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Brazil Rejects the Gamaleya Vaccine

230 points by Clewza313 5y ago

koreanguy 5y ago
Brazilians are easily played
chupasaurus 5y ago
The respone from Gamaleya: https://sputnikvaccine.com/newsroom/pressreleases/sputnik-v-statement-on-brazilian-health-regulator-anvisa-s-decision-to-postpone-authorization/ https://sputnikvaccine.com/newsroom/pressreleases/sputnik-v-...
- major505 5y ago
  To me Gamaleya is turning a thecnical decision in a political one. Thanks to mistakes and possible crimes commit by the Brazilian goverment, when rejecting other vacines, they are now being pressured in accepting this vaccine no matter what. I don't think this is how a sanitary inspection agency should act, approving things based in pure pressure.
  - marcosdumay 5y ago
    > Thanks to mistakes and possible crimes commit by the Brazilian goverment, when rejecting other vacines Well, that's the first COVID-19 vaccine the Brazilian government has rejected.
    - guhcampos 5y ago
      Not really, Covaxin was also rejected about a month prior. However I believe the original comment refers to the refusal of the Brazilian government to commit/invest in any of the vaccines while they were being developed, then stubbornly dismissing the importance of vaccination while promoting snake oil treatments.
      - major505 5y ago
        Yes. The president of Brazil is now fighing a against a Comission in the brazilian senate that is revising all the work of lack of that the brazilian federal goverment put in the figth against Covid. This is now problably the moment of more political fragility he ever been, Governors and mayors tired of waiting for the federal goverment that is still dennying the gravity of the situation, formed a group to import vacines by themselves. The problem is that there's no vacins avaliable in the market because there still a lot of nations that got first in the line, and production is still not enougth. The alternative that they got was coaxin that was rejected, and the russian vacine, that have thisconfidence problems that led to it being reject.
    - rbanffy 5y ago
      Bolsonaro actively campaigned against the vaccine that is responsible for about 98% of the doses administered to Brazilians because it was seen as sponsored by a political adversary.
- Clewza313 5y ago
  Which Derek Lowe tears to shreds in a followup: > These claims are bullshit. Posting them is a disgrace. https://blogs.sciencemag.org/pipeline/archives/2021/04/28/russian-vaccine-behavior https://blogs.sciencemag.org/pipeline/archives/2021/04/28/ru... For the record, I believe that's the very first time I've seen him use the word "bullshit", and I've been following him for over 10 years.
  - seppin 5y ago
    " I have a great deal of sympathy for the Russian people, who over the years have managed to make great contributions to humanity while cynically being abused by their leaders, who have too often been a series of despots and thieves." Hot damn.
deleted 5y ago
[deleted]
hardtke 5y ago
I wonder how much we are seeing general problems with adenovirus vector vaccines (e.g. blood clotting and this manufacturing issue) only because we've never rolled a vaccine out to a large population so quickly. Regulatory agencies are likely afraid to approve any at this point, which does not bode well for other vaccines using the same technology.
- ummonk 5y ago
  Intuitively speaking, using a viral vector has inherent risks that aren’t present with mRNA or protein subunit vaccines. To the extent that the latter technologies prove effective for vaccines against various viruses, I would think viral vectors should not be a preferred technology going forward for vaccine development.
  - 627467 5y ago
    Intuitively, the risks of viral vector vaccines are well known because they have been used for at least a decade while mRNA are being used in large scale for the first time only now.
    - Exmoor 5y ago
      Perhaps previously, but at this point hundreds of millions of people have been injected with mRNA vaccines and the safety profile and efficacy seem much better than any other vaccine technology.
      - riffraff 5y ago
        But we haven't seen long term effects of mRNA vaccines. I am not expecting a "children of men" distopy, and I'd rather have an mRNA vaccine than any other, but it is possible there might be some unexpected issues in the long run.
    - ummonk 5y ago
      Weren’t the first viral vector vaccines (for Ebola virus) only recently approved? As to track record, the first viral vector vaccines in widespread use (i.e. the COVID vaccines) will have killed hundreds (possibly even thousands) of people via blood clots. That’s a worthwhile trade off for a disease as deadly as COVID. But it would be less acceptable against less dangerous diseases, particularly if safer vaccine technologies are available.
temporalparts 5y ago
For me, this really calls into question the efficacy numbers published for the Gamaleya vaccine. e.g.: The Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) have reported that the Sputnik V Covid-19 vaccine showed a 97.6% efficacy. [0] [0]: https://www.pharmaceutical-technology.com/news/russia-sputnik-v-efficacy/ https://www.pharmaceutical-technology.com/news/russia-sputni...
- vbezhenar 5y ago
  Lancet seems to be a respected journal and it confirms those numbers.
  - dikei 5y ago
    Most scientific journals only do peer-review by sending articles to other scientists. These scientists, most of the time, only check for logical errors, and are not able to replicate the experiments.
