Covid vaccine uptake - poll

[AlexWilliamsGloves]

Posted this in another thread, but thought some might be interested in what i learned....the new vaccine isnt like other typical vaccinations.....ie, it DOESNT inject a small amount of the virus into you. So those who are afraid of contracting covid from the vaccination are incorrect...

The COVID-19 mRNA vaccine: What is it and how has it been developed so quickly? - FactCheckNI

The Pfizer/BioNTech coronavirus vaccine has been approved for use in the UK from the week commencing 6 December 2020. This means that the UK has become the first country in the world to approve the vaccine for widespread use. MHRA, the British regulator, says the jab, which offers up to 95%...

factcheckni.org

What is this COVID-19 mRNA vaccine?

The Centers for Disease Control and Prevention described this COVID-19 vaccine as a messenger RNA vaccine — or a mRNA vaccine.

This type of vaccine does not put a weakened or inactivated germ into our bodies. Rather, mRNA teaches our cells how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies. COVID-19 mRNA vaccines give instructions for our cells to make a harmless piece of what is called the “spike protein”. This “spike protein” is found on the surface of the virus that causes COVID-19. The immune response to this — our body’s production of antibodies — is what protects us from getting infected if the real virus enters our bodies.

It has been explained that a major advantage of RNA vaccines is that RNA can be produced in the laboratory from a DNA template using readily available materials, less expensively and faster than conventional vaccine production.

 

[roubaixtuesday]

With regards to liability take a look at this

https://uk.reuters.com/article/uk-h...ield-against-side-effect-claims-idUKKCN26D0UG

My understanding of this is that indemnity is being offered to companies who are providing at low or no profit basis.

Normally the companies would fund indemnity from profits - if they're not making, or are limiting profits then the EU is funding indemnity. Which makes sense.

But it's hard to find details.

There are well established schemes for vaccine compensation which require a lower standard of proof so people can be assured of support even if they can't definitively show a vaccine link, in order to assuage fears.

Vaccine Damage Payment - Wikipedia

en.m.wikipedia.org

 

[FCBarca]

Well, this is clearly false. The direct effectiveness has been measured, with clear statistical significance using symptomatic disease as an endpoint. Transmission reduction, as I understand it, can't be measured in such a trial and only assessed through the rollout. So you'd never assess this without approval. Very happy to be corrected if wrong on this.

It is very clearly true. What I thought was clear is that with Pfizer's proposed vaccine, they demonstrated effectiveness at a certain stage & the base strain (There are at least 5 known mutations nevermind future ones) of COVID-19 - that effectiveness changes depending on stage & strain. And the effectiveness Pfizer claims is on reducing your symptoms, not transmission effectiveness or how long your symptoms are reduced - does it impart longterm immunity if faced with renewed exposure? They do not know this yet. As part of confirming effectiveness of a drug/vaccine, to date no peer review of their published results has been done - primarily because those results have yet to be published in its entirety, only press releases.

Even the EU just came out critical of the UK for their rapid approval without taking adequate time to ensure quality, effectiveness and safety is guaranteed or at least meets standards

It's been framed as benefits over risks, that's not assuring. Won't even discuss the -70C temps of storage reqd up until 5 days of administration - that's a significant bottleneck atm as well

Pharmacovigilance normally refers to monitoring through routine use, though formally includes clinical trial data. Of course this cannot be assessed long term - it's a new product. The reason conditional rather than formal approval is given is so trials can be mandated to continue. But approval of all treatments is on a risk/benefit basis. Most vaccine AEs are rapid at the point of administration. The risk - even for young, healthy people - of COVID infection is high.

These don't remotely add up to a "roll of the dice on many fronts". They are low probability, low impact scenarios. The worst case scenario is pretty trivial compared to the current pandemic, and is very unlikely.

Worst case scenarios being either low impact on transmission (vaccinated people are still protected), long term protection drops off (boosters required) or unknown high consequence low frequency long term adverse events.

I wasn't feigning ignorance here, more stating the obvious as you have = there simply is no safety data long-term since it is too early. That is precisely why drug/vaccine development takes far longer than <12 months.

Let's be honest here, we don't know the long-term consequences of COVID-19 infection even if you do not become seriously ill much less die to know what sort of medium to long-term impact this vaccine will have - a roll of the dice is because it is indeed a gamble. We are not going in blind but we are throwing a dart into an ocean hoping to stem the tide

 

[FCBarca]

I am sure they do, however if everyone decided to wait a year or two can you imagine what a mess the world would most likely be in? Potentially millions dead, economies far more fucked worldwide than they already are, mass poverty and disease, most likely resulting in more conflicts and maybe even a big one of the likes we have been dreading for decades.

My concern is safety, obviously. This is my area of expertise, not virology per se but drug/vaccine development as a physician/clinician/researcher. There's a reason why we have these development standards, when you rush through them you have to go in knowing you are taking risks. It's precisely why I proposed that they should prioritize highest risk groups first while continuing to work.

Imagine if in 12 months we're no better positioned if not worse and everyone put all their eggs in this vaccine basket. Ordinarily I would say that is unlikely since in all probability parallel activities will continue to better understand COVID as well as treatment/vaccine possibilities. However, I have also seen governments around the globe failing to do the obvious thus far and opting for risk mitigation scenarios at the expense of lives

So I am cautious, not cynical - just we need to appreciate this isn't a miracle that some are certain of

 

[blueparrot]

Who knows if what we read is fake news or not.

