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Brazil Rejects the Gamaleya Vaccine

blogs.sciencemag.org

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Re: Brazil Rejects the Gamaleya Vaccine

#31

Post by toast0 »

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.

These are the first widely deployed adenovirus vector vaccine.

There have been several rounds of trials of adenovirus vectors vaccines, but they never went forward to widespread use.

Viral vector vaccines are a less new concept than mRNA vaccines, so it might be easy to see one as new and the other as traditional, but they're both new.

Re: Brazil Rejects the Gamaleya Vaccine

#32

Post by sudosysgen »

meepmorp wrote: post #27
lindy2021 wrote: post #23

Earlier quoted context omitted.

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.

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 supp…

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.

Re: Brazil Rejects the Gamaleya Vaccine

#33

Post by kspacewalk2 »

jacquesm wrote: post #10
tzumby wrote: post #5

Earlier quoted context omitted.

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_an...

> Lancet is not a respected journal Of all the nonsense I've read over the years on HN this pretty much takes the cake. > has a history of controversies No, over the many decades (190+ years) it has been in publication there have been a (low) number of problematic papers that passed its review, and for each and every one of those there is a very well documented history and in most cases a retraction. Like every other…

It's a respected journal, but lately it's been publishing research that is of questionable quality for its "top-tier" reputation.

Re: Brazil Rejects the Gamaleya Vaccine

#34

Post by sudosysgen »

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 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.

Re: Brazil Rejects the Gamaleya Vaccine

#35

Post by Clewza313 »

sudosysgen wrote: post #32
meepmorp wrote: post #27

Earlier quoted context omitted.

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 supp…

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. T…

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-...

Re: Brazil Rejects the Gamaleya Vaccine

#36

Post by js2 »

b0sk wrote: post #29
SpaceRaccoon wrote: post #11

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…

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.

Re: Brazil Rejects the Gamaleya Vaccine

#37

Post by sudosysgen »

Clewza313 wrote: post #35
sudosysgen wrote: post #32

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. 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. T…

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

Re: Brazil Rejects the Gamaleya Vaccine

#38

Post by Clewza313 »

chupasaurus wrote: post #18

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

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/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.

Re: Brazil Rejects the Gamaleya Vaccine

#39

Post by meepmorp »

sudosysgen wrote: post #32
meepmorp wrote: post #27

Earlier quoted context omitted.

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 supp…

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. T…

> 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.

Re: Brazil Rejects the Gamaleya Vaccine

#40

Post by sudosysgen »

meepmorp wrote: post #39
sudosysgen wrote: post #32

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. 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. T…

> 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 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.

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