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Brazil Rejects the Gamaleya Vaccine

We have two pieces of news about the Gamaleya Institute’s “Sputnik-V” vaccine today. Neither of them are going to be enjoyable to go into.

First off, many may have heard that the Brazilian regulatory authorities had a hearing yesterday to see if this vaccine would be approved for use there. They have turned it down, for several reasons. (Update: here are their slides, in Portuguese). Among these are questions about the manufacturing and scale-up processes, which I have to say have not been very well documented for this vaccine. Readers may recall the reports from Slovakia about the authorities there getting what appeared to be completely different formulations of the vaccine all shipped together, so there is some room for clarity about how these processes are controlled. But the bigger news was that 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. Let’s back up for a second to appreciate what the means, for readers who don’t do this stuff for a living. The next few paragraphs are background; skip if you like.

The adenovirus vector vaccines (all of them so far in the pandemic – AZ/Oxford, J&J, Gamaleya, CanSino) are made by removing most of the adenovirus DNA instructions from some form of the virus, and inserting DNA to make coronavirus antigens instead. Oxford has a chimpanzee adenovirus, J&J has been using the Ad26 strain, CanSino has the Ad5 adenovirus, and the Gamaleya vaccine is one shot of Ad26 followed by a shot of Ad5. But all of them carry the DNA to make the coronavirus Spike protein (some of them in its native state, others with stabilizing amino acid mutations). And all of them have had key parts of their original genome removed to make them unable to replicate in the body (deleting a gene called E1 is the standard way to do this).

That means that when you’re injected with such a vector vaccine, each viral particle is a one-shot deal. It infects a cell in your body and instructs it to make Spike protein (thereby setting off your immune response when that foreign protein gets presented), and that’s it. A real wild-type virus would of course make the whole suite of viral proteins, which would be assembled into countless new virus particles. These would then be released when the cell finally breaks apart and dies from the overload. Now, there have been debates over the years about whether you’d get a more effective vaccine that way, with a “replication-competent” adenovirus, but generally it’s believed that you can do fine with the “replication-incompetent” ones, which let you *not* give your patients a new viral infection at the same time.

Adenoviruses are everywhere. What happens when you’re infected with a wild-type variety? Generally you get respiratory infections that vary according to the person. With Ad5 and Ad26 they’re generally mild, sometimes unnoticeable, but in some people there can be serious trouble, which is another reason to avoid giving them replicating virus. The Ad5 variety has infected a solid proportion of the entire human race, as far as we can tell, which is one reason why you see people moving to less-common platforms like Ad26 or adenoviruses from other primate species entirely (as with Oxford/AZ). It’s believed that if you already have antibodies and T-cells primed against the Ad5 vector itself (for example) that delivery of its payload will thus be impaired, leading to a less-effective vaccination. This also makes you wonder about diminished efficacy of booster-shot regimens with such vectors, no matter what strain you start with, and what happens if you want to get vaccinated a few years later against a completely different pathogen whose vaccine uses a viral vector you’ve already been exposed to. For now, it looks like the booster-shot idea can work, although the second shot is surely chewed up more by the immune response. The second concern is still an open question, as far as I know. Presumably both of these would be even bigger concerns with a replication-competent vaccine, because you’re hitting the patients with an even stronger viral challenge.

OK, now we need to talk about how you make big piles of virus if you’ve kept them from replicating. That’s an interesting question that has a slick solution: you’re going to be using human cells (often the HEK293 line) to expand your virus production, and what you do is engineer those human cells so that they make the missing E1 protein that the virus needs to replicate. So as long as you’re growing up virus in these engineered cells, you’ll make more, but if they infect normal human cells that haven’t been jiggered to make a key viral protein (as in when you inject them as a vaccine) they’ll stall out on replication immediately. Problem solved!

Mostly. There are still places where this can go wrong. Double-stranded DNA breaks, which can happen more or less randomly, are generally repaired by processes called “homologous recombination” and “nonhomologous end joining”, and these can lead to mix-and-match behavior between DNA from different sources. This process can be deliberately harnessed for gene editing – that’s what the classic CRISPR enzyme Cas9 does – but it can also be a source of trouble in a system like this one. There is a chance that the occasional viral particle might be able to regain the DNA sequence for the E1 protein by picking it up from the human-cell background. If that goes right (well, wrong), then that will turn it back into a replicating virus, and that’s just what it will do in your cell culture tanks.

This problem has been recognized for many years, of course, and no one’s forgotten about it. There are assays to screen for this sort of thing, and every time work gets going on a proposed new viral vector, updated assays are developed to screen that one, too. You can dive into these references for details on how to engineer both your viral vectors and your human cell lines to cut down on the chances of this happening as well. This is an accepted part of the vector vaccine production process.

Which is why the news that the Sputnik vaccine contains replicating adenovirus was surprising and unwelcome. As mentioned, this is probably not going to cause big problems in its vaccinated population, but it’s a completely unnecessary risk. And if such a vaccine is going into tens of millions of people (or more), it seems certain that there will be some people harmed by this avoidable problem. If you’re going to make a replication-competent vaccine, make one and run the clinical trials with it, and if you’re asking for regulatory approval for a replication-incompetent one you shouldn’t show up with an undefined mixture of replicating and non-replicating viral particles instead. This sort of thing calls into question the entire manufacturing and quality control process, and I can see why the Brazilian regulators are concerned.

The response from the Sputnik V camp has not been good. The official Twitter account has accused Anvisa of having “invented fake news” about the vaccine, when what you’d hope to see is more of the good ol’ “We stand by our manufacturing process, but take these concerns seriously and are working with the authorities to resolve this question” sort of thing. But no, it’s all for “political reasons”. Their official statement is no more conciliatory. A tip for the vaccine’s manufacturers: don’t immediately start accusing your critics of bad faith, especially when they are the regulatory authorities. Step up and act like responsible drug developers: address the issues directly, with transparency, and work to find a solution. Throwing fits on Twitter is not the answer. But that brings us to the next post, coming up shortly. . .

97 comments on “Brazil Rejects the Gamaleya Vaccine”

  1. Palo says:

    Even when I agree on how Gamaleya could have handled this differently, some of the complaints are bizarre (“the vaccine is produced in different locations”) and the brazillian commission that handled this is very suspect. The head of their FDA, Barra Torres, is a military friend of Bolsonaro with no vaccine or regulatory experience whatsoever according to the news, only there because he’s a friend of Bolsonaro, who’s not only a COVID-denialist and anti-vaccines but firmly anti-Russia (Trump administration proudly informed how it was asking the brazillian government to reject the russian vaccine even before ready). Here’s a fragment of news report on Barra Torres:

    “The history of pleasing President Jair Bolsonaro guides Barra Torres’ actions. His disregard for public health and the global norms established to mitigate the risks of transmission of the coronavirus are nothing new, but they have grown as a result of his approach to Bolsonaro. Torres is known to the president in the military circles of Rio de Janeiro. Due to his long friendship, he gained prominence with the military nucleus of the government. Like Bolsonaro, Torres has always said that drastic measures should be avoided in relation to the coronavirus so as not to create a climate of panic in the country. For him, this pandemic is an obstacle ”

    (“The Accidental Expert”: https://istoe.com.br/um-tecnico-acidental/)

    1. Carlos Silva says:

      While your observations about Bolsonaro’s indications are valid, the Anvisa response was backed by their researchers, and all conclusions were formed based on data and documents supplied by the vaccine manufacturer himself, which makes their reaction really bizarre.