  - major505 5y ago
    it's important to make clear that what make the vacine being reject was not because of this number. The problem is that they remove the dna part of the virus that allow it to replicate once injected. But in all samples that they tested, in multiple batchs, they found replicant Adenovirus, that could make people who received the vacine sick. That said, this is not a total rejection of the vacine. This is a rejection of the batches that where going to be imported. There are plan to produce this vacine in Brazil, and this batches could be approved in the future, if they did not find the same problems.
  - tzumby 5y ago
    Did you forget the /s here ? Lancet is not a respected journal and has a history of controversies https://en.wikipedia.org/wiki/The_Lancet#Andrew_Wakefield_and_the_MMR_vaccine_(1998) https://en.wikipedia.org/wiki/The_Lancet#Andrew_Wakefield_an...
    - 5y ago
eliseumds 5y ago
The same organisation is putting pressure on Pfizer as well for lack of quality-control data: https://valor.globo.com/brasil/noticia/2021/04/26/impasse-com-pfizer-e-sputnik-v-poe-em-risco-200-milhoes-de-vacinas.ghtml https://valor.globo.com/brasil/noticia/2021/04/26/impasse-co... (in Portuguese). It looks like it shouldn't have been approved in the first place then.
- cyclo64 5y ago
  it reports that they in fact had the data they needed for the Pfizer vaccine in February. Sounds to me like it was just a communication issue between Anvisa & the Ministry.
SpaceRaccoon 5y ago
A reminder that "U.S. officials pushed Brazil to reject Russia’s coronavirus vaccine" [0] for political reasons. > Under a section titled “Combating malign influences in the Americas,” the HHS report states that countries including Russia “are working to increase their influence in the region to the detriment of US safety and security.” The global affairs office coordinated with other U.S. government agencies “to dissuade countries in the region from accepting aid from these ill-intentioned states,” it says. The concerted effort to smear the Russian vaccine is clearly the Western version of the anti-vaccine misinformation Russia has been accused of spreading. Textbook projection. [0] https://www.washingtonpost.com/world/2021/03/16/hhs-brazil-sputnik-russia/ https://www.washingtonpost.com/world/2021/03/16/hhs-brazil-s...
- lindy2021 5y ago
  Further, Sputnik V is the most effective (91.4%), non-mRNA vaccine. Therefore the best vaccine to take to minimise personal risk. US officials are doing Brazilians no favor.
  - major505 5y ago
    The problem if the vacine was not the efficiency. It was rejected based on poor documentation, and quality control. Both serious problems that need to be solved before approval in any serous regulatory agency.
  - meepmorp 5y ago
    Ignoring your efficacy claims, the linked article indicates that the vaccine being distributed now is likely not the same as the one that was used in clinical trials. In particular, > 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. This is a serious issue because none of the virus vector is supposed to be competent to replicate. Something is very clearly wrong with the vaccine that's being distributed. It's not the Americans.
    - sudosysgen 5y ago
pixelkritzel 5y ago
Virologist Dr. Angela Rasmussen about the ability of the vector virus to replicate https://mobile.twitter.com/angie_rasmussen/status/1387397186372005893 https://mobile.twitter.com/angie_rasmussen/status/1387397186...
- gnfargbl 5y ago
  In the linked Twitter thread, Dr Rasmussen says that a consequence of the Ad5 vector becoming replication competent is that the E1 gene might have replaced the spike protein, rendering the vaccine ineffective. Are there any other consequences to the Ad5 vector virus being able to replicate? Is the virus harmful to humans in any way, or does it have the potential to become harmful?
  - ArgyleSound 5y ago
    Typically Ad5 causes upper respiratory tract infections which may manifest as a cold if you’re lucky or lead to pneumonia if you’re not, although things like conjunctivitis and gastroenteritis are not unheard of. Obviously we don’t know how applicable this knowledge is to the Sputnik Ad5.
  - bildung 5y ago
    From the article: "The Ad5 variety has infected a solid proportion of the entire human race [...]. 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."
marcodiego 5y ago
Covid19 has been extremely politicized in Brazil. President's supporters were mostly against vaccine until coronvac (sinovac vaccines) was approved by anvisa, Brazil's equivalent to FDA. In Brazil this pandemic took ridiculous proportions. In the beginning, it was said that it wouldn't kill even 800 people[0]. It was said that it would be no more than a little flu and that children should not skip schools[1]. After thousands deaths, the president said, when asked about it, "So what?"