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The Russian Vaccine Data

An open letter has appeared about the recently published data from the vaccine development effort at Russia’s Gamaleya reseach center. This is of course the one that the government announced had been “approved” before even going through any Phase III trials, an even that I characterized at the time as a “ridiculous publicity stunt” (a description that I stand by). It’s worth mentioning that paper describes two n=38 studies, and it’s not even clear to me if there were more before the government announced its approval. But there may be more than just a ridiculous aspect to this.

The letter notes that the figures in the paper (illustrating antibody responses in the Phase I patients, for example) have unusual features that are difficult to explain. Specifically, there are patterns in the points for the individual patients that repeat, in almost every figure in the paper. Now, some of these are discrete variables, such as the antibody numbers that are the reciprocal of a given dilution factor, it’s still odd to see them lining up just the same way again and again (see image). And the problem shows up in the cellular data, which should be continuous variables – the same patterns seem to repeat inside the figures for different groups.

As the authors of this letter note, the actual numerical data behind all these data points was not provided in the Lancet publication, and that would be very helpful in figuring out what’s going on. But I agree with them that the patterns shown are “highly unlikely” at best. These are the sorts of repetitions that people search for in papers when they’re suspecting fraud, and that (needless to say) is not a good look for a paper of this degree of visibility and interest. I look forward to an explanation.

84 comments on “The Russian Vaccine Data”

  1. Reader says:

    This is a joke? even in your picture, you can see that after a single injection, antibody titers reach a plateau by day 21 and do not differ from day 28, which is typical for vector vaccines. The letter of the Italian experts is completely engaged anti-scientific nonsense.

    1. Reader 2 says:

      That is not the argument. The exact values from Day 21 are being copied and pasted to Day 28. While on average antibody titres may not change from Day 21 to Day 28, you would expect some slight variations in the data points due to biological and technical factors, even within the same person.

      1. Reader says:

        even if title values are in steps of 400 800 1600? What is the problem that 9 people in a 21 and 28 days group did not increase their titers by one dilution step? and what’s the problem with adjusting the data so that it looks beautiful if there is such a goal?

      2. SteveM says:

        If you download the pdf of the paper and zoom into the graphs you can that in tests:
        Gam-COVID-Vac:only rAd5-S, Gam-COVID-Vac-Lyo:only rAd26-S, only rAd5-S the min, max and median lines for days 21/28 are clearly not aligned, indicating different data was used to generate the 21 vs 28 day plots. I.e. the data was not simply copied and pasted.

        In test Gam-COVID-Vac:only rAd26-S the 21/28 day reference lines do appear to be co-linear.

  2. EugeneL says:

    Some flaws of the attempted debunking:
    1) The green boxes on fig 2 are not the same.
    2) The statement “the variable under study (cell proliferation %) is continuous in nature” is false. The data is clearly discreet, which might be caused by the measuring apparatus.
    3) What’s photoshopped about the purple boxes on fig 3? They are not even on the same y, three of them.
    3) What’s photoshopped about the green boxes on Fig 3. They are just one point on the level 2.

    One has to understand that the data presented is discrete and that the error bars are derived information. If you see that the probability of points taking the same discrete levels is quite high, and weight in the number of opportunities for the coincidences to happen, then you’ll realise that “photoshoping artefacts” are not that unlikely to happen by coincidence. Also there is no photoshopping of the complex structures, where the coincidences would be really unlikely. Understanding of statistics beyond the basic level would help too.

    The overzeel in an attempt to debunk the study suggests that the data in the study might actually be real.

  3. Reader says:

    In addition, the authors of this letter have highlighted a number of colored rectangles “forgetting” to include some points, outside of their logic. isn’t it engage?

  4. SteveM says:

    Moreover, these days with science being so heavily politicized along with everything else, I always ask Cui Bono? (To whose benefit?).

    Gamaleya isn’t an academic lab that just wants to get some arcane work published. There is a lot of private money invested. The Theranos fiasco proves that in the financial world of medicine with the rigorous proof of concept demands only a lunatic like Elizabeth Holmes could think that he/she could actually get away with it. Why would Gamaleya crudely game data when their alleged ruse would be obviously found out?

