DNA template is controlled by qPCR and defined in the DS specification, and the levels for all five batches are demonstrated to be well below the acceptance criteria."

          1. J Curwen says:

            But you agree that there is a small amount of DNA in the mRNA vaccine?
            This DNA has never been tested in combination with the new LNPs for genomic integration.

  13. Ghyu says:

    How many people develop autoantibodies against PF4 but don’t immediately suffer from thrombosis? What if the cases we find are just the tip of the iceberg and adenovirus vaccines are also creating a much larger population that can’t be treated with heparin in the future?

  14. Possum says:

    “The mRNA platform doesn’t have as much to worry about in that regard – the lipids involved in the formulation don’t seem to set off an immune response of their own (from what I’ve seen, although there could always be some rare exceptions)”

    Derek, can you address the possible link between PEGylated lipids and adverse immune reaction? Both Moderna and Pfizer contain polyethylene glycol (PEG) in their composition. I know that people can have preexisting PEG antibodies, which may account for some of the adverse reactions we’ve seen. I have been digging through the literature and there’s accounts of elevated complement system activation in response to the PEGylated forms of some medications, like Doxil and Cremophor EL. I’m concerned that there’s an interaction occurring between the lipid nanoparticles and the complement system (its been called “complement (C) activation-related pseudoallergy” in some studies). This could explain some of the not-fatal-but-still-intense side effects people are reporting from the mRNA drugs, like massively elevated heart rate, changes in blood pressure, headaches, and even mast cell activation-like allergic reactions. I am particularly concerned by the number of women reporting unusual periods that are prolonged or weirdly clotted. It reminds me of immune thrombocytopenic purpura, which may triggered by PEGylated drugs (treatment with PegIntron caused incidents of thrombocytopenic purpura in hep C patients).

    If I’m barking up the wrong tree here, I’d love to be proven wrong. I was just terribly surprised when I started seeing a history of unusual lipid drug (particularly those with PEG) interactions with the immune system and the similarity of reported side effects. And before anyone says “the occurrence is so rare, who cares” – I get it and I’m not telling anyone to avoid the vaccine from this alone. I’m just a curious person. I feel like there could be a connection happening and want more brains than mine thinking about it.

    1. FoodScientist says:

      You have to think of it more like “a rare immune system variant having a reaction with a common drug”. Human immune systems are incredibly variable, for good reason.

      If you have a family history of ITP, then you probably shouldn’t’ get the adenovirus vaccine.

  15. luysii says:

    Hopefully this isn’t too snarky, but welcome gentlefolk to the world of the physician. Every decision we make balances risk and reward. No drug is without side effects. No surgery is without complications. It is good to see the readership wrestle with these things.

    But unlike the practice of medicine for far too long the readership is throwing actual data around and it’s great to see them reasoning with it.

    Controlled trials of therapy for stroke treatment and stroke prevention were thin on the ground. The definitive NASCET study on what to do with carotid stenosis came out in 1999. Trials of anticoagulation for transient ischemic attacks (TIAs) and stroke by the leaders of American and English neurology (Walton, CM Fisher, Scheinberg, Rose) in the early 60s involved too few patients to be statistically significant. They would never be published today. This is what I had to go on when trying to treat people. It was like quoting scripture. Father Fisher says .. ., Sir John says . .

  16. Marko says:

    Good thread on today’s ACIP presentation about the J&J vaccine and CVST :

    https://twitter.com/kakape/status/1382413725399912454

    1. Marko says:

      The main takeaway for me is this risk analysis, which shows that the “one in a million” story disintegrates when you focus on the group of women of age 20-50 :

      https://pbs.twimg.com/media/Ey9Qp9TXAAUkfZ2?format=jpg&name=small

  17. Robert says:

    As has been pointed out here, there were reports of thrombocytopenia and clotting with the mRNA vaccines. Here is a link to a New York Times article published Feb. 8, 2021:
    https://www.nytimes.com/2021/02/08/health/immune-thrombocytopenia-covid-vaccine-blood.html?searchResultPosition=1

    From the article:
    “It is not known whether this blood disorder is related to the Covid vaccines. More than 31 million people in the United States have received at least one dose, and 36 similar cases had been reported to the government’s Vaccine Adverse Event Reporting System, VAERS, by the end of January. The cases involved either the Pfizer-BioNTech or Moderna vaccine, the only two authorized so far for emergency use in the United States.
    But the reporting system shows only problems described by health care providers or patients after vaccination, and does not indicate whether the shots actually caused the problems.”

    I saw this at the time. Got the Pfizer-BionTech vaccine (both shots) later that month. No side effects for me other than a somewhat sore arm a day or so later. And I am glad I did.

    Nevertheless, it is somewhat curious that there has been such an emphatic suggestion that the mRNA vaccines are completely free of this risk.

    Having been in the drug discovery business myself for 35 years (retired now) I can appreciate that all medications are associated with some risk. The benefits here seem at this point to overwhelm the relative risk. But the pause seems justified if for no other reason than to caution patients and physicians about this, and particularly about the fact that standard anticoagulant therapy (e.g., heparin) would not be appropriate. That message has to get out.

    1. Marko says:

      “Nevertheless, it is somewhat curious that there has been such an emphatic suggestion that the mRNA vaccines are completely free of this risk.”

      The claim, properly made, would be that no cases of CVST with thrombocytopenia have been seen with the MRNA vaccines, but I take your point. If similar such problems do arise with the mRNA vaccines, I suspect the initial reports will come from outside the US. My faith in the FDA as an honest broker is a tiny fraction of what it was a few decades ago.

    2. Marko says:

      Some more slides from ACIP, the first of which summarizes the thromboembolic and hemorrhagic events reported to the VAERS system for all three vaccines, thru 4/9/21:

      https://twitter.com/abuttenheim/status/1382408933948657667

      1. Another Idiot says:

        Interesting.

        My own (decidedly non-quantitative or statistical) look at the data it would seem that the mRNA vaccines have marginally lower rates of these effects. No idea if the difference is in any way statistically significant. Not that VAERS data is in any way reliable, controlled, or valid either, but I would assume that there’s a lag time in physicians reporting things into VAERS that would favor the mRNA vaccines further.

    3. Foxy says:

      These deaths and SAE’s were ignored as background (best case) or covered up. I suspect the latter. In the EU there have been many instances of media blackouts or search engine hiding of vaccine adverse event stories. During the initial AZ pause only US media picked up on the death of a young medical student in Spain. At least this was all that was to be found on search engines. Very strange.
      In light of mRNA vaccines now being tested in children there needs to be a serious look at this potentially very real safety issue. Before some parent loses their child due to regulatory incompetence. There is no reason to vaccine kids or anyone in a statistically qualified at risk group from Covid. Or those individuals who have been given truly informed consent – expressly told that the length of immunity is unknown, the medium to long term safety benefits are unknown, protection from circulating variants is not guaranteed and future variants is unknown. The risk of ADE must also be clearly stated. THIS IS THE NUREMBERG CODE. I AND MANY OTHERS HERE ARE MEDICAL PROFESSIONALS AND IN THE DRUG DEVELOPMENT INDUSTRY. THESE ARE HUMAN RIGHTS FOR OUR PATIENTS.

      1. A Nonny Mouse says:

        The AZ vaccine wasn’t tested in Spain….. It was in the UK, Brazil and South Africa.

        There was a case of a young medic who died in Brazil, but he was not in the vaccine arm of the trial.

        Probably a mistake by the US source which is why there is no other account of this…..

          1. bob says:

            @Foxy, I cant help but wonder why your first thought is “it must be a conspiracy!” instead of numerous other possibilities? I mean mathematical odds of an actual conspiracy for this single story would be pretty astronomical:
            EU, with 1000s of media organisations and a fairly low record of media control decide to censor a fairly inconsequential story of a single student’s death… Despite the fact they’ve been taking a fair amount of heat when they started bringing these incidences of bloodclots to public’s attention earlier this year. Think of a number of people who would have to be involved to achieve that sort of suppression and for what benefit?

          2. WST says:

            All French main media carried the story next day, but you have to google in French, the language used in France.

