So excuse me if I ask a simple question here ? If .... following the normal regulatory procedures would still take a long term, then having taken a shorter term/time to roll out, it follows that the normal regulatory procedures have simply not been followed ?

Normal regulatory procedures have been followed and will still be followed for a long term. That is the normal regulatory procedure.There is no other way to pass a long term, it takes a long term. While the long term passes, things may be found out. That is why Emergency Approval is normal.

You continue to assert that "Normal regulatory procedures have been followed " It seems clear to me and others that this stage, having been given Emergency Approval in these abnormal circumstances the vaccine has passed from Phase III trials to Phase IV under a temporary waiver. Under this the whole public health edifice is intent on vaccinating everyone as fast as possible while this waiver is extant. I leave it to everone to make their own decision as to whether their perception of risk of vaccination and potential long term adverse effects outweighs their perception of risk of infection by Covid-19. The effort the government and its vaccine zealots have gone to and the depths of deceit the government have stooped to tell me as much about vaccine safety as the number of informed papers I have read on this subject. As you were fon.

Point me to documentation on long-term side effects.

So let's try this again.

Can you confirm you refuse to take any medical treatment or intervention for any disease if it hasnt had regulatory approval for at least 2 years?

Do you treat EVERY new medicine, new vaccine or new treatment as "experimental"?
The little gang of vaccine zealots here seem unable to admit that the vaccines that have been rushed out,

Rushed out?
You mean full Phase I,I,III trials and the related subsets with HIGHER sample group sizes than is normal?

Do you think these, or any other vaccines would be "safer" if we left them sitting on a shelf for 2 years doing nothing after approval?
with minimal testing and given emergency licenses are not as well tested as other medicines.

Which bit of the identical clinical trials procedure and authorisation process is confusing you exactly?

As for emergency use - you're clearly unaware how many receive this perfectly normal process in general.
And ignoring the fact EHRA and others granted full, non-emergency approval.

You seem utterly determined to ignore the fact that the vaccines have undergone absolutely identical trial and approvals to anything else. You just dont like THIS one for some reason.
You seem to think "FAST" is bad with no justification.

Lets try this one... Which bit exactly of the Phase I,II,III trials by Pfizer do you have issues with? Specifics?
Which bit exactly of the MHRA approval procedure do you have problems with?
Specifics. Not "Wah its untested, fast, bill gates" nonsense.

As I have pointed out to you before you seem to be totally ignorant of the normal FDA process for the certification for clinical use ALL new pharmaceuticals treatment. On which the equivalent regulatory process all around the world are based. The regulatory protocols for mass usage vaccines are far more rigorous than even for OTC drugs. Why do you think most vaccine candidate trials fail. Usually after a few years. Because that how long it takes to find long term side effects. A few years.

I use the term experimental because NONE of these vaccines have gone through the full MULTI-YEAR trial process that is required for all new pharmaceuticals used for any kind of medical treatment. The current waiver is just that, a temporary waver. At some stage the waiver will be removed and all current vaccines will have to go through the full multi-year clinical trials that every other vaccine has had to go through over the last 60 years.

Yet this very simple fact seem to elude you - It take years for long term effects to manifest themselves. Which is why the length of trial before final FDA certification always runs to years. Absolutely no vaccine which had limited trials spaced over a matter of months is in any way equivalent to all other general use vaccines which had been trialed and tested for quite a few years before they were ever administered to the general public.

Has any other mRNA vaccine received a full regulatory certification in the past? No. For very good reasons. Do the SARs CoV2 vaccines have even the same order of magnitude of adverse reactions and fatalities as the nearest equivalent mass use vaccine, the Influenza A vaccine? A very definite NO. As of the most recent CDC data the SARs 2 vaccine is about 40 times more dangerous than the flu shot and for old people > 75 it looks like it could be as high as 100 time more dangerous. Those are just the immediate < 5 days adverse reactions. Not even short term or long term effects. And by dangerous I mean causes death.