    I never say never, but it’s hard to imagine the Russian developers gaming the data if inevitable failure would cost them millions.

    Maybe someone else here has a more transparent rationale for why gaming the data could be beneficial to Gamaleya in the long run.

    1. Nesprin says:

      What a bizarre idea. There’s a huge pile of national pride tied up in Russia having the first vaccine, and judging by this comments section alone, and an active disinformation campaign. Due to the lack of a free press , within Russia it doesn’t matter if this is nonsense. Cui Bono? the Russian Government. Who gets hurt? the rest of us.

      1. SteveM says:

        Re: “Due to the lack of a free press , within Russia it doesn’t matter if this is nonsense. Cui Bono? the Russian Government. Who gets hurt? the rest of us.”

        The Federal government in Russia may be monolithic but information is freely exchanged and freely available in Russia. Who gets hurt? It would be the Russian people and Gamaleya, not us and not the Russian government. And believe it or not, the Russian government actually wants its own people protected from Covid.

        That Russia has national pride and the Gamaleya vaccine may actually work is not disjoint. Note that NASA had no problem launching astronauts into space with Russian rockets.

      2. Shazbot says:

        One of the basic rules of this kind of propaganda is to always attack. also follows a similar three-point pattern to some other ones. Start off with a denial.

        “This letter isn’t real, because it’s been politicized!”

        Do note that’s patently false. The article is written with specific examples of what’s wrong, pictures demonstrating it from the original data, and descriptions on what ways their findings are limited.

        Then, blame the victim. Or in this case, the reporter.

        “Gamaleya isn’t to be trusted, because some completely different group once committed medical fraud by falsifying data!”

        That’s a particularly stupid line because this is someone reporting about falsified data, and showing their work on it. Claiming that you can’t trust someone because data can be faked, when they are showing data that looks fake is stupid. It’s like saying that you cant trust someone saying that water is wet, because everyone knows water is wet.

        The last bit is a lovely attempt at subject changing, trying to move things from “Is the data fake” to “Why would they fake data?”

        The first can be answered. It’s fake. The second is always going to be muddy and subjective, therefore it’s a much-preferred topic.

        1. anon says:

          Let’s start with the fact, that the authors of the letter are trying to leverage a lie about lacking data and completely omit the fact that the data is available upon request and to the reviewers. Then one of the signatories insinuated that the Gamaleya found nothing better to do than to “photoshop” the data. The coincidences pointed out in the letter are merely a cover for the smear campaign.

    2. FoodScientist says:

      There’s also the “because they can” / “general power move”. I bet the researchers were given some resources and told to make a really good looking paper. It’s kind of like how the Russian opposition leader was poisoned with novichock agent(sp?) or doctors fall through plate glass windows out of buildings or have mysterious grenade accidents.

      1. Mark says:

        Strangely, Russians are usually accused of propaganda. What is the significance of the novichok in this case? they, that unlike Cansino (Ad5) and j & j (Ad26) cannot make a working vaccine by combining them? what is the problem? looks like anti lancet letter

      2. Marjorie says:

        I think that the subject of the Russian vaccine already contains enough sources of debate without adding inexhaustible subjects such as Novichok poisoning, which we would all love to discuss with you but rather over a beer than here.

  5. Dr. Seymour Tushi says:

    Wow, looks like these guys were really Russian for approval on this one

  6. Kirsten says:

    Given the comments written, it looks like a fake

  7. SteveM says:

    Incidentally, the Note of Concern contains these lines:

    “In lack of the original data, while potentially of great interest, the research described in the article published by Lancet presents several different points of concern. In the following, they are briefly reported.”

    “Please note that, in lack of the original numerical data, no conclusions can be definitively drawn on the reliability of the data presented, especially regarding the apparent duplications detected.”

    While the Lancet paper contains this invitation:

    Data sharing
    Individual participant data will be made available on request, directed to the corresponding author (DYL). After approval of a proposal, data can be shared through a secure online platform.

    I’m surprised the Italian reviewers did not request the original data from the developers. Or if they did and their request was rejected, they did not state that in their Note.

    Somebody should request the original data and put this issue to bed one way or another.