      2. Philipp says:

        “In the EU there have been many instances of media blackouts or search engine hiding of vaccine adverse event stories”

        You are quickly outing yourself as a friend of “alternative facts”, i.e. conspiracy theories.

        1. Foxy says:

          Hey man- see my reply above, the links will need to be copied and pasted. Weird how no major national news outlets in the EU picked up on a healthy 24 or 26 year old dying soon after AZ vaccine. I’m afraid that you can do your own research there was denialism at the EMA around that time, assurances that there was no link, that the vaccines was proven safe and effective. Do your own searching. The truth is out there – in this case it is hidden.

        2. Foxy says:

          Ironically my reply seems to have been moderated out – it contained several links to news stories covering the tragic death of that 26 year old medical student in Nantes following the AZ vaccine. I still can’t find the story on any mainstream EU news channel. It was a sensitive time for the AZ shot, EMA vigorously denying safety issues while looking like the Astronauts at their press conference who just came back from the moon. Censorship, lies and media manipulation are undeniable facts. Prove me wrong. Show me that news in a European media outlet. Are the ones in China, US, Tanzania etc. reporting fake news?

          1. bewick says:

            Norwegian COVID-denier ‘dies of coronavirus’ after hosting illegal gatherings

            Hans Kristian Gaarder, a prominent conspiracy theorist in Norway, has reportedly died after contracting COVID-19.
            The 60-year-old had suggested the virus was “something that will be like a cold or light flu” and claimed restrictions were a means of “camouflaging that the coronavirus does NOT spread from person to person”.

            He is reported to have hosted two illegal gatherings at his barn in Gran on 26 March and 27 March, less than two weeks before he died on 6 April.

            Officials believe Mr Gaarder had been ill for more than a fortnight without seeing a doctor and may have infected others.

            While he had not been tested for the virus before his death, an autopsy revealed he was infected.

      3. Joseph Scherzer ND says:

        Thank you for being the first to even MENTION the possibility of ADE, seen in ferrets, cats and monkeys, which has proved fatal to these test animals. As yet, in my view, we simply cannot know if we will see antibody dependent enhancement in humans injected with the mRNA vaccines.

  18. A says:

    Any data or thoughts on taking aspirin prophylactically?

    1. Marko says:

      I think it depends on whether you prefer bleeds over clots.

  19. Gus says:

    excuse me I am a layperson. What I would like to know is:

    1. When the majority of people had this condition (ie not between 4 – 20 days or whatever but an actualy breakdown of how many people got it on day 5, how many on day 6 etc, their ages etc)

    2. Why do you need a second jab with the AZ – by tjat I mean specifically what does it do that the first didn’t – I am looking for a reasonably detailed technical explanation

    3. They say you are less likely to get this condition from the second jab – but could that be just because less people have had the second jab ?

    4. What are the potential long-term side effects of a viral vector vaccine (eg AZ) and if these come to light how long , if ever, does it leave your system ?

    5. Did the people who end up getting this condition happen to have worse initial side effects too ?

    1. JG says:

      For #1, see Case Reports section and Table 1 at https://www.nejm.org/doi/full/10.1056/NEJMoa2104882 … 5 health care workers (out of 132,686 vaccinated with AZ first jab in Norway) … hospital admissions with severe thrombosis and thrombocytopenia on Day 8 (37 yo female), Day 10 (42 yo female), Day 7 (32 yo male), Day 10 (39 yo female), and Day 7 (54 yo female)

  20. Jack says:

    If the clotting problem is related to the use of an adenovirus vector, then the reaction to the Russian Sputnik V vaccine ought to be examined. This vaccine uses an adenovirus 26 prime followed by an adenovirus 5 boost. It is in use in Russia, Belarus, India, Venezuela, and the United Arab Emirates.

  21. Daniel says:

    If this is a general adenovirus vector side effect, shouldn’t we also see this for adenovirus infections?

  22. Marko says:

    Gamelaya Center press release :

    https://sputnikvaccine.com/newsroom/pressreleases/the-gamaleya-center-statement/

    The free DNA theory may turn out to have legs, but Russia-bash away, nonetheless….

    1. CJM says:

      Here is a link to a 2013 paper in the journal Blood titled “Complex formation with nucleic acids and aptamers alters the antigenic properties of platelet factor 4.” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3709655/

      Bullet points of the article: In some instances, PF4 binds to double stranded DNA or double stranded RNA leading to an epitope that also binds PF4/heparin antibodies. A resulting immune response can then lead to heparin induced thrombocytopenia (HIT).

      This could support the free DNA hypothesis, but it doesn’t answer the question of the source of free DNA. Is it dose dependent based on adenovirus or is it a purification artifact as implied by the Gamelaya Institute press release?

  23. maehara says:

    “to the best of my knowledge, there have been no reports like this at all with either the Moderna or the Pfizer/BioNTech vaccine.”

    UK regulator noted in their press release on the AZ clotting that “Up to and including 31 March we have received 2 reports of blood clots (thromboembolism) reported with thrombocytopenia for the Pfizer/BioNTech vaccine. By this date, approximately 11 million first doses and 3.5 million second doses had been given.” ( https://www.gov.uk/government/news/mhra-issues-new-advice-concluding-a-possible-link-between-covid-19-vaccine-astrazeneca-and-extremely-rare-unlikely-to-occur-blood-clots )

    Where that falls as far as levels of concern go, not qualified to comment…

  24. Red Fiona says:

    Possibly related, I got my appointment call today and one of the questions was “am I on any blood thinners?”. I’m more concerned that my doctor’s surgery needed to ask than the vaccination 😉

  25. Albert says:

    I feel quite comfortable to call the AZ vaccine trial in UK a “rushed trial”, what can be more rushed than getting your math wrong on the dose?

    1. J says:

      Some reporting at the time

      https://www.bbc.co.uk/news/health-55086927

      Other articles available including Lancet. This was all handled correctly through the Regulators.

    2. Richard Head says:

      “The documents published in The Lancet confirm that the error lay with the Oxford researchers. A common emulsifier, polysorbate 80, used in vaccines to facilitate mixing, had interfered with the ultraviolet-light meter that measures the quantity of viral material, according to the documents. As a result, the vaccine’s viral concentration was overstated and Oxford ended up administering half doses of vaccine, believing they were full doses” (from Reuters)

      Then when the error was discovered they went back to the regulators who told them to carry on with the half-dose leg and to add another test group with the full dose. Which was done.

      Since nobody got the maths wrong, you’ll have to look for another reason to support your belief that things were rushed (as opposed to accelerated).

      1. E Ray says:

        You’d think they would have a qPCR release assay for the amount of DNA present in the sample, as well as a chromatographic UV method that separates the PS-80 from the adenovirus capsids…

  26. Blaine White, M.D. says:

    Does anybody know if serial platelet counts were done during the clinical trials? I offer a test of my worry this could go the choice of Spike antigen. Will we see any platelet depletion with NovaVax – a straight protein vaccine??

    1. Doug H MD says:

      not sure i follow you here

      1. Blaine White, M.D. says:

        Hi Doug. My worry is based on the bench lab studies showing that both the Spike protein itself and the Fc-end of the Spike-IgG immune complexes can activate platelets. That and the commonly diminished platelet counts and platelet microclots seen in SICK C-19 patients, who in fact have high antibody levels, suggests to me an Occam’s straight line explanation – Spike-immune complexes –> Fc-gamma receptor-Syk platelet activation –> hypercoagulability –> clots and platelet consumption. I don’t need to multiply causes to something like DNA fragments from vectored vaccines, and given that we have billions of cells bust and some unknown number of DNA NETs every day, that explanation stretches my credulity. If my worry were correct, it might not matter where Spike came from – direct mRNA, or DNA vector for transcription and translation, or straight Spike protein made by insect cells (Novavax). The test is whether Novavax also induces some platelet activation, consumption, and clots. I think we should be carefully looking for that with serial labs in trial subjects. – Blaine

        1. Lane Simonian says:

          Your explanation is much more simple and more likely to be correct.

          1. Blaine White, M.D. says:

            Exactly, Doug. And also Zlamal J et al. cAMP prevents antibody-mediated thrombus formation in COVID-19. MedRxiv 2020; https://doi.org/10.1101/2020.12.15.20247775.

