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Approval of vaccines: authorities, processes and responsibilities

by Anton TheunissenandJillis Kriek | 3 Sep 2022, 07:09

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Long, long ago, when I question time in the room and in the Volkskrant of 28 June, Minister Kuipers indicated that the vaccines for the age group under 60 have not been approved by the EMA (European Medicines Agency). If he did have this group vaccinated, the minister would be responsible for any side effects, he said. Kuipers did not want to take this risk at the time and gave a negative advice for this group. If the EMA approval did come on time, it could only be done if the already accelerated procedure was shortened again. It raises the question why such approval always took about five years. And whether the politicians will also go along with it if approval only lasts 5 days, including assessing safety in the medium to long term.

An article by Jillis Kriek and Anton Theunissen

What is the current situation?

Both the EEA and the Health Council of the Netherlands previously explicitly stated that these vaccinations cannot be recommended for people under 60. At the time, it was the same vaccine that had already been given, although there were already hopes for a modified variant that protects against both Wuhan and the Omicron variant BA.1. The first of the so-called bivalent vaccines. We now know that the vaccinations aimed at the Wuhan variant no longer protect well and that the BA.5 variant is now circulating. A not too virulent variant. A bivalent vaccine against the BA.5 variant has now also been approved by the FDA and one (1) day later by the European Medicines Agency (EMA).

Variants of the coronavirus SARS-CoV-2 | RIVM

How long do approval procedures take?

The approval process for the second bivalent Pfizer vaccine, which we would like to vaccinate with in the Netherlands, has run out, according to Pfizer 22 August set in motion. This is the latest adaptation of the "Comirnaty" vaccine, now not only targeting the Wuhan but also the BA.4/5 variant.

The approval for the Spikevax vaccine, a mix of the old vaccine and a reformulated vaccineWould according to the EEA at the shortest it will last 150 days, or about 5 months. This procedure started on 22 July. The start date of the vaccination campaign is already mid-September, a deadline of about 60 days. That is one third of the time needed for an accelerated and shortened procedure, in which long-term effects again do not seem to exist. Not even for the group of 12 years and older, which the minister is talking about.

You could almost say: if they don't take those (medium) long-term effects into account, can't it be done a little faster?

Another possibility is to use a Rolling Review to get the vaccines through the inspection in two weeks. This was conceived earlier during the pandemic because it was an emergency situation. Would this scheme still apply, and for which emergency? These procedures are 15 and started June 17 (Pfizer and Moderna).

Because people who have only had the basic series have now developed a less effective immune response against corona than people who have not been vaccinated (negative effectiveness: so more chance of illness and death when the shots wear off), there is a strong urge to take a booster shot to temporarily boost the resistance again. It is not so important which vaccine is used.

What about the negative effectiveness when the booster shot has worn off will only be seen if the disease ever becomes dangerous again.

The Medicines Evaluation Board has now helped the Minister out of the fire and Spikevax approved as booster prick for 12 years and older.

That is admittedly not true with what's on the RIVM site But that may need to be updated. Just to indicate what kind of panic football is being played. People are at their wits' end.

About Spikevax

It doesn't make a chaotic impression for nothing: Basic series, booster shot, repeat vaccination and all with different age limits, which in turn differ per vaccine because a second shot is better or less bad than a first – or vice versa. And that while a major failure threatens if the negative vaccine effectiveness in the upcoming flu seasons starts to play a role.

Corona has become, thanks to the inexpert policy, the disease against which only vaccinated people need to be vaccinated.

If there had been no positive advice, the old vaccine would have been injected, we read on the rijksoverheid.nl.

Wie is verantwoordelijk voor bijwerkingen van de herhaalprik? - 47377
https://www.rijksoverheid.nl/actueel/nieuws/2022/07/29/herhaalprik-tegen-corona-voor-alle-12-plussers#:~:text=Er%20wordt%20geprikt%20met%20ge%C3%BCpdatete,het%20Europees%20Geneesmiddelenbureau%20(EMA).

