Role reversal. You have been the guinea pigs for experiments by academics. Now those Healthcare workers are guinea pigs for you!! #MSCOVID19

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The vaccination against SARS-CoV-2 is seen as a great hope to get back to some form of normality. Reducing the pool of people who can be infected is key to this aim. I am not sure we are going to achieve this as it seem there are too many people who don’t care and don’t want to do their bit for Society.

There is a strong anti-Vax movement and this may help ensure that this virus hangs around forever and hopefully it will not mutate so that makes the succes of making vaccines and therapeutic antibodies irrelevant.

However, there are plenty of things flying round the internet, frightning people away from taking the COVID-19 vaccine. It will be interesting to see how many health care workers (HCW) take the vaccine. If they do not enguage how are we going to enguage the general public?

In this respect we have to demyth some of the rumours flying round the internet. Indeed someone I know was telling people that the vaccines change your DNA…

COVID BREAKFAST: How do I say this politely, this is a load of cobblers!! Covid vaccines do not affect your DNA. They do not integrate into your DNA and they are not going to to make you sterile. It you read this you need to call it for what it is. Maybe you can report some of the mad ideas you have heard.

Why does it take so long for MS drugs to arrive? This is in part due to the regulatory process. So this is part of the MS education process. It is to understand how drugs are developed

For drug development, brave human guinea-pigs like yourselves take risks and volunteer for trials of MS drugs. Trials are done such that treatments can be tested and shown to be safe and effective and the dosing schedules can be worked out and approved.

I may think that you don’t need to dose people as often as every 6 months with ocrelizumab, but I wouldn’t dream of doing this outside of a proper study. It seems the British Medical Association don’t think that Health Care Workers (HCW) should be human guinea pigs for you.

Why say this? Well many of you will be in either group 4 or 6 but the healthcare workers and care home workers were in groups 1 and 2 and have had one vaccine open to them and this was the Pfizer vaccine. Therefore, they were guinea pigs for you.

Within the first day we heard of two health care workers having anaphylaxis (severe life-threatening allergic reaction), In the states it has been estimated that this occurs in about 11 people in a million (CDC website). This is now why you have to wait at least 15 minutes after your jab. Anaphylaxis is usually rapid, FYI but it can occur after 15 minutes (range = 2–150 minutes).

However, HCW have been your guinea pigs in another UK experiment and the British Medical Association is apparently not happy (BBC News). The experiment is the length of time between the Pfizer jabs. It has been designed for a two dose study. This should be 3 weeks apart according to the manufacturer but the British Government is saying it should be up to 12 weeks, so we can get more people vaccinated. This gap is far longer than the advice from the manufacturer and the World Health Organisation. The BMA has said the UK’s strategy has become increasingly isolated internationally and risks undermining public and the profession’s trust in the vaccination programme and could reduce efficacy.

I suspect that by the time you are offered a vaccination they will have either run out of the Pfizer vaccine supply (Hopefully only joking) or more likely HCW will have been followed and the truth will be known. Therefore, you should not worry about this.  

So what is the fuss all about? When you look at the vaccine response at three weeks, the antibody response is not great and the neutralization and the antibody blocking response is below the level of detection in most people. You don’t see this change until 7 days after the second dose (See graph below). Perhaps this is the concern, The Moderna RNA vaccine should be dosed at 4 weeks apart and the second dose does not boost this So would the Pfizer vaccine induce this at 28 days and beyond to 12 weeks?. The simple answer is we do not know. This is why the HCW are acting as human guinea pigs. In the trials people were dosed 21 days apart the longest interval dose was 6 weeks according to the UK government website.

