Spudnik V....the russian vaccine

03-02-2021 1:09pm #1

their claiming 91.6% efficiay and similar for over 60s

Should the EU pull plug on the diaster that is the astra deal and purchase this instead??

(Dunno how to add a yes/no poll.option)

https://edition.cnn.com/2021/02/02/health/russia-sputnik-v-phase-3-intl/index.html

Sarn · 03-02-2021 1:13pm

It would still need to go through the EMA first for approval, but another option is always good.

hynesie08 · 03-02-2021 1:20pm

Why not both?

Sanjuro · 03-02-2021 1:38pm

Spudnik V? This a new Irish-developed vaccine?

Thats me · 03-02-2021 1:48pm

Sanjuro wrote: »

Spudnik V? This a new Irish-developed vaccine?

Guessing OP meant this one: https://en.wikipedia.org/wiki/Sputnik_V_COVID-19_vaccine

Not sure about efficacy since 90+% is not disease prevention, it is prevention of symptomatic cases and also unlikely this data including UK strain. But personally i would be interested in getting this jab because of less potential side-effects comparing to Pfizer.

acork · 11-02-2021 6:51pm

Sanjuro wrote: »

Spudnik V? This a new Irish-developed vaccine?

Yes, we manufacture it in Cork.:p

NeuralNetwork · 11-02-2021 9:03pm

The Russians are 100% welcome to apply to the EMA for approval just like anyone else. They even said they were going to be applying last month but I've heard no more since.

The reality is if the state rolls out an unapproved vaccine, there are risk that haven't been mitigated and legal risks, particularly somewhere as litigious as Ireland, are astronomically high.

Rodney Bathgate · 11-02-2021 9:05pm

What makes you think the EU won’t **** up again with Spudnik, OP?

hmmm · 11-02-2021 9:06pm

They can't even manufacture enough to vaccinate their own population. It's a perfectly good vaccine which is similar to the Oxford vaccine in how it works, but the hype about it is just propaganda.

NeuralNetwork · 11-02-2021 9:09pm

Well, you could argue the same with the UK coverage of the EU. There's endless Euro-bashing coming from the British tabloids and politics and the EU being a bit slower on the rollout has been used as an attempt to justify Brexit, even though any EU country could do similar and if they wanted to grant authorisation outside the EMA process for emergency use, which is all the UK did btw.

The vaccine rollout here has been slightly more cautious but it's still moving at pace, it's just not as fast a pace as the UK which threw caution to the wind in this.

There's a lot of vaccine nationalism and nationalism in general around this. Russia and China are very keen to claim superiority and the UK is more or less following the same track in recent months, which is rather unfortunate to see as it should be a global battle against a virus, not about flag waving.

The reality is the EU (and programmes like in the US and elsewhere) will ramp up exponentially as the supply chain stablises and broadens, particularly for the mRNA vaccines. There's huge capacity coming on for Pfizer/BioNTech, with the addition manufacturing facilities bought in and also from Sanofi and there are others on the way too.

This vaccine campaign could also end up being something we're all going to need to get boosters of every year or two anyway to keep up with variants, so it's not exactly going to be a short haul programme.

BorneTobyWilde · 11-02-2021 9:10pm

Spunknik No thanks , I want nothing from Putin The Poisoner

Purgative · 11-02-2021 9:15pm

BorneTobyWilde wrote: »

Spunknik No thanks , I want nothing from Putin The Poisoner

It gives me a bit of a shudder too. Though any port in a storm.

mrasgar · 11-02-2021 9:43pm

Pretty sure Putin wasn't part of the vaccine development team... the Russian vaccine published their data in the Lancet recently, just like the other vaccines, and it's shown to be effective. Also it costs lower than current vaccines.

We wouldn't reject US vaccines just because the US has bombed millions of innocent people in the middle east. NeuralNetwork is right, there's no need for nationalism and irrelevant attacks, when we're faced with a global pandemic like this one.

Galwayguy35 · 11-02-2021 9:45pm

BorneTobyWilde wrote: »

Spunknik No thanks , I want nothing from Putin The Poisoner

Relax I doubt you are on his hit list.

c montgomery · 11-02-2021 9:46pm

I wouldn't trust Any Russia lab studies.

Just look at their Olympic testing program. All athletes pass all tests while being doped to the eyeballs.

Still banned from Olympics meaning the IOC don't trust that they have changed their ways.

Dirty to the core.

hmmm · 11-02-2021 9:49pm

c montgomery wrote: »

I wouldn't trust Any Russia lab studies.