The RIVM does not say whether it concerns the new or old vaccines, as long as it contains mRNA then it is good:

RIVM keeps it general, at least something with mRNA in it.

Approvals are also being pushed through in the US, but that doesn't happen everywhere: "Decision-making in the FDA and the CDC is at odds with that in other countries. InSwedenhave not recommended vaccinating children aged 5-11 years. Other European countries, such asDenmark, Norway, Finland, FranceandIcelandhave stopped the use of the Moderna vaccine by adolescents and young adults" we read on overnu.nl,

United Kingdom: not 12+, but 18+

In the UK, approval given for Spikevax. From 18 years and older, and not from the age of 12 as Minister Kuipers and his EMA indicate, you can receive this repeat vaccination there. Moderna just can't manage to produce enough vaccines for the whole UK and they are going to vaccinate with different vaccines. According to the official bodies doesn't matter very much, and this vaccine is just a marginal improvement.

What chaos.

Denmark: not 18+, but 50+

In a previous article we reported that in Denmark the lower limit for corona vaccines had been set at 18 years. This has now been increased to 50 years. The Danish Health Authority:

Who will be offered vaccination this autumn?
We expect to offer covid-19 vaccination to everyone who is 50 years of age or older.

People under the age of 50 with a higher risk of serious illness as a result of covid-19, for example people with a weakened immune system, can be offered a booster vaccination against covid-19 after a specific assessment by a general practitioner or hospital doctor. The Danish health authority will later assess whether all pregnant women, or only selected pregnant women, should be offered vaccination after a specific medical assessment.

Danish Health Authority

Just a little while and Denmark will say "never mind, unless a doctor advises otherwise"

Emergency Use Authorization Expirations

We have almost lost the fact that the current vaccines were approved as an emergency provision at the end of 2020. Such an EUA is valid for 1 year and has been extended, with the vaccine now also safe for babies from 6 months, according to the FDA.

One of the conditions for approval under conditions of an emergency is that no medicines are available.

On the FDA's own website state a number of medications Listed. It is explicitly stated that this not may be seen as an alternative to vaccination. Why not? No further explanation: that's just not allowed, period. That will be a useful disclaimer for the vaccines, should legal proceedings follow about the proportionality of the vaccination risks.

For us, we are dealing with some of the ema approved medicines for use in Europe. Who questions the approvers about the need for vaccination? And why are these alternatives not an alternative?

of the website of the Central Bureau for Medicines, the authority that has to approve use in the Netherlands

Look for a complete up-to-date list on the website of EMA. There are many medications available, from prophylactic to infusions.

How can we still vaccinate in the Netherlands?

People are only too happy to vaccinate, with any vaccine. If only to mask the fact that vaccinated people have suffered a weakened immune system because they have followed the expert advice. But signals from abroad point to other insights and the responsibility is passed on like a hot potato. How are we going to tackle that?

For children aged 5-11 it was always easy: the responsibility lies with the parents.

The vaccine is available to everyone on the advice of a doctor. But people would like to be vaccinated in a less cumbersome way. At the insistence of the CDA, doctors and agencies that advocate for the health of vulnerable people, detours are created to be able to implement the plans. A rather sloppily drafted corona law is being introduced and the minister has asked the OMT-v an opinion . That does not read like advice but as three gratuitous scenarios, such as previously described.

GPs were allowed to solve it...

Minister Kuipers had decided early on to launch the vaccination campaign. The vaccine didn't matter or maybe he saw the EMA approval as a formality. In any case, he has asked the general practitioners to compile a list of people who are eligible for vaccination. They are therefore responsible for who will receive a shot.

There is a list of people who also receive an invitation for the annual flu vaccine, but this list now had to be updated more quickly. Some of the GPs were not happy with this and suggested a "Motion of Sorrow" on the Basis of Education. Previously, they were completely bypassed in this procedure and they were called in as puncture stations, which they were not satisfied with either.

We wonder if doctors realize that there may be the possibility that they will also be responsible for any side effects.