[2]. Parallel to that, special secretary of culture, (which was once ministry of culture), was ousted[3]. She was replacing the previous secretary who (SERIOUSLY) emulated Goebbels on an official announcement[4]. On the education side, a "twitter-boy" with spelling difficulties[5] replaced the previous minister who was very weak technically[6]. It was then replaced by a liar[7] and then by an homophobic[8]. Some states then started restrictive measures to control the spread of the virus. The president was against it, the supreme court had to intervene to guarantee that states could apply restrictive measures[9]. A false narrative started trying to blame problems during the pandemic on governors because the president "couldn't act". A false dichotomy also spread by supporters saying that restrictive measures hurt economy and that it could kill more people than the pandemic. It actually is the opposite, but it has grown among his supporters. Then came choloquine, hidroxicloroquine, ivermectin, and nitazoxanide, not exactly in this order. The Chloroquine 'venture' was the most interesting. The president pressured the health minister to encourage it. As he refused, he was ousted[10]. The same pressure was tried on the next minister. He was ousted too[11]. Things got worse and his supporters began anti-democratic demonstrations asking for a pro-president coup[12]. Supreme court was attacked and people were arrested[13]. While the president discouraged the use of masks and social distancing, the number of daily deaths stayed on an elevated plateau[14]. Debauchery of sick and dead became common[15]. By the end of the second half of 2020, some vaccines were offered but refused[16][17]. The minister asked "why such a hurry?"[18] and the president said "The hurry is not justified"[19]. Things improved a little by the end of the year, people relaxed and met their relatives on year end's festivities. This had consequences and 2021 arrived. New variants surged and number of deaths started to rise again. In Manaus, hospitals run out of O2 and people suffocated to death[20]. Variants continued spreading and another health minister was replaced. Vaccines were approved and people began to be vaccinated. By the end of April with around 14% of the population having at least one vaccine dose, numbers of daily deaths began to fall. Some facts were not listed on the correct order, but today is April 28 and, according to worldometers.info, we're now at position 14 and soon there will be more deaths per million than in the UK. Brazil has the lowest median age population among nations with the most deaths. No other country handled the pandemic worse than brazil. [0] https://www.dw.com/en/opinion-bolsonaro-lets-100000-die-of-covid-19-in-brazil/a-54533605 https://www.dw.com/en/opinion-bolsonaro-lets-100000-die-of-c... [1] https://edition.cnn.com/2020/05/23/americas/brazil-coronavirus-hospitals-intl/index.html https://edition.cnn.com/2020/05/23/americas/brazil-coronavir... [2] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31095-3/fulltext https://www.thelancet.com/journals/lancet/article/PIIS0140-6... [3] https://www1.folha.uol.com.br/internacional/en/culture/2020/05/regina-duarte-leaves-position-as-brazils-secretary-of-culture.shtml https://www1.folha.uol.com.br/internacional/en/culture/2020/... [4] https://www.theguardian.com/world/2020/jan/17/brazil-culture-minister-goebbels-roberto-alvim-nazi https://www.theguardian.com/world/2020/jan/17/brazil-culture... [5] https://www.france24.com/en/20200110-brazil-s-education-minister-mocked-for-twitter-spelling-error https://www.france24.com/en/20200110-brazil-s-education-mini... [6] https://brazilian.report/power/2019/03/28/brazil-disastrous-ministry-education/ https://brazilian.report/power/2019/03/28/brazil-disastrous-... [7] https://www.theguardian.com/world/2020/jul/01/brazil-education-minister-carlos-decotelli-resigns https://www.theguardian.com/world/2020/jul/01/brazil-educati... [8] https://www.telesurenglish.net/news/brazil-education-minister-inquired-after-homophobic-statements-20200929-0004.html https://www.telesurenglish.net/news/brazil-education-ministe... [9] https://www.aljazeera.com/news/2021/3/20/bolsonaro-asks-supreme-court-to-reverse-covid-19-restrictions https://www.aljazeera.com/news/2021/3/20/bolsonaro-asks-supr... [10] https://brazilian.report/liveblog/coronavirus/2020/05/21/former-health-minister-president-tried-to-change-chloroquine-label/ https://brazilian.report/liveblog/coronavirus/2020/05/21/for... [11] https://www.hindustantimes.com/world-news/bolsonaro-s-love-for-hydroxychloroquine-costs-brazil-another-health-minister/story-jkEFmRFR4sZYneLZxQjb1J.html https://www.hindustantimes.com/world-news/bolsonaro-s-love-f... [12] https://www.dw.com/en/brazilian-president-bolsonaro-sides-with-anti-democracy-protesters/a-53235241 https://www.dw.com/en/brazilian-president-bolsonaro-sides-wi... [13] https://brazilian.report/liveblog/coronavirus/2020/06/14/brazil-another-weekend-protests-despite-pandemic/ https://brazilian.report/liveblog/coronavirus/2020/06/14/bra... [14] https://www.theguardian.com/world/2020/jun/23/brazilian-judge-tells-bolsonaro-to-behave-and-wear-a-face-mask https://www.theguardian.com/world/2020/jun/23/brazilian-judg... [15] https://www.theguardian.com/world/2020/jul/08/bolsonaro-masks-slur-brazil-coronavirus https://www.theguardian.com/world/2020/jul/08/bolsonaro-mask... [16] https://theconversation.com/brazils-president-rejects-covid-19-vaccine-undermining-a-century-of-progress-toward-universal-inoculation-150821 https://theconversation.com/brazils-president-rejects-covid-... [17] https://apnews.com/article/virus-outbreak-brazil-state-governments-health-sao-paulo-b7b5b620ba54f402dbf803e26fe6b842 https://apnews.com/article/virus-outbreak-brazil-state-gover... [18] https://www.nytimes.com/article/brazil-coronavirus-cases.html https://www.nytimes.com/article/brazil-coronavirus-cases.htm... [19] https://www.reuters.com/article/uk-health-coronavirus-brazil-idUKKBN28U01B https://www.reuters.com/article/uk-health-coronavirus-brazil... [20] https://www.caritas.org/2021/02/oxygenformanaus/ https://www.caritas.org/2021/02/oxygenformanaus/