Just look at their Olympic testing program. All athletes pass all tests while being doped to the eyeballs.

We don't have to trust them thankfully. The process is they submit to the EMA, and both their data and production facilities are vetted.

Nothing stopping them doing this.

The idea that you would just sign a contract without this review is mental though. I'd be happy to sell someone a million vaccine doses if they wanted to take that approach.

whisky_galore · 11-02-2021 9:54pm

It's funny how sniffy Irish people get about the Russian vaccine, just digging up a heap of unrelated stuff to prove their point. Jesus we must be saints how we never deal with countries with any dubious dealings whatsoever...

odyssey06 · 11-02-2021 9:57pm

mrasgar wrote: »

Pretty sure Putin wasn't part of the vaccine development team... the Russian vaccine published their data in the Lancet recently, just like the other vaccines, and it's shown to be effective. Also it costs lower than current vaccines.

We wouldn't reject US vaccines just because the US has bombed millions of innocent people in the middle east. NeuralNetwork is right, there's no need for nationalism and irrelevant attacks, when we're faced with a global pandemic like this one.

The US has a free press and its companies operate independently.
Russia is a gangster country run on that basis.
The data coming out of Russia could be the truth or it could be garbage.
What's that phrase trust but verify - in this case it would be distrust and verify.

But the main point is that it's not like there are large amounts of Sputnik sitting around that Russia isn't using that we could use right now. That would be a game changer.

NeuralNetwork · 11-02-2021 10:00pm

Let's say the Irish Government went ahead and approved some vaccine outside the EMA programme and if something subsequently went wrong?

We could all hope that nothing would go wrong and fingers crossed it doesn't anywhere, but you can easily predict what would happen if it did.

The state wouldn't have a leg to stand on and the same people who are ranting and raving about how we need to cut the red tape and approve anything and everything without any protocols would be the exact same voices and posters who'd likely be condemning the state as reckless and demanding resignations and compensation.

It would end up in tribunals and enormous lawsuits and we all know this, but sure just rant, rant, rant..

Anything that launches here will be approved through a competent regulatory process through the EMA. It's as simple as that.

The state isn't going to just sign off on any vaccines outside of that for both safety and liability reasons.

mrasgar · 11-02-2021 10:00pm

odyssey06 wrote: »

Russia is a gangster country run on that basis.

That's bonkers. Like hmmm said above, just look at the vaccine data - no need to go looking for press or companies who have their own biases.

political analyst · 11-02-2021 10:01pm

NeuralNetwork wrote: »

The Russians are 100% welcome to apply to the EMA for approval just like anyone else. They even said they were going to be applying last month but I've heard no more since.

The reality is if the state rolls out an unapproved vaccine, there are risk that haven't been mitigated and legal risks, particularly somewhere as litigious as Ireland, are astronomically high.

An injection of something from a Russian lab - what does that remind me of? :rolleyes:

NeuralNetwork · 11-02-2021 10:12pm

political analyst wrote: »

An injection of something from a Russian lab - what does that remind me of? :rolleyes:

There's no point in writing off Russian technology entirely either.
I mean, if you look at say Finland they've been successfully using VVER nuclear reactors which were adapted and approved to fully comply with European safety standards.

However, it a vaccine were used it would need to be EMA approved, have proper evidence, independently verifiable studies and have production facilities that complied with EMA approval too.

There's a huge validation chain involved in all of these products that goes from tests and trials to every minute aspect of production.

We have a world-leading regulatory agency, the EMA, which is up there with the FDA in terms of being a 'gold standard' for drugs and medicines safety. This is our agency. We pool our resources with the other countries, pay for it and fully partake in it. It's got Irish staff including the director.

It makes sense to use the facilities we have, given they're world leading.

You simply cannot just ship in some random injectable product from an unknown source from a regulatory point of view. It dosen't work like that and never will.

Hungary approved stuff entirely independently of the EMA and EU. So that's a case of them exercising their sovereignty within the EU but also it's entirely on their head if something goes wrong.

TheRiverman · 11-02-2021 10:13pm

It's called Sputnik V.

c montgomery · 11-02-2021 10:15pm

hmmm wrote: »

We don't have to trust them thankfully. The process is they submit to the EMA, and both their data and production facilities are vetted.

Nothing stopping them doing this.

The idea that you would just sign a contract without this review is mental though. I'd be happy to sell someone a million vaccine doses if they wanted to take that approach.

It's not the review I'm concerned with, it's the data.
I wouldn't trust the data they submit.