  8. johnnyboy says:

    It’s a testament to how sh*tty Russia has become that its ‘scientists’ can’t even fake data properly.

    1. Elise says:

      Not. This is evidence of how biased the world is towards Russia, that you are not even going to take a critical look at the arguments of the authors of the letter. easy enough to accuse of rigging

      1. The Iron Chemist says:

        All right Boris…

  9. Harvey 6'3" says:

    I shouldn’t be surprised that so many Russian trolls/bots jumped on this post (like Reader and SteveM and probably Elise), but it is a little concerning.

    As to the actual data in the Lancet paper, at page 7 of the PDF, the data in Figure 2A for the 21 and 28 day points are identical for Ad26, and differ by one patient improving titer for Ad5. It is hard to tell if the data has been “adjusted” but a release of the underlying raw data could help with that.

    1. SteveM says:

      Re: “I shouldn’t be surprised that so many Russian trolls/bots jumped on this post”

      That lame accusations like that pollute an excellent science blog is pretty pathetic. I hope those interested in objective truth reject this personalized, politicized trash.

      1. Shazbot says:


        Is there any other data, or is it just two studies of 38 patients each?

        1. ScienceFirst says:

          Sure. Several hundred vaccinated in Moscow. Probably would be surprised to read this blog

          1. Shazbot says:

            Got a paper?

    2. Reader says:

      You yourself confirm what you wrote at the beginning. no increase in antibody titer is observed between 21 and 28 days. and in the case of hell5 it’s only 1 person

  10. Erik Dienemann says:

    Great catch. Reminds me of the scene in “The Fugitive” when the pathologist tells Dr. Kimball that all of the samples supporting the clinical research for the atherosclerosis drug, “Provasic” came from the same liver.

  11. Anon(by penalties) says:

    ” The Russian Vaccine Data “: An honest analysis of that title would show that “politics” and “science” are helplessly entwined and need to be reformed. Lets start with the arogant elitism controlled by the east cost.

    1. Damien.T says:

      This post by Derek shows his bias. he was silent for 5 days about the data of the Russian vaccine despite the links, and now he published data based on a dubious open letter. “good overview”

      1. DriveOrReverse says:

        The author has a real job, and writes blog posts only in spare time.

  12. Sacu.Nim says:

    Has anyone read this investigation by Italian scientists? Or did everyone just like the idea that the Russians are cheating? Each of their colored rectangles either has an explanation or is a manipulation. Has anyone done Elisa by poin-by-point titration?

  13. A different Steve says:

    I completely agree with EugeneL. This is discrete data, and that makes all the difference. The “continuous” variable in Fig. 3 clearly has a resolution of 0.1%, which means that you get points that lie exactly on the grid lines at the low end (0.1, 0.2, and 0.3, for example), but not the high end of the log-scale y-axis, just like the data shows. This simple observation completely blows apart the arguments in the letter regarding Fig. 3.

    Moreover, the letter makes the claim that “9 out of 9 patients had exactly the same titers on days 21 and 28” (paraphrasing), which are in the red boxes in Derek’s graph. You simply can’t make that claim based on this data, since we just don’t know the measurements for any individual patients at all–we only see the distribution of all 9 patients at two time points. Noise in the measurements (or real changes) could have allowed two individuals to swap tiers, but the distribution (which is the only thing being reported) would remain exactly the same.

    Improbable? Maybe, but definitely not impossible, and not nearly as improbable as most people would think.

    First of all, it’s not *that* improbable for the underlying distributions, or least their widths, for these titer measurements to be similar. Taking into account the discrete nature of the data–that every value in Fig. 2 is rounded to the nearest unit–and moreover, that the width of the distribution is close to one unit, you would expect to obtain identical random samples of 9 measurements maybe ~2% of the time. Not too probable, right, since any two distributions would be different 98% of the time? But here’s the catch: the critical authors are comparing not just one pair of distributions, but all the 14-, 21-, and 28-day measurements for each of the 4 conditions in the top half of Fig. 2 (otherwise they wouldn’t have noticed the similarities of the cyan boxes). Thus they are looking at all the 12*13/2=78 different pairs of distributions in Fig. 2, and the probability that they would *all* be different is only 0.98^78 = 0.21. Thus, it turns out that there is a 79% chance that there is at least one identical pair. But wait, you say, there are two identical pairs! Well, the probability of finding exactly one identical pair is 32%, and the probability of finding 2 identical pairs is still 25%, which is still higher than finding no identical pairs at all.