    2. Guilherme Rocha says:

      As Carlos says, there is enough technical FACTS in the ANVISA slide deck to support the rejection.

      I am not sure where your comment about manufacturing taking place in multiple locations comes from: I could not find anything like that on these slides. It would be helpful if you pointed to the specific place where you see that complaint. What I did find was mention of data that it was not possible to ensure the lot sent to Brazil matched properties of lot reported. In my view, this is even more reason to support that rejection.

      1. Palo says:

        I’m still scratching my head at that Anvisa presentation. It really comes down to this: the lots in question are labeled as containing “less than” 10^2 RCA, and it seems clear it is a detection limit and the number was below their specs. But 1) why did Anvisa misled so deliberately with the statement saying that it had “corroborated” the presence of RCA? We all understood that was the case and it was not 2) Why, if the RCA spec number was know for months in documents… why the vaccine was not rejected then on the grounds of “it doesn’t meet our specs”? I know the scientists at Anvisa are excellent, but the voting Directors seem to be political hacks. That presentation was disgraceful (plus… all copy and past of images and text from biotech companies and FDA… bizarre)

    3. Verônica Morandi says:

      I think you cannot ignore that the scientific basis for their report is really very solid. In the world of “normal” people and institutions, the vaccine developer would simply provide the best evidence to the technical questions raised by ANVISA (or any other rigorous regulatory agency). To our knowledge, this scrutinized analysis of the Sputnik V vaccine was the very first, since ANVISA was not able to get any feedbacks or copies from the argentine and mexican reports. The other countries involved in the acquisition of the russian vaccine barely have regulatory structures.

  2. rvh says:

    The fact that RCA is being detected implicates that the upstream manufacturing process might not be stable. Sputnik has a full length native spike protein. The native spike protein has fusogenic properties that can significantly interfere in your viral culture process and yields (it can promote fusion of cells which is usually detrimental for your cells).
    If the expression is not silenced during culture (AZ/Oxford and J&J do silence transgene expression), there is strong selection on recombination events. This could include exchange of E1 between host cell and vector, but also introduction of random (silencing) mutations in the transgene which have a strong evolutionary advantage during manufacturing process which can affect the expression of the transgene after vaccination.

    1. PNitty says:

      This is really helpful and interesting additional context, thanks for posting!

    2. wk says:

      Hi rvh your comment is really interesting. Could you or someone like perhaps PNitty or Derek explain in a little more detail or break it down more for someone who has a science (physics) background and some basic knowledge of molecular/cell biology, but not quite to the level of virology or genomics? Specifically silencing, silencing mutations, transgenes and recombination events etc.

      1. Fabian Schleich says:

        I will try my best so:
        -silencing means turing off, here especially turing off the virus production during the up scale (lage production in bio fermenters of the cells used later for virus production). You dont want the virus production to start early during the mass production of the cells bc it f*cks up the full process/kills cells….
        -silencing mutations are mutations (changes in the sequence of a gene) that turn it off bc no protein can be produced anymore aka the mRNA is defective has a stop to early for example.
        -transgenes are the “new” gene that is introduced into the viral vector here it is the full lebght spike. Silencing mutations would stop spike production and therefore the point fo getting the shot.
        -recombination events are genetic information exchange events this can happen when the code for gene a is damaged but gene b exists and this info can be used to correct it. So bc the hek293T cells were made by using parts of a adenovirus this E1 gene could be reintrodiced into the adenovirused for vaccination creating a replication competent virus.
        -fusogenic properties means that two cells are meared viruses tend to do thid to cells to create more efficient “virus farms”. But the mix of two cells could increase the recombination of the (double) chromosomes or lead to huge genetic instability followed a lot of recombination events with potential to reintroduce E1 into the adenovector.

        Hope that helps 🙂

        1. This explanation was very helpful. Thank you!

        2. Tespa says:

          In short, should I worry about my grandma who received the first dose last week?

          1. eyesoars says:

            If your grandmother is a cancer patient, has a transplanted organ, or is otherwise immunologically compromised, then yes.

  3. Peter says:

    Completely unprofessional and unacceptable response from the Russians here. I assume the Twitter is directed by the government, as the government investment fund is responsible for the vaccine.

    You don’t respond to a serious technical issue from regulators by effectively typing in all caps on social media and denying it could possibly be true and the regulators are acting in bad faith. Especially not on what should be a common goal (distribute vaccine on emergency basis to suppress pandemic).

    The part where the manufacturing access and disclosure don’t meet normal standards is also totally unacceptable. The United States just had a serious problem with this – with an Ad vector manufacturer, mind – so it’s not like this is irrelevant.

  4. Venkat says:

    What a great blog post! Keep it coming sir!

  5. Christian Weisgerber says:

    Thank you for linking to the ANVISA slides. My ability to read Portuguese is limited, but I think I got the gist, and it is a brutal takedown. The second component contaminated with replication-competent virus. Studies riddled with methodological problems. Lack of demonstration that the scaled-up product is equivalent to the one used in the clinical studies. Lack of demonstrated quality control. Lack of everything really. Jee-zus.
    .

    1. Derek Lowe says:

      My impression as well. There’s a lot to clear up here, and so far the Sputnik folks don’t seem very interested in doing that.

      1. Ja says:

        Personally, from a messaging point of view, I think it would be in the best interests of vaccine manufacturers and the medical community to go on the attack against Sputnik and shut it down internationally. It would demonstrate (the obvious) that vaccine manufacturers do take seriously the analysis of data (a constant concern from those who are vaccine hesitant) and that any shortcuts (which this clearly appears to be) will not be tolerated. JnJ and AZ went along with their vaccines being halted because the safety data was sensitive to extremely rare cases yet Sputnik will continue to be distributed following shoddy processes.

        1. Shandyman says:

          Vaccine manufacturers, no; Medical community, maybe; regulators yes. Imagine the outcry if J & J publicly denigrated the Sputnik V vaccine, “they want to shut out competition to make more profit” people would say or “J & J are just a shill for the US Govt”. What vaccine manufacturers need to do is be transparent about development, efficacy and manufacturing processes and let the regulators/experts decide.

          1. confused says:

            Yes, exactly.

            Making this more of a Company A vs B, or even Country A vs B, issue than it already is wouldn’t be a good thing.

        2. OC says:

          You know 15,000 people a DAY on Earth are STILL dying of this pandemic right? Including 2,500 Brazilians?