exmadscientist 5y ago
If the vector is replicating, does that explain some piece of why Sputnik V is significantly more effective than the other adenovirus vector vaccines? (If that's even true, of course, since it may well not be!) Or is it simply a more effective preparation of a vaccine, due to things like the Ad5/Ad26 combination?
- marcosdumay 5y ago
  Has there been any controlled study on the efficacy of Sputnik V? I haven't heard of any.
  - drewblaisdell 5y ago
    You're asking if there has been any controlled study of Sputnik V, a vaccine which has been administered to millions?
  - sanxiyn 5y ago
    Yes there has been. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00234-8/fulltext https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
- dragonwriter 5y ago
  > If the vector is replicating, does that explain some piece of why Sputnik V is significantly more effective than the other adenovirus vector vaccines? The observed discrepancy between the delivered vaccine and the one described in the published clinical trial could, if not explain, hint at the reason the published clinical results are better than other vaccines in the same class.
- Exmoor 5y ago
  Unlikely, because the part of the adenovirus they delete that allows it to replicate is what they replace with the portion that generates the spike protein antigen. So if some of the adenovirus is replicating it's inherently not doing what you want it to do to produce an immune response.
Animats 5y ago
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. Sounds like a manufacturing quality-control problem. This is why you need so much sampling and analysis in drug production. It's probably fixable, but denial will not help.
throwaway4good 5y ago
I thought this NY times op piece on Russian and Chinese vaccines was interesting: https://www.nytimes.com/2021/02/05/opinion/covid-vaccines-china-russia.html https://www.nytimes.com/2021/02/05/opinion/covid-vaccines-ch... It’s Time to Trust China’s and Russia’s Vaccines Basically non-western medical companies such as the Russian and Chinese vaccines companies have a much higher bar to reach in order to get their products approved. Quality control issues and incomplete documentation are serious problems, but also fixable. Right now the world (maybe not us in the west) need Russian and Chinese vaccines as what the west can offer is not enough to go around.
weinzierl 5y ago
I'm a complete layman but reading about the replication prevention I wonder: Could it be that they left E1 intact deliberately? I suppose (naively) that a virus that replicates should cause a stronger immune system response and therefore increase efficacy. Being an adenovirus the worst thing that could happen is that you get a common cold. Common cold once vs potential death is not the worst trade-off imaginable, if you ask me.
- sanxiyn 5y ago
  Gamaleya themselves says they removed E1. There is no reason to doubt it.
  - weinzierl 5y ago
    Thanks, that makes sense.
- fsh 5y ago
  This is addressed in the article: 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.
  - weinzierl 5y ago
    Thanks, that takes away the premise of my question.
- d1sxeyes 5y ago
  Also, would this be transmissible? Could vaccinated person A infect unvaccinated person B, leading to community transmission of immunity? I'm not an expert in this field, but it sounds logical at least, and provides a motive for the discrepancy.
zgcarvalho 5y ago
I would like to add information that I believe is very relevant. During the pandemic, the congress approved a law (Article 16, Law No. 14.124/2021)[1] that defines a limit period of 30 days for Anvisa to approve or disapprove the vaccine. If, after 30 days, Anvisa does not issue its final recommendation, the vaccine is automatically approved. I think this law is absurdly stupid, but let's get back to the facts. Days before denying Sputinik's authorization to use, Anvisa asked the Federal Supreme Court (STF) to suspend the 30-day period alleging that the data received were incomplete and information was missing. A supreme court judge denied, on March 26th, the suspension of the deadline saying that this possibility was not manifested in the law. And he added that Anvisa's decision must be technically based, "not admitting the mere allegation of insufficient documentation or the simple allusion to potential risks". And if Anvisa does not decide on import and distribution authorization requests within 30 days, the interested parts are automatically authorized to import and distribute Sputnik V [2]. One day after the judge denied the suspension of the term and one day before the deadline, Anvisa denied the request. [1] https://www.in.gov.br/en/web/dou/-/lei-n-14.124-de-10-de-marco-de-2021-307745858 https://www.in.gov.br/en/web/dou/-/lei-n-14.124-de-10-de-mar... [pt] [2] https://agenciabrasil.ebc.com.br/saude/noticia/2021-04/lewandowski-nega-prazo-maior-para-anvisa-decidir-sobre-sputnik-v https://agenciabrasil.ebc.com.br/saude/noticia/2021-04/lewan... [pt]
- meepmorp 5y ago
  The automatic approval law is incredibly stupid. Your timeout mode shouldn’t be to automatically approve medicines when the regulator takes over a month to issue a decision. Thanks for the context, this is probably a large part of the decision. Not enough time for due diligence, and the only option to prevent automatic release of a potentially problematic medicine is outright rejection.