    But wait, you say, what about the yellow boxes, where *most* of the points are identical? Well, the probabilities start increasing considerably when you look at only subsets of the distributions and ignore outliers. Again, noting that all measurements are rounded to the nearest unit and that the distribution width is close to one unit, the probability that you would obtain an identical distribution of the highest or lowest 7 of 9 measurements is ~5%. But again, the probability of being different is only 95%, and since we’re doing 78 comparisons, the cumulative probability of all 78 pairs being different is 0.95^78 = 0.02, just 2%.

    My numbers may be off by a little bit but the concepts remain the same. It is actually not improbable to see the same distributions (especially subsets of distributions) for discrete, small sets like these.

    1. Shazbot says:

      Try 220 possibilities, assuming four possible values and 9 people.

      There are six graphs with those numbers, not 78, which makes it 99.5^6, which makes it 97% for no matches.

      Of course, there are four pairs of matches, and more than four possible data points so..

      Yeah, highly unlikely doesn’t begin to cover it.

      It’s also interesting to see someone using the cruddiness of the data provided (no individual tracking, very few possible data points) is being used in an attempt to defend the quality of said data.

      1. EugeneL says:

        Shazbot, can you please estimate the probability of the coincidence found in another proof of photoshoping by Russia? This time it’s satellite imagery. Someone spotted photoshoping of this kind: “a whole bunch of pixels was copied exact same distance to the right”. The red and blue pixels have the same colour and are offset by exact same distance on the picture. This prooves that the image was photoshoped, right? It’s impossible that 100 or so pixels duplicated and shifted all by themselves.

      2. A different Steve says:

        Sorry, I should have been more clear. I never said it was good data, and I make no claims about whether their conclusions are true or not. But I am trying to rebut the serious claims of the writers of the letter of concern that this data is suspect because it “looks” manipulated. EugeneL and I both explained why you might expect duplicates to appear in this data set.

        And when I was talking about the number 78, I was referring to the number of pairs of distributions when you select two out of the possible 12 graphs among the 14-, 21-, and 28-day titer distributions in Fig. 2. You have to look at the total number of pairs, not the number of distributions, because it is each *pair* that has an independent chance of being identical with probability 2%.

        It’s the same principle as the birthday paradox, where all you need is 23 people in a room to have better than a 50% of two of them having matching birthdays. The reason is that with 23 people you have 23*22/2=253 pairs of people.

        I admit I did get the number wrong, though, and I do apologize for that. There are actually 66 pairs of distributions, not 78, which puts the probability in my scenario of getting 0, 1, or 2 matches at 26%, 36%, and 24% respectively. So having two identical distributions is actually slightly less likely than getting none. But it’s still close, and probably far more likely than many people would think.

        1. Shazbot says:

          There’s some mistakes in what you’re saying here, (birthday paradox is because each previous person is removing one possible free birthday from a limited number of possibilities), but there’s a more fundamental issue.

          Are you arguing that their results can be replicated through random chance?

          ..because that would mean, by definition, that the trial isn’t strong enough to prove anything about the candidate, and approving it is simply not caring if it is safe, if it works or not, etcetera.

          1. Marjorie says:

            I believe that the two statements “each previous person is removing one possible free birthday from a limited number of possibilities” and “with 23 people you have 23*22/2=253 pairs of people” are right and used for the demonstration of the birthday paradox.

          2. Shazbot says:

            “And why would an eight-foot-tall Wookie live on Endor?”

            Sorry, Marjorie, but I’m trying to figure out how the data can both be so awful as to be indistinguishable from random noise, while being sufficiently compelling to have a vaccine approved on it.

          3. EugeneL says:

            Shazbot, with you understanding of the birthday paradox please take a look at the picture 4 posts above and tell whether 100 random pixel of random colour being copied exact same distance to the rigth is a result of an application of a clone brush or Russians did not cheat? The chances of this occuring as a coincidence are diminishingly small, isn’t it?