          Brazil isn’t the U.S. It hasn’t distributed 68 MILLION more doses of vaccine than has been injected into people’s arms. It doesn’t have the luxury of owning half the Pfizer, Moderna and J&J vaccine production capacity and EXPORTING PRECISELY ZERO DOSES!

          Suggesting countries should shut down a vaccine that is actually being exported and has likely already saved tens of thousands of lives is a bizarre stance to take for somebody who has ANY concern about human health.

          The option MOST countries on Earth have are the following:

          1) Take vaccines that have low efficacy (e.g. Sinovac), very low but real risks of blood clotting (Astra Zeneca if you can even get some from the hopelessly delayed COVAX) or may have less than 1 in 1 BILLION replication competent adenoviruses (testing revealed LESS THAN 1 x 10^2 RCA in a stand 1 x 10^11 dose of Sputnik);

          2) Let COVID-19 rampage through your population killing upwards of 0.5% of the population, collapsing your health system and leaving a significant percentage of the population permanently impaired.

          For all the obviously intelligent people on this site there appears a remarkable lack of basic understanding of exponential growth factors and statistics. The continual caution has already seen 3+ MILLION people killed by a completely preventable disease.

          Rather than heap on the Russians how about you rightly ask why the U.S. continues to block exports of vaccines despite a MONSTROUS and growing glut and continues to enforce IP legislation in the middle of the largest public health disaster in history that prevents overseas plants from making the two mRNA vaccines alongside the J&J adenovirus shot???

          1. Fyodor says:

            “US legislation …that hat prevents overseas plants from making the two mRNA vaccines alongside the J&J adenovirus shot???”

            Dear uninformed and poorly paid Russian troll, Pfizer/Biontek is manufactured at Puurs, Belgium, and does filling at the French site of the Delpharm factory at Saint-Rémy-sur-Avre, new production site at German city of Marburg is being approved by EMEA.

            Moderna produces at the active substance manufacturing site (Lonza, Visp) and newly approve filling site at in Rovi, Spain.

            …and there are more sites in Switzerland, Italy and Ireland.

            Otherwise you say that Sputnik saves lives, well, how do you know that ? Why should anybody believe an obviously unreliable information source.

    2. Filipe says:

      I second that. They found way more issues than the replicating adenovirus, and went all the way to sending people over to inspect the factories. This was a pretty extensive analysis.

    3. Verônica Morandi says:

      I think that the Brazilian regulatory agency really did a great job. ANVISA was shaped and created in the 90’s on the basis of the most rigid organisms and the report was backed by all of their scientific personnel. The poor reaction coming from the russian developer is atypical, to say the least…

  6. Hopeless Scientist says:

    Great post! Your discussion about the adenovirus vectors and primed immune response upon repeated exposure brought up another question for me: Does this affect yearly flu shots? I’m not sure what vector they use, but I know most people recommend taking them. Just curious to hear what your thoughts are about it. Thanks!

    1. Derek Lowe says:

      The flu shot is just traditionally inactivated influenze virus (plus adjuvants), grown in chicken eggs. No infectious influenza virus, and no other viral vector. There are some attenuated-virus nasal spray vaccines, and one recombinant protein one that is like the Novavax coronavirus vaccine (cell-produced protein(s) plus adjuvant. To the best of my knowledge, there are no viral-vector influenza vaccines.

      1. Loonybean says:

        Purely anecdotal, but I had my flu jab, followed a week later by a Pneumovax jab, then 3 weeks later, my first AZ jab. I had a fairly strong reaction to the AZ jab, feverish, a few aches and pains, none of which were unexpected. My 52 year old immune system certainly felt like it was doing what it should, so I’m assuming no adenovirus vectors in the Pneumovax jab either.

        Thanks for all the great reporting and analysis you and your colleagues have been doing through all this, it’s really appreciated that you’re keeping us all up to speed, even, as a layperson, if some of the more esoteric stuff goes over my head, I am still understanding a lot more than I thought I would.

  7. G Carr says:

    I’m in the tourism business and have no background in this field (other than reading every post by Derek, and Beth Mole over at Ars, since the pandemic began), but I have a serious question.

    Is it possible that the combination of a replicating adenovirus expressing spike proteins creates a new type of virus altogether, that is neither adenovirus or coronavirus, but rather some new mutant virus that we should be concerned about?

    Because Derek did not address this in his post, I’m assuming that the answer is no, but would like to know for sure. Thank you.

    1. Derek Lowe says:

      Fortunately, the answer is indeed no. These two are way too far apart on the general viral family tree; it would be like hoping for a dachshund-lemur crossbreeding project to produce the cutest animal in the world.

      The bigger worry, IMO, is that the tools for altering genomes are getting so powerful and so user-friendly that the possibility of some evil lunatics whipping something up on their own becomes a bit more possible every year. Sort of like Aum Shinrikyo and their homemade nerve gas in the Tokyo Subway, but with a greater likelihood of actual competence. Fortunately, the overlap of the small set of people who are crazed enough to want to do this does not overlap well at all with the set of people with the technical know-how to get it done. But I fear that the overlap may perhaps be nonzero nonetheless.

      1. Eugene says:

        https://en.wikipedia.org/wiki/1984_Rajneeshee_bioterror_attack, seems like it already happened in the US without any special skills.

      2. En Passant says:

        The bigger worry, IMO, is that the tools for altering genomes are getting so powerful and so user-friendly that the possibility of some evil lunatics whipping something up on their own becomes a bit more possible every year.

        I share that concern.

        Sort of like Aum Shinrikyo and their homemade nerve gas in the Tokyo Subway, but with a greater likelihood of actual competence.

        A minor clarification, or minor nit about the issue of “actual competence”.

        Aum Shinrikyo (which now calls itself “Aleph”) manufactured the nerve agents Sarin, a binary Sarin-like agent, and VX with sufficient competence that they killed at least 21 people with Sarin and 1 with VX, and injured more than 1500 in three attacks in 1994 and 1995.

        They also cultured and released Bacillus anthracis spores, with no resulting epidemic. The spores were real. Their attack method was not competent.

        They also attempted to release HCN in a Tokyo subway. Had their attack method been competent, the HCN quantity was sufficient to kill 10,000 or more.

        Their incompetence was not in synthesizing the agents or culturing the anthrax spores; their chemists produced the nerve agents at least accurately enough to be fatally effective.

        Their lack of competence was in their methods of attack with the agents. Their troops of attackers apparently were not led by experts sufficiently competent in chemical warfare to kill the numbers they intended.

        In today’s context of altering viral genomes, I do not doubt that “evil lunatics” could manufacture communicable deadly viruses. But I do not know enough to comment about the means to spread them and cause widespread death and mayhem. So I certainly share your concern that it becomes “a bit more possible every year.”

      3. Charles H says:

        Unfortunately, that’s not a valid argument. It’s a valid argument that it’s unlikely, but we’re dealing with a HUGE population of replicating viruses. Consider how the hemoglobin protein got into the pea root nodes. There are other cases. It’s rare, but it happens.

