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Brazil Rejects the Gamaleya Vaccine

blogs.sciencemag.org

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Re: Brazil Rejects the Gamaleya Vaccine

#81

Post by mattkrause »

coliveira wrote: post #78
mattkrause wrote: post #56

Earlier quoted context omitted.

On top of that, peer review is more advisory than adversarial: it’s meant to catch honest mistakes and point out possible interpretations that the authors might have missed. Catching out-and-out fraud, a la Wakefield, is way beyond the reviewers’ remit.

Every journal in the world is like this. Why you're raising questions about Lancet when all scientific journals operate the same way? There is no such thing as American science or Russian science, it is all the same.

I agree! I was just trying to say that it's unfair to tar them with Wakefield's nonsense.

Re: Brazil Rejects the Gamaleya Vaccine

#82

Post by Animats »

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.

Re: Brazil Rejects the Gamaleya Vaccine

#83

Post by IG_Semmelweiss »

coliveira wrote: post #73
temporalparts wrote: post #3

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-sputni...

You cannot trust the Brazilian government to make this judgement. It is a policy of that government to delay the approval of vaccines as much as possible, as if there was no actual pandemic going on. Other governments around the world have analyzed the vaccine, including Argentina and Mexico, and they're using it without any problems.

article clearly states that other governments have raised similar concerns. Its not just brazil

in fact, article states brazil wasn't even the first

Re: Brazil Rejects the Gamaleya Vaccine

#84

Post by orr721 »

ArgyleSound wrote: post #7
vbezhenar wrote: post #4

Earlier quoted context omitted.

Lancet seems to be a respected journal and it confirms those numbers.

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 problem in Slovakia is that the delivered vaccines are in the form of a lyophilisate (pulver), one dose per vial. The vaccine described in Lancet was in liquid form, five doses per vial.

Re: Brazil Rejects the Gamaleya Vaccine

#85

Post by cyclo64 »

eliseumds wrote: post #6

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-co... (in Portuguese). It looks like it shouldn't have been approved in the first place then.

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.

Re: Brazil Rejects the Gamaleya Vaccine

#86

Post by petertodd »

Exmoor wrote: post #62
exmadscientist wrote: post #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?

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.

Not inherently. We don't know how it's replicating.

Furthermore, this isn't even an an/or situation: the actual virus in the vial of vaccine isn't going to be 100% uniform. You could have both virus material that can and can't replicate simultaneously. The extra immune response induced by the subset that can replicate might even make the immune response against the spike protein stronger, even if your theory is correct. Remember that vaccines usually have to use adjuvants to induce a stronger immune response than the active part itself does. An actual infection could do that quite effectively.

Re: Brazil Rejects the Gamaleya Vaccine

#87

Post by nikolay »

xvilka wrote: post #25
hardtke wrote: 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.

I am not a virologist, but blood clotting might be related to the specific payload rather than the platform. The original SARS-CoV2 has the same property. Could it be related to the spike protein?

The adenoviruses themselves are known to cause blood clotting for years and were questioned long ago as being a good vector.

Re: Brazil Rejects the Gamaleya Vaccine

#88

Post by petre »

Clewza313 wrote: post #71
sudosysgen wrote: post #59

Earlier quoted context omitted.

The "Sputnik V team" is the not the Gamelaya research institue, again the article you cited says they are affiliated with the Russian sovereign wealth fund. "Powered by" is weasel word 101. When you see a website where it's written "Powered by NodeJS" does that mean the website literally is from NodeJS?

I'm not sure what you're even trying to say here. Whoever wrote that response is quite clearly authorized speak on behalf of Gamaleya and the Sputnik V vaccine team, and while I'm sure there are plenty of conscientious scientists at Gamaleya, as Derek says this really is the worst possible public response. Tackle the problem seriously, sort out the manufacturing process, and the world will have one more weapon in the…

It's the post-Soviet Russian way of doing things, comrade. First claim fake news, then quietly fix the vaccine and deny accountability. Some vaccine scientists are due to accidentally fall off their apratment windows while doing Easter cleaning, with a helping hand from the FSB.

Re: Brazil Rejects the Gamaleya Vaccine

#89

Post by throwaway4good »

I thought this NY times op piece on Russian and Chinese vaccines was interesting:

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.

Re: Brazil Rejects the Gamaleya Vaccine

#90

Post by [deleted] »

marcodiego wrote: post #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 t…

[deleted]
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