            Your question about vaccine design is central. My personal “bookie bet” is Covaxin. It’s been developed by the major vaccine company Bharat in india and is a whole-inactivated virus vaccine (WIVV). Unlike similar WIVV preps from China, Bharat’s inactivation procedure should have minimally cross-linked or denatured the C19 proteins, thus leaving them well-exposed to the immune system. They used beta-propiolactone, which alkylates guanine nucleotides, to inactivate the virus; technical control of the reaction can minimize the lesser interactions with cysteine, methionine and histidine. In fact, this approach to a WIVV was effective in animal trials against 2003 SARS CoV (Roberts et al. Immunogenicity and protective efficacy in mice and hamsters of a β-propiolactone inactivated whole virus SARS-CoV vaccine. Viral Immunol 2010; 23:509–519). Bharat added an aluminum-based immune adjuvant, and the vaccine has been effective in primate and human trials, inducing antibodies against multiple C19 proteins and both CD4 and CD8 T-cell responses. Last month they reported 81% efficacy in an interim Phase-3 analysis of 25,800 study participants, with no serious complications. Serum samples from vaccinated subjects are effective against the current viral variants. The Indian government has issued an EUA, and the only current limitation appears to be production capacity. Bharat has now partnered with Ocugen (Pennsylvania) for the U.S. market. I’m hoping the broader based antigenic approach specifically targeting diversified T-cell production will maintain effectiveness against variants and avoid problems that we may be seeing with immunizing with lots of Spike only. I’ve had Pfizer (took my aspirin), but hope my one-time booster will be Covaxin or another more broadly based antigen set. – Blaine

          2. Cass says:

            Hi Blaine,
            One concern about beta-propiolactone is that there are several papers that suggest using it as the inactivating agent may cause a significant number of spike proteins to shed their S1 unit and move from pre- to post-fusion conformation. Coronavac also uses this method (is there some other prep difference from Covaxin?). Thoughts?

            Here’s one link: https://pubmed.ncbi.nlm.nih.gov/33058760/
            “Here we have shown that beta-propiolactone-treated SARS-CoV-2 viruses exhibit most of their spikes in the postfusion conformation. It is possible that β-propiolactone could induce this conformation change, yet we cannot rule out the effect of purification and concentration procedures… As of July 7, 2020… β-propiolactone was used in three of four candidates as the inactivation reagent (Chen et al., 2020; Gao et al., 2020; Wrapp et al., 2020a; Xia et al., 2020) (Table S3). One of the vaccine candidates, PiCoVacc, was purified and inactivated the same way as in this study, and not surprisingly also showed substantial postfusion spikes, even though a prefusion state was incorrectly claimed (Gao et al., 2020).”

        2. Doug H MD says:

          if that proves to be the case, what should future vaccines look to target if not the spike protein?

          1. simmtomm says:

            Sorry, response here to the entire thread above rather than to Doug H.

            Severely reduced pre-fusion Spike in a beta-propiolacton inactivated wholevirus vaccine will directly mean less of a neutralising antibody response and a possibly affected overall antibody response to Spike from vaccination. My assumption would be that the lukewarm protections from the Sinovac vaccine (as heard in the chatter, should be straightforward to find data) have their root causes directly there. We are effectively being given the result of a study, what protection a vaccination without neutralizing antibodies can give, and what the relative importances of neutralizing anti-spike antibodies versus the bulk of all induced T cell immunity plus all other antibody effects (including CDCC and ADCC) have. Kind of neat and provocative.

  27. theasdgamer says:

    We can look at pathology reports and see that cell-mediated immunity is involved in microvascular injury and thrombogenesis in covid.

    https://link.springer.com/article/10.1186/s13000-020-01017-8

    Is there a similar effect with vaxxes? It will take research to tell.

  28. theasdgamer says:

    A physician I know who occasionally deals with HIT (heparin-induced thrombocytopenia) was skeptical about any link between heparin allergy and any vaccines.

  29. Richard Ward says:

    Sadly we are now making perfect the enemy of the good. The bottom line is that both AZ/Oxford and J&J vaccines both have a very positive risk/benefit profile in the current situation. There is no point refusing vaccination with them waiting for enough mRNA vaccine supply to become available if your chance of dying whilst doing so is bigger than the risk from the vaccine.

    It seems to me that regulators have become massively over cautious here, perhaps thinking they themselves will get less criticism for allowing people to die from covid19 compared to a (much) smaller number dying from the vaccination (for which they would be criticised). This over caution also plays directly into the hands of the anti-vaxxers and leads to more vaccine hesitancy.

    1. theasdgamer says:

      I’ll go with antivirals over the vaxx, thanks.

      Given early, they are effective and have a known risk as opposed to vaccines.

      It will take years before we have a safety profile on vaccines.

      1. MK says:

        @theasdgamer Antivirals?? WTF? No antiviral is significantly effective.

        1. theasdgamer says:

          Here’s the science on antivirals ivermectin and HCQ:

          80% effective at reducing hospitalization and death if given within 4 days post symptom onset

          1. Tsar Lazarevitch says:

            I don’t see the “science” you speak of. however, I do see that you are using it “off-label”, which is definitely done at your own risk, and should never be construed as “good advice”; it certianly doesnt’ belong here in a forum where people discuss probabilities in real numbers based on peer-reviewed research,

            But if you like here’s the peer-reviewed on ivarmectin. Good luck!

            https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19

            Now, back to our regularly-scheduled programming after that commercial break for libertarian lunacy.

          2. theasdgamer says:

            Cool rhetoric. Do you also do science?

          3. theasdgamer says:

            Also really appreciated your eminence-based science. That will allow us to rid ourselves of expensive research and pesky data. Just rely on some pseudo-religious “scientific” clergy to tell us what to believe.

            Oh, btw, you can find a long list of research links at c19study.com .

            I click on the early tab to select out early treatment studies.

  30. Danish vikingj says:

    The unilateral Danish decision to completely scratch the AZ has raised some heated discussions in Denmark.
    Last night Lars Igum from the Danish newspaper Politiken was asked how explain the story, and to explain how the Danish authorities calculated that there were side effect in 1:40.000 of vaccinated people, which is more frequent than previous estimates of the AZ vaccine.
    He answered the following (this is my own transcription of selected points he raised in his TV speak in the Danish progamme Deadline):

    “In the UK more than 20 million people had previously been vaccinated by the AZ vaccine.”

    “After only 150.000 vaccination in Denmark, two cases were identified of the serious side effect, and one person died.”

    “Since the reports from Denmark and Norway we have seen similar results begin to emerge from other countries, suggesting that other countries may not have equally good means of detecting side effects.”

    “Denmark has 200.000 AZ vaccines stored in freezers right now. According to the new calculations this means than five people would get the specific kind of serious clots if they were used.”

    “By not using the 200.000 AZ vaccines, and instead other vaccines that are available, there will 14 days delay in completing vaccination of older people in Denmark which means one additional person will require emergency treatment.”

    So ist comes down to this: Five serious cases of blood clots (in possible younger individuals) versus one case of emergency hospitalization in one older individual.

    1. Chris Phillips says:

      He was asked to explain the basis of the estimate and he just repeated the estimate without explanation? And backed it up with another estimate that also wasn’t explained? And then compared the two unexplained estimates? .

      1. Some idiot says:

        This was at a press conference. The full description with background behind the decision can be found here (in Danish): https://www.sst.dk/-/media/Udgivelser/2021/Corona/Vaccination/Notater/Notat-vedr-fortsat-udrulning-af-COVID-19-vaccine-i-Danmark-uden-Vaxzevria140421.ashx?la=da&hash=BD137594D767A4C9C9C10DE443A042B728B4109E

        The estimate came from an examination of data from Norway and Denmark. The data has been submitted for publication (Reference 20; Anton Pottegård, SDU).

  31. Danish vikingj says:

    Several countries are interested in buying them, but I think the present strategy is to donate the Danish AZ vaccines to poor countries.
    Also, now that the J&J vaccine is possibly also associated with side effects the above calculations may be wrong. The delay in Denmark could be months, not weeks, and the disease burden may suddenly increase. So the calculations could be flawed and so the policies may change again (would not be the first time either…)

    1. Chris Phillips says:

      “Several countries are interested in buying them, but I think the present strategy is to donate the Danish AZ vaccines to poor countries.”