230 points by Clewza313 5y ago

Brazilians are easily played

The respone from Gamaleya: https://sputnikvaccine.com/newsroom/pressreleases/sputnik-v-statement-on-brazilian-health-regulator-anvisa-s-decision-to-postpone-authorization/ https://sputnikvaccine.com/newsroom/pressreleases/sputnik-v-...

major505 5y ago
To me Gamaleya is turning a thecnical decision in a political one. Thanks to mistakes and possible crimes commit by the Brazilian goverment, when rejecting other vacines, they are now being pressured in accepting this vaccine no matter what. I don't think this is how a sanitary inspection agency should act, approving things based in pure pressure.
- marcosdumay 5y ago
  > Thanks to mistakes and possible crimes commit by the Brazilian goverment, when rejecting other vacines Well, that's the first COVID-19 vaccine the Brazilian government has rejected.
  - guhcampos 5y ago
    Not really, Covaxin was also rejected about a month prior. However I believe the original comment refers to the refusal of the Brazilian government to commit/invest in any of the vaccines while they were being developed, then stubbornly dismissing the importance of vaccination while promoting snake oil treatments.
    - major505 5y ago
      Yes. The president of Brazil is now fighing a against a Comission in the brazilian senate that is revising all the work of lack of that the brazilian federal goverment put in the figth against Covid. This is now problably the moment of more political fragility he ever been, Governors and mayors tired of waiting for the federal goverment that is still dennying the gravity of the situation, formed a group to import vacines by themselves. The problem is that there's no vacins avaliable in the market because there still a lot of nations that got first in the line, and production is still not enougth. The alternative that they got was coaxin that was rejected, and the russian vacine, that have thisconfidence problems that led to it being reject.
  - rbanffy 5y ago
    Bolsonaro actively campaigned against the vaccine that is responsible for about 98% of the doses administered to Brazilians because it was seen as sponsored by a political adversary.
Clewza313 5y ago
Which Derek Lowe tears to shreds in a followup: > These claims are bullshit. Posting them is a disgrace. https://blogs.sciencemag.org/pipeline/archives/2021/04/28/russian-vaccine-behavior https://blogs.sciencemag.org/pipeline/archives/2021/04/28/ru... For the record, I believe that's the very first time I've seen him use the word "bullshit", and I've been following him for over 10 years.
- seppin 5y ago
  " I have a great deal of sympathy for the Russian people, who over the years have managed to make great contributions to humanity while cynically being abused by their leaders, who have too often been a series of despots and thieves." Hot damn.

deleted 5y ago

[deleted]

hardtke 5y ago

I wonder how much we are seeing general problems with adenovirus vector vaccines (e.g. blood clotting and this manufacturing issue) only because we've never rolled a vaccine out to a large population so quickly. Regulatory agencies are likely afraid to approve any at this point, which does not bode well for other vaccines using the same technology.

ummonk 5y ago
Intuitively speaking, using a viral vector has inherent risks that aren’t present with mRNA or protein subunit vaccines. To the extent that the latter technologies prove effective for vaccines against various viruses, I would think viral vectors should not be a preferred technology going forward for vaccine development.
- 627467 5y ago
  Intuitively, the risks of viral vector vaccines are well known because they have been used for at least a decade while mRNA are being used in large scale for the first time only now.
  - Exmoor 5y ago
    Perhaps previously, but at this point hundreds of millions of people have been injected with mRNA vaccines and the safety profile and efficacy seem much better than any other vaccine technology.
    - riffraff 5y ago
      But we haven't seen long term effects of mRNA vaccines. I am not expecting a "children of men" distopy, and I'd rather have an mRNA vaccine than any other, but it is possible there might be some unexpected issues in the long run.
  - ummonk 5y ago
    Weren’t the first viral vector vaccines (for Ebola virus) only recently approved? As to track record, the first viral vector vaccines in widespread use (i.e. the COVID vaccines) will have killed hundreds (possibly even thousands) of people via blood clots. That’s a worthwhile trade off for a disease as deadly as COVID. But it would be less acceptable against less dangerous diseases, particularly if safer vaccine technologies are available.

temporalparts 5y ago

For me, this really calls into question the efficacy numbers published for the Gamaleya vaccine. e.g.: The Gamaleya National Research Center of Epidemiology and Microbiology and the Russian Direct Investment Fund (RDIF) have reported that the Sputnik V Covid-19 vaccine showed a 97.6% efficacy. [0] [0]: https://www.pharmaceutical-technology.com/news/russia-sputnik-v-efficacy/ https://www.pharmaceutical-technology.com/news/russia-sputni...