We can never be fully sure, but if it’s from a reputable media source,we know it is a hell of a lot more reliable than random youtube internet channels,and twitter social media experts, where people live that tell you the earth is flat.

 

[blueparrot]

Won't even discuss the -70C temps of storage reqd up until 5 days of administration - that's a significant bottleneck atm as well

Not where I live it isn’t.

 

[roubaixtuesday]

at a certain stage

What does this mean?

the base strain (There are at least 5 known mutations nevermind future ones) of COVID-19 - that effectiveness changes depending on stage & strain.

No, the results are not delineated by strain. And there is no evidence of differences in response to currently known mutations.

does it impart longterm immunity if faced with renewed exposure? They do not know this yet.

We agree on that at least. This is a risk, although the consequences are not high.

As part of confirming effectiveness of a drug/vaccine, to date no peer review of their published results has been done - primarily because those results have yet to be published in its entirety, only press releases.

Peer review is not, and has never been, a requirement for approval. Approval is a regulatory process

It's been framed as benefits over risks, that's not assuring.

That is true of absolutely every single treatment ever approved. This seems to be the root of your criticism - you want zero risk. That will never be possible.

 

[FCBarca]

What does this mean?

No, the results are not delineated by strain. And there is no evidence of differences in response to currently known mutations.

We agree on that at least. This is a risk, although the consequences are not high.


Peer review is not, and has never been, a requirement for approval. Approval is a regulatory process


That is true of absolutely every single treatment ever approved. This seems to be the root of your criticism - you want zero risk. That will never be possible.

I mis-spoke, I was speaking of Phases rather than stages. This was an expedited Phase III trial, skipping I & II altogether.

There is not enough information to even draw a conclusion that there are no differences between strains.

Seeing that the EMA and FDA have yet to approve the vaccine, UK jumping the gun nevertheless. Since this falls under EUA in terms of regulatory application/review, peer review of data is not part of the FDA's regulatory process although this is a quality control measure to ensure there is transparency & due diligence. Having submitted INDs and other clinical trial research to the FDA, I know it's highly unlikely they could possibly review the extent of the data made available - everything will be done at topline data level, especially due to it being an emergency. We are again in that familiar 'unprecedented' path - that's more pandora's box than science

It's an oversimplification to suggest I am talking zero risk, few things are without any risk. No drug/vaccine has ever come to market this quickly much less for something that has affected more lives than current - I would counter that the calculation of risks has been rushed in the hopes of benefits. As I have mentioned, a drug company that wants immunity from liability for safety issues, even in a pandemic, is obviously not thinking of safety first & foremost

 

[roubaixtuesday]

This was an expedited Phase III trial, skipping I & II altogether

Sorry, but this is simply incorrect. You can read the peer reviewed phase I/II results here.

Phase I/II study of COVID-19 RNA vaccine BNT162b1 in adults - Nature

In a dose-escalation study of the COVID-19 RNA vaccine BNT162b1 in 45 healthy adults, RBD-binding IgG concentrations and SARS-CoV-2 neutralizing titres in sera increased with dose level and after a second vaccine dose.

www.nature.com

There is not enough information to even draw a conclusion that there are no differences between strains.

Agree - yet you claimed, in direct contradiction, they demonstrated effectiveness at... ..the base strain... ...effectiveness changes depending on stage & strain. You're not being at all consistent here.

On other points - peer review publication is not part of any regulatory processes. Though I agree it should proceed as fast as possible here, and I'm sure it will.

Benefits here are evidently not mere hopes - efficacy has been shown to a level of benefit way above what would be the baseline requirement for approval, and way above any measure of statistical significance.

Your position would be valid if benefits were low - if this were a chickenpox vaccine perhaps. But the benefits are very, very high with over 0.1% of the UK population already dead despite unprecedented measures to suppress the virus.

 

[SWP's back]

Posted this in another thread, but thought some might be interested in what i learned....the new vaccine isnt like other typical vaccinations.....ie, it DOESNT inject a small amount of the virus into you. So those who are afraid of contracting covid from the vaccination are incorrect...

The COVID-19 mRNA vaccine: What is it and how has it been developed so quickly? - FactCheckNI

The Pfizer/BioNTech coronavirus vaccine has been approved for use in the UK from the week commencing 6 December 2020. This means that the UK has become the first country in the world to approve the vaccine for widespread use. MHRA, the British regulator, says the jab, which offers up to 95%...

factcheckni.org

What is this COVID-19 mRNA vaccine?

The Centers for Disease Control and Prevention described this COVID-19 vaccine as a messenger RNA vaccine — or a mRNA vaccine.

This type of vaccine does not put a weakened or inactivated germ into our bodies. Rather, mRNA teaches our cells how to make a protein — or even just a piece of a protein — that triggers an immune response inside our bodies. COVID-19 mRNA vaccines give instructions for our cells to make a harmless piece of what is called the “spike protein”. This “spike protein” is found on the surface of the virus that causes COVID-19. The immune response to this — our body’s production of antibodies — is what protects us from getting infected if the real virus enters our bodies.

It has been explained that a major advantage of RNA vaccines is that RNA can be produced in the laboratory from a DNA template using readily available materials, less expensively and faster than conventional vaccine production.

Great post