Rodney Bathgate · 11-02-2021 10:21pm

TheRiverman wrote: »

It's called Sputnik V.

That makes more sense that ‘Spudnik’, what with the Soviet satellites etc.

11-02-2021 10:39pm

c montgomery wrote: »

It's not the review I'm concerned with, it's the data.
I wouldn't trust the data they submit.

The process is a lot more thorough than looking at their data. Their systems have to meet standards also. Independent accreditation by a recognised body is a requirement, and they have methods of detecting falsified data.

The technology the Russians are using is similar to others, so in theory should be just as successful. There is no evidence however to suggest they have the manufacturing capacity to match their propaganda campaign. Very low rollout numbers in Russia.

CalamariFritti · 11-02-2021 11:35pm

Vaccination campaign in Russia seems to be going very slow. But the Russian vaccine has applied for EMA approval. Its claims of high efficacy have now also been independently confirmed. Germany is talking about producing it together with Russia. Its good apparently but its not going to be here in any numbers soon.

Polar101 · 12-02-2021 7:04am

NeuralNetwork wrote: »

There's no point in writing off Russian technology entirely either.
I mean, if you look at say Finland they've been successfully using VVER nuclear reactors which were adapted and approved to fully comply with European safety standards.

Yes, but they only bought the Soviet reactors because of political pressure, they wanted to buy West German reactors at the time. So while the reactors still work, they preferred something else - a situation not unlike the vaccine situation.

If they actually had millions of vaccines in storage somewhere, then it'd be an interesting option - but they haven't even managed to vaccinate their own population. That's the only way Sputnkik would have been a big hit in the west - get it ready first, vaccinate first, and thus demonstrate to the rest of the world how good it is.

Big fan of the "Spudnik" spelling, though.

is_that_so · 12-02-2021 9:50am

CalamariFritti wrote: »

Vaccination campaign in Russia seems to be going very slow. But the Russian vaccine has applied for EMA approval. Its claims of high efficacy have now also been independently confirmed. Germany is talking about producing it together with Russia. Its good apparently but its not going to be here in any numbers soon.

Well, applied is a relative term. They wanted to and they think they have but EMA say they haven't. AZ took about 17 days from application to approval so that probably means closer to April at this stage once the process starts.

EDIT: Here's the latest from the EMA on this.

https://www.ema.europa.eu/en/news/clarification-sputnik-v-vaccine-eu-approval-process

paw patrol · 12-02-2021 10:16am

NeuralNetwork wrote: »

The reality is if the state rolls out an unapproved vaccine, there are risk that haven't been mitigated and legal risks, particularly somewhere as litigious as Ireland, are astronomically high.

The UK , USA and EU have provisions for EUA Emergency Use Authorisation) of medical treatments.

They still need to be approved to be granted an EUA but the reality is all these vaccines are "unapproved" but are legal due to the EUA.

I'm sure people will be along to say an EUA is approval... sure if that floats your boat.

But people should be aware that there is approval and "approval"

https://www.thelancet.com/journals/laninf/article/PIIS1473-3099(20)30923-3/fulltext

The European Medicines Agency has reportedly indicated its willingness to approve a candidate COVID-19 vaccine with efficacy of less than 50%,16 which is less than the threshold set by the FDA for COVID-19 vaccines and the European Medicines Agency's requirement for influenza vaccines.8 To facilitate COVID-19 candidate vaccines attaining emergency use designation, the European Medicines Agency has started rolling reviews of leading candidate vaccines, which enable European regulators to quickly analyse results as they become available, rather than wait for a full application.8 The UK's Medicines and Healthcare products Regulatory Agency has adopted a similar approach.

Given a "temporary" licence
https://www.ecdc.europa.eu/en/news-events/first-covid-19-vaccine-authorised-use-european-union

UK versions - which is easier to read. both vaccines
https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/conditions-of-authorisation-for-pfizerbiontech-covid-19-vaccine

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-moderna/conditions-of-authorisation-for-covid-19-vaccine-moderna

Thats me · 12-02-2021 4:06pm

Deleted User wrote: »

There is no evidence however to suggest they have the manufacturing capacity to match their propaganda campaign.

What makes huge difference, they do not sell vaccine itself but licensing its local production instead. In contrast to Pfitzer and Modena, Spudnik does not require unique equipment (which seem to be a main limiting factor for manufacturing of these vaccines) and can be produced by local manufacturers. As far as google knows at least Hungary, UAE and Brasil have licensed vaccine and producing it locally.

Spudnik V....the russian vaccine

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