vbezhenar 5y ago
Lancet seems to be a respected journal and it confirms those numbers.
- dikei 5y ago
  Most scientific journals only do peer-review by sending articles to other scientists. These scientists, most of the time, only check for logical errors, and are not able to replicate the experiments.
- major505 5y ago
  it's important to make clear that what make the vacine being reject was not because of this number. The problem is that they remove the dna part of the virus that allow it to replicate once injected. But in all samples that they tested, in multiple batchs, they found replicant Adenovirus, that could make people who received the vacine sick. That said, this is not a total rejection of the vacine. This is a rejection of the batches that where going to be imported. There are plan to produce this vacine in Brazil, and this batches could be approved in the future, if they did not find the same problems.
- tzumby 5y ago
  Did you forget the /s here ? Lancet is not a respected journal and has a history of controversies https://en.wikipedia.org/wiki/The_Lancet#Andrew_Wakefield_and_the_MMR_vaccine_(1998) https://en.wikipedia.org/wiki/The_Lancet#Andrew_Wakefield_an...
  - 5y ago

eliseumds 5y ago

The same organisation is putting pressure on Pfizer as well for lack of quality-control data: https://valor.globo.com/brasil/noticia/2021/04/26/impasse-com-pfizer-e-sputnik-v-poe-em-risco-200-milhoes-de-vacinas.ghtml https://valor.globo.com/brasil/noticia/2021/04/26/impasse-co... (in Portuguese). It looks like it shouldn't have been approved in the first place then.

cyclo64 5y ago
it reports that they in fact had the data they needed for the Pfizer vaccine in February. Sounds to me like it was just a communication issue between Anvisa & the Ministry.

SpaceRaccoon 5y ago

A reminder that "U.S. officials pushed Brazil to reject Russia’s coronavirus vaccine" [0] for political reasons. > Under a section titled “Combating malign influences in the Americas,” the HHS report states that countries including Russia “are working to increase their influence in the region to the detriment of US safety and security.” The global affairs office coordinated with other U.S. government agencies “to dissuade countries in the region from accepting aid from these ill-intentioned states,” it says. The concerted effort to smear the Russian vaccine is clearly the Western version of the anti-vaccine misinformation Russia has been accused of spreading. Textbook projection. [0] https://www.washingtonpost.com/world/2021/03/16/hhs-brazil-sputnik-russia/ https://www.washingtonpost.com/world/2021/03/16/hhs-brazil-s...

lindy2021 5y ago
Further, Sputnik V is the most effective (91.4%), non-mRNA vaccine. Therefore the best vaccine to take to minimise personal risk. US officials are doing Brazilians no favor.
- major505 5y ago
  The problem if the vacine was not the efficiency. It was rejected based on poor documentation, and quality control. Both serious problems that need to be solved before approval in any serous regulatory agency.
- meepmorp 5y ago
  Ignoring your efficacy claims, the linked article indicates that the vaccine being distributed now is likely not the same as the one that was used in clinical trials. In particular, > 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. This is a serious issue because none of the virus vector is supposed to be competent to replicate. Something is very clearly wrong with the vaccine that's being distributed. It's not the Americans.
  - sudosysgen 5y ago

pixelkritzel 5y ago

Virologist Dr. Angela Rasmussen about the ability of the vector virus to replicate https://mobile.twitter.com/angie_rasmussen/status/1387397186372005893 https://mobile.twitter.com/angie_rasmussen/status/1387397186...

gnfargbl 5y ago
In the linked Twitter thread, Dr Rasmussen says that a consequence of the Ad5 vector becoming replication competent is that the E1 gene might have replaced the spike protein, rendering the vaccine ineffective. Are there any other consequences to the Ad5 vector virus being able to replicate? Is the virus harmful to humans in any way, or does it have the potential to become harmful?
- ArgyleSound 5y ago
  Typically Ad5 causes upper respiratory tract infections which may manifest as a cold if you’re lucky or lead to pneumonia if you’re not, although things like conjunctivitis and gastroenteritis are not unheard of. Obviously we don’t know how applicable this knowledge is to the Sputnik Ad5.
- bildung 5y ago
  From the article: "The Ad5 variety has infected a solid proportion of the entire human race [...]. 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."

