Will you have an unlicensed vaccine?

MHRA LOGOThe Government want to distribute vaccines against Covid-19 which are unlicensed. They have issued a Consultation and invite responses by this Friday 18th September 2020.

We link the Consultation here and urge you to respond to it.

After entering your details, the Consultation is very short. There are just five blocks in which you can place a response. They are headed:
‘Temporary authorisation of the supply of unlicensed products’
‘Civil liability and immunity’
‘Expansion to the workforce eligible to administer vaccinations’
‘Vaccine promotion’ and
‘Provisions for wholesale dealing of vaccines’

The UK’s Regulator

Medicines are licensed in the UK by the Medicines & Healthcare products Regulatory Agency (MHRA). Furthermore, from 31st December the UK will be on its own and not subject to additional EU regulations on medicines.

Stephen Lighfoot, Chairman of the MHRA

Stephen Lighfoot, the new Chairman of the MHRA

  The MHRA is a quango, an ‘executive agency’, of the Department of Health and Social Care.

  The Government website says its chairman is Stephen Lightfoot. He succeeded Prof Sir Michael Rawlins GBE only this month. Sir Michael held the post for just under six years. MHRA chairmen seem always to be knighted after a year or two in the job.

Mr Lightfoot is an NHS insider. He says he wants MHRA to develop ‘new regulatory processes which are proportionate, evidence-based and transparent, so that patients can gain earlier and safer access to new medical products than ever before.’ That sounds good, so long as corners are not cut along the way. Maintaining a reasonable degree of public safety, as we read in the Bible’s book of Leviticus, is the responsibility of government.

MHRA Board’s vaccine company shareholders

Here is the MHRA ‘About us’ page.

Here is the list of members of the MHRA Board.

Finally, here are the MHRA Board members’ financial interests.

From it, we see the new chairman, Mr Lightfoot himself, is a shareholder in giant vaccine manufacturer Glaxo Smith Kline. Two other members, Amanda Calvert and Anne-Toni Rodgers, are shareholders of AstraZeneca Pharmaceuticals, another huge vaccine manufacturer.

Big Pharma

The world has many manufacturers of vaccines. Here is a list of them. However, Glaxo Smith Kline is probably the biggest. It boasts on its website that it has teamed up with Sanofi to be selected to supply the United States Government with 100 million doses of COVID-19 vaccine under ‘Operation Warp Speed’.

Meanwhile, AstraZeneca is looking to Europe and the Far East. The BBC reports that AstraZeneca is planning to make two billion doses of a coronavirus vaccine. It’s CEO, Pascal Soriot, said manufacturing was beginning already because, ‘we want to be as fast as possible’.

The HQ of Chinese vaccine firm BioKangtai, now teamed up with AstraZeneca.

The HQ of Chinese vaccine firm BioKangtai, now teamed up with AstraZeneca.

Fierce Pharma reports AstraZeneca has done a deal ‘with Chinese firm BioKangtai to help provide its adenovirus vector-based COVID-19 vaccine candidate’. This is the vaccine ‘created by the University of Oxford’. That’s the vaccine whose study was recently temporarily put on hold owing to an ‘adverse reaction.’

AstraZeneca themselves claim to be about to ‘supply Europe with up to 400 million doses of Oxford University’s vaccine at no profit.’

Consultation Introduction

Turning to the Consultation , we’ll first look at its introduction. It starts by claiming: ‘COVID-19 is the biggest threat this country has faced in peacetime history…’

No, it isn’t. We have had worse post-war influenza epidemics. But certainly the absurd, destructive lockdown has been the biggest threat this country has faced not just in peacetime history but for over 300 years. It goes on:

‘… the UK government is working to a scientifically led…’ Hollow laugh.

‘… step-by-step action plan …’ Lurching from one incoherent decision to another.

‘… for tackling the pandemic …’ The UK epidemic has been over since May.

‘… taking the right measures at the right time …’ Like the ‘Rule of Six’?

And then: ‘Effective COVID-19 vaccines will be the best way to deal with the pandemic.’

We disagree. Building up immunity in the population will be the best way. In fact it may be just that happening which has spooked the vaccine enthusiasts. That’s because if the efforts of the younger element succeed in developing collective immunity we won’t need the vaccine. The epidemic is over. It could soon be all over for the vaccine too. And then millions of pounds of research money will have been poured down the drain.

Rigorous

‘Any vaccine must first go through the usual rigorous testing and development process and be shown to meet the expected high standards of safety, quality and efficacy before it can be deployed.’

Bill Gates

Bill Gates has invested billions in vaccines since year 2000 through the Bill & Melinda Gates Foundation.