It remains unclear

Dick Bijl, former general practitioner and epidemiologist, in this conversation with Marlies Dekkers on (from 33 minutes), that he also doesn't know exactly how it all works. Why should the minister be responsible if doctors send the invitation and administer the vaccination? Isn't it true that a doctor is responsible for any side effects of that vaccination? We also do not know where the legal responsibility lies in this case.

Did the minister act with insider information, because he assumed that the EMA would approve the (new) vaccinations? He then agrees to the turbo approvals of these vaccines. Minister Kuipers says he will certainly not bear responsibility for side effects of the new vaccination round himself. In the end, it will be passed on to the citizen, who has not been obliged to do anything and has made his own choice. After all, there is an emergency!

EMA comes to the rescue again: everything solved

Despite the necessary deadlines, the EMA has therefore approved the bivalent BA.1 vaccines for use in emergency situations at lightning speed. From the available information we can conclude that once again the trials of the vaccine manufacturers have been used for its approval. No further research seems to have been done. The BA.5 vaccines will not be long in coming because they too have just been approved by the FDA. The EMA will only need a few days to prepare a statement. It would go faster if the EMA was just taken out; They no longer play a functional role in this procedure, it only slows things down. And what does the excuse for the hasty approval boil down to?

  • "It was a small adjustment to an already approved formula"
    The previous formula is not even "approved" yet only allowed under emergency conditions, the studies for approval are still ongoing. Side effects are poorly monitored and provoke discussions. The emergency approval was given in a few weeks at the time, based on a shipment of documents that Pfizer said it would take 50 years to make public anonymously, following a court ruling.
  • "It's an emergency"
    There is no emergency. It is a totalitarian way of thinking to give a minister the legal mandate to declare an emergency so that he can introduce restrictions on freedom if his mind tells him to. This also changes the procedure on the liability of the side effects. If the advantages outweigh the disadvantages, it seems good enough by now.
  • "It's an A disease"
    The same minister, obsessed with risk avoidance, determines the status of the disease. It is still called Covid-19 but has not had any characteristics of it for some time. It has become a completely different clinical picture without public health risks.
  • "There are no medicines available"
    There are indeed medicines available. There are even life-saving advice against infection available that does not go beyond a passing mention. Look, for example, at ventilation and medicines such as Budesonide, see also the recent Ivermectin study among 88,000 people.

EMA, European Medical Agency, which approves or rejects our vaccines, states that (emergency) vaccines can only be approved if all conditions are met:

  • positive benefit-risk balance
    this is lacking for almost all (age) groups; the risks minimally investigated
  • additional data will be available quickly
    control groups are vaccinated so this is impossible
  • there are no alternative treatments
    They do exist (see above), as well as medicines that have been lobbied away
  • immediate availability outweighs the risk of missing data
    this is obviously NOT the case for the group under 65 years

Is it safe and effective?

Safe: Statistically, it has been proven in the various studies that no more than 1 in every 300 people die. You can perhaps compare that to something like spoiled food...? Far from 'safe'.

Effective: Against a virus that does not or hardly make people sick, it is virtually impossible to demonstrate effectiveness. Not to mention the necessity. They want to vaccinate everyone and then see in the winter if it helps. Those were also about the words of Marjolein van Egmond on the NOS news. "We hope..." She does not seem to realize that she is violating the Nuremberg Code. (And that while a submission from her was the reason to start this blog...)

Putting it all together, there are three reasons for this vaccination campaign.

  • At the top, they want to hide the fact that the vaccines are counterproductive in the longer term (after about six months) and thus eliminate the negative vaccination effectiveness.
  • The interests of the pharmaceutical companies, which are represented in many decision-making bodies, are obvious: the more dependent people become on the injections, the better.
  • The entire medical profession is drilled to respect each other's expertise, to rely on studies from manufacturers and has neither the time nor the ambition to research and study themselves. After all, they have to help patients and the developments are still impossible to keep up with. They have thus become a willless army that repeats the mantras that come from above: from the producers and other stakeholders. Disciplinary measures are taken against doctors who nevertheless form a critical opinion. Politicians want to remove them from the BIG register.