marcodiego 5y ago

Covid19 has been extremely politicized in Brazil. President's supporters were mostly against vaccine until coronvac (sinovac vaccines) was approved by anvisa, Brazil's equivalent to FDA. In Brazil this pandemic took ridiculous proportions. In the beginning, it was said that it wouldn't kill even 800 people[0]. It was said that it would be no more than a little flu and that children should not skip schools[1]. After thousands deaths, the president said, when asked about it, "So what?"[2]. Parallel to that, special secretary of culture, (which was once ministry of culture), was ousted[3]. She was replacing the previous secretary who (SERIOUSLY) emulated Goebbels on an official announcement[4]. On the education side, a "twitter-boy" with spelling difficulties[5] replaced the previous minister who was very weak technically[6]. It was then replaced by a liar[7] and then by an homophobic[8]. Some states then started restrictive measures to control the spread of the virus. The president was against it, the supreme court had to intervene to guarantee that states could apply restrictive measures[9]. A false narrative started trying to blame problems during the pandemic on governors because the president "couldn't act". A false dichotomy also spread by supporters saying that restrictive measures hurt economy and that it could kill more people than the pandemic. It actually is the opposite, but it has grown among his supporters. Then came choloquine, hidroxicloroquine, ivermectin, and nitazoxanide, not exactly in this order. The Chloroquine 'venture' was the most interesting. The president pressured the health minister to encourage it. As he refused, he was ousted[10]. The same pressure was tried on the next minister. He was ousted too[11]. Things got worse and his supporters began anti-democratic demonstrations asking for a pro-president coup[12]. Supreme court was attacked and people were arrested[13]. While the president discouraged the use of masks and social distancing, the number of daily deaths stayed on an elevated plateau[14]. Debauchery of sick and dead became common[15]. By the end of the second half of 2020, some vaccines were offered but refused[16][17]. The minister asked "why such a hurry?"[18] and the president said "The hurry is not justified"[19]. Things improved a little by the end of the year, people relaxed and met their relatives on year end's festivities. This had consequences and 2021 arrived. New variants surged and number of deaths started to rise again. In Manaus, hospitals run out of O2 and people suffocated to death[20]. Variants continued spreading and another health minister was replaced. Vaccines were approved and people began to be vaccinated. By the end of April with around 14% of the population having at least one vaccine dose, numbers of daily deaths began to fall. Some facts were not listed on the correct order, but today is April 28 and, according to worldometers.info, we're now at position 14 and soon there will be more deaths per million than in the UK. Brazil has the lowest median age population among nations with the most deaths. No other country handled the pandemic worse than brazil. [0] https://www.dw.com/en/opinion-bolsonaro-lets-100000-die-of-covid-19-in-brazil/a-54533605 https://www.dw.com/en/opinion-bolsonaro-lets-100000-die-of-c... [1] https://edition.cnn.com/2020/05/23/americas/brazil-coronavirus-hospitals-intl/index.html https://edition.cnn.com/2020/05/23/americas/brazil-coronavir... [2] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31095-3/fulltext https://www.thelancet.com/journals/lancet/article/PIIS0140-6... [3] https://www1.folha.uol.com.br/internacional/en/culture/2020/05/regina-duarte-leaves-position-as-brazils-secretary-of-culture.shtml https://www1.folha.uol.com.br/internacional/en/culture/2020/... [4] https://www.theguardian.com/world/2020/jan/17/brazil-culture-minister-goebbels-roberto-alvim-nazi https://www.theguardian.com/world/2020/jan/17/brazil-culture... [5] https://www.france24.com/en/20200110-brazil-s-education-minister-mocked-for-twitter-spelling-error https://www.france24.com/en/20200110-brazil-s-education-mini... [6] https://brazilian.report/power/2019/03/28/brazil-disastrous-ministry-education/ https://brazilian.report/power/2019/03/28/brazil-disastrous-... [7] https://www.theguardian.com/world/2020/jul/01/brazil-education-minister-carlos-decotelli-resigns https://www.theguardian.com/world/2020/jul/01/brazil-educati... [8] https://www.telesurenglish.net/news/brazil-education-minister-inquired-after-homophobic-statements-20200929-0004.html https://www.telesurenglish.net/news/brazil-education-ministe... [9] https://www.aljazeera.com/news/2021/3/20/bolsonaro-asks-supreme-court-to-reverse-covid-19-restrictions https://www.aljazeera.com/news/2021/3/20/bolsonaro-asks-supr... [10] https://brazilian.report/liveblog/coronavirus/2020/05/21/former-health-minister-president-tried-to-change-chloroquine-label/ https://brazilian.report/liveblog/coronavirus/2020/05/21/for... [11] https://www.hindustantimes.com/world-news/bolsonaro-s-love-for-hydroxychloroquine-costs-brazil-another-health-minister/story-jkEFmRFR4sZYneLZxQjb1J.html https://www.hindustantimes.com/world-news/bolsonaro-s-love-f... [12] https://www.dw.com/en/brazilian-president-bolsonaro-sides-with-anti-democracy-protesters/a-53235241 https://www.dw.com/en/brazilian-president-bolsonaro-sides-wi... [13] https://brazilian.report/liveblog/coronavirus/2020/06/14/brazil-another-weekend-protests-despite-pandemic/ https://brazilian.report/liveblog/coronavirus/2020/06/14/bra... [14] https://www.theguardian.com/world/2020/jun/23/brazilian-judge-tells-bolsonaro-to-behave-and-wear-a-face-mask https://www.theguardian.com/world/2020/jun/23/brazilian-judg... [15] https://www.theguardian.com/world/2020/jul/08/bolsonaro-masks-slur-brazil-coronavirus https://www.theguardian.com/world/2020/jul/08/bolsonaro-mask... [16] https://theconversation.com/brazils-president-rejects-covid-19-vaccine-undermining-a-century-of-progress-toward-universal-inoculation-150821 https://theconversation.com/brazils-president-rejects-covid-... [17] https://apnews.com/article/virus-outbreak-brazil-state-governments-health-sao-paulo-b7b5b620ba54f402dbf803e26fe6b842 https://apnews.com/article/virus-outbreak-brazil-state-gover... [18] https://www.nytimes.com/article/brazil-coronavirus-cases.html https://www.nytimes.com/article/brazil-coronavirus-cases.htm... [19] https://www.reuters.com/article/uk-health-coronavirus-brazil-idUKKBN28U01B https://www.reuters.com/article/uk-health-coronavirus-brazil... [20] https://www.caritas.org/2021/02/oxygenformanaus/ https://www.caritas.org/2021/02/oxygenformanaus/

exmadscientist 5y ago

If the vector is replicating, does that explain some piece of why Sputnik V is significantly more effective than the other adenovirus vector vaccines? (If that's even true, of course, since it may well not be!) Or is it simply a more effective preparation of a vaccine, due to things like the Ad5/Ad26 combination?