      My God – which is worse? Saying a vaccine is too dangerous for your own people, but selling it to someone else? Or donating it to someone poorer?

      1. Some idiot says:

        With all due respect, that comment does not reflect the context in which the news was released.

        It was clearly stated in the press conference (and in the backing paper) that the decision to stop using the AZ vaccine was a weighing up of risk/benefit _in_Denmark_right_now_… The relevant point being that (a) stopping the use of the AZ vaccine would only delay full vaccination by a few weeks, and (b) the epidemic is currently pretty well much under control here at the moment. Therefore, the calculated number of deaths/serious illness from continuing using the AZ vaccine_in_Denmark_now_ would be greater than the number of deaths/serious illness caused by delaying the “full vaccinated” by a few weeks.

        The authorities also said very clearly that if the epidemic had not been under control, then they would have continued the use of the AZ vaccine, because the risk- benefit ratio would have been different.

        So therefore, in my view, your statement is a bit too simplistic. In my view, a more realistic statement of the situation would be “The risk-ratio is unfavourable in Denmark, so we will donate them to a country where the risk-benefit _is_ favourable.”

        In my view, that sounds very morally reasonable: making sure that the vaccines can do most good. I accept that you may feel otherwise, but I really do believe that the issue is more nuanced than the way you expressed it.

      2. J says:

        Danish Health Authority, 14th April

        https://www.sst.dk/en/english/news/2021/denmark-continues-its-vaccine-rollout-without-the-covid-19-vaccine-from-astrazeneca

        “The Danish Health Authority has decided to continue the rollout at this time without AstraZeneca, but this does not exclude that we may re-introduce the vaccine at a later date if the situation changes. ”

        Apologies if this reply is not correctly ‘positioned’ – it is tricky trying to follow some of these threads.

        1. J says:

          Might interest – The Lancet 30th March.

          https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00762-5/fulltext

          “When making decisions on the use of drugs based on pharmacovigilance, it is important to take into account the natural incidence of illnesses, such as venous thromboembolisms, that might be interpreted as serious adverse events. Here, based on pre-pandemic incidence rates from the entire Danish population, we report that the number of venous thromboembolisms reported in relation to the Oxford–AstraZeneca COVID-19 vaccine does not seem to be increased beyond the expected incidence rate. Nevertheless, recent reports of thrombocytopenia-associated cerebral venous sinus thrombosis, multiple thrombosis, and bleeding within a short timeframe after receipt of the vaccine are concerning and are receiving due attention from health authorities. “

      3. Danish vikingj says:

        The calculation above is also an example of how it is possible to present the complicated issue of very, very rare vaccine side effects to the public without creating vaccine skepticism.

        (In short, vaccinating 200.000 Danes with the storage of AZ vaccines would at present result in estimated five cases of blood clots (mortality rate:40%). Whereas not using the 200.000 doses would delay the roll out 14 days and result in estimated one serious case of Covid in one older person.)

        One very positive thing that has come out of the pandemic is that many “lay people” have learned at lot about science, statistics, side effects by following the public media.

  32. J says:

    https://www.nytimes.com/2021/03/11/us/politics/coronavirus-astrazeneca-united-states.html

    This report is a month ago in the US. Are we running into ‘shelf life’ issues and potential waste in various countries across the world?

    1. Danishvikingj says:

      Perhaps the best solution would have been to first vaccinate all older people in the entire world and not the entire population of the rich countries first? Even if that was not a competely naive suggestion, would it even have a positive effect?

    2. Christian Weisgerber says:

      Shelf life of the AZ vaccine:

      Unopened vial: 6 months when stored in a refrigerator (2°C – 8°C)

  33. joh says:

    Assuming that one will need a booster every lets say 6 months and may need an
    “updated ” vaccine (for serious variants) every year —how will that influence your risk for associated clotting disorders? Will it be the same risk every time or increased risk? Can one assume that if you had no complication with the first vaccination , that you will be safe for any subsequent vaccination? Suppose time will tell and nobody will have an answer

    1. Danishvikingj says:

      Yes, time will tell. I guess the hope is that the mRNA vaccines will not cause clotting and could be used from now on. I think the EU has just placed an order of 1.8 billion Pfizer/biontech vaccines.

    2. Gus says:

      This isa very good question – anyone want to hazard an answer ?

  34. Hirudin says:

    Can you just take a cheap asprin a day before the shot to zero out your clotting risk ?
    Sure the shot may cause clotting but if there is a cheap and relatively safe fix like asprin why not use that where possible?

    1. E Ray says:

      Aspirin will do nothing for these very serious clotting events.

  35. J says:

    Hitting the press currently from Oxford University

    https://www.ox.ac.uk/news/2021-04-15-risk-rare-blood-clotting-higher-covid-19-vaccines

    Link at bottom to full report

  36. A Nonny Mouse says:

    A new comparison vaccines and Covid clotting events

    https://osf.io/a9jdq/

    1. sPh says:

      Thank you. That is exactly the question I was asking above, and the question that was missing from the “Things We Don’t Know” slide in the 14-Apr CDC staff summary presentation. If this study is confirmed the risk of severe clotting events following COVID19 is between 9x-18x the risk of such an event after the riskiest vaccine. Which leaves very much open the question of whether the people who experienced the events after vaccination were also at serious risk should they have contracted COVID19.

    2. bewd says:

      According to this study published , the risk of developing rare blood clotting known as cerebral venous thrombosis is about the same with (Pfizer) and Moderna’s Covid-19 vaccines as with (AZN). In both cases, the risk of blood clots is much higher in people who contract the Covid-19 virus.

      is this true??

      1. A Nonny Mouse says:

        Not necessarily; much smaller set and much bigger error bars

        1. Chris Phillips says:

          Hmm. Do people know of a larger dataset with smaller error bars for the mRNA vaccines?

          It seems to me that if this did turn out to be an intrinsic problem with all the vaccines, people would very much regret the bone-headed strategy of telling the public that a vaccine with a 1-in-a-million risk of fatality is unsafe, when the disease has a 1-in-a-hundred risk of fatality – and when quite possibly for most people the choice will be whether to get immunised by the vaccine or whether to wait for the disease to do it.

          Still, I’m fairly confident the bone-headed stupidity won’t spread far enough to prevent me getting my second dose of AZ in 7 weeks’ time. I hope it won’t, anyway.

          1. theasdgamer says:

            “when the disease has a 1-in-a-hundred risk of fatality”

            maybe if you’re 80+

          2. Not-an-epidemiologist says:

            I dunno, the R0 value of bone-headed stupidity appears to be even higher than covid, and there doesn’t seem to be any effective intervention or treatment.

            (The very fact that this study is actually being used to by some to suggest that “all vaccines are bad”, as opposed to “covid is so very much worse even if you only consider the risk of cerebral blood clots” being a case in point.)

          3. Chris Phillips says:

            Not-an-epidemioogist

            Yes. You’ve convinced me it’s a waste of time posting here.

          4. theasdgamer says:

            Not an epidemiologist

            You’ve convinced me that the anti-early treatment crowd isn’t interested in science.

        2. Jonathan B says:

          And more to the point, the data on the AZ vaccine is taken from a different study entirely, on a different population. So numerical comparison would be unwise.

          However I don’t think it is unfair to say that the data we have here suggests the risks of the two vaccine types are comparable, and in both cases more than in an unvaccinated (and non Covid-infected) population but significantly less than the risk of the same condition in those diagnosed with Covid-19.

          However putting numbers on the balance of risk also needs to take into account the way Covid diagnoses under-represent total cases, and the fact that not every vaccinated individual would necessarily have got Covid if they hadn’t been vaccinated.

      2. Marko says:

        I think the important thing about the UK study, if accurate, is that you can’t statistically distinguish the CVT risk difference between any vaccine because of the small numbers. It’s probably a similarly rare event in all of them. It could all boil down to the same rarity of persons who mistakenly get an IV vs. an IM injection, which might trigger any number of unexpected side effects.