This descision is apparently on the advice of a few scientist bods on the Joint Committee on Vaccination and Immunisation. You can read the minutes of the meetings, but it is not clear this issue is properly discussed. There was no mention of data. There may be some from the phase I dosing study but it is not clear. However, there was a first dose statement (click)

When considering vaccination schedules JCVI often considers first principles, and regularly advises schedules which differ from the marketing authorisation. In every case, the advice of JCVI is aimed at maximising protection in the population”

I have to say I think this sounds like cowboy science. If one just consider first principles, then why bother doing trials? Why bother working out doses and dosing schedules. From first principles we can do it all. From phase I studies we could see that humans make antibodies, we can show they work to neutralise the virus, from first principles we think we know they will work. Therefore, we should have been mass vaccinating from April 2020 using such a logic. But are they safe? From phase I (first in human) and II (safety) studies from first principles we could have known this to some extent, but you need phase III trials to show clinical effect.

You follow a protocol. Bucketshop cowboy, scientists don’t….they tinker here and there with the protocol because they think they can do it better but that is why pharma often don’t use academic scientists to test drugs……because they can’t follow a protocol.Have the JCVI being doing too many bucket shop studies in third world nations, without a care for the processes that the first World have created?

The MHRA/EMA/FDA make companies spend millions of pounds doing just this. They make them do trials and they make them do dose-responses and they make the companies create a label on how to safely use the treatments.

The JCVI can be more confident about the Astrazeneca trials as they were (from the outside view) conducted like cowboy science, where they were dosing people without the correct supply. So rather than the planned 4 week dose interval some people had to wait for 26 weeks. They didn’t seemingly follow protocol. Indeed, many people had to wait for 12 weeks to get their second dose. This maybe where the idea came from indeeed the longer you waited between doses the higher the levels of the antibody were seen

, but in the Pfizer studies the protocol aimed for the second dose at 3 weeks and no one got their second dose after 6 weeks. The JCVI say they work from first principles but there is no experience with RNA vaccines, this is the first time they are being used in human. I guess desparate times mean desparate measures

They say “published efficacy between dose 1 and 2 of the Pfizer vaccine was 52.4% (95% CI 29.5-68.4%). Based on the timing of cases accrued in the phase 3 study, most the vaccine failures in the period between doses occurred shortly after vaccination, the period before any immune response is expected. Using data for those cases observed between day 15 and 21, efficacy against symptomatic COVID-19 was estimated at 89% (95% CI 52-97%), suggesting that short term protection from dose 1 is very high from day 14 after vaccination. Similar findings were seen with the Moderna mRNA vaccine out to 108 days after the first dose”

“The level of protection gained from a single dose of the AstraZeneca vaccine was assessed in an exploratory analysis. Vaccine efficacy from 22 days post dose 1 was 73% (95% CI 48.79-85.76). High protection against hospitalisation was seen from 21 days after dose 1 until two weeks after the second dose, suggesting that a single dose of the AstraZeneca will provide high short-term protection against severe disease. Protective immunity from the first dose likely lasts for a duration of 12 weeks (unpublished data)”.  

“With most vaccines an extended interval between the prime and booster doses leads to a better immune response to the booster dose. There is evidence that a longer interval between the first and second doses promotes a stronger immune response with the AstraZeneca vaccine”.

There is currently no strong evidence to expect that the immune response from the Pfizer-BioNTech vaccine would differ substantially from the AstraZeneca and Moderna vaccines.

Left graph shows there is Antibody response at 21 day. At 21 day the level of neutralization level is below the lower level of detection of activity (LLoQ). At day 21 the second dose arrives, is the stronger response at day 28 the result of the boost or would thi s have happened naturally we can see from the HCW who are now the guinea pigs for this experiment. The Moderna vaccine uses 3 times more RNA and the antibody levels increase for 2 to 4 weeks after one dose.

Here lies the crux of the matter

“The rate of vaccine delivery in the UK is currently limited by vaccine supply rather than by workforce capacity. An extended interval between vaccine doses together with in initial prioritisation of the first vaccine dose would increase the flow of vaccine supply in the short term. This will allow for more first doses to be delivered to more people earlier”.  

In their next meeting they discuss withholding doses so the second dose can be guarenteed but they say………

“It was noted that the arrival of future batches of the vaccine could not be guaranteed in a specific timeframe, and this could leave a long interval between doses”.

