To think the EU countries are utter fuckwits over the AZ vaccine?

[annonnymous]

Words fail me at the utter stupidity and reckless behaviour of many EU countries over the whole vaccination thing and in particular the AZ vaccine.

40 people with blood clots with AZ ..... which is statistically lower than the average number of people who get blood clots anyway and the same as the Pfizer one! And the twatty french president saying AZ was quite ineffective in the over 65s and the whole of the EU slow the give it to over 65s because there was no evidence (because it wasn't tested on them) that it worked. It does, and sheer logic says it will. Your immune system doesn't fold up at 65.

With covid cases rising, Paris hospitals shipping out seriously ill patients to other areas, Italy in serious problems again, they need to stop this.

On no real evidence they are putting the lives of thousands of people at risk and putting a question mark over an effective vaccine which makes no profit and can be used worldwide cheaply.

The WHO say it's safe. FFS Europe, get a grip and stop the politics.

@mac12

I wasn’t clear, I didn’t mean the EMA, I meant the regulators of the European member states (also regulators in other countries outside Europe ) You are right though, I didn’t read the full thread.

The national regulatory authorities. The MHRA is the British one.

The EMA didn't tell the member states to do anything. They stated that in their view AZ was safe and the risks outweighed the benefits. The member states can do what they want.

e.g. Hungary uses the Russian vaccine Sputnik, which is not approved by the EMA.

The benefits outweighed the risks

@FatCatThinCat

You do know that Pfizer has the same issues don’t you? In fact in the uk it has slightly clots as a possible side effect

So why haven’t the EU kicked off about that?

More clots

I think this is sadly quite likely to happen

twitter.com/mark_toshner/status/1371748287255097345?s=19

I've had a thought....It's just possible that the various countries chose to suspend their vaccination schedules because they would possibly be on the hook for compensation claims. 🤔

Reuters....Unexpected side-effects after a drug has regulatory approval are rare, but the speed at which a COVID-19 vaccine is being pursued increases the risks of unforeseen conditions.

The deal with AstraZeneca, which shifts some of the risks involved in the roll-out of a vaccine to taxpayers, was struck in August and its liability clauses have not previously been reported.

Under the deal, AstraZeneca would only pay legal costs up to a certain threshold, the official said, declining to elaborate on how the costs would be shared with individual European governments or the cap

[quote UtzAreBetterThanNuts]For those interested in opinions of people with scientific and medical background : www.bmj.com/content/372/bmj.n699/rapid-responses[/quote]
Thanks for linking

For those who can't access the BMJ article above this is a fair summary of the situation and why scientists are tearing their hair out:

"Germany, France, Italy, Spain Portugal, and Slovenia have all paused the rollout (9), despite the reassurance given by those at the helm of medicines safety. It is not just a case of precautioning against any side effects, as these delays and doubts are likely to ingrain themself into public consciousness and further exasperate the lag in vaccine uptake seen in the previous months in some European states (10). It has been suggested that “if one was being cynical, one might suggest that some countries in Europe are using AstraZeneca as a scapegoat in order to disguise their own failures in respect of their own vaccine rollout programs (10)’’.

"Pausing the AstraZeneca vaccine rollout does not mean that populations are now indisputably less at risk, as the risk of severe COVID infection has thus far claimed 2.5 million lives (11) and damaged the health and livelihoods of millions more across the globe. The Oxford AstraZeneca vaccine has yielded 100% protection from severe disease, hospitalisation, and death in Phase III trials (12), and every day this vaccine is not utilised, more casualties will sadly be recorded for every country. If unvaccinated, those in Europe have a 1 in 4 chance of hospitalised, and a 1 in 10 chance in the UK (13). With the EU already threatening to sue the UK over trading to Northern Ireland protocol (14), this is already a politically and legally charged arena, we do not need to promote tension between and within countries further. As public demand for safe vaccines continues, politics must not allow the science to be ignored."

@Myalternate . I've had a thought....It's just possible that the various countries chose to suspend their vaccination schedules because they would possibly be on the hook for compensation claims.

Well not the EU countries. The EU is covered on that one. That was part of the longer approval process. They didn't use emergency authorisation. The British gov't on the other hand gave legal immunity to the manufacturers and they put limits on compensation in case of claims.