        The importance of the revelations about the AZ CVT events (with thrombocytopenia) is that it awakened us to the need to avoid heparin until it can be determined that the event is not HIT-like. CVT of any kind is a nasty side effect, however, so I’m not so sure I’d choose to have an mRNA vaccine-induced CVT as opposed to one induced by an adenoviral vaccine.

        1. theasdgamer says:

          No reason to think that heparin need be avoided. Your thinking is just wrong about this.

          “Heparin-like” doesn’t imply heparin allergy chemistry.

          1. Marko says:

            Don’t tell me , tell the hematologists writing the guidelines for treatment. I’m sure they’ll be thrilled to hear from you :

            https://b-s-h.org.uk/media/19530/guidance-version-13-on-mngmt-of-thrombosis-with-thrombocytopenia-occurring-after-c-19-vaccine_20210407.pdf

          2. theasdgamer says:

            Lol @ eminence-based medicine

            Those hematologists are following a zebra strategy of overabundant caution.

            There are tests for allergy to heparin, you know. If heparin isn’t causing the “HIT-like” condition, no reason to avoid heparin or to think it will exacerbate things. Likely, heparin will help fix the problem unless the patient has a heparin allergy. It’s the heparin-antibody complex that brings on HIT. If that complex doesn’t exist, heparin treatment shouldn’t exacerbate existing thrombocytopenia. Whether to use heparin or not is a matter of weighing the risk.

            That said, using non-heparin treatment shouldn’t be a mistake from a purely medical perspective where cost isn’t an issue. And physicians might be a little cautious and watch patients like a hawk if they use heparin. (Which watching is actually delegated to nurses with instructions to call the doctor anytime if evidence of increased thrombocytopenia were to occur.)

            I’m sure the US will take a less cautious view and we’ll see some reports from people who have tried heparin.

          3. Marko says:

            “There are tests for allergy to heparin, you know. If heparin isn’t causing the “HIT-like” condition, no reason to avoid heparin or to think it will exacerbate things. Likely, heparin will help fix the problem unless the patient has a heparin allergy. ”

            That is exactly what I said: “The importance of the revelations about the AZ CVT events (with thrombocytopenia) is that it awakened us to the need to avoid heparin until it can be determined that the event is not HIT-like.”

            You don’t simply treat with heparin upon presentation. You run the anti-PF4 antibody test to see if heparin is allowable.

            First you said I was wrong. Now you say I’m right. Make up your mind.

          4. theasdgamer says:

            Marko,

            You are confused. Read the thread again.

          5. theasdgamer says:

            Marko,

            HIT tests are ordered _after_ symptoms of HIT occur…

            “When you are receiving heparin therapy and your platelet count significantly decreases (thrombocytopenia), especially when you also have new blood clots (thrombosis)”

            https://labtestsonline.org/tests/heparin-induced-thrombocytopenia-pf4-antibody

            U of Iowa recommends ordering PF4 test if HIT is suspected after giving heparin–not before

            https://www.healthcare.uiowa.edu/familymedicine/fpinfo/Docs/HIT%20Guide.pdf

            This may be standard of care in US hospitals. Three independent hospital sources confirm. Feel free to do your own investigation.

          6. Marko says:

            Boy, I bet the CDC and the all major Hematology Associations wish they had the benefit of your expertise, because they must also be very confused. They seem to believe that something has changed recently, and past practices need to be adjusted. They’re recommending HIT testing even when heparin has never been administered. You really need to straighten them out:

            CDC HEATH ALERT 4/13/21: Cases of Cerebral Venous Sinus Thrombosis with
            Thrombocytopenia after Receipt of the Johnson & Johnson
            COVID-19 Vaccine

            https://scdhec.gov/sites/default/files/media/document/10487-CHA-04-13-2021-COVID-19.pdf

            “For Clinicians:
            …3. In patients with a thrombotic event and thrombocytopenia after the J&J COVID-19 vaccine, evaluate initially with a screening PF4 enzyme-linked immunosorbent (ELISA) assay as would be performed for autoimmune HIT. Consultation with a hematologist is strongly
            recommended.
            4. Do not treat patients with thrombotic events and thrombocytopenia following receipt of J&J COVID-19 vaccine with heparin, unless HIT testing is negative.
            5. If HIT testing is positive or unable to be performed in patient with thrombotic events and
            thrombocytopenia following receipt of J&J COVID-19 vaccine, non-heparin anticoagulants
            and high-dose intravenous immune globulin should be strongly considered….”

          7. theasdgamer says:

            Marko,

            Lol @ your doubling down on eminence-based medicine from the gang that couldn’t shoot straight.

            Is there any scientific evidence (even an observational study that was rushed or even any reports of heparin-allergy linkage by clinicians) that HIT is a thing with vax-based clotting?

        2. J says:

          This has been posted before on another article I think. It may be of interest to some.

          https://www.theguardian.com/society/2021/apr/13/how-uk-doctor-marie-scully-blood-clotting-link-astrazeneca-covid-jab-university-college-london-hospital

          Thank you Marko for all your commentary which I follow with interest.

          1. J says:

            This has been posted on another article I think previously.

            https://b-s-h.org.uk/about-us/news/guidance-produced-by-the-expert-haematology-panel-ehp-focussed-on-vaccine-induced-thrombosis-and-thrombocytopenia-vitt/

            Following the exchanges and thread discussions is becoming a little difficult so hope it ends up in a useful position.

        3. Nigel says:

          This thread is getting confusing . There is a difference between CVST and CVST with thrombocytopaenia , or indeed any clot with thrombocytopaenia .
          Since you are never going to exhibit an anticoagulant without an FBC , you will always know the platelet count .
          Clearly with our current knowledge you would be three parts mad to exhibit heparin in the presence of thrombocytopaenia , and so , in accordance with the guidelines you would use an alternative and investigate. Should the antibody test be negative then you might consider changing to heparin , but I can see no reason to do so.
          Should you have no reason to suspect VITT ,ie no vaccine no thrombocytopaenia , then yes there is no reason to withhold heparin or check antibodies unless the patient goes on to develop HIT like problems.

          Reading the guidelines it seems urgent treatment with immunoglobulin is rather more urgent than anticoagulation.

    3. Tony M says:

      Table 1 of this report is very interesting:

      Of the 224 patients with Covid-19 who developed PVT:
      – 54.1% or 123 had past PVT; 57.% had Hypertension; 156 or 69.6% had Venous Disease; 163 or 72.8% had Liver Disease; 80 or 35.7% had Diabetes mellitus; 92 or 41.1% had Maligency; 47 or 21.0% had Ischemic heart diseases; etc, etc

      Of the 20 patients with Covid-19 who developed CVT:
      – 3 or 15.0% had past CVT; 5 had Hypertension; 5 had Ischemic heart diseases; 3 had Venous Disease; 5 had Chronic lower resp. disease; 5 had Diabetes mellitus; 3 had Malignancy; etc, etc

      Again what this paper highlights to me is the urgent need for more detailed accurate data on Covid-19. Specifically, we need to be able to specific specific risks from Covid-19/benefits of vaccines not just on age brackets but on age/sex/comorbidity;

      1. Gus says:

        /hi – to which paper are you referring exactly ?
        tx

        1. Tony M says:

          Research paper posted by A Nonny Mouse above on : 15 April, 2021 at 9:15 am:
          https://osf.io/a9jdq/

          Regards

      2. theasdgamer says:

        You’d have to look at relative comorbidity differences from the general population.

      3. Tony M says:

        For those interested, Oxford University has produced a Covid-19 Risk Calculator:

        https://qcovid.org/Calculation

  37. ELS says:

    Automobile travel in the US. Orange line is chart of annual deaths per million people. Deaths, not just treatable blood clotting events. If you want to make your life safer, get vaccinated and stop riding in automobiles.
    https://en.wikipedia.org/wiki/Transportation_safety_in_the_United_States#/media/File:US_traffic_deaths_per_VMT,_VMT,_per_capita,_and_total_annual_deaths.png

    1. Gimbal says:

      Yeah what a comparison, but the fact is that these experimental vaccines have only started their car journey and it’s been a very bumpy ride. Many have died as a result, lots of young people with potentially many good years left to live. Please don’t try and downplay unforeseen risks. Tell it like it is. Inform of unknown risk rather than compare it to those we know pretty well. It’s been well over a century for analysis of automotive adventure and misadventure. Within months we’ve had 2 vaccines paused or pulled, the remainder either aren’t very effective (according to Derek’s post here) or have big questions to answer regarding similar VITT issues, mid-long term safety is only a guess and initial efficacy signals could easily be outfoxed by viral evolution. Who knows what emerges next! Certainly not you or I. Each to their own. Immune priming can have disastrous consequences as seen with MERS and SARS vaccines. Fauci can keep his Ouchie and his double masks. I’d rather drive a Volvo, much better safety record.