            This picture:

          4. Shazbot says:

            I can’t say anything specific about that, I’m no expert on image analysis, and certainly can’t give you a number on exactly how unlikely that thing is.

            If I am going to try to make an attempt, I do want an unedited version to look at first, one that doesn’t have the red arrows and such over it, as well as the original location and sufficient context. What little I do know tells me I should know things like the date the image was taken, the location it was retrieved from, the photography equipment (what kind of satellite) could all make a difference, etcetera.

            I’m also not certain what you’re pointing out. Different pixels with exactly the same digitized values in the image? I’d certainly need the original to make a guess on that.

            I mean.. yeah, images can be edited using clone tools and what not, but to say that this one was with confidence I’d need to see the original, not a copy of it that certainly has been edited by adding red marks and arrows.

          5. EugeneL says:

            The original can easily be found, eg with an image search (below). The highlighted pixels do indeed have exact same colour and are offset identically. Given that there are 256 grayscale levels on the picture you can estimate the probability of coincidence for 100 pixels, which is indeed vanishingly small.


          6. EugeneL says:

            I hoped you could calculate the diminishingly small probability of coincidence on the image. Then I’d show that prety much any 256-colour image would have such a coincidence.
            In fact it would mean that an image had been manipulated if no such coincidences could be found.

            However, if the satelite image was true colour, then a pattern of diplicated pixels would be practically impossible to occur on its own. Likewise, if in the vaccine study the data was continoous (not discreed) then the image duplication would mean manipulation. But it’s clearly descrete. The data can well be genuine.

  14. anon the II says:

    Why do all these comments sound like they were written by Natasha and Boris?

    1. SteveM says:

      I dislike making political statements on this site. But the Russia Hate meme in these entries mirrors the Russia Hate of “progressives” who ginned up the meme as an excuse for Hillary Clinton losing the election in 2016.

      I.e. Trump Hate => Russia Hate => Dismissing those who do not believe that Russia is merely a gigantic gas station populated by incompetent drunks. The level of irrational Russia Hate because of the Trump Hate by “progressives” is off the charts

      And believe it or not, there are those (like me) who have no respect for Donald Trump but do have respect for good science wherever it is done.

      The Gamaleya developers obviously put a lot of hard work into developing their product. They are currently implementing a 31,000 subject Phase 3 clinical trial. We’ll see what the results say. If it works – it works. If it doesn’t – it doesn’t. That’s science and business. I’m not going to Hate on Gamaleya or wish for failure because they are Russian regardless of the cheap “Boris and Natasha” insults from Trump Hating “progressives”.

      1. PDINV says:

        Here’s the difference and it is a very important one. Western pharma stated clearly that they will not release their vaccines early when certain govs were pressuring for quick results. Gamaleya is playing along and using the vaccine outside trials.

        Same goes for sinovac who recently posted laughable results of GMT 1:40 shortly after second dose (practically useles esp if we take into account that immunity will drop with time. Yet that did not stop them from immunising all their employees and others, before they even started their phase 3 (which I’m not even sure why they are doing).

        1. Marko says:

          1:40 is a respectable titre on an IC50 neutralization assay , and their regular Ab titres were also reasonable.

          1. PDINV says:

            Respectable by whom? GMT of convalescent patients is about 160 and this is also the FDA recommendation. 40 is 4 times lower and also measured at the peak, how do you think this is going to look like a couple of months later? How is any of that “respectable”?

          2. Marko says:

            “Respectable by whom? GMT of convalescent patients is about 160 and this is also the FDA recommendation. ”

            Think about what you’re saying. The FDA recommends a titre of 160 or above in convalescent plasma used to treat patients who are already sick. If you infuse 300 ml of that plasma , you end up with a patient titre that’s diluted at least 10-fold relative to the titre of the infused plasma , or ~1:16.

            Many , if not most , patients recover on their own from mild or asymptomatic disease showing neutralization titres of 1:40 or less. A vaccine that replicates what the immune system does in resolving a natural infection is , by definition , respectable , at the least.

            Would you want to see higher titres from your vaccine? Probably. But also , maybe not. We just don’t know yet.