  It must simply be tested for the length of time they anticipate there could be problems. Vaccine supremo Bill Gates himself told BBC’s Nicky Campbell earlier this year that if you want to know a vaccine is safe against possible reactions for two years you test it for two years. Even then, you will never pick up the one-in-a hundred-thousand adverse reaction.

  ‘A temporary authorisation of the supply of an unlicensed vaccine could be given by the UK’s licensing authority under regulation 174 of the Human Medicines Regulations (see below). A COVID-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality and efficacy of the vaccine. ‘Unlicensed’ does not mean ‘untested’,’ says the Government.

Another stupid decision

That is weird. Either the MHRA approve the vaccine or they don’t. If they are satisfied it’s safe and efficacious, what stops them licensing it? It’s an authority. It authorises a license. How long does that take? Can you imagine a meeting during which the MHRA board agree to ‘authorise’ a medicine rather than license it? So it’s not quite safe and efficacious enough for a license but we’ll put our name to it all the same?

The MHRA blog says: ‘new applications typically take 90 working days to process.’ But surely they don’t have to take that long. If it really is that urgent, why can they not send the inspectors around a bit quicker and then have a Zoom meeting?

Some of us won’t take this vaccine under any circumstances. But do the Government seriously believe anyone is going to take a vaccine which is unlicensed? Not only will folk be worried about the vaccine, but slackening off the rules will undermine public confidence in the whole regulatory framework. This has the makings of another very stupid decision.

Policy Objectives

These are the five headings in the Consultation to which you will be responding:  You can follow our lead but put it into your own words.

Under the heading of ‘Policy Objectives’, the Government say:
‘1. … clarify our approach to a pre-existing provision (regulation 174) in the HMRs, that enables the licensing authority to temporarily authorise the supply of an unlicensed medicinal product for use in response to certain specific types of public health threat, including the suspected spread of pathogens.’

This is short-sighted and driven either by panic or vaccine vested interests.  We say: No. Either license it or don’t. Do not invent a lesser category where a medicine may be ‘authorised’ but not ‘licensed’.  That risks destroying public confidence in the whole framework for safety of medicines.  Who will ever trust a medicine in the United Kingdom again?  The vaccine should not be licensed unless it has been rigorously tested for two years.  Meanwhile, any ‘public health threat’ from Covid-19 is vanishing day by day.

‘2. Clarify the scope of immunity from civil liability which regulation 345 of the HMRs puts in place for certain products whose unlicensed use is recommended by the licensing authority …’

The UK grants immunity to companies in return for the UK itself compensating those adversely affected by a vaccine. It doesn’t mean those adversely affected would not be compensated. Compensation is in another place. It’s the reverse side of the immunity coin. But clearly this all boils down to the licensing again.  So we say The taxpayer must not pick up a compensation bill If companies are granted immunity for an unlicensed product.

More Policy Objectives

‘3. Ensure that the UK has the available workforce to administer the COVID-19 vaccine and influenza vaccine.’

This means hastily training up non-medical people to administer the vaccine – and indemnifying them if something goes wrong. The Government have convinced themselves that tens of thousands of needle-wielders will be needed to inject millions of us queuing up for the vaccine. In reality, demand for an unlicensed vaccine will be low, even before the anti-vaxxers get going (they will be barred from Facebook and Youtube of course.) We say: This is cutting corners and must not happen. Demand for the vaccine may well be lower than expected, especially as we build up collective immunity and the virus, like all SARS infections before it, peters out. An army of hastily-trained needle-wielders will not be required.

‘4. Ensure that the vaccines and treatments used in response to certain specific types of public health threat, such as a COVID-19 vaccine, can be promoted as part of national vaccination or treatment campaigns.’

Of course they will want a ‘national campaign’. The problem is, ‘Currently there is a prohibition on promoting an unlicensed medicine to healthcare professionals and the public.’ We say: The prohibition on promoting unlicensed medicines is quite right and must remain, to maintain public confidence in the safety of medicines.

‘5. Make short-term provisions for wholesale dealing of COVID-19 and flu vaccine …’

This seems to all about ensuring the NHS and / or armed services can move the vaccines around swiftly. But we may not have seen all the implications of it.  We say: If the current system is there to maintain public safety and confidence, it must stay in place.

Nature of the consultation

They say: ‘1. Timing … having to move quickly means having less time than we would like to consult on these proposals – indeed, we are asking for comments by the end of Friday 18 September 2020.’

‘Therefore, please do not refrain from commenting simply because the official period for receiving comments is at an end. If you have something that you want to say about these proposals, the UK government wants to hear it.’

All the same, let us who are responding please try to keep to the official date.

2. Targeted discussions: ‘Even though we are happy to receive comments from anyone, the purpose of this consultation exercise is to engage directly with specific stakeholders that we have identified.’

