Please create an account to participate in the Slashdot moderation system

 



Forgot your password?
typodupeerror
×
Medicine

Brazil Rejects Sputnik V Vaccine, Says It's Tainted With Replicating Cold Virus (arstechnica.com) 110

Artem S. Tashkinov shares a report from Ars Technica: Health regulators in Brazil say that doses of Russia's Sputnik V COVID-19 vaccine contain a cold-causing virus capable of replicating in human cells. The unintended presence of the virus in the vaccine can "lead to infections in humans and can cause damage and death, especially in people with low immunity and respiratory problems, among other health problems," Brazil's Health Regulatory Agency, Anvisa, said Wednesday in a translated statement. Russia has unequivocally denied the claim, lobbed legal threats at Anvisa, and accused the respected regulators of being politically motivated to reject the vaccine. Still, Brazil's findings raise serious questions about the quality and safety of the vaccine, which is now being used in many countries. The findings also support concerns of Slovak regulators, who said earlier this month that batches of Sputnik V they received did not "have the same characteristics and properties" as the Sputnik V vaccine that was described in a peer-reviewed publication and found to be 91.6 percent effective.

Moreover, quality-control issues weren't the end of Anvisa's concerns. In an overall evaluation of the Russian vaccine, Brazil's regulators found its safety and efficacy were based on insufficient, limited, and sometimes faulty data and analyses. "Flaws... were identified in all stages of clinical studies," Anvisa said. The agency also reported that its inspectors who traveled to Russia to assess the vaccine's production were barred from vaccine facilities at Gamaleya Institute, which developed Sputnik V. Russia touts that "the safety and efficacy of Sputnik V has been confirmed by 61 regulators in countries where the vaccine has been authorized." However, Brazil's regulators said that of the 51 countries it contacted, only 14 were using the vaccine, and most of those countries did not have a tradition of vigilant drug-safety monitoring.

This discussion has been archived. No new comments can be posted.

Brazil Rejects Sputnik V Vaccine, Says It's Tainted With Replicating Cold Virus

Comments Filter:
  • by teg ( 97890 ) on Friday April 30, 2021 @03:49AM (#61331198)

    The Brazilian incident [arstechnica.com] is not the only instance of delivered vaccines being of lower quality than one should expect..

    Slovak testing indicated serious quality control issues [arstechnica.com] three weeks ago.

    • by e3m4n ( 947977 ) on Friday April 30, 2021 @05:45AM (#61331362)
      It can happen. We had to throw out 15M doses of the J&J vaccine in the US due to mixing the base ingredient from a different vaccine by accident. https://www.google.com/amp/s/w... [google.com]
      • by teg ( 97890 ) on Friday April 30, 2021 @06:35AM (#61331438)

        It can happen. We had to throw out 15M doses of the J&J vaccine in the US due to mixing the base ingredient from a different vaccine by accident. https://www.google.com/amp/s/w... [google.com]

        The key difference here is that this incident was found by quality control before shipping the vaccines, while Sputnik seems to have been delivered to the vaccination authorities without any quality control (ref links in my original post).

        • by arglebargle_xiv ( 2212710 ) on Friday April 30, 2021 @07:10AM (#61331500)

          Sounds like standard practice for dodgy suppliers, the first batch you get, and submit for certification, easily meets IEC 60950 / EN 60 950 / UL 60950. and you wonder how they can make them for the price you're paying them (if you're in on it, you can even specifically request a version of the product for certification rather than one for sale). Then once it's certified and you happen to pull apart what they're shipping you now, you realise why they can make it for that price.

          Sounds like the Russian vaccine is being made under the same principles...

          • > the first batch you get, and submit for certification, easily meet

            The problem with ALL of these rushed vaccines is that all the research and papers were done by the top scientists in small batches in the best labs.

            Then they need to scale that up by six orders of magnitude and it's different people, different equipment, different facilities, and - most importantly - different incentives.

            QA is meant to compensate for these differences but when it's rushed the processes are just too big to do a good job.