  8. Bash says:

    This may sound like a stupid question, but would it ever be possible to have a “contagious” vaccine via a replication-competent viral vector?

    1. stewart says:

      If I recall and understand correctly the live polio vaccine (no longer used) was such.

      https://en.wikipedia.org/wiki/Vaccine_shedding

    2. sgcox says:

      Well, the very first vaccine by Edward Jenner was cowpox against smallpox. So yes 🙂

    3. Derek Lowe says:

      Not crazy at all, and that idea has indeed been proposed. Brings up a lot of medical ethics questions, though, doesn’t it? To the best of my knowledge there’s been nothing like that in the modern era.

        1. confused says:

          Definitely ethically iffy due to informed-consent issues, but something like this might be necessary/worth it if a 1918-level or worse pandemic ever hit again?

          1. Eugene says:

            I have no doubt that the current pandemic could and does (in some parts of the world) reach an order of magnitude or closer of the 1918 pandemic if not for modern medicine like widespread Oxygen administration, mono-clonal antibodies, anti-virals and Steroids being available to blunt some of the worst effects.

          2. anon says:

            Wouldn’t it be ironic if those anti-science folks end up wearing masks because they did not want to be “vaccinated”?

          3. confused says:

            Well, in the US, with modern medicine, it’s already within an order of magnitude – 560,000+ deaths out of 330 million, vs. ~650,000 deaths out of a bit over 100 million.

            But the US seems to have been rather less hard hit by the 1918 pandemic than some places, at least if one believes the CDC’s 50 million estimate for global deaths (world population then was only 1.8 billion).

            But I think 1918 flu also had more ‘society-damaging potential’ than COVID, not just due to the raw number of deaths per million, but the age distribution of deaths.

  9. Pablo E Garibotti says:

    Gamaleya has strongly denied the presence of RCA in their vaccine:
    https://sputnikvaccine.com/newsroom/pressreleases/sputnik-v-statement-on-brazilian-health-regulator-anvisa-s-decision-to-postpone-authorization/

    Basicalluy they claim that ANVISA is lying due to political pressure from USA
    A strong point they have is from the DHHS 2020 Annual Report (pa 49):
    “Combatting malign influences in the Americas: OGA used diplomatic relations in the Americas region to mitigate efforts by states, including Cuba, Venezuela, and Russia, who are working to increase their influence in the region to the detriment of US safety and security. OGA coordinated with other U.S. government agencies to strengthen diplomatic ties and offer technical and humanitarian assistance to dissuade countries in the region from accepting aid from these illintentioned states. Examples include using OGA’s Health Attaché office to persuade Brazil to reject the Russian COVID-19 vaccine, and offering CDC technical assistance in lieu of Panama accepting an offer of Cuban doctors”
    https://www.hhs.gov/sites/default/files/2020-annual-report.pdf

    If this is in an official USA document, would you discard the possibility of the CIA contaminating the samples? Even with the help of Mr. Bosonaro’s Secret Service?
    So ANVISA is not lying, just misled

  10. Filipe says:

    Brazilian here, but not from any biomedical field. They actually found more issues than the one being described, mostly associated with quality control and testing. They also went all the way to sending specialists over to Russia to look at the factories, having been denied visits to one key plant (always a bad sign).

    1. Filipe says:

      Official note linking to slides: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2021/anvisa-nao-aprova-importacao-da-vacina-sputnik-v

      There are three technical bodies within Anvisa, all of which looked into this and independently recommended against the vaccine. Slides linked on Dereck’ s the post are from the first such body (GGMED). You can find links to the slides from the other two on the link above, including their findings in visiting the vaccine production and testing plants in Russia.

      It’s all in Portuguese, but Google translate should help here. I’m a native speaker and can also help with any translation issues.

      1. Filipe says:

        The meeting was also live streamed. Also in Portuguese: https://www.youtube.com/watch?v=H23DK0AvKJc

      2. Google says:

        Google translation
        DICOL

        Anvisa does not approve the import of the Sputnik V vaccine
        Evaluation of available data to date points out flaws in the development and production of the immunizer. There is an absence or insufficiency of data on quality control, safety and efficacy of the product.
        Share:
        Updated 28/04/2021 11:55
        Due to the lack of consistent and reliable data, the Anvisa Collegiate Board (Dicol) unanimously decided not to authorize the exceptional import of the Russian Sputnik V vaccine. of the 30-day period established by the Federal Supreme Court (STF), in a decision rendered by Minister Ricardo Lewandowski.

        The decision was made based on data collected and evaluated by the technical teams of the General Management of Medicines and Biological Products (GGMED), Sanitary Inspection and Inspection (GGFIS) and the Monitoring of Products Subject to Health Surveillance (GGMON). The General Management of Ports, Airports and Customs Enclosures (GGPAF) and the Office of International Affairs (Ainte) also participated in the survey.

        According to the rapporteur of the process, director Alex Machado Campos, the decision is a portrait of the moment. He pointed out that the Agency is known for making access to medicines and vaccines feasible and that, in this pandemic moment, the institution has acted at the limit, but that there is no flexibility in relation to product safety.

        The rapporteur also stated that Anvisa’s daily challenge is to establish whether the benefits of vaccines outweigh the risks related to the product. “Security is an inalienable aspect in view of the uncertainty of risk. We got here hand in hand with science and supported by evidence ”, said the director.

        To date, 14 states have sent import orders for the Sputnik V vaccine to Anvisa: Acre, Alagoas, Amapá, Bahia, Ceará, Maranhão, Mato Grosso, Pará, Pernambuco, Piauí, Rio Grande do Norte, Rondônia, Sergipe and Tocantins, in addition to the municipalities of Maricá and Niterói in Rio de Janeiro.

        Failures and inconsistencies
        According to GGMED, flaws in product development were identified in all stages of clinical studies (phases 1, 2 and 3). There is also an absence or insufficiency of data on quality control, safety and efficacy. One of the worrisome information regarding the evaluation of the data available so far is that the cells where the adenoviruses are produced for the development of the vaccine allow their replication. This 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.

        This aspect deviates from the quality standards recommended by the World Health Organization (WHO) and the International Council for Harmonization of Technical Requirements for Medicines for Human Use (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – ICH), followed by the main regulatory agencies in the world, including Anvisa.

        In addition, inadequate characterization studies of the vaccine were detected, including with regard to the analysis of impurities and contaminating viruses during the manufacturing process, in addition to the lack of validation / qualification of quality control methods, among several other aspects. It was also verified the absence of reproductive toxicity tests, which allow to verify if the product may or may not be harmful to the reproductive cells.

        In its analysis, GGMON reinforced aspects pointed out by GGMED, but drew attention especially to the question of ignorance of short, medium and long term adverse effects resulting from the use of the vaccine.

