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.
Why are you repeatedly posting statements which are totally false. FDA Waivers and "Emergency Approval" are very rare. For example the last FDA vaccine waiver was for Ebola and that only happened because of the political fallout from the H1N1-09 vaccine balls up a few years before.
I posted the actual regulatory regime for vaccines and other pharmaceutical molecules on another thread but I will post again.
Here is the FDA 505(b)(1) approval process timeline. I use the FDA to illustrate the approval process because they are the benchmark regulatory regime and there is an enormous amount of documentation on-line on exactly what is involved.
https://drug-dev.com/development-timelines-drug-development-times-what-it-takes-part-3/
It takes 4 to 6 years on average. None of the SARs Cov 1 vaccine candidates got beyond the initial trials stage process because they had so many serious problems.
All new vaccines like SARs CoV 2 vaccines must follow the 505(b)(1) approval process timeline.
Here is a good summary why.
https://www.nuventra.com/resources/blog/505b1-505b2-pathways-for-new-drugs/
So please stop posting patently untrue statements about a subject you seem to have not even bothered to do the most basic background research on.
Waivers are not normal. They are always politically motivated. And all current SARs CoV 2 vaccines have not even completed the preliminary phase of the normal approval process testing and trials. In the normal approval process the first limited general population trials would only start in year 2 or 3 for particularly promising vaccine candidates.
All current SARs COv 2 vaccines are essentially untested by the standards of other genral uses vaccines and the rush to mass roll is unprecedented and unique in the history of modern vaccines. So stop pretending there is anything normal about what is going on at the moment. There is nt. All the normal regulatory controls and safeguards have been very deliberately abandoned. For the sake of political expediency.
Jmc you have the patience of a saint which is deliberately being sorely tested..your posts make sense to me and I am in agreement with them..there are several who post on here with one mission in mind but are not very clever about it..
😉
Jmc you have the patience of a saint which is deliberately being sorely tested..your posts make sense to me and I am in agreement with them..there are several who post on here with one mission in mind but are not very clever about it..
😉
These people actually serve a very useful purpose. Think of them as very convenient irritants. Gadflies that make it easier for us to present our arguments. As a way of getting useful information and arguments to the lurkers.
In these sort of on-line discussions the goal is not to convince the stubborn counter-party that you are correct. To change their mind. One rarely does that. You argue your point in your posts to persuade those who only read the thread but dont actively contribute to the discussion. The lurkers. The other 98% or 99%. Those are the people you are trying to persuade of the correctness of your arguments and opinions. That is the actual audience you write for when it comes to persuasion in online discussions.
So I dont mind at all having to constantly restate my position with these people in various threads. It just means I get an opportunity to hone my arguments, present better arguments or data sources, and hopeful get better at presenting the case for my position. Plus it means that even more lurkers will see my arguments and hopefully be persuaded by them.
As you might have guessed I have been actively involved in on-line discussion for many decades. Since the early 1990's. So very much an old hand. The other parties you might be referring to are totally harmless in my opinion. In fact very useful. So I hope they stick around in their current online personas and keep presenting me and others opportunities to persuade the lurkers that the is real merit in being very skeptical of the current official narrative. Because if you go looking for the science that backs the official narrative you will find none.
Readers may be interested in the following sources of information on adverse reactions to, first, the Pfizer and, secondly, Moderna bio agents;
This is the European EudraVigilance Database which records adverse reaction events.
Two significant features stand out in addition to the number and type of crippling and debilitating reactions: first, the vast majority of reported adverse reactions fall in the 18-64 category (around 80%); secondly, these are overwhelmingly in women (70%+).
It does make you wonder why significantly fewer adverse reactions are being recorded for the older age groups which were, after all, primary targets for the experimental bio agent programmes. One possible explanation is that relatively large numbers died in short order and their deaths have been attributed to other things - as if.
th 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.
That's hogwash. We can calculate the relative risk reduction in trials lasting months not decades. It does not necessarily take years to gather the efficacy data. If the people who have been given the vaccine stay well, while the people given the placebo get the disease, then your vaccine works. If you want more data, use bigger groups. Eventually the dogs in the street will realise the sick people are the ones not vaccinated. You might figure it out in the end for all your bluff and bluster. Let's work out how much safer the Pfizer vaccinated people are using the real data.
22,000 vaccinated,8 got covid19, 8/22k=0.036% of group got covid19
22,000 placebo, 162 got covid19, 162/22k= 0.74% of group got covid19
We can already see that that the vaccinated group is much safer. If you want more data, increase the group sizes. But we're interested in relative risk reduction
0.036/0.74 = 5% Which means that the Pfizer vaccinated people had a 95% smaller risk of getting covid19 than those in the placebo group. That's the relative risk reduction. And this was calculated in trials lasting months not decades.