Coronavirus vaccine: Pfizer given protection from legal action by UK government

www.independent.co.uk/news/health/coronavirus-pfizer-vaccine-legal-indemnity-safety-ministers-b1765124.html

theconversation.com/uk-citizens-get-less-legal-protection-for-covid-jabs-than-other-vaccines-and-that-could-undermine-confidence-151455

and the EU

EMA licensing of COVID-19 vaccine will hold companies liable
timesofmalta.com/articles/view/ema-licensing-of-covid-19-vaccine-will-hold-companies-liable-peter.836351

What is the difference in liability between EU Conditional Marketing Authorisation vs Emergency Use Authorisations?

Under an EU Conditional Marketing Authorisation (CMA), liability is with the holder of the marketing authorisation. The marketing authorisation holder will be responsible for the product and its safe use.

ec.europa.eu/commission/presscorner/detail/en/qanda_20_2390

I got up to about page 29, but kind of gave up!

I think it’s fair to say that the press have a lot to answer for with their reporting throughout much of the last year. And I think it’s got worse due to Brexit-linked clickbait headlines.

I also think the EC have behaved shoddily in some of their actions recently re trying to divert attention away from vaccine procurement issues.

The UK govt definitely have questions to answer to re the whole handling of pandemic. And a number of politicians from around the world have, on record, said made shocking statements - in relation to the severity of the pandemic and also in relation to the vaccines. I’m still slightly struggling with the CONSTANT bad press re AZ, I’m not a tin foil hat person in every day life, but it seems to be constant!

I’ve really appreciated the measured remarks, particularly from a couple of people from a Denmark, explaining things.

It is definitely right that matters are investigated. And, as posters have said, hopefully the vaccine rollout won’t be too impacted. Each country will, just like the UK, have ordered different numbers of each vaccine.

My biggest worry is that the negative press will impact take-up of a not-for-profit, easily stored/transported vaccine. Especially in poorer countries around the world. A pp crassly said that the UK were guinea pigs for the AZ vaccine - I’m happy for that to be the case if it means that other countries can see the data of how our numbers are improving (as well as using Israel as real time data for the Pfizer vaccine).

I’ve tried to be balanced here - but I still think Macron and UVDL are complete muppets!

@oldegg123
This is an extract from just ONE opinion (from UK). I've posted it clearly to show balanced opinions and some of them support EU's decision.

1. 'Although more Pfizer doses had been delivered (10.7m vs. 9.7m) [1] the Oxford vaccine had generated many more Yellow Card reports (54,180 Yellow card reports vs. 33,207), generated many more adverse reactions (201,622 vs 94,809) and more fatal reactions (275 vs 227) [2,3].'

1. '[4] In a series of experiments, sera and immunoglobulin (IgG) fractions isolated from COVID-19 patients were able to induce apoptosis in platelets from healthy donors. There was a strong positive correlation for phosphatidylserine externalization as late stage marker of the apoptosis pathway with SARS-CoV-2-antibodies (r=0.57; P=.0064). Platelet apoptosis in turn may contribute to increased TE risk in COVID-19 patients but has also been implicated in PE independent of COVID-19.[5]

Thus, antibody-induced procoagulant platelets could be an unifying mechanism for our epidemiological observations and potential vaccination-related adverse events such as TP and TE complications. Future studies are urgently needed to analyse this potential link in patients post-SARS-CoV-2 infection and after vaccination.'

3.'The clinical trials of all COVID-19 vaccines conducted in different countries with different numbers of volunteers mainly focused on immunogenicity and safety, and they primarily stated only the side effects and adverse events that arose a few days after vaccination. A long-term follow up is yet to be completed. In the meantime, given the urgency to tackle COVID-19, most of the countries have approved the vaccine rollout. Since COVID-19 patients exhibit diverse clinical symptoms and signs, clinical trials could include those events as secondary endpoints, and a final analysis could state that the vaccine is ‘perfectly safe’, rather than just ‘well tolerated’. An extensive follow-up is warranted to assess the safety of the vaccines. Further, it will be pragmatic to investigate whether any persistent chronic disease triggers the episode of blood clotting when the individuals are administered the COVID-19 vaccine.'

4.The fact that the clotting problems reported in association with the Oxford Astra Zeneca vaccine are not listed as side effects does not rule out a possible association and is of little reassurance.

Narcolepsy and cataplexy were not initially listed in the side effects in the Summary of Product characteristics for Pandemrix, something the MHRA should be mindful of when responding to concerns re the possible connection between clotting problems and the Oxford Astra Zeneca vaccine today.

1. It is, therefore, not unreasonable to hypothesise that the genetic CoViD vaccines may also directly infect platelets and megakaryocytes triggering mRNA translation and consequent spike protein synthesis intracellularly. This may lead to autoimmune response against platelets and megakaryocytes resulting in reticuloendothelial phagocytosis and direct CD8+ T cell lysis.