        Oversight
        The Inspection area has also detected a number of problems related to the Sputnik V vaccine, including as a result of an inspection mission sent to Russia. According to GGFIS, the lack of a technical product approval report culminated in the need for face-to-face inspection to allow the assessment of the manufacturing conditions of the companies involved in the production of the biological pharmaceutical input and the vaccine.

        During the visit, no manufacturing conditions were identified that demonstrate that the products are consistently manufactured and controlled, resulting in a product with the quality required for its intended use. GGFIS also reported that, on Russian soil, the inspection team was denied access to the facilities of Gamaleya, the institute that developed the vaccine.

        Confidence
        According to director Meiruze Freitas, society expects Anvisa’s speed and responsibility in approving the quality, safety and efficacy of medicines and vaccines. “I express here with sincerity that we are doing everything we can to ensure that vaccines for Covid-19 reach the people of this nation and that they meet the standards of quality, safety and efficacy. Whenever a Brazilian or Brazilian, including members of our own family, receives a dose of the vaccine against Covid-19, when their arms are offered, they need to have confidence in the work of Anvisa’s public servants, ”said the director.

        Meiruze Freitas also reinforced that vaccines against Covid-19 are drugs developed and produced to save human lives, so there is a requirement for consistent data on the product. “I hope that, in fact, the Sputnik V vaccine process adapts your information and resolves compliance issues quickly, because millions of people need access to safe and effective vaccines,” he concluded.

        Director Cristiane Rose Jourdan Gomes reinforced that the analysis made by the technical team does not yet seem to include the minimum of sufficient data that contrasts with the countless uncertainties that exist. “In fact, this is a delicate issue, since the availability of yet another vaccine, as long as it is approved by Anvisa, is a priority to compose a range of immunizers to combat Covid-19. As an optimist, I hope that, in the shortest possible time, Sputnik V’s lack of information will be overcome ”, said Cristiane.

        In his speech, CEO Antonio Barra Torres made a point of reinforcing that the institution is respected nationally and internationally and that he will not abdicate his mission. He stressed that the Agency has already authorized five vaccines, two of them in record time in the world. “But also, within the scope of our competence, we will never allow, without the necessary necessary evidence, that millions of Brazilians are exposed to products without proper proof of their quality, safety and efficacy or, at least, in the face of the serious situation we are going through, a favorable risk-benefit ratio ”.

        Law
        The evaluation of the exceptional import request for the Sputnik V vaccine was made based on Law 14.124 / 2021, which determined that entities that request authorization for emergency and temporary use of vaccines against Covid-19 must submit a series of information to Anvisa. Among the requirements is the technical report of the evaluation, issued by certain international health authorities, capable of proving that the vaccine meets pre-established quality, efficacy and safety standards. In the absence of the technical report, the Agency’s decision period is up to 30 days. The assessment also follows the rules of the Resolution of the Collegiate Board (RDC) 476/2021.

        Therefore, for director Romison Rodrigues Mota, Law 14.124 / 2021 , which enables and brought to the legal framework the figure of exceptional importation, recognizes in the Agency the competence to evaluate requests of this nature. “We cannot give up our responsibility, Anvisa’s competence to act on issues related to health surveillance, which is the institution’s objective to exist”.

  11. Russian Troll says:

    Derek, thanks a lot for the article, and Filipe, thanks for the link to primary source slide decks. Read them with Google translate and residual knowledge of castellano. Most serious issues are:

    * replication-competent Ad5
    * denial of access to Gamaleya labs
    * possible violations of GMP at the Ufa Vita plant
    * shifting (and shifty) inspection schedule at the Vladimir Generium plant

    Looks like at least some part of the Sputnik V operation has been taken over by the same folks that did ‘creative anti-doping testing’ at the Sochi Olympics. Also, scaling up is hard.

    ANVISA slide decks aren’t perfect, either (makes sense given the tight schedule). Plenty of irrelevant visual cruft, abundant weasel wording, cut-and-paste article screenshots. One would want to know exact stats on differences between lab and plant-manufactured vaccines, and what the GMP violations were detected at the Ufa bioweapon (sorry, vaccine) production site.

  12. HA2 says:

    Any idea what this means for people who got that vaccine?

    I have family in Russia and that’s the one they got, of course. Are they probably protected? Or probably not?

    Is this news an indication that the Sputnik vaccine’s a scam and doesn’t work, so people who got it should behave as if they got a placebo, or just that they’re playing cavalier with risk and so it’s got a higher chance of unexpected side effects, and people who already had it are fine?

  13. naive questions about this case says:

    This post is extremely helpful, especially the explanation of how the process of making the virus non-replicant can go wrong. Thanks. Here’s my question(s): Doesn’t Gamaleya also use ths same techniques and the same viruses (Ad5 and Ad26) for a Ebola vaccine? If so, then is this really an issue of poor production of this particular COVID vaccine, perhaps a product of the rush to make too much too quickly? And, assuming there’s anything to the first 2 questions, is it possible that the production problems may vary facility-by-facility, and that it’s possible that the stuff sent to Brazil has replicating adnoviruses but other batches don’t?

    1. Ilya says:

      For an Ebola vaccine, they manufactured it on Gamaleya plant only AFAIR – that is very small, almost lab-scale. for a Sputnik-V, they transferred it to quite-a-large-scale Russian manufacturing site, including new-built ones.

      1. naive questions about this case says:

        Thank you, Ilya. So this sounds like a problem linked to the effort of trying to produce large volumes in a short period of time (what I was trying to suggest in my second question).

        1. Ilya says:

          That’s the question. This problem could be:
          1. Inherenent one;
          2. Scale-up one;
          3. Not a problem at all. Unfortunately, we couldn’t eliminate a possibility that it’s not a science issue – but a politics one.

  14. J says:

    “Russia calls on Slovakia to return Sputnik V doses after dispute”
    8th April, 2021

    https://www.reuters.com/article/us-health-coronavirus-slovakia-sputnik-idUSKBN2BV2GP

    Given this situation with Brazil authorities is there reliable up to date information on the Slovakia situation?

  15. Flávio da Fonseca says:

    I don’t if someone has already brouht that up, but having a replicative adenovirus bearing the SARS-CoV2 Spike coding gene on the lose sounds quite dangerous to me….

  16. As a Brazilian, professor at a university, specialist in Health Surveillance, and passionate about this field of knowledge, I watched the ANVISA meeting and I am confident of the quality of the analyzes. A post like this has a very special meaning for the recognition of the Brazilian Health Surveillance.

    1. Selma A. Gomes says:

      Regarding ANVISA’s announce about having found replicating Adenovirus in the Spitnick vaccine batches.
      ANVISA is an institut of biological and medical control, so ANVISA does not carry out scientific experiments. ANVISA can only inspect drug, vaccine and medication development places and analyze reports.
      In all reports about ANVISA decision and even at the ANVISA website, it is not informed how ANVISA concluded that Sputnick lots have replicant adenovirus.
      Journalists and autorities should ask this question
      to Anvisa: How did you come to the conclusion that there is a replicating adenovirus in the vaccine batches, since ANVISA do not perform experiments, do not perform biological control and Gamaleia institute reports that they did not find these viruses in Sputnick batches. What document provided by the Gamaléia Institute leads to this conclusion?