Just who are these ‘stakeholders?’ Don’t you and I have a stake in this nation? How do you become a ‘specific stakeholder?’

Conclusions

But seriously, if you are a complete anti-vaxxer, it might be wise not to say that. After all, the opinion of those who won’t take the vaccine anyway is of little value to the Government here. Concentrate on how this proposal will undermine public confidence in the whole regulatory regime.

Proverbs 12:23 A prudent man concealeth knowledge: but the heart of fools proclaimeth foolishness.

Furthermore, if you are really stuck, and in any case, pray and then respond from the heart:

James 1:5 If any of you lack wisdom, let him ask of God, that giveth to all men liberally, and upbraideth not; and it shall be given him.

That’s all for now. Click HERE for the Consultation. You can save it and come back to it and you’ll soon see the five blocks to place your response. Once again, they are headed:
‘Temporary authorisation of the supply of unlicensed products’
‘Civil liability and immunity’
‘Expansion to the workforce eligible to administer vaccinations’
‘Vaccine promotion’ and
‘Provisions for wholesale dealing of vaccines’

And finally let us pray for an adverse reaction to this proposal.

 

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13 comments

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  1. Another extremely good and very well-researched and referenced article!
    I hope that all of your readers will agree and oppose this dangerous and short-sighted proposal.
    Onwards and upwards … although it seems to be a very steep climb these days …

  2. No, I will not consent to this vaccine, that has no way been tested to prove its safety, in fact, results so far show some people who have taken it as a test, HAVE been taken ill.

  3. The adverse reaction was damage to the nerves in the spinal cord, which caused inflammation. It was censored by the British media for patient confidentiality reasons, but reported in the American papers. One would have thought you’d give up confidentiality about medical reactions in a medical trial, so it sounds like a lie.

    I don’t really need a vaccine as I have little contact with strangers in my job. I do not think I could trust the Oxford vaccine. Normally I don’t take any pharmaceuticals and in fact don’t even use their soap. I think the world definitely needs a vaccine. Out of the lot I would be most trusting of the Chinese for a safe vaccine. They have shown to be honest during this crisis and very decent in helping out stricken countries. They do tend to admit their mistakes.

    1. Isn’t it sad when we have to admit the Chinese or the Russians are more honest than our own government. Patient confidentiality? What rubbish.

      Good honest soap made simply from beef fat and lye solution is available here: https://www.greyalders.co.uk/product/good-honest-soap/

      1. Being a doctor I cannot agree that patient confidentiality is rubbish. The case in question was transverse myelitis, a well-known condition. As far as I know nothing about it was hidden. I know of no evidence that it was caused by the vaccine. The trial would have been stopped as a belt-and-braces measure in a vain attempt to avoid the fog of suspicion that cranks will inevitably generate.

        1. I did not say patient confidentiality is rubbish. If you take the context into account, I was observing that to use that as an excuse to avoid discussing the adverse reaction was rubbish. Was anyone proposing to name the individual? No. Could the individual be identified solely from the condition, which is known only to the researchers and his/her doctor? No. Then there was no issue of confidentiality. It was just a smoke-screen.

            • jsampson45
            • John S on 18 September 2020 at 12:22

            I accept that you did not mean to say that patient confidentiality is rubbish, although it comes over like that. The case in question has been in the British press for some time so any cover-up must have been short-lived. The case has been called an adverse reaction but this prejudges the issue – the “post hoc, propter hoc” fallacy. Not that there will be no adverse reactions. Every medication has them. And I don’t know what possessed you to say the UK epidemic has been over since May.

            • Stephen
            • Stephen on 18 September 2020 at 14:11
              Author

            I’ll tell what possessed me to say the epidemic was over in May. As the Telegraph reports here it was ONS data analysed by the the Centre for Evidence-Based Medicine at the University of Oxford. I’ve been possessed by a spirit of statistics!

            According to this website, the RCGPs have an epidemic threshold for a flu epidemic of 200 consultations per 100,000 population per week. This website puts the figure at 1,000 per 100,000.

            According to the BBC, Rhondda Cynon Taf has been shut down because of ‘82.1 infections per 100,000 people over the past seven days’. Infections! Not even proper cases, let alone people going to hospital. The rate across Wales and much of the UK is believed to be in the twenties per 100,000. It’s over. And it’s been over since May.

      2. Quite so, but it is how I feel. They are so positive and optimistic compared to our country. I love chatting to them.

    2. My view is that your opinion of the Chinese is breathtakingly naive!
      This is an authoritarian government which systematically subdues its population with the most horrendous oppressive measures. As examples, they have virtually completely destroyed Tibetan culture and are repeating this process in the the Uighur Muslims in Xinjiang province in the far north-west.
      The Chinese government (under the guise of combating Islamist terrorism) are conducting what amounts to a gradual and (to the rest of the world) almost silent genocide, designed to obliterate their culture and (Muslim) religion. Millions of people are interned in ‘re-education’ camps for ‘offences’ as slight as having a beard or reading the Koran and continuous high tech surveillance is used. In addition, thousands of Uighurs have been moved to factories to become forced labour, producing many products exported to the West, including manufacture for Nike, Adidas, Samsung, Apple and Microsoft.