1. I read with interest the report of cases of thrombosis after vaccination with the Astra Zeneca vaccine. I share the opinion that a causal link is not so far demonstrated and the events could coincidental. Nonetheless, some hypothesis may be advanced to safeguard from other adverse events.

We have published a preprint article in Biorxiv www.biorxiv.org/content/10.1101/2020.12.21.423721v1.full.pdf showing the spike protein can engage with cd147 receptor on human peri vascular cells and act as a ligand to activate Erk1/2 signaling Interestingly, cd147 is associated with thrombotic events and there are reports of cd147 polymorphisms (RS8259)increasing the risk of acute thrombotic events. I posit that the cases reported for thrombosis should be genetically assessed and if an association emerges with genetic variants of cd147, screening should be done to avoid complication after vaccination.

1. The blood clots formation after COVID-19 vaccination is an interesting issue [1]. Regarding the thrombosis triad, the effect of vaccine might be on blood viscosity. The post vaccination stimulaion of immuneresponse might relate to the problem. In a recent report, a person with evidence of previous infection has a significant more immune response [2]. This might be a possible cause of hyperviscosity, an important component of thrombogenesis. Anyone with underlying vascular disase should be carefully evaluated before vaccination. It is also questionable whethere there should be a prevaccination screeening for SARS VoV2 antibody.

OP…I can’t understand the ‘fuckwit’ comment. You are speaking with emotions. Look at the drug ‘cerivastatin’. There is a reason it takes years to get drugs to market and even then after rigorous testing, it can all fall apart. Several vaccines are still pending trial and approval. It would be very ignorant to assume that none of these will have any serious side effects… in the future… that will require some to be pulled off the market at some stage. There is always a trade-off. There are short-term and long-term side effects to consider. And everyone has to be seen to be doing the right thing... for the court cases that can occur.

Can it be possible that the Oxford vaccine should be precluded from being given to a particular cohort? There has been no time given to this - again because of the rate of delivery required?

Why not pause to ascertain which cohort this should be applied to? Where is the fuckwittery in that?

There is also the money factor, AstraZeneca are unable to deliver quite simply, first or second quarter. Quite unbelievable. Yet they have been paid. A way of negating contracts is that the product isn't fit for purpose, which arguably it is not because for many contracts the product doesn't exist i.e has not been delivered to create a fulfilled outcome which was the purpose of the product (1 dose - 2 dose product complete) and secondly it is not efficacious. Whatever that situation the EU needs a better scientific contract writer without a doubt.

I caught Covid before Xmas .Trouble breathing and Accident and Emergency put me on blood thinners straight away .Turned out I have clots on lung from Covid.Seems that blood clots are more common from Covid than they are from the vaccine

UtzAreBetterThanNuts

Is it true that the author of that opinion is a member of the UK Medical Freedom Alliance?

@Myalternate

Which one? There are 7 different opinions from 7 different people.

[quote UtzAreBetterThanNuts]@Myalternate

Which one? There are 7 different opinions from 7 different people.[/quote]
The first one....as you said This is an extract from just ONE opinion

@Myalternate

I was replying to oldegg123 who posted a 'summary' of the report and quoted only one opinion of the article. My comment is showing 7 different views of the article about AZ investigation. They are all in the link I posted, available for everyone to read.

Apologies, I misunderstood.🙂

@Cornettoninja

Helpful *@Taikoo*

100,000 Britons are needlessly dead, Cornet. All due to your incompetent govt.

Denmark health chief said when they paused the vaccine it was going to be temporary. It’s hardly impressive to predict that it the pause is a pause. Here in Denmark it is absolutely expected to resume in 9 days time. I’ve absolutely no doubt it will be billed as a ‘u-turn’ in GB 😏

Even the Remain outlets and pro-EU sites that I follow think the European countries are behaving appallingly. You don't have to be pro-Brexit to see that.

From Politico: Politics threaten to cloud EU countries’ pause of Oxford/AstraZeneca vaccine

www.politico.eu/article/politics-threatens-cloud-eu-countries-pause-oxford-astrazeneca-vaccine-coronavirus/

"But criticism also came from some voices in Brussels. The European Commission’s Sylvain Giraud of DG Sante tweeted on Tuesday: "What is the point to have scientific institutions like [European Medicines Agency] and WHO if decisions on vaccines are taken on political grounds?"

"Resisting scientists' advice now seem to be seen as a good point for politicians," he added."