        • by e3m4n ( 947977 )
          is this quality control issues or design? The chinese vaccine is clearly a vector vaccine like the oxford, but they deliberately chose to use a human adenovirus instead of chimpanzee. Adenovirus is one of the virus associated with the 'common cold'. So either sputnik v has always been human adenovirus and brazil just didnt understand what they were buying, or maybe to fill in the shortage russia is re-branding the chinese vaccine?
          • Sputnik has always been two human adenoviruses. But they are supposed to be castrated, unable to reproduce. Brazil is claiming that the vectors in the vaccine batch they have received are able to replicate.

            • by e3m4n ( 947977 )
              i guess thats why the oxford vaccine went with chimpanzee adenovirus, which is harmless in humans?
              • Nope, because this is how you'd make the virus jump species. Theirs is unable to replicate as well, with the downside that they use the same vector for both shots making the recipient partially immune to the second shot.

          • brazil just didnt understand what they were buying, or maybe to fill in the shortage russia is re-branding the chinese vaccine?

            Brazil has a lot of socio-economic problems, but it is not a STEM-lightweight, specially in the pharma, nuclear energy and aerospace fields. Sorry, but no. I am going to have a very hard time believing that scientists and regulators at Anvisa didn't know what they were buying.

        • by rtb61 ( 674572 )

          The difference is whose lobbyists have the best access. As desire for the vaccine wains so they are fighting over fewer doses and much reduced profits which can to a degree still be achieved as long as competing products are pushed off the market. They are attacking each others products because of a shrinking market, those willing to take the vaccine. It looks awful from the outside because the lobbyists are willing to say anything to win for the pharmaceutical paying them, a lobbyists war.

          • by e3m4n ( 947977 )
            but the cost is like $10 or so (at least the astrazennica one was) .. seems like a shitty game of competition if you ask me. The cost was deliberately low in order to ensure everyone got the jab. I would pay $10 for someone if they didnt have $10 for the shot.
      • The critical difference here being that the faulty vaccine was thrown out at the point of manufacture. They didn't say, "Hell, ship it!"

    • by qaz123 ( 2841887 ) on Friday April 30, 2021 @08:18AM (#61331710)
      Brazil didn't tested "instances" of delivered vaccines.
      The discovered that Sputnik used replicating viruses by "analyzing the documents"
      whatever that means https://cbn.globoradio.globo.c... [globo.com]
  • Scaling up is hard (Score:4, Insightful)

    by tinkerton ( 199273 ) on Friday April 30, 2021 @03:59AM (#61331220)

    I suspect that the scaling up aspect of vaccine effectiveness is a bit underestimated. It's mentioned for Sputnik vaccine but I'm thinking in general.
    The test batch may have certain testresults but then telling people to scale it up to hundreds of millions of doses, distributing them , innoculating people correctly, that is a huge challenge. There were leaked mails about the Pfizer vaccine that in the early stage(before approval, i don't know about afterwards) the concentration was half of what it was in the testbatch.
    It's possible that there are quality problems with the final product, as well as with later batches where early batches were fine.

    I know cases where the very last step of administering the vaccine was fucked up. They aimed too high and the vaccine likely ended up in the shoulder joint.

    • I know cases where the very last step of administering the vaccine was fucked up. They aimed too high and the vaccine likely ended up in the shoulder joint.

      There are something like 100 entries in VAERS of mostly hospital staff complaining about receiving intravenous covid injections rather than intramuscular. From some of the comments its hard to believe hospitals can so royally fuck up something so simple.

      • That is a serious communication failure. If we can assume for every complaint from hospital staff there are many cases which are never reported then there will be (guesstimate) tens of thousands of people who think they've been vaccinated and haven't been. Just for one type of mistake.

        • I am not a healthcare provider but, as far as I know, the order of preference for injection is SC, IM, IV. That is, if you give something that is supposed to be sub-cutaneous as an intra-muscular, it still works without side effects and the same is from IM->IV. If you take something that is supposed to be IV and shoot it into the muscle (non-diluted) it will hurt like heck and not necessarily work. But if an IM injection becomes IV due to the technician making a mistake and hitting a vein, it's not cl
          • That is a good point, maybe it will just work.
            I assumed however that once you tune it for one approach you can't count on it working for the other approach. Maybe you need a much larger dose, or a different composition.