        2. PDINV says:

          Minimum titer for convalescent plasma for transfusion 1:640, not 1:160. Again, if at the peak, following 2 doses of the vaccine, they measure 1:40, what happens a couple of months later?

          1. Marko says:

            This is what you said in your comment just above :

            “GMT of convalescent patients is about 160 and this is also the FDA recommendation”

            Then , because I easily destroyed your argument , you now claim it’s 640. Get your story straight.

            Anti-spike or anti-RBD Ab titers by ELISA and other methods are not the same as neutralization titers , and titers of any kind are not comparable across labs unless standardized.

          2. PDINV says:

            I’m not talking about elisa titers which are usually in the 1000s but about neutralisation titers. FDA recommendation with what is used in studies are not the same thing, obviously most go for higher than 160, Vlad.

          3. SteveM says:

            Re: PDINV says: “FDA recommendation with what is used in studies are not the same thing, obviously most go for higher than 160, Vlad.”

            Why don’t you just stick to the science and leave your insulting “Vlad” cheap shots out of it?

            BTW, if the Sputnik 5 vaccine turns out to work – it works. If it doesn’t – it doesn’t. Regardless of the Russia Hate you throw into the mix.

    2. Marjorie says:

      This current theatralization of geopolitics makes discussions increasingly complicated. Personally, I didn’t come here to discuss Ian Fleming’s novels.

      1. Anon says:

        I think the Boris and Natasha Wisecrack refers to the TV cartoon series “The Rocky and Bullwinkle Show”, not James Bond.

    3. Marko says:

      ” Why do all these comments sound like they were written by Natasha and Boris? ”

      Boris and Natasha defected to America , so I assume that you’re referring here to the reflexive, Russia-bashing comments , which are indeed tiresome.

      The story behind their defection is revealed in the 1992 movie ” Boris and Natasha ” , a can’t-miss spy thriller that I might watch some day.

      ” Boris Badenov and Natasha Fatale are still spies for the mean little country of Pottsylvania, where, sandwiched between the nations Wrestlemania and Yoursovania, the Cold War is still frigid. Their Fearless Leader hatches a plan to capture a time-reverse micro-chip, using the two spies as high-profile patsies. They clumsily defect to America and try to unravel F.L.’s master plan. But can these dim-witted fools survive a secret assassin, exploding potatoes and the temptations of capitalism? And what of their old foes, “Moosk unt Squoirrel”? “

  15. PDINV says:

    Dear Derek,

    I was wondering if you can make a comment on published Sinovac trial results. They issued a very cheerful press release with the topline in older adults that in my opinion is not supported by the data (the same is true for their data on younger adults on medarxiv).

    In particular, they reported seroconversion for adults 1:8 which is very low. In the same paper (linked below) titers from convalescent patients was about 1:160 which also happens to be the minimum threshold required by FDA.

    In addition this 1:40 threshold is at or very near the peak as they checked at max 28 days after last dose. Not only that but the phase 3 they submitted they specify in the protocol that they will check seroconversion at 14 days afer 2nd dose. This all seems very pointless to me.

    Also not that the formulation of the sinovac vaccine in these trials is NOT adjuvanted as mentioned is some investment circles mostly (the “covid geniuses”).

    You can see the info on the published data from younger adults here, according to their press release yesterday, same results in order adults.


    1. PDINV says:

      *They reported seroconversion in adults using a titer threshold of 1:8

    2. PDINV says:

      Minor correction “this 1:40 threshold” -> “this 1:40 titre”

  16. PDINV says:

    Minor correction “this 1:40 threshold” -> “this 1:40 titre”

  17. Daren Austin says:

    Data looks entirely reasonable. for a low probability of moving between two titers from day 21 to 28, this is the pattern one would expect. Note it’s really ordered categorical data based on dilution not continuous data (and not subject to rounding digit bias that is a thing in log plots). Median and IQR would have been better to report than geomean and 95%CI. Would have also been nice to connect the dots for each subject too, but those plots become a bit noisy. Google benford distribution and start your tax return with a 1!

    1. TallDave says:

      hehe good old Benford

      caught some fraudulent elections in South America too

  18. Marjorie says:

    Have you ever seen this 2007 study using the same vectors as the Russian vaccine on mice and monkeys, in the same order?