      1. Redeemed says:

        “Gimbal” –

        I wanted to thank you for your considered scientific analysis of this terrible situation. You’ve changed my life.

        You see, (and this is hard to talk about) yesterday a bunch if monkeys flew out of my butt. I was convinced that this was a result of the flying monkey embryos that I had consumed the night before. But no! After reading your fine treatise on considering that unknown risks are more dangerous than known ones, I realized that this must have been due to the vaccine that I had received 8 weeks ago. I had seen reports (sorry, I can’t find the link) of this horrible side effect on web sites that people were unfairly mocking. But after experiencing them personally I can attest personally that they are very real.

        I highly recommend that people should weigh the terrible risks associated with vaxxeeens, lest the same fate befall them.

        1. Gimbal says:

          Hi Redeemed,
          You got a vaccine 8 weeks ago, if it was AZ the Jenner institute developed it, it didn’t work in their NHP studies and as you are clearly an ape I’d be a little concerned. They have a brutal track record of fudging and lying about preclinical results (do your own research, this is factual) and even worse carrying these lies to fund human clinical trials with non-efficacious and dangerous product – stuff of Nazi doctor experiments, trials of this vaaaaxxxx in SA were likely not conducted on any white kids so at least they were not apartheid too. Sounds made up? Do your own research. They couldn’t count their dosage properly either so the flying monkeys out your butt – simian virus and human embryonic kidney cells mixed in those hands…
          If you want to review the scientific evidence of previous disasters (for lab animals) with similar vaccines I can send you a link of collated articles as you clearly can’t do your own research. Before you decide to go down that rabbit hole I’d recommend that you see a shrink first as the shocking realization of the nature of the experiment you have entered into might be too much for your limited intellect to process. I always wondered if a lab rat could think, you’ve somewhat answered that question.

          1. Redeemed says:

            Gimbal

            Why are you being so nasty? I’m trying to warn the world about the dangers of vaxxeeens, like you are. We alternative fact guys have to stick together.

            I’m afraid that I can’t take your reference list. theadsgamer clearly said that information should not be collated by anyone else, and I believe everything he says, especially about not believing what anybody else says (he’s my pal, even though he does get cranky from time to time). That’s OK, though, I have my own list of references describing terrible vaxxeeen-related things, like vaxxeeen research camps for left-handed people on the far side of the moon, mass vaxxeeen deaths during the reign of Ramses I, and mind control nanite vaxxeeen delivery through 5G radio waves. I wouldn’t have believed them if I hadn’t seen them online. Horrible stuff. Just horrible.

        2. theasdgamer says:

          When those monkeys flew out I hope they didn’t damage your head before they exited.

          1. Redeemed says:

            Thanks, adsgamer! I appreciate your concern. But I’m fine – I always wear a Faraday cage on my head, to keep out the 5G.

  38. Brain wave (or brain fart) says:

    Something strange here, very strange. One in a million side effect emerges in 2 coworkers in an Austrian village, a trillion to one, damn near impossible. What else links the geography of these clusters? Geographic clusters reported in Italy, check, Norway check, Germany too. Landing and rapid deployment of batches (you’ll remember the side effects were thought to be batch related!) of AZ aside this is too much of a coincidence. Pity that the geographic locations can’t be properly mapped. Is there another extraneous factor at play? Prior or recent covid infection with a strain local to these regions has maybe primed this immune response after vaccination? Healthcare worker profile was certainly at high risk of exposure. Could something like this be partly responsible? Could also help to explain why some countries apparently have a far lower incidence like the UK.

    1. Matt says:

      Very good point. Could even be something as simple as the chemicals they use to treat water in that area or some other environmental factor in that area. Or yes – batches. Could batches have been contaminated somehow in some areas ?

      1. Arty says:

        Probably as the adverse reactions are not 1 million to one, more like in the tens of thousands to 1 and are drastically under reported. Somebody on here commented that there was a conspiracy theory about a young medial student in Nantes dying soon after the AZ vaccine. I took the time to look into it, there is indeed a huge amount of coverage but very little or none from the EU, including one story from the UK (belittling Macron’s skepticism of Oxford’s finest vaccine)
        https://www.express.co.uk/news/politics/1413711/AstraZeneca-vaccine-safe-France-Emmanuel-Macron-student-dead-Nantes
        Turns out the guy was right and was wrongfully attacked.

        1. Mariner says:

          I read an article on the Financial Times website earlier today (don’t have the link to hand, I’m afraid – it was fed to me on my phone by Google), which indicated that the most up to date numbers available from the MHRA (up to 5th April) counted 100 cases of these severe clotting incidents in the UK with 22 deaths. This from around 20 million doses of the AZ vaccine used.

          My initial take away from this was that increased vigilance must be allowing suitable treatments to reduce the fatality rate. We’ve gone from 79 cases and 19 deaths (1 in 4 death to case ratio) up to 31st March to 1 death in every 7 of the 21 cases which have arisen the following week. This assumes that this is a fair reflection in the numbers. No idea about the age breakdown of these 21 ‘new’ cases, however. I don’t believe that was mentioned in the FT article.

          Regardless, this seems a very, very long way from the claims of a case of these severe clotting incidents per tens of thousands of doses given.

          1. bewick says:

            It does seem now that every blood clot and death will be linked to the Vaccine whether its the cause or not? for example the latest fatality in Australia
            https://www.theguardian.com/australia-news/2021/apr/16/australia-records-first-fatality-from-blood-clots-linked-to-astrazeneca-covid-vaccine

            “In relation to this case, VSIG agreed that the case was consistent with causal association to immunisation although for this patient, anti-PF4 antibodies were absent,” the TGA said.

            Anti-PF4 antibodies which activate platelets have been found in almost all other cases reported internationally of blood clots with thrombocytopenia associated with the AstraZeneca vaccine.

            The TGA said despite the atypical clinical features and the negative antibody test a causative link to vaccination should be assumed.

        2. WST says:

          How true, the Nantes student cover up is terrible, only some marginal French media reported it:
          Le Figaro
          Le Monde
          Ouest-France
          France 3 Region
          France24
          Le depeche
          LCI
          Europe 1
          L’Expresse
          20Minute
          Le Parisien
          Huffington Post
          Le dauphine
          La Croix
          Le Midi Libre

          1. Arty says:

            This is getting stranger. I take it you didn’t google search from within the EU? Any Europeans willing to try a google search?
            Enter “vaccine death nantes” and you won’t find those stories, pages 1,2,3 all from obscure non EU news sites. So the cover up is real after all.

          2. Bill says:

            This is weird. Media blackout is real. Someone in the EU please google ” vaccine death nantes” see what comes up on page 1,2,3… obscure non-EU stories. Makes ya think. I’m pretty certain WST didn’t search from within the EU

          3. Nigel says:

            Don’t know how obscure you think the daily express is .
            https://www.express.co.uk/news/politics/1413711/AstraZeneca-vaccine-safe-France-Emmanuel-Macron-student-dead-Nantes
            First result on a page full of reports.

          4. Arty says:

            Is the UK in the EU again?

          5. WST says:

            RE: Arty
            If you want to know if French media related the death in a French city of Nates, please do a search in French, which is the language used in France : “vaccine décès nantes”
            Then of course knowing major French media is also helpful, the major ones reported the event next day and are present in my list.
            (check out en.wikipedia.org/wiki/Mass_media_in_France)

            You can also change a search region in Google “settings”.

          6. Arty says:

            What multiplier would you put on this vaccine death? Say the average age of covid “death” is 80 years plus and this guy was 26. 50 times worse or 100 times worse? We also have to factor in that lots of people have innate immunity to the virus. Unknown how many but the risks of covid killing a 26 year old are pretty remote.