Communication

The (repeat) boosters should prevent vaccinated people from performing worse than the unvaccinated. This is a difficult message to convey in communication, both for pharmaceutical companies, policymakers and collaborating doctors. It would only emphasize the negative effectiveness and that is not conducive to the willingness to vaccinate. So it has been made of "you must have had the basic series to be eligible for a booster." As a result, people are now being urged by the vaccine proponents to still get the completely pointless basic shots so that they can get the booster afterwards. This will probably not be rectified by the pharmaceutical companies.

Moral of the story

What you do yourself is up to you, but for heaven's sake: Don't get your children vaccinated! I have insisted on this before and it came to me with some criticism (too activist). Yet I stand by it: what we have done to our children, also regarding their future, and what we still want to do to them by damaging their health, that is an unforgivable disgrace.

This will later turn out to be a period of our history that will be looked back on with horror because in less than a decade we burned out the economy, squandered science, wanted to master nature, shook off our culture and deliberately damaged our children for the rest of their lives.

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5 Comments
  1. jan van ruth
    jan van ruth the 03 / 09 / 2022 to the 08: 03

    Done business does not take a turn.
    That is the principle behind this whole plandemic.
    as much genetic manipulation as possible in as many people as possible.
    and what is in there never goes out.
    And by the time people discover en masse that they have been fooled, it is too late.

    In China, not a single mRNA shot has been used, except in Hong Kong.
    Why would that be?
    Maybe because Beijing wouldn't mind so much if the population of Hong Kong died en masse from aggressive cancer and/or lost a lot of fertility?
    And Russia has not used mRNA shots either.
    Is there something that the Chinese and Russians know that we don't?

    5
    Answer
  2. Sander
    Sander the 03 / 09 / 2022 to the 10: 45

    Our minister's attitude reminds me very much of what I once read about a bizarre experiment. Students turned out to be willing to administer electric shocks to other students, increasingly stronger up to so-called life-threatening levels (but electric shocks were fake, as were the 'victim' students, who were secretly actors who pretended it hurt). The research showed that people are willing to harm the other even with the risk of a fatal outcome, if they 1. and 2. do not have to bear the responsibility themselves. Exactly the behavior of Kuipers. He should be a medical scientist himself. But he is fine with it, if he can hide behind anything as far as his responsibility is concerned, then go for it. What a fake leader, scary people this. They do well in totalitarian systems. In that respect, a very good hiring policy there at D66 because that is exactly what they (and among others they) are striving for. Anyway, all terrible. Outrageous and criminal. And still incomprehensible to me. That I woke up in this nightmare. I would never have thought this possible three years ago. Well and as far as Ernstje is concerned: would he have that vaccine in it himself, preferably all three or four or what is it at the moment? I hope so. Otherwise it is really criminal.

    4
    Answer
    • Anton
      Anton the 03 / 09 / 2022 to the 12: 53

      The Milgram experiment https://virusvaria.nl/kuipers-milgram-en-de-hete-aardappel-van-verantwoordelijkheid/

      1
      Answer
  3. leo
    leo the 03 / 09 / 2022 to the 12: 39

    I think the writer forgets an important fact. The trials and documents of the Pharmaceutical Industry serve as primary evidence on which the (emergency) approvals are based. Everyone seems to forget that the pharmaceutical industry on which people now blindly rely regularly have billions of claims on their pants for committing fraud, concealing side effects, incorrect information, etc., etc. So all signals would have to be red before one should trust these interested parties with such a past at all. (See also The Real Anthony Fauci where bad practices with names, locations and times are listed.)

    7
    Answer
  4. Klaas Wever
    Klaas Wever the 03 / 09 / 2022 to the 12: 43

    In the run-up to the WPG, politicians are finally demanding a broad and rapid evaluation. A STOP must be put in this thundering machinery of deceiving the people. Come on Representatives of the People STAND UP and MAKE YOURSELF HEARD!

    5
    Answer

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