marcosdumay 5y ago
Has there been any controlled study on the efficacy of Sputnik V? I haven't heard of any.
- drewblaisdell 5y ago
  You're asking if there has been any controlled study of Sputnik V, a vaccine which has been administered to millions?
- sanxiyn 5y ago
  Yes there has been. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00234-8/fulltext https://www.thelancet.com/journals/lancet/article/PIIS0140-6...
dragonwriter 5y ago
> If the vector is replicating, does that explain some piece of why Sputnik V is significantly more effective than the other adenovirus vector vaccines? The observed discrepancy between the delivered vaccine and the one described in the published clinical trial could, if not explain, hint at the reason the published clinical results are better than other vaccines in the same class.
Exmoor 5y ago
Unlikely, because the part of the adenovirus they delete that allows it to replicate is what they replace with the portion that generates the spike protein antigen. So if some of the adenovirus is replicating it's inherently not doing what you want it to do to produce an immune response.

Animats 5y ago

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. Sounds like a manufacturing quality-control problem. This is why you need so much sampling and analysis in drug production. It's probably fixable, but denial will not help.

throwaway4good 5y ago

I thought this NY times op piece on Russian and Chinese vaccines was interesting: https://www.nytimes.com/2021/02/05/opinion/covid-vaccines-china-russia.html https://www.nytimes.com/2021/02/05/opinion/covid-vaccines-ch... It’s Time to Trust China’s and Russia’s Vaccines Basically non-western medical companies such as the Russian and Chinese vaccines companies have a much higher bar to reach in order to get their products approved. Quality control issues and incomplete documentation are serious problems, but also fixable. Right now the world (maybe not us in the west) need Russian and Chinese vaccines as what the west can offer is not enough to go around.

weinzierl 5y ago

I'm a complete layman but reading about the replication prevention I wonder: Could it be that they left E1 intact deliberately? I suppose (naively) that a virus that replicates should cause a stronger immune system response and therefore increase efficacy. Being an adenovirus the worst thing that could happen is that you get a common cold. Common cold once vs potential death is not the worst trade-off imaginable, if you ask me.

sanxiyn 5y ago
Gamaleya themselves says they removed E1. There is no reason to doubt it.
- weinzierl 5y ago
  Thanks, that makes sense.
fsh 5y ago
This is addressed in the article: 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.
- weinzierl 5y ago
  Thanks, that takes away the premise of my question.
d1sxeyes 5y ago
Also, would this be transmissible? Could vaccinated person A infect unvaccinated person B, leading to community transmission of immunity? I'm not an expert in this field, but it sounds logical at least, and provides a motive for the discrepancy.

zgcarvalho 5y ago

I would like to add information that I believe is very relevant. During the pandemic, the congress approved a law (Article 16, Law No. 14.124/2021)[1] that defines a limit period of 30 days for Anvisa to approve or disapprove the vaccine. If, after 30 days, Anvisa does not issue its final recommendation, the vaccine is automatically approved. I think this law is absurdly stupid, but let's get back to the facts. Days before denying Sputinik's authorization to use, Anvisa asked the Federal Supreme Court (STF) to suspend the 30-day period alleging that the data received were incomplete and information was missing. A supreme court judge denied, on March 26th, the suspension of the deadline saying that this possibility was not manifested in the law. And he added that Anvisa's decision must be technically based, "not admitting the mere allegation of insufficient documentation or the simple allusion to potential risks". And if Anvisa does not decide on import and distribution authorization requests within 30 days, the interested parts are automatically authorized to import and distribute Sputnik V [2]. One day after the judge denied the suspension of the term and one day before the deadline, Anvisa denied the request. [1] https://www.in.gov.br/en/web/dou/-/lei-n-14.124-de-10-de-marco-de-2021-307745858 https://www.in.gov.br/en/web/dou/-/lei-n-14.124-de-10-de-mar... [pt] [2] https://agenciabrasil.ebc.com.br/saude/noticia/2021-04/lewandowski-nega-prazo-maior-para-anvisa-decidir-sobre-sputnik-v https://agenciabrasil.ebc.com.br/saude/noticia/2021-04/lewan... [pt]

meepmorp 5y ago
The automatic approval law is incredibly stupid. Your timeout mode shouldn’t be to automatically approve medicines when the regulator takes over a month to issue a decision. Thanks for the context, this is probably a large part of the decision. Not enough time for due diligence, and the only option to prevent automatic release of a potentially problematic medicine is outright rejection.