      1. Dave says:

        >>Russian Troll<<

        1. Alex says:

          Who is the troll now?

          “Anvisa did not perform an RCA test. As is the norm, the agency relied on documentation provided by the manufacturer. ”

          Leia mais em: https://bdtcgc2udslhnzpbe5r2txkq3y-ac4c6men2g7xr2a-super-abril-com-br.translate.goog/blog/bruno-garattoni/anvisa-nao-testou-a-presenca-de-replicantes-virais-na-vacina-sputnik/

  17. Anna Stenzel says:

    Two questions – I do not have a medical background; rather 20 years of analytical experience in pol/mil. I apologize in advance if these questions have been addressed in some fashion already. AND, thank you so much for this blog. It is very helpful.

    1. How is the Sputnik V vaccine, as described above, affecting Sputnik V inoculated individuals? Is it causing no immunity, limited immunity, decreased immunity; new strains? Are the vaccines contributing to a larger problem of COVID-19 vaccine outbreak in human populations? (speculation is welcome if there is no definitive answer)

    2. Is it known if the Chinese vaccines have the same issue as described above?

    3. Is the ability for the virus to ‘regain’ function from CRISPR alteration similar to what happened with China’s attempt at swine vaccine development for African Swine Fever Virus? The ASFV vaccines have been accessed through illicit means among Chinese farmers, which has created new strains of ASFV as a result.

  18. OC says:

    Sorry but Anvisa under Bolsonaro’s kakistocracy can hardly be held up as a model of impartiality. The fact they paused a trial for a SUICIDE a full week after the event and where police had already ruled it as such is damning. This act (in the middle of a MASSIVE pandemic) no doubt has killed thousands of people through delay (given the exponential nature of a pandemic):

    https://www.google.com/amp/s/mobile.reuters.com/article/amp/idUSKBN27Q04C

    Anvisa’s determination in this case may be accurate.

    Having said that it is unusual that none of the other regulatory bodies that have looked at and approved this vaccine wouldn’t have discovered similar problems.

    E.g. Hungary, India, Mexico, Argentina, Egypt etc. Are all these bodies completely incompetent?

    Given the Gamalaya institute is apparently suing for defamation one would be wise not to jump in head first supporting a regulator with at least one completely indefensible action of political interference under its belt.

    1. trusting brazilians' authorities is a joke says:

      i recall a USA politician confirm the USA was trying it’s best to push Brazil not tu allow Sputnik, and congratulating himself when the latter did as being told. Outside of the political humiliation for Brazil, it’s also inhumane from the USA to force other countries’ hand (especially one where covid keeps increasing) regardless of humans lives that could be saved …

      1. OC says:

        Yep quite ironic that all these people pushing the precautionary principle seem quite unpertubed about the close to 15,000 people A DAY that are dying from a completely preventable disease. Brazil is seeing 2,500 people a day die but the biggest risk is they might get an infection of Ad5 which practically every single one of them would already have been exposed to???

        1. Fyodor says:

          Nice to see that you acknowledgment that the AD5 vaccine is contaminated with the replicating AD5 viruses.
          And if former infection with AD5 is common and non-issue, then the AD5 jab will be ineffective because of subjects’ resistance to the AD5 vector.

          May I suggest reading up on the Freud’s kettle argument ?

          1. OC says:

            Even if you have been exposed to Ad5 (which you HAVE been) a dose of 100,000,000,000 virions delivered directly into your upper arm muscle WILL still deliver its DNA payload into hell of A LOT of cells.

            0-100 replication competent virions out of the standard 100,000,000,000 virion dose are hardly going to make much difference. That is how many the test results from Gamalaya found. I.e. LESS than 1×10^2 virions in a 1×10^11 dose.

            If you are concerned about this then you should be REALLY concerned about cancer therapies using replication competent adenoviruses. There the doses are typically upwards of 5×10^11 virions PER DAY for MANY days in a row. Funnily enough though they appear safe. Not really a surprise though given Ad5 is endemic and causes very mild symptoms if any at all.

            Or you can take your chances with a novel beta coronavirus that kills upwards of 0.5% of people it infects and leaves MANY more permanently impaired. Remember Brazil is not the U.S. it hasn’t distributed 70 MILLION more vaccines than it has injected into people’s arms because it owns a huge percentage of mRNA vaccine capacity and HASN’T EXPORTED A SiNGLE DOSE! The public there are predominantly unprotected. In my view it is immoral and unethical to deny them a vaccine that has proven efficacy and safety when a raging pandemic is killing 2,500 PER DAY.

          2. OC says:

            May I instead suggest you try to even get SOME semblance of proportionality in your thinking and a reminder that the statistics that are being reported every single day involve real people?

            So 3 batch test results showing LESS than 1 x 10^2 RCA out of 1 x 10^11 virions and so far ZERO credible results of harm occuring from said “contamination” vs. raging pandemic infecting 750,000 people a day, killing 15,000 a day and leaving tens and tens of thousands more permanently impaired.

            Remember 61 countries drug regulators have approved the vaccine and tens of millions of doses have been exported and injected into people.

            Hmmm. No we’ll just stop using that vaccine because a regulatory body run by a puppet of a right wing populist says so.

            Not like the vast majority of the world is massively short suitable substitutes!

  19. arsian says:

    Order of magnitude difference in tolerance of FDA for gene therapy versus vaccine spec according to translation reported by Beth Mole on arstechnica

    https://arstechnica.com/science/2021/04/brazil-rejects-sputnik-v-vaccine-says-its-tainted-with-replicating-cold-virus/

    of

    https://www.gov.br/anvisa/pt-br/composicao/diretoria-colegiada/reunioes-da-diretoria/votos/2021/copy2_of_rextra-7-de-2021/voto-120-2021-dire5.pdf

    In a 21-page report from Anvisa, the regulator wrote (translated from Portuguese on page 8), “Although international guidelines have established that replicating viruses should not be present in the vaccines, the [Sputnik V developers] set the limit of 1×103 [1,000] RCA per dose of 1×1011 [100 billion] viral particles, which is considerably above the limits allowed in the guidance of the American FDA” for gene therapies.

    The US Food and Drug Administration’s guidance for gene therapies states that the agency recommends “a maximum level of 1 RCA in 3×1010 [30 billion] viral particles.” That would allow for no more than about 3.33 RCA in 100 billion viral particles, not 1,000.

    In another report, Anvisa wrote (again translated): “It is noteworthy that the replicating adenovirus was detected in all batches presented for component II [Ad5-based second dose] of the vaccine and not evaluated in component I [Ad26-based first doses].”

    Source for this other report was not given.

    1. OC says:

      Those are NOT binding limits.