    Comparative Seroprevalence and Immunogenicity of Six Rare Serotype Recombinant Adenovirus Vaccine Vectors from Subgroups B and D

    They conclude by
    “In the present study, the highest magnitude and most durable responses were generated using the rAd26 prime, rAd5 boost regimen. In fact, the rAd26 prime, rAd5 boost regimen appeared as immunogenic as the DNA prime”

    1. Smart_blog says:

      Good article. Interestingly, did Russian scientists use it to develop their vaccine? The scientific validity of 26+5 choice is obvious

  19. Stanislav Radl says:

    Derek has evidently strong prejudice toward the Russia, OK. Only time is the judge and I hope Derek is able to accept his mistake, in case the Sputnik vaccine is safe and efficient.

    1. anon says:

      Hi Stanislav,

      I think you are missing the point here. In respect to Derek’s stance towards the Sputnik vaccine, it is irrelevant whether it will ultimately be found safe and efficacious.

      In the very possible case that Sputnik proves to be safe and efficacious in the future, the outcome can only be attributed to luck and not to convincing data. No reasonable scientist says that Sputnik can’t be safe or efficacious by design. Just that we FIRST need the data, not approve first and THEN collect data.

      1. Derek Lowe says:

        I agree with that completely – that’s exactly the problem here.

        1. anon says:

          What is the problem with data? The data is available upon request, and obviously the reviewers had a chance to review it, after all it’s published in the Lancet. I think your dishonest reporting is the problem here.

      2. EugeneL says:

        Why all the fuss about “approve”. In Russia an approval was needed to run phase 3 of the trial, that’s it.

        1. SDimm says:

          Absolutely. The problem is that nobody understands that Russian “temporary registration” and “approval” are not the same. No one in the world will be vaccinated until the end of phase III. No need to be afraid.

          1. Derek Lowe says:

            So that’s why Putin said that the vaccine was “quite effective” and that his own daughter had taken it. And why Moscow’s mayor has said he’s gotten it. And why the Defense Minister was shown receiving the shot. They’re just letting us know that the vaccine has moved along another step in the careful regulatory process.

          2. TallDave says:

            now I’m confused, is the vaccine in trials or in distribution? if the former, seems like much ado about nothing

            is it just being given to high gov’t officials and their families first?

            “A website for Sputnik V says a phase III efficacy trial involving more than 2000 people will begin on 12 August in Russia, the United Arab Emirates, Saudi Arabia, Brazil, and Mexico.”

          3. SteveM says:

            Derek Lowe: “So that’s why Putin said that the vaccine was “quite effective” and that his own daughter had taken it. And why Moscow’s mayor has said he’s gotten it. And why the Defense Minister was shown receiving the shot. They’re just letting us know that the vaccine has moved along another step in the careful regulatory process.”

            Those inoculations were no doubt done for PR purposes and to also to help assuage any concern of citizens about volunteering for the formal clinical trials. I.e., the careful regulatory process required for international registration.

            Those initial subjects; Putin’s daughter, the Mayor, General Shugoy and others who volunteered, are not part of the actual clinical trials. If they gave their fully informed consent after the Sputnik 5 Phase 1 and Phase 2 trial results were evaluated, is there anything unethical about that?

            That’s a real, not a rhetorical question.

          4. EugeneL says:

            They are starting phase 3 in earnest right now. In Moscow 35k volunteers enrolled. There was indeed a publicity stunt part to it but they are not going to mass vaccinate before phase3 gives a better idea about efficiency and safety.

      3. anon says:

        There is data, and it’s available upon request, as indicated in the article, Derek and the authors of the letter are just lying, because they have a political agenda. One of the signatories already said the data looks “photoshopped”, which makes it clear, that it’s just a smear campaign

  20. SteveM says:

    Re: “No reasonable scientist says that Sputnik can’t be safe or efficacious by design. Just that we FIRST need the data, not approve first and THEN collect data.”

