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.

Same here. If what they say is true, that there was viral reproduction in the vacine, theres no way is gonna pass. They schedule a session in congress with Anvisa to defend their position, and decided to not show up to the meeting. The resistance in allowing European heath agencies entering and inspecting it's labs is also a bad sign.

I talked with a friend with ties in Anvisa. After all the bullshit the current president make they go through, with all the hydroxychloroquine thing, they kind of done a no interference pact over there among the staff, to not allow political pressure to dictate the result of their work. That say, nothing is immune to politics. But I don't think this was the case.

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

It is not that Anvisa is taking a political stance, but they operate under requirements of the government. The government is making it difficult for Anvisa to gather the data they need to make a decision.

How did the government interfere?

Here's a follow-up post on the behavior by the Sputnik V Twitter account https://blogs.sciencemag.org/pipeline/archives/2021/04/28/ru...

Greg Lowe is a very respected commentator on all things vaccines.

Derek Lowe.

This is not mutually exclusive with the findings of the Brazilian investigators. More than likely this will spur other investigations which should find the same thing if the Brazilian investigators were correct.

Making sense in your head and fitting a narrative is not enough to make a claim correspond to reality.

Brazil is using the Chinese vaccine. Don't think they would if those claims were true

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.

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.

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 basically a cold. Still far from perfect, but it is incredibly unlikely to effect efficiency.

This should be a pretty easy fix, actually.

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 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.

Update: Here's Gamaleya's official response, which immediately smears the decision as "political" and basically dismisses Anvisa's findings as impossible.

https://sputnikvaccine.com/newsroom/pressreleases/sputnik-v-...

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 happen then I guess we will have to see some hard data.

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.

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 fight against COVID. But if the response to every piece of bad news is "hurr hurr political fake news", then nobody will trust Sputnik-V, and quite rightly so.

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.

As laughable as it sounds, this is the sad truth.

> 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 basically a cold.

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.

> This should be a pretty easy fix, actually.

The fix is Gamaleya taking their current production facilities offline figure out where the problem is and fix it. Unless you're suggesting that regulators should just go full YOLO on this and let it slide, which is a stupid idea.

>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 vaccine marginally less safe. Not by much. Empirically, after millions of doses administered, the safety profile of the vaccine is more than acceptable as is.

>The fix is Gamaleya taking their current production facilities offline figure out where the problem is and fix it. Unless you're suggesting that regulators should just go full YOLO on this and let it slide, which is a stupid idea.

I literally say the exact same thing. In any case, Gamelaya right now is trying to get other people to produce the vaccines, but sure they should fix this issue. It will not be complicated.

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

Why is there any reason to think it wasn't? Replicant viruses are very easily explained by a QA failure, and Brazil doesn't claim that non-replicant viruses aren't there anymore.

That QA failure means the vaccine injected is different: they tested without reproduction competent in the trials. What else could they have missed along with this?

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.