      They are recommendations as pg 34 shows pretty clearly of the FDA document.

      https://www.fda.gov/media/113760/download

  20. OC says:

    Turns out the whole RCA issue is due to a test report provided by Gamalaya which showed the test batches all had RCA LESS THAN 1 in 10^2 virions per dose (standard dose contains 1×10^11 virions). For all we know the test didn’t have the sensitivity to do any lower cut off than this.

    https://super.abril.com.br/blog/bruno-garattoni/anvisa-apresenta-documento-russo-sobre-virus-replicante-na-sputnik-v/

    In any case let’s assume the doses average 0.5×10^2 virions that are self replicating. I.e. 50 out of the standard dose of 10^11 (i.e. 100 BILLION) virions.

    Two things to note:
    1) The FDA standard of 1 in 3×10^10 virions that Anvisa reference is for gene therapies costing THOUSANDS of dollars per patient. NOT an emergency use authorisation for a vaccine costing less than $10 per dose during a pandemic STILL KILLING 2,500 Brazilians A DAY!!! I.e An annual mortality rate of 0.43% from a single cause!!!

    https://www.fda.gov/media/113760/download. See pg 34.

    2) 50 self replicating virions in TOTAL delivered into a patient is likely to have NO effect given adenoviral PFU’s/ml for cell experiments are in the range of 2×10^5 – 1×10^6! I.e. 200,000 to 1,000,000 virions per ML.

    Remember Brazil is NOT the US. It isn’t sitting on a stockpile of > 60m Pfizer, Moderna and J&J doses PLUS tens of millions of yet to be released J&J and Astra Zeneca. It is short vaccines big time and is being absolutely ravaged by this disease.

  21. Strange says:

    Does replicated adenovirus keep the spike payload? If so, does that mean that a vaccinated person can infect someone else with replicating adenovirus with spike payload and this person can infect another and another?
    I mean… does Russians accidentally or intentionally created a potentially self-propagating viral vaccine?
    If so, what could be the consequences of such uncontrolled spread? Or are my assumptions wrong and it can’t propagate through the population?

  22. sgcox says:

    It can actually make a very nice Hollywood blockbuster.
    Two scenarios:

    1. Evil Russians create deadly “vaccine” and spread it around the world to cause massive infertility crises which wipes out next generation and create lebensraum for protected elite.
    Dwarfed by 007 who seduced all gorgeous Gamaleya girls.

    2. Covid vaccine marked is currently estimated by $100 billions or something. Evil pharma creates single use vaccine types to reap all the profit, just like Evil GM companies sell billions $ worth of infertile seeds each year to “protect environment”. But heroic maverick Russian scientist create clandestine variant that spreads around world, saving millions of lives and dwarves Evil Pharma plot. Also seduces glamourous CIA and MI5 agents (can be the same as in 1 for inclusivity)

    Hmm, may be I should copyright it.

  23. J says:

    “Scientists back Brazil’s move to ban import of Russian “Sputnik V” COVID vaccine”

    https://www.cbsnews.com/news/sputnik-v-vaccine-covid-brazil-russian-vaccine-ban-efficacy-recombination/

    Derek (Lowe) is quoted in the above article.

  24. Graziela Rodrigues says:

    People seem to be missing here that, unlike was reported in various news outlets, Anvisa did not perform any tests. They have stated that repeatedly at this point, to clarify the confusion, which arose from the wording in the original presentation.
    Their conclusions were soley based on their interpretation of the documentation received.

  25. Mike says:

    If we use cell line PERC.6 why we have this issue, i understand if it’s HEK293.

  26. Samaritan says:

    CDC has published that it convinced Brasil not to take it. The Americans sometimes have very convincing ways 🤪

    1. Fyodor says:

      source ? Other then Russia Today or ‘daily brief to Russian trolls’ .

      CDC did not publish anything about Sputnik V vaccine.

      1. Ilya Golubev says:

        Well, it was actually – but the Samaritan made an error, it was not CDC but HHS: https://www.hhs.gov/sites/default/files/2020-annual-report.pdf (page 49)

        1. Fyodor says:

          Ilya, this is 2020 annual report, ANVISA rejected Sputnik in April 2021. I would guess that the text you refer to concerns some earlier episode.

          1. Ilya Golubev says:

            Yes, it’s 2020 report. And now, in April 2021 we see that Brazilia follows HHS’ advice. Whether on science ground or not – that’s the question.

            RDIF (be blamed their name!) signed an agreement with some Brazilian mfg site on late _October_2020_: https://www.reuters.com/article/us-health-coronavirus-brazil-sputnik-idUSKBN2782VS . I don’t know what about you, but I recognize an evident correlation between those two facts.

          2. Fyõdõr says:

            … more you write more it looks like the HHS claim was an empty one.
            They said “done deal” last year but the agreement goes ahead and ANVISA makes an evaluation, inspects Russian plants etc.
            The world is complex (outside Russia) and different parts of public authorities can act in an independent and contradictory way.

    2. Derek Lowe says:

      No. This did not happen, and you cannot cite a CDC document to that effect, as you seem to be saying.

      1. S.M.Visitor says:

        This is from Washington Post:

        Buried deep in the dry, 72-page annual report of the U.S. Department of Health and Human Services lay a startling admission: U.S. health officials under President Donald Trump worked to convince Brazil to reject Russia’s Sputnik V coronavirus vaccine…

        https://www.washingtonpost.com/world/2021/03/16/hhs-brazil-sputnik-russia/

      2. OC says:

        You know the sign of a mature individual is the ability and willingness to admit when they are wrong right?

        Your article has trashed the reputation of Gamalaya and gone into bat for the clearly troubled administration of Anvisa under the right wing demagogue of Bolsanaro. This despite them having already shown form in the disgraceful and completely unjustified pausing of the Sinovac trial one week after a suicide and POST the police report reporting it as such.

        It reflects poorly on your professional reputation that you don’t edit your work when you have implied something that isn’t true (Anvisa tested for RCA – they didn’t) and argued something that isn’t particularly supportable on the facts (that the Anvisa presentation was fair and balanced – it clearly wasn’t).

        Then you continue to deny things that anybody who isn’t obtuse would find incontrovertible. I.e. The HHS lobbied Brazil and other Latin American states to not use Russian vaccines.

        It is IN THEIR ANNUAL REPORT that they applied political pressure to reduce the influence of the Russians. The fact they have used weasel words and NOT CATEGORICALLY DENIED the accusation that they lobbied for refusal of the vaccine is proof positive that they did it. Otherwise they would have gone on the record to do so.

        Why is it so hard for you to accept that YOU ARE WRONG?

        https://www.washingtonpost.com/world/2021/03/16/hhs-brazil-sputnik-russia/

        1. Marko says:

          Bolsonaro is in trouble. First the Lula-jailing “Lava Jato” prosecution is exposed as the fraud it was from the outset, and now, just like Modi, he’s being accused of crimes against humanity for his mishandling of the pandemic. He’s dancing at the ends of US puppet strings, the one outside entity powerful enough, and willing, to rescue him.

