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Brazil Rejects the Gamaleya Vaccine

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Re: Brazil Rejects the Gamaleya Vaccine

#41
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-c...

[1] https://edition.cnn.com/2020/05/23/americas/brazil-coronavir...

[2] https://www.thelancet.com/journals/lancet/article/PIIS0140-6...

[3] https://www1.folha.uol.com.br/internacional/en/culture/2020/...

[4] https://www.theguardian.com/world/2020/jan/17/brazil-culture...

[5] https://www.france24.com/en/20200110-brazil-s-education-mini...

[6] https://brazilian.report/power/2019/03/28/brazil-disastrous-...

[7] https://www.theguardian.com/world/2020/jul/01/brazil-educati...

[8] https://www.telesurenglish.net/news/brazil-education-ministe...

[9] https://www.aljazeera.com/news/2021/3/20/bolsonaro-asks-supr...

[10] https://brazilian.report/liveblog/coronavirus/2020/05/21/for...

[11] https://www.hindustantimes.com/world-news/bolsonaro-s-love-f...

[12] https://www.dw.com/en/brazilian-president-bolsonaro-sides-wi...

[13] https://brazilian.report/liveblog/coronavirus/2020/06/14/bra...

[14] https://www.theguardian.com/world/2020/jun/23/brazilian-judg...

[15] https://www.theguardian.com/world/2020/jul/08/bolsonaro-mask...

[16] https://theconversation.com/brazils-president-rejects-covid-...

[17] https://apnews.com/article/virus-outbreak-brazil-state-gover...

[18] https://www.nytimes.com/article/brazil-coronavirus-cases.htm...

[19] https://www.reuters.com/article/uk-health-coronavirus-brazil...

[20] https://www.caritas.org/2021/02/oxygenformanaus/

Re: Brazil Rejects the Gamaleya Vaccine

#42
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?

Re: Brazil Rejects the Gamaleya Vaccine

#43
post #2

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.

My intuition, given the absolute (small) magnitude of blood clots, is that it’s not a huge issue.

Except that it is, because it has people spooked. Humans, myself included, are just terrible at gauging relative risk, and it doesn’t really matter that you are way more likely to die in your car driving to get the vaccine than from any vaccine complication. You are putting this in your arm, and people find it scary when even the tiniest issues crop up.

(I’ll snark a bit here: wonder how many people who are scared of vaccines smoke cigarettes…because, in terms of risk…hoo boy.)

Re: Brazil Rejects the Gamaleya Vaccine

#44

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?

Has there been any controlled study on the efficacy of Sputnik V? I haven't heard of any.

Re: Brazil Rejects the Gamaleya Vaccine

#45

Earlier quoted context omitted.

Yes, it's entirely possible that this is a manufacturing fuckup, but as Lowe points out in the linked article: > 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 au…

Certainly, but I don't see what this has to do with the vaccine. From the very same article, this Twitter account is not ran by the Gamelaya institute but by a separate government institute. EDIT: The link you send is not from Gamelaya either. Gamelaya's webiste is https://www.gamaleya.org/en/ . The link you sent is by the same non-scientific governmental marketing agency. If they claim that this indeed did not happe…

The PR is titled "Sputnik V statement", is from the "Sputnik V team", and says "Powered by The Gamaleya National Center" at the bottom of the page.

Re: Brazil Rejects the Gamaleya Vaccine

#46
post #14

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 dis…

Brazilian here, but just a regular guy, I didn't dug deep into this. Anvisa (our health regulatory agency) is well stablished before current president, supposedly independant and more often considered in opposition to current government. I find it unlikely that they are fabricating a rejection and more likely they are being cientific about it.

It's not only that, but the manufacturer refusal to present all kinds of evidence was very public and undeniable.

Re: Brazil Rejects the Gamaleya Vaccine

#47

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 t…

> No other country handled the pandemic worse than brazil.

Yup, even Bloomberg agrees: Brazil is at the very bottom of the resilience rankings.

https://www.bloomberg.com/graphics/covid-resilience-ranking/

Re: Brazil Rejects the Gamaleya Vaccine

#48

The respone from Gamaleya: https://sputnikvaccine.com/newsroom/pressreleases/sputnik-v-...

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.

> 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.

Re: Brazil Rejects the Gamaleya Vaccine

#49

Earlier quoted context omitted.

> Hmm, not necessarily no. This can be a simple imperfection in the manufacturing process, it happens. There is not necessarily anything very wrong, just deficient QA. You don't sell medicines to people which don't meet the specs you made public about them. > The vaccine is going to work essentially identically to if it wasn't able to replicate. The difference is that you might get an adenovirus infection, which is b…

>You don't sell medicines to people which don't meet the specs you made public about them. Sure, and I never said otherwise. But all things considered this is pretty minor. >They've made the vaccine demonstrably less safe, either through carelessness or because they don't care. Don't minimize that, or assume it's the only place where the reality of sputnik doesn't match up to the phase 3 data. Yes, this does make the…

You don't know that this is the same vaccine as what was injected before.

Re: Brazil Rejects the Gamaleya Vaccine

#50

Earlier quoted context omitted.

The vaccine described in the paper published in The Lancet was explicitly described as using an replication deficient Ad5 vector, while the vaccine received by Brazil seems to have been replication competent. Considering Slovakia also said that Russia did not deliver a vaccine matching the characteristics of the one in The Lancet, I think those data are basically irrelevant now.

The vaccines delivered to Brazil also have a replication deficient Ad5 vector, Anvisa says that among the vast majority of replication deficient vectors some replication-able viruses were present. There is pretty much no chance at all that this affects efficacy.

> Anvisa says that among the vast majority of replication deficient vectors some replication-able viruses were present.

Do you have the source for this claim? Linked Anvisa slides page 6 says "todos os lotes" (all lots) had replicating virus.

I agree this is about quality control and it is extremely unlikely to affect vaccine efficacy. (If anything, it would improve vaccine efficacy.)

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