  • by Dirk Becher ( 1061828 ) on Friday April 30, 2021 @04:11AM (#61331234)

    May cause birth defects.

  • I was under the impression that Sputnik V was a vector-virus vaccine similar to the Oxford and Chinese vaccines. But unlike Oxford, who used a chimpanzee adenovirus, the Chinese and Russian vaccines used a human adenovirus (cold virus). The downside to that approach was that should the patient already have been exposed to that strain of adenovirus, the antibody response could be too swift for the host to build up new immunities to the vector material. In addition you are, in fact, infecting the recipient wi
    • by mark-t ( 151149 )
      Doesn't a vaccine ordinarily contain an attenuated form of the virus so that it can't replicate inside the host?
      • by e3m4n ( 947977 )
        no, there are different sort of vaccines. What you are describing is a very old method like the poleo vaccine. A vector virus vaccine infects you with a not-so-bad virus whose genetic code has been altered in order for your immune system to identify it as Covid instead of the adenovirus it really is. An mRNA vaccine like pfizer and maderna infect your cells, and instead of making new viruses, build strings of the spike protein genetic material, to train your body to identify the spike proteins on the surf
        • This isn't quite accurate either. An adenovirus vector vaccine uses a *weakened* cold virus but not the target virus. There are polio vaccines that do use attenuated polio virus (and I believe that has resulted in some cases). One could imagine a vaccine using an attenuated version of the coronavirus although such vaccine types are out of favor. The adenovirus vector coronavirus vaccines use a weakened cold virus (so you don't get sick) that also has the coronavirus spike protein (so you can build immuni
        • by mark-t ( 151149 )
          That's why I said "ordinarily" I realize that mRNA vaccines are new and utilize a wholly different mechanism.
    • I was under the impression that Sputnik V was a vector-virus vaccine similar to the Oxford and Chinese vaccines. But unlike Oxford, who used a chimpanzee adenovirus, the Chinese and Russian vaccines used a human adenovirus (cold virus).

      China's Sinovac is not a fancy newfangled viral vector. It is just old school "dead" bits of actual virus.

    • Sputnik V is two human adenoviruses, but there are two genes that are supposed to be removed from the viruses. Removing those genes prevents replication.

      In samples that Brazil (and Slovakia) tested, those genes were not removed. One, the other, or both genes were still active depending on the sample, which points to a quality control problem.

  • They fix your covid infection, but in exchange you get something else...
  • by Anonymous Coward

    I was vaccinated with the Sputnik V vaccine, in Russia, so here is my experience. I'm almost 40. The OP here.

    I didn't feel anything after the first shot, but the place where I got the injection hurt for up to 36 hours, and I couldn't sleep on that side because it hurt too much. I didn't have a fever or anything like that, just pain in my left arm.

    After the second shot in my right arm, I felt like I was either dying or was poisoned. My mind was extremely foggy (I'd never felt this way even after alcohol)

  • ANVISA is suffering a lot of pressure from politicians and, in some cases, companies that are expecting to make big money. But they're clearly inspecting all incoming vaccines with scientific approach. For all current allowed vaccines here, they spent a reasonable time deeply investigating, verifying scientific papers with studies and visting the manufacturer site.

    So far, ANVISA approved Pfizer, Oxford and Sinovac.

    The pro-Bolsonaro group is pressuring ANVISA to give the green for the India one, Covaxin, but

  • "Anvisa, the Brazilian drug agency, said that every single lot of the Ad5 Gamaleya shot that they have data on appears to still have replication-competent adenovirus in it." – Derek Lowe, https://blogs.sciencemag.org/p... [sciencemag.org]. The article gives an extended account of why this is Bad.

    Also, this from Lowe on the conduct of Russia in response to this rejection, "I mentioned the Twitter response to the Brazilian rejection of the Gamaleya vaccine. I believe that the official blue-check-marked “Sputnik V

You can tell how far we have to go, when FORTRAN is the language of supercomputers. -- Steven Feiner

Working...