So given that there has been no large upswing in excess deaths in the last year (nothing out of the ordinary) and most of the SARs CoV 2 pneumonia deaths seem to be purely substitute cause deaths, its mostly just another hospital acquired pneumonia , why are you so enthusiastic in defending an untested experimental vaccine. Untested by the regulatory standards of every other vaccine I've ever been given. Or given my kids without the slightest qualm.

9markshaw1

What a great post JMC. Everything you have written follows logic and is honest. All I want to see is things being done properly and cautiously.

We all need to keep a cool head and not let panic influence our medical decisions. First do no harm and remember that we might not know as much as we think we do!

The human body is amazing and our immune system (given time) is phenomenal. Perhaps human beings have got a little ahead of themselves with respect to how they believe they can improve human physiology. Perhaps mankind has also become a little spoilt in wanting to live longer and longer but, at the same time, not endure the natural consequences of the ageing process or ill health. We want it all ways - but that can lead to even bigger problems.

Mark Shaw

I see it as pure opportunism.

The pharma companies have new technology that's only been around a couple of years, can't wait to try it out. Governments say - gimme quick we'll indemnify you - zero risk to you! So they roll it out for a free huge trial at zero risk. All paid for by you and me.

So excuse me if I ask a simple question here ? If .... following the normal regulatory procedures would still take a long term, then having taken a shorter term/time to roll out, it follows that the normal regulatory procedures have simply not been followed ?

All they did was the very first set of limited small scale clinical trials and that's pretty much it. In no way equivalent in any form to any other approved vaccine. They did maybe 5% of the standard approval timeline testing process.

The only data they actually have is that large numbers of people did not die immediately and they extrapolated exceptionally optimistic vaccine efficacy rates from essentially statistical meaningless data sets. It like someone saying they have a sure fire lottery wining technique just because they guessed 4 of the 5 winning numbers last week. About that level of statistical relevance.

With a low R0 respiratory illness like SARS CoV 2 with very high cross immunity in the general population it would take a minimum of at least 12 to 18 months to even start getting a reliable data and statistics on actual real world efficacy rates in the general population. There is a very good reason why the approval process take 4 to 6 years on average . It takes years to gather reliable data. Years.

So what you actually have is a vaccine with no reliable data on how effective it is or for how long it will work against a virus where all the historical indicators are than any vaccine will not have high efficacy and will only have a short duration effect. The reason why I keep mentioning the Influenza vaccine is that will be the real world model of how any potential SARs CoV 2 vaccine will actually work in the general population. The is no scientifically plausible scenario where any SARS Cov2 vaccine will be more effective or longer lasting the the current annual flu shots. Which are not that effective and dont have any meaningful impact on the mortality rates or hospitalization rates of the most vulnerable demographic.

A vaccine needs a strong immune system to work against. Which is something that old sick frail people do not have.

So excuse me if I ask a simple question here ? If .... following the normal regulatory procedures would still take a long term, then having taken a shorter term/time to roll out, it follows that the normal regulatory procedures have simply not been followed ?

Thanks for that simple question, and like many simple questions it has a long answer.

In some cases it might take longer than a long term, i.e. a very long term. Put simply, the longer the term, the later the time before the medicine is usable, the shorter the term, the sooner the medicine is usable.

Too long a term, and the medicine is too late, too short a term, the greater the chance a surprise lurks in the medicine. So it boils down to this, how long is enough? Well that depends on the impact of the medicine, i.e how much do you need it? If you had bad cancer, you might use less time. If you don't mind waiting, you might be minded to take your time.
It's very straight forward, how much time can you afford?

If you can't afford much time, since the nation is in lockdown and 115,000 vulnerable people have died, you do what testing you can, then you use your judgement and all the available test data.

There's a lot to be said for judgement, and pre-existing data. It's not the same as knowledge. If we waited for knowledge we might have endless lockdown and115k vulnerable people die every year, at least until a long term is up. So it's a very important decision that the MHRA has to make, I'm glad I do not have to make it, to be honest.

So it boils down to this. Sooner or later you have to shit or get off the pot.