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.
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.
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