So maybe those 12 weeks will be longer 🙁

So give a clap (if the novelty hasn’t warn off) for many of the BartsMS Team and all the NHS staff who are working hard to treat and vaccinate people

I guess we should also thank them for being guinea pigs, if they have been vaccinated, as they get to show us how good one dose of an RNA vaccine really works to limit infection and protect people. I hope that none of the HCW does badly or maybe we will see who in the JCVI decided it was a good idea make the NHS be a non-randomised, uncontrolled population experimental study without pilot data…Now doesn’t that sound like cowboy science?

At least with your help and ProfGs and Kits efforts we will be able to look, so thank you for your help.

NOW PLEASE READ ABOVE

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MouseDoctor

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  • MD, is there any preference between the mRNA vaccines or Oxford vaccines for people with MS (assuming the proper protocol is being followed)? Obviously mRNA effectiveness seems higher, but potentially shorter immunity? Also I read about Moderna vaccine being able to adapt to new strains quicker etc?

    • You can make arguments both ways, both technologies can be adapted but the RNA route would be quicker as you just change the sequence.

      In the UK we have a bigger supply of astrazeneca and it is easier to administer and the influence of extended dose intervals is known. 1 Dose antibody levels = 8,000 2 doses 4 weeks apart 22,000 2 doses more than 12 weeks apart ~67,000, 1 dose in someone with past infection >150,000.

  • Had the Oxford vaccine on Monday. The Excel centre was strange, there was nobody there, I saw ONE other patient. Ocrevus due in a week.. but will be pushed back. Now I feel like being an Oxford guinea pig is better with this whole dosing schedule. Mum and sister also the Pfizer guinea pigs. With Ocrevus – if we are having the second dose 12 weeks into another course, is the booster dose not going to be as effective as we would just be newly depleted? Also I felt ill yesterday, the vaccine common side effects – does that mean I’ve developed an immune response despite being on Ocrevus? I was kind of excited I seemed to have a reaction… I had nothing to last years flu jab.

    • You are another ocrelizumab pioneer. Thank you. The sore are is normal. This has been a difficult agent to deal with ideally we would do the the two courses (over 5-6weeks) before starting to dosing for those on dosing it is difficult. Dosing towards the end of the cycle maximises chance of responding to first dose. The second dose may not be optimal but the infusion should not effect existing T cells and antibody producing cells. It will be important to monitor so if people are interested volunteer for DrRuths study because this way we can check to see what happens and then change advice. There was concern of waiting for 4 months to get the full course, “we should call this split dose the “Debbie Protocol” as the first time I heard of this idea was from Debbie on this blog.

      • Yes I think I was the excels first MS patient!! They said I didn’t look over 80 and everyone kept asking me if I was a renal patient. Thats good to know about the second dose.. I presumed most exciting action happens in the first one. I will ask when I go in for my infusion 🙂
        I don’t like the idea of delaying Ocrelizumab 4 months because I had new lesions in my last MRI – I think id rather have my sub optimal vaccine and maximum Ocrevus!

  • Is cowboy science like bucket chemistry – one dose fits all regardless of size / age / sex / metabolism… 😉

    It’s more understandable with an MS drug but with something we will all be taking, to be this reckless is just horrifying. Pharmacovigilance exists for a reason – those thalidomide kids passed on mutations down (currently) 4 generations and counting. As you say, we have proper trials and post-marketing studies for a reason. We have yellow forms for a reason. We spend billions and billions in this sh1t for a reason and that reason is safety. Drugs that work also have adverse effects – almost by definition.

    Academics need to open their eyes a bit, protocols aren’t just there as a box ticking exercise to force them to do boring stuff instead of exciting science. Protocols make the exciting science scientific. Otherwise it’s just tinkering in the garage.

    Thank you for your article MD – you’re spot-on.