    The reasonable scientists include those at Gamaleya. The limited approval was for the high risk population in Russia. As noted earlier, Gamaleya is presently conducting a 31,000 subject clinical trial. Will that data be convincing enough? Questions and criticisms about Sputnik 5 were addressed here:

    Feel free to rebut those answers. Gamaleya also refutes the claims that it used phony data in its Lancet paper:

    “The center gave The Lancet full clinical protocol and all the data that we received during the scientific trials. The data was thoroughly examined by the journal’s reviewers, who, before publishing, asked all the necessary questions about the content of the article and the data that it was based on, and received exhaustive response,” Logunov said.”

    I don’t think the “Boris’ and Natasha’s” here believe that Sputnik 5 should be released to the general public without the standard clinical trial protocols being successfully completed. And it’s not clear how Gamaleya is attempting to circumvent them.

  21. debinski says:

    And now Sinopharm in China has vaccinated “100’s of thousands” with their vaccine which has not completed phase 3.

    1. Derek Lowe says:

      And that’s not a great idea, either – we are asking for trouble if we play fast and loose with mass vaccine dosing. I hate to give any ammo to the anti-vax movement, but there’s a reason that we try to test in huge trials before approving a new vaccine. The human immune system is both extremely powerful and extremely variable, and has to be approached with caution.

  22. DTX says:

    It’s notable that in a recent study of “vaccine intent” was lowest in Russia of the 27 countries studied. Specifically, 46% of Russians indicated they would NOT get the vaccine.

    However, it would take much to understand this low level of vaccine confidence in Russia. It’s not just a matter of trust in the quality of vaccines.

    China also gave rapid approval to partial (military) use of their Covid-19 vaccine. In addition, China has had many very serious problems with vaccine quality. Yet, vaccine intent was highest in the world – just 3% said they won’t get the vaccine.

    As further contrast, the US has superb vaccine quality and normally required (pre-Trump) a very high level of safety & effectiveness testing before approval, yet 33% of Americans indicated they won’t get the vaccine.

  23. emba says:

    ‘As the authors of this letter note, the actual numerical data behind all these data points was not provided in the Lancet publication, and that would be very helpful in figuring out what’s going on.’

    This is isn’t honest on the part of the authors. The Lancet paper has a clear Data Sharing section:

    Data sharing
    Individual participant data will be made available on request, directed to the corresponding author (DYL). After approval of a proposal, data can be shared through a secure online platform.

    If they didn’t share after request, that’s another matter.

  24. Marjorie says:

    The hypothesis that Russia or the Gamaleya institute (and all it’s searchers) have grossly falsified the data of their research when they will soon repeat these studies in several countries, is extremely unlikely. It would inevitably lead to a huge autogoal for a little moment of so-called victory.

    The Russians have not yet published all their data? They are not the only ones, but let’s already analyze what we have on the assumption that they are real.

  25. DrC says:

    Lowe has always been blatantly russophobic. Russophobia is always a sign of ignorance, bad education and ultimately a mean personality.

    1. gennady_ says:

      I’m Russian and certainly not Russophobic, so perhaps my perspective will be more palatable.

      All the self-serving and self-righteous indignation about the constant humiliation, degradation, and oppression of the Russian People does not actually add up to a cohesive domestic scientific policy. And this matters, because eventually the oil and minerals will become impractical to extract (or perhaps the demand will fall?) and the CIS will need robust scientific spheres to have any hope of maintaining relevance. Now, the CIS did inherit the popular reputation of scientific rigor and quality from the Union (though not the reputation of scientific ethics), so the least it could do is try to perpetuate and justify it it, because building up to having international respect from zero, without that history, will be practically impossible. Skolkovo is a joke and not a very funny one, so we’re already pretty deep.

      So hopefully you can see why I feel that trading on that reputation is a horrific blunder. Every time Lukashenko says he’s going to develop his own vaccine, for $2.5M (presumably with blackjack, etc.), it’s funny, of course, partly because of how inane it is. But it’s also sad — we’re seeing a multinational reputation, built by the colossal efforts of half a century of mathematicians, physicists, and chemists, getting fed into the boiler to accomplish unconvincing short-term political gains.

      За державу обидно.

    2. Derek Lowe says:

      Hey, at least it doesn’t lead to weirdly sensitive overgeneralizations. So I have that going for me.

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