          7. Arty says:

            Thanks for the search tips… Germany is Frances neighbour. Der Spiegel und Das Bild are two of the main national newspapers/online media outlets Search for results from Germany ‘impfstoff tod nantes’ and add ‘spiegel’ and ‘bild’ – you’ll curiously draw blanks. You can easily repeat this exercise in neighbouring Spain if you like.

  39. EditrixR says:

    I’m thinking I’m not buying stock in any companies working on developing adenovirus-based delivery of anything because it’s starting to look like they’re a bad idea across the board. The first death in a gene therapy trial, in 1999, involved a clotting disorder that due to a weird immune reaction to an adenovirus vector.

  40. Michael Bell says:

    This is a good approach, and fortunately there are two other vaccines in the US with plenty of supply, and supplies of those are ramping up quickly. So this delay for the J&J shouldn’t affect us too much.

    If on the other hand, the J&J was the ONLY covid19 vaccine, it would NOT have been put on hold simply because 6-7 cases out of 7 million would clearly justify the risk of administering the vaccine.

  41. IreneJ says:

    I am an ENSEMBLE (J&J vaccine phase 3) participant and I am a little surprised by that many media state that this adverse reaction was not picked up in the clinical trial and unexpected. All ENSEMBLE participants after October 2020 received a very clear explanation about the fact that one study participant developed a serious blood clot in the brain. And this was found when the sample size was small (n = around 1000).

    In fact, I vividly remember that this was the most important topic during the orientation (one-on-one with a medical doctor). All participants have this disclosure in the written format.
    I am not selectively remembering this as a retrospective confirmation bias after the recent news. I work in the biomedical field, and I was paying very close attention last year and this was the biggest potential risk. My guess is that they applied causal scoring like Bradford Hill criteria and couldn’t exclude it as a random event. I appreciated their disclosure.

  42. Hudson says:

    I’m not a scientist…just wondering how this factors in…?

    https://onlinelibrary.wiley.com/doi/10.1002/ajh.26132

  43. bewick says:

    Johnson & Johnson privately asked other vaccine manufacturers to join a study of blood clot risks, reported The Wall Street Journal
    Only AstraZeneca, which has been dealing with reports of patients suffering blood clots after receiving its vaccine in Europe, agreed to join the study
    Pfizer and Moderna declined the offer, saying their vaccines appeared safe and over worries about tarnishing their reputations by association

  44. bewd says:

    In short, a single dose of the Oxford–AstraZeneca COVID-19 vaccine was shown to be very immunogenic in previously naïve individuals and able to induce antibody levels that exceed those following a mild or asymptomatic natural infection.

    https://www.medrxiv.org/content/10.1101/2021.04.09.21255194v1

    1. Marko says:

      Thanks, that’s an interesting paper. I’d question the direct comparison of antibody levels between naive vaccinated vs. seropositive unvaccinated, without knowing that the sample timings were consistent for peak antibody levels. It’s hard to find such comparisons that are really apples-to-apples. For the vaccinated, 4-5 wks post-vaccine may be close to the peak, but the convalescent plasma samples used would have likely had variable and perhaps much longer times post-infection. The half-life of antibody titers from the peak is on the order of ~2 months (varies dependent on assays used), so this matters in such comparisons.

    2. theasdgamer says:

      Hmm, could those levels become toxic and cause a clotting cascade? We may have antibodies against antigens that aren’t problems if antigen levels are low. Maybe some immune shutoff gets overwhelmed somehow?

      Just swagging…

      1. Derek Lowe says:

        I can’t stop any particular person from posting here, but at this point, I have to say that I would not be upset if you could find some other forum for your views. I honestly think that you went beyond any possible benefit to yourself and to the other readers here quite some time ago, and I’d recommend reconsidering how you’re spending your time.

  45. Marko says:

    Today’s NEJM:

    Pathologic Antibodies to Platelet Factor 4 after ChAdOx1 nCoV-19 Vaccination

    https://www.nejm.org/doi/full/10.1056/NEJMoa2105385

    1. Marko says:

      And:

      SARS-CoV-2 Vaccine–Induced Immune Thrombotic Thrombocytopenia

      https://www.nejm.org/doi/full/10.1056/NEJMe2106315

    2. Marko says:

      J&J responds:

      Thrombotic Thrombocytopenia after Ad26.COV2.S Vaccination — Response from the Manufacturer

      https://www.nejm.org/doi/full/10.1056/NEJMc2106075?query=featured_coronavirus

  46. Marko says:

    Better late than never, I suppose :

    White House funnels $1.7 billion to help track and fight coronavirus variants

    https://www.msn.com/en-us/health/medical/white-house-funnels-2417-billion-to-help-track-and-fight-coronavirus-variants/ar-BB1fIOBA

    1. Danish vikingj says:

      Thank you!

  47. DocD says:

    Seeing Bell’s Palsy in young vaccinated people – probably unrelated background cases and temporal association only? If the vaccine is causing this immediate nerve related harm it augers very badly for long term safety. Very concerning

    1. Nigel says:

      Bells palsy is not uncommon . How many have you seen?

      1. Docd@yahoo.com says:

        Two so far, iatrogenic rather than idiopathic in my mind. No previous history for either. Not signal stuff but very unexpected

    2. Gus says:

      Please elaborate, Exactly what would it indicate for long term and how long term are we talking?
      Tx

      1. Docd says:

        Can’t elaborate on long term effects R’s until time passes, my opinion is that an autoimmune cascade has somehow been triggered. To see the actual long term effects we can only wait and see. The short term effects are distressing and devastating for these patients. High dose pred and Hail Mary hopeful course of antivirals might reverse facial paralysis

        1. Gus says:

          Where do you work mate? . Would anyone else with a background in virology like to comment on this?

    3. Big Fool says:

      DocD – Are you referring to patients vaccinated with the J&J vaccine in particular, or to all vaccines? 2 in one doc’s practice would seem like more than a coincidence if both are immediately following a vaccination, assuming that you are a primary care practitioner.

  48. Marko says:

    Even among nursing home residents, a single vaccine dose is sufficient for seropositives:

    https://jamanetwork.com/journals/jama/fullarticle/2778926

    1. Doug H MD says:

      suspect CDC being stubborn about this since it means one size does NOT fit all and makes vaccine campaign MUCH harder to pull off

  49. James Millar says:

    Given that we don’t know what causes some people to be at risk of the heparin induced variety, is there a possibility it could be in some way associated with adenovirus antibodies resulting from exposure in the wild?

  50. Danish vikingj says:

    The Danish decision to stop using the AZ vaccine is based on a study that has not been published yet. It is still under review. This has raised criticism in the Danish research community. Especially during the pandemic is common to publish results as preprints first. In the Danish newspaper Information (16.04.21), the author of the study, Anton Pottegaard has defended the decision to not publish as preprint. His argument is that the results can easily be misinterpreted and that the particular Danish/Norweigian context is very important and therefore the review process is particularly important. Secondly, he says that the results can hardly come as big surprise: In Denmark and Norway 280.000 people have been vaccinated with AZ vaccine and there seven cases of clotting. That gives a ratio of 1:40.000.
    Nonetheless, it is going to be interesting to see the paper when it hopefully soon is released.

    1. J says:

      DV: thank you for keeping us informed of the Danish situation.

      I’ve struggled to find newspaper reports in English. Found below for those interested.

      https://www.thelocal.dk/20210416/denmark-to-consider-individual-choice-over-astrazeneca-vaccine/

    2. Not-an-epidemiologist says:

      His argument is that the results can easily be misinterpreted and that the particular Danish/Norweigian context is very important and therefore the review process is particularly important.

      If the review process is particularly important, that’s an even greater reason to release a preprint to seek as much feedback as possible prior to publication, you’d hope. An odd choice.

      If there have been 7 CVST cases from 280,000 vaccinations, then there’s a highly significant difference (P<0.001, Fisher's exact test) between what's been observed in Denmark and the EU + UK as a whole.