          Bolsonaro makes his promise to the US to trash Sputnik, then sets out to establish the mechanism to fulfill that promise:

          12/7/2020: INSIGHT-Bolsonaro turns to military allies to set Brazil’s coronavirus vaccine policy

          https://www.reuters.com/article/health-coronavirus-brazil-vaccine-idUSL1N2IC1SD

          “Brazil’s leader Jair Bolsonaro is moving to assert control of the nation’s independent health regulator, Anvisa, a move some health experts fear will politicize the agency and give the president, one of the world’s most prominent coronavirus skeptics, free rein over vaccine approvals.

          Bolsonaro on Nov. 12 nominated a retired soldier, Jorge Luiz Kormann, to take one of Anvisa’s five director posts. Kormann, a former lieutenant-colonel with no background in medicine or vaccine development, would lead the unit charged with greenlighting vaccines. If he is confirmed by Brazil’s Senate, as is expected, Bolsonaro allies would occupy three of Anvisa’s five directorships, giving them a majority in all decisions taken by the agency…..”

          Covid twitter and this blog’s commentary have become less and less about facts and science. First the AZ smears, now this. They now more closely resemble a bunch of clueless Trumptards mindlessly chanting: “USA! USA! USA!”, which is why I’m done with it all.

          1. Fyõdõr says:

            “President Jair Bolsonaro has given up on appointing reserve lieutenant colonel Jorge Luiz Kormann to the board of Anvisa (National Health Surveillance Agency). Romison Rodrigues Mota, the career server who has been with the agency since 2005, took the second director’s seat. The nomination was published this Tuesday (March 16, 2021) in the Federal Official Gazette .

            Kormann is the current deputy executive secretary of the Ministry of Health. He had been appointed to Anvisa’s board in November last year. Since then, the military has been waiting for the Senate’s hearing, which needs to approve the names for regulatory agencies. The session was never scheduled.

            The appointment of the military was not well received at Anvisa.”

        2. Crni says:

          CDC did not do this. OGA did it.

        3. Raf says:

          You seem to be utterly ignorant about how Anvisa works and does not seem to be aware of the protocols which were backed by Anvisa’s founder himself (clearly not alligned with Bolsonaro) when the regulator suspended Coronavac trials. Also, there are five directors in the board, which you seem to ignore.

          Go read about protocols regarding these kind of trials before trashing others in the internet.

  27. J says:

    There has been various mentions of authorisation status of vaccines on recent articles. Wikipedia appears to have comprehensive data on this.

    https://en.wikipedia.org/wiki/List_of_COVID-19_vaccine_authorizations

  28. Rob McMillin says:

    The thing that struck me a little bit ago: Russia isn’t doing their own manufacturing, but instead rely on (South) Korean and Indian manufacturers.

    If this is a manufacturing bug, isn’t it a condemnation, in fact, of Serum Institute, et al.?

    1. Mariner says:

      I remember reading some months ago (no idea where) some quotes from Russian scientists which indicated that they were having manufacturing problems with the Ad5 component of the vaccine. The quote was something to the effect that it was a poor choice to aim for the two component vaccine as you were then effectively developing two different vaccines.the logic for improved efficacy is there but the risk of production issues is certainly doubled.

      I wonder if this is why we’re seeing these issues reported? Is the Ad26 component easier to manufacture and they are having to drop the quality control on the Ad5 component to keep up?

      Might be worth just using the Ad26 component on its own, if so…

    2. Ilya Golubev says:

      Well, it’s half truth. Russia manufactures Sputnik-V by itself on several sites; but it also nagotiates to outsource it too as we dont’t have manufacturing facilities eniugh for all who wants its (and Russians are not very happy when vaccine doses that could be used inside the country are being sold to Argentina etc…).

  29. Alexander Nater says:

    Please update your article. ANVISA has not tested any vaccine batches for the presence of RCA and no RCA has been found in any of the released vaccine lots. This is purely an issue about permissable threshold limits of RCA during vaccine production quality control. The ANVISA presentation was very misleading in this regard and the media (this article included) was eager to take this up and turn it into a “dangerous RCA found in Sputnik vaccine batches” without asking any critical questions about the used methodology. The vaccine developers are rightfully not amused about this very unprofessional behavior of ANVISA and it is hard to imagine that this communication blunder was strictly unintentional.

    1. S.M.Visitor says:

      “and it is hard to imagine that this communication blunder was strictly unintentional”
      Especially in light of the recent revelation about Brazilian government promising to US that they would not use Sputnik.

  30. J says:

    “Brazil Defends Decision to Reject Russia’s Covid-19 Vaccine, Citing Safety and Efficacy
    Health authority says Russia lacks experience and was defensive in its responses to the agency”
    3rd May, 2021

    https://www.wsj.com/articles/brazil-health-authority-doubts-efficacy-level-of-russias-sputnik-v-covid-19-vaccine-11620064520

    It will be interesting to hear the findings of the EMA and the WHO this month.

  31. Bill says:

    I see a lot of lofty considerations here. I have no idea if Brazil made the right call, but I think the process should be:

    Will my population ultimately be better off with or without it? That will obviously vary from country to country. But Brazil? Gotta think they need all the help they can get — even if imperfect.

  32. UserFriendlyyy says:

    Just thought you might want to know your blog got name checked here:
    https://www.brasilwire.com/brazil-is-ground-zero-for-the-genocidal-logic-of-u-s-vaccine-diplomacy/
    FWIW the fact that “Anvisa rejected Sputnik V on a technicality without conducting their own tests.” Goes quite a way towards proving their bad faith. But since when has US imperialism cared about how many poor people die anyways?

    1. UserFriendlyyy says:

      But any country that openly brags about withholding life saving treatment and doctors from poor people as a geopolitical win is just so obviously genocidal it hardly merits a mention.

      Page 48
      https://www.hhs.gov/sites/default/files/2020-annual-report.pdf

      Combatting malign influences in the Americas: OGA used diplomatic relations in the Americas region to mitigate efforts by states, including Cuba, Venezuela, and Russia, who are working to increase their influence in the region to the detriment of US safety and security. OGA coordinated with other U.S. government agencies to strengthen diplomatic ties and offer technical and humanitarian assistance to dissuade countries in the region from accepting aid from these illintentioned states. Examples include using OGA’s Health Attaché office to persuade Brazil to reject the Russian COVID-19 vaccine, and offering CDC technical assistance in lieu of Panama accepting an offer of Cuban doctors.

      This country is so unimaginably evil, every time I think I’ve found the limit to our depravity I find a few more million poor people we’ve murdered to save capitalism.

      1. sgcox says:

        Not really sure what Brazil is thinking and doing, it is their business anyway.
        But one small European country took a different view and enjoy good life now.
        https://www.wantedinrome.com/news/san-marino-reopens-thanks-to-sputnik-covid-vaccine-from-russia.html

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