    • Far not there is adequate pharmacovigilance going on and if ther are adverse reactions they will get reported. The vaccines have adverse events, injection site pain, swelling and fatigue and sometimes abit of a temperature.
      I am sure the scientists have had the best intentions and we will be all thanking them, but part of our job is to educate you guys how it works and we have to call it when we see it. Otherwise the emporer gets new clothes

    • Pharmacovigilance exists for a reason – those thalidomide kids passed on mutations down (currently) 4 generations and counting.

      Sorry, but that is BS as is made clear here thalidomide’s action mimics a genetic mutation. It does not cause genetic mutation.

      Building on years of previous research, researchers found that thalidomide acts by promoting the degradation of an unexpectedly wide range of transcription factors – cell proteins that help switch genes on or off – including one called SALL4. The result is the complete removal of SALL4 from cells.

      The degradation of SALL4 interferes with limb development and other aspects of fetal growth. The result is the spectrum of complications indelibly linked to thalidomide: the deformed limbs and defective organs in children whose mothers took thalidomide during pregnancy as a treatment for morning sickness.

  • Hi MD – Thank you and the BartsMS Team for all their work, ongoing information and explaining the ‘blanks’ from all the daily briefings (if you punish yourself to watch!). It goes without saying the there are lots of strange changes to the initial dosing plan and the logic baffles and makes my blood boil (depending on what time of day it is 🙂 )

    I’m only grateful, that we have lots of people looking at how the vaccines work, should work, side effects, efficacy, availability, whose monitoring you after vaccine and lastly political b.s.!

    All the above mentioned in bold and large font please – as from a pwMS and on Ocrevus along with other commodities, I would be delighted to have any one of the vaccines asap! I have lost 4 possible Covid related members of my family along with a good friend’s Father and the anxious state of mind that this pandemic is leaving on us – I just want a vaccine! Anytime, any place (I’ll travel) and I’m willing to put myself forward to get some sort of immunity (if poss) to enable me to feel that I have a chance, if I do go to my Uncle’s funeral tomorrow. Sadly, a SCAM email purportedly from NHS got me all excited on Tues – and I haven’t heard to-date.

    I also, look out for my elderly neighbours who have had the first dose of the Pfizer one and are now worried & over anxious that they won’t receive their 2nd dose. They’re in their 80s and are being very cautious too. Part of me wants to say – that, hang on – I’ve not received my first dose yet & I’m equally important to survive, aren’t I!?!

    My point is – let’s all get vaccinated with any of the 3 – asap and yes worry about the problems of lack of sense & issues dealing with this pandemic, as I have to say there are plenty. But, to have one dose and then feel a bit less anxious & possibly surviving COVID if infected – than dying from the virus as you’re so possibly vulnerable & not too little, too late! Of course, be aware, share and keep on looking at the potential side effects – as we are all so individual & are all reacting differently to meds & vaccines. Monitor, monitor and monitor & keep rolling it out.

    Take care and keep safe all,

    Jane xxx

  • I’m a HCW and was lucky enough to get the Pfizer jab on day 1 and therefore one of the very few to get the second dose 21 days later. I’m on ocrelizumab.

    Where I work I am pleased to say that the vast majority of staff have welcomed the vaccine. They are no longer ‘allowed’ to give the second doses until 12 weeks sadly.

    Anecdotally, the AZ vaccine has given more side effects amongst people I know. Some are saying the people who have had covid before seem to have worse reactions to the vaccine but that may be hearsay.

    I didn’t have any reaction at all (other than sore arm) to dose one or dose two. Of course now I’m wondering if that means I didn’t mount an immune response 🙁

    • Thank for the info…You are probably protected.
      I am happy that most people have welcomed the vaccine, I am told this is the BartsHealth experience, but sadly I know of some places where the untake is very low.
      My friends who have had AZ have said they have really sore arm, but it is supposed tobe less on second dose. I am not sure I understand why as I would expect more of response second time round and likewise I would expect more of reaction in infected people, it is immunology 101. Sore arm is a reaction to the dose. The way to find out if you have a reaction is to get antibody test…sign up to Barts test if you havent already.

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