  51. Marko says:

    Good thread on the competing theories to explain the clotting/thrombocytopenia side effects:

    https://twitter.com/RolandBakerIII/status/1383763965386268672

  52. J says:

    Oxford Vaccine Group, 14th April

    https://www.ovg.ox.ac.uk/news/uk-and-eu-regulators-conclude-benefits-of-vaccination-continue-to-outweigh-the-risks

    https://www.ovg.ox.ac.uk/news/alternating-vaccines-trial-expands-to-include-two-additional-vaccines

    Does anyone have information on how countries now restricting use of Astra Zeneca vaccine (age range or not at all) are actually dealing with second doses with a different vaccine e.g. data collection & monitoring arrangements, choice of the individual?

  53. J says:

    https://www.ovg.ox.ac.uk/news/alternating-vaccines-trial-expands-to-include-two-additional-vaccines

    Does anyone have information on how countries now restricting use of Astra Zeneca vaccine (age range or not at all) are actually dealing with second doses with a different vaccine e.g. data collection & monitoring arrangements, choice of the individual?

    1. Some idiot says:

      An excellent question… In the case of Denmark, at least, the current official answer is “we are working on it…” More specifically, the official Q&A page says something like “We are in the process of deciding how to continue … When we have decided, the relevant people will be contacted…”

      I have also (I think) seen commentary from some authorities saying that if someone had had their first vaccination with AZ, and wanted the second to also be AZ, then this is something the authorities would consider. To the best of my knowledge, this has not yet become actual practice.

      Btw, thanks for the article in your next post. Kinda makes sense. I have had the feeling that it would probably be logical that if someone was predisposed to this, then it would show up in the 1st, so that the likelihood of it first cropping up in the second would be very, very low… Nice to see some data, though…! In my book, data wins over speculation!

  54. J says:

    https://www.ovg.ox.ac.uk/news/uk-and-eu-regulators-conclude-benefits-of-vaccination-continue-to-outweigh-the-risks

    Note: ‘To date, there are no reports of the extremely rare thrombosis/thrombocytopenia events following receipt of the second dose of the AstraZeneca COVID-19 vaccine. All those who have received a first dose of the AstraZeneca COVID-19 vaccine should continue to be offered a second dose of AstraZeneca COVID-19 vaccine, irrespective of age. The second dose will be important for longer lasting protection against COVID-19.’

  55. Christian Weisgerber says:

    News release from the European Medicines Agency:

    “COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
    EMA confirms overall benefit-risk remains positive”
    https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood

  56. Marko says:

    “Very rare cases of pericarditis, myocarditis are being seen after mRNA vaccines. We’ve seen a few here in San Diego, too. It’s time to get a handle on frequency and determine the mechanism.”

    https://twitter.com/EricTopol/status/1384734833809625089

    “Very rare” sounds like he already has something of a “handle on frequency”. Maybe not. I won’t be surprised if we see more reports on this soon, probably coming from outside the US. Topol seems like he’s preparing us.

    1. Not-an-epidemiologist says:

      “Very rare” sounds like he already has something of a “handle on frequency”.

      I would really, really hope so in the current climate, but a later tweet by him suggests not (“That’s precisely why I called it out. To find out the denominator. To find out if it is caused or facilitated by the vaccines. And if so, why?” … yikes. Twitter is not the place for this sort of explosive speculation.)

      This study suggests that pericarditis and myocarditis are seen in a pretty high proportion (~1:6000) of small pox vaccinees. I assume that he’s not seeing these sort of rates, because they’d have been detected long before now. However, the study also usefully gives a background population rate of ~2:100,000 within a 30 day window. That’s easily high enough to appear noticeable over the numbers being vaccinated.

      But unlike Eric Topol, we can actually get some clear, hard figures on this from the EU. Checking in EudraVigilance, there have been 117 cases of pericarditis and 139 cases of myocarditis reported from >60m doses of the Pfizer vaccine. That’s well below even the background figure in the above paper. (Honestly, Eric, would it have been so hard to take the time to look it up before tweeting?) There’s clearly no association here.

    2. Not-an-epidemiologist says:

      “Very rare” sounds like he already has something of a “handle on frequency”.

      I would really, really hope so in the current climate, but a later tweet by him suggests not (“That’s precisely why I called it out. To find out the denominator. To find out if it is caused or facilitated by the vaccines. And if so, why?” … yikes. Twitter is not the place for this sort of explosive speculation.)

      Arness et al (2004) Am J Epidemiology 160:642–651 suggests that pericarditis and myocarditis are seen in a pretty high proportion (~1:6000) of small pox vaccinees. I assume that he’s not seeing these sort of rates, because they’d have been detected long before now. However, the study also usefully gives a background population rate of ~2:100,000 within a 30 day window. That’s easily high enough to appear noticeable over the numbers being vaccinated.

      But unlike Eric Topol, we can actually get some clear, hard figures on this from the EU. Checking in EudraVigilance, there have been 117 cases of pericarditis and 139 cases of myocarditis reported from >60m doses of the Pfizer vaccine. That’s well below even the background figure in the above paper. (Honestly, Eric, would it have been so hard to take the time to look it up before tweeting?) There’s clearly no association here.

      1. Marko says:

        That’s useful. Thanks.

  57. Marko says:

    “About 3/4 of Kansas counties have turned down new shipments of coronavirus vaccine over the past month. “It is kind of stalling. Some people just don’t want it,” said a nurse in rural Decatur County, where just 29% of residents have had at least 1 dose.”

    https://twitter.com/MikeStobbe/status/1384972991587565569

    I think they’ll probably be OK. No self-respecting CoV-2 would want to visit Kansas.

  58. Marko says:

    “Good news on J&J vaccine from the CDC’s Advisory Committee, with the pause now lifted.
    Reaffirmed use for all age ≥ 18 (with a warning statement to be worked out) ”

    https://twitter.com/EricTopol/status/1385698501011533824

  59. Cassandra says:

    https://www.timesofisrael.com/israel-said-probing-link-between-pfizer-shot-and-heart-problem-in-men-under-30/
    Another EARLY safety problem does appear to be arising. These experiments will end in tears, rare, incredibly rare, I hear you say. These are young healthy people who had nothing to fear from Covid. Thank god that they were found before needless mass vaccination of innocent children.

  60. Alex Beribisky says:

    Somewhat surprising, yet very good news – only a two fold reduction in neutralization of B.1.617 (aka, the Indian variant) by convalescent and vaccine sera:

    https://www.biorxiv.org/content/10.1101/2021.04.23.441101v1.full.pdf+html

  61. Brussels bureaucrat says:

    Good to see more follow up studies of possible and very rare side effects of vaccines. An important issue that must never be ignored:
    https://www.reuters.com/world/middle-east/israel-examining-heart-inflammation-cases-people-who-received-pfizer-covid-shot-2021-04-25/

  62. J says:

    Apologies if this is already posted, but with the increasing collection of very interesting articles and debate there is likely to be duplication.

    https://www.webmd.com/vaccines/covid-19-vaccine/news/20210422/scientists-find-how-astrazeneca-vaccine-causes-clots

    Does anyone yet have a copy of the paper (in English) of the Danish analysis which the author declined to publish as a pre print? Thank you.

    1. J says:

      Links to related papers. Article, editorial and opinion. I recall there was much debate on the Danish research and official statements.

      Paper
      “Arterial events, venous thromboembolism, thrombocytopenia, and bleeding after vaccination with Oxford-AstraZeneca ChAdOx1-S in Denmark and Norway: population based cohort study” May 5, 2021
      https://www.bmj.com/content/373/bmj.n1114

      Linked editorial
      “Thromboembolism and the Oxford-AstraZeneca vaccine” May 5, 2021
      https://www.bmj.com/content/373/bmj.n1159

      Linked opinion
      “Thrombosis and bleeding after the Oxford-AstraZeneca covid-19 vaccination” May 5, 2021
      https://blogs.bmj.com/bmj/2021/05/05/thrombosis-and-bleeding-after-the-oxford-astrazeneca-covid-19-vaccination/

      Our thanks go to all those in universities, research centres and commercial organisations in their development of vaccines in particular. We also value reading the articles on this blog by Derek and the commentary of many of the individuals who post on it.

  63. Jena says:

    Wonderful and useful information. It is very useful for everyone in this situation, who are worried to put vaccination. Hope everything goes fine. Stay safe in home.

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