      The idea that they are “honest” and “decent in helping out stricken countries” is bizarre!
      They systematically lie about what is going on in Xinjiang, NEVER admit any mistakes they make and are only “helping out” other countries as part of their policy of soft colonial invasion, as they spread their evil tentacles throughout as much of the world as they can, relying on the venality and feigned ignorance of compliant governments about what they are doing to their own people.

      1. The Chinese have a terrorist problem with the Muslims. There have been mass shootings and other highly evil stuff. Re-education is designed to stop them doing this and to behave themselves.

        You are out of date regarding Tibetans. You talk about what happened in Mao’s cultural revolution. We are severely lied to about China in our popular press. You have only been fed bits of the whole story in order to obfuscate the true picture.

        1. I have to say that, sadly, what you are saying is straight out of Chinese propaganda. You are clearly hopelessly ill-informed. And, by the way, I do NOT get any of my information from the “popular press”. I read and research myself.

          So the Uighurs should “Behave themselves”?!? I can’t believe that anyone would seriously use such terminology in these circumstances. Regarding Tibetans, only very recently prayer flags were banned. Their culture has been, as I said, systematically destroyed, over many decades.

          I find your blinkered kowtowing to the Chinese Communist party line very distressing.

  4. The corona flu plandemic is definately over and the only reason why it is being continued by the Project Fear campaign, is to take away our freedoms and destroy our society. It is far easier to control a society by fear and removal of freedoms and this has obviously been far too attractive for the present fake conservative Government.
    The childish misuse of various figures and statistics is almost comical – 3000 (or so) ‘new cases’, in mid September. That’s 3000 out of a population of about 70 million. Then there is absolutely nothing, nothing about whether any of these ‘new cases’ have resulted in any actual deaths, and that is deaths genuinely attributed to corona flu, not something else (In the USA Reuters reported that doctors were paid $1,300 to record deaths as corona). I think I heard a figure of 20 deaths being touted by the British Brainwashing Corporation. Again, out a population of 70 million. Now, surprise, surprise, they are fear-mongering about new cases being up to 6,000. Again, how many result in a death?
    Isn’t it good that there are more infections? They do not automatically mean death, death, death as the biased, Project Fear media insinuate. Surely it means more immunity?
    Never do they report the recoveries, never is it put into context, never, ever do they allow any contrary or questioning point of view to be reported, never are the many heroes of the medical profession who have dared to whistle blow and as a result been persecuted out of their jobs, allowed into an interview. This is a disgrace and I pray that God will bless those medical staff who have been persecuted out for righteousness sake. Also I want to say thank you, to all you medics who have been honest but sadly suffered as a result.
    The recovery rate from corona flu is a staggering 95.75%. So why is that not reported? Because Project Fear must be kept running as long as possible.
    Thankfully there is now a slow awakening taking place that we have been, and are being lied to on an epic scale. People are not so stupid that they cannot work out that if there are say, 3000 new cases in a day or week, there should be a corresponding rise in deaths – and there is not.
    I also note the almost hilarious bleating, scaremongering from the ‘experts’, with their deliberately alarmist statements which they nearly always use with their Project Fear graphs. The Sunday Telegraph reminded readers this week about Al Gore’s famous ‘Hockey Stick’ graph. Remember that?
    Last week we were told that an appalling exponential rise was what we could expect but it was not a prediction. Well what is it then? This was all based on, wait for it, ‘modelling’. Would that be the same modelling that SAGE used to predict 500, 000 deaths at the beginning of the plandemic? Well not exactly the same model I guess but the same idea, you feed into assumptions and get out of it the scare mongering that you and your paymasters the Government want. Computer model get garbage in, computer model get garbage out. Very like radiometric dating that is used to prop up the evolution hoax.
    What is clear is that the forces of evil have tried very hard to put a curse of fear and death over Britain and this is one of the first things that needs to be confronted and revoked by prayer and the Word of God.
    Finally, what a terrible Government. The conservative-marxist Government that we have been handed over to, has no vision, it offers no future, no hope, no good news, no nothing except more doom, gloom, lockdowns, restrictions, isolation, fines, doom, doom, doom. Any Government that cannot map out some kind of hope for the population is destined for the scrapheap. This one has nothing to offer apart from doom so the sooner it is gone, the better. I am now going to pray for a change of it.

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