I just got this link from New Scientist. It is factually and fairly simply written and covers things no other media source has mentioned. I hope it will answer some of the questions floating around out there.
Please note it says a few times that information will be available in the next few days as it is processed. Until these things are published there is no point asking the questions about them - because as yet no-one outside the company knows the figures and it is the regulators view that is important - not what a "science and medicine" correspondent divines from their runes.
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PMRpro
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A helpful article. I would like to know what adjuvants, if any, they are putting in to make the immune system go out looking for the protein spikes produced by our cells. Also, for those of us who think or know they’ve had Covid and are long haulers, is it going to be ok? I wonder because they think the continued immune response to inactive virus particles may be driving the long term symptoms. What will be body’ response be to the sudden production of Covid-like proteins. I guess the argument could be that the same would occur with reinfection, just that the vaccine is not going to do the acute business like the virus would.
I suppose that will only emerge when they do some antibody tests on long Covid patients - they may not need it. I thought it mentioned patients who have had CV? Or was that somewhere else this morning!
Thank you. This clarifies many things. However we still don’t know enough about people who have serious autoimmune diseases and are on strong immunosuppressants and steroids. Hope we will be able to get this information soon.
I do agree. We keep hearing it mentioned about people with serious autoimmune diseases but never telling us should we have it or not. Must be patient I suppose.
The vaccine hadn’t been tested on people in that category but I understand this will be done... but when? I feel it’s a bit late since the vaccine has been released for injection! Too soon obviously. EU member countries are being more careful in releasing the vaccine for use, I have more trust in such a decision. Because of this I am not sure I will have the vaccine although it’s a difficult decision... am not anti vaccine but I need to feel safe before having it.
If they waited to have tested it in all groups there would be another 6 months where the vast majority of the population who don't have a/i disease have to wait which is rather unfair really and a bit silly as the more healthy people who are vaccinated, the safer the rest of us are.
There IS a group for whom it will not be suitable, the severely immunocompromised: patients with HIV/AIDS, cancer, post solid organ transplant and those who have developed severe immunoglobulin deficiencies. It isn't because it would be dangerous but because if you have no immune system, it can't develop immunity so there is no point injecting it in the first place.
People who are on pred and most immunosuppresants will develop some immunity - as you do when you get the flu jab. And some immunity is a far better place to be than no immunity.
Thank you PMRpro. However I noticed that the effects of the vaccine is still not known on people taking strong immunosuppressants (I am on Jak inhitors which suppress my immune system further and unfortunately it still doesn’t control my RA, Sjogren’s well). Hence my reservations obviously. I hope it would be safe even though the immunity provided might not be as strong as will somehow whose immune system isn’t so compromised. I appreciate your input and thanks for the link.
No, I didn’t know that. Must have missed reading on it. Am on Baricitinib and it doesn’t really control my RA etc.... That’s interesting and gives me a little more optimism. I really don’t want risking making my situation worse, having enough to cope with. However with COVID-19 it adds more problems. Catch 22. Thanks again.
Thanks for this. Nice and clear.I have lots of questions though, which you may be able to answer! First, how does the body know that the new bit of protein (Cv spike) is foreign and should be attacked? Is it because they put an adjuvant in with it? What happens between the new protein being first replicated by the body and then attacked? If it knows that it is foreign then why does it first replicate it? (Or have I misunderstood it all?)Then how do you think our bodies will fare as they are compromised by the Pred and not able to mount a proper response or attack? Could it be dangerous to us? I wonder what the adjuvant is.
Then the question of our immune system already being confused and attacking itself - won't this confuse it even more and cause more autoimmunity? Headless chicken!
This is all fascinating but a bit scary I think.
Do you think that the Oxford one is 'safer'. It sounds like it. I wonder why they chose this Pfizer one. Any thoughts?
The immune system is pretty clever - it is able to recognise self and non-self and that is part of the problem in autoimmune disease, part of the immune system is unable to recognise your body as self and attacks it by mistake causing damage.
When the immune system senses there is a stranger in the camp it calls in its defences and that's what happens with a vaccine which presents a harmless bit of the virus or bacterium in question so the body learns to recognise it and then keeps a database of what it already knows.
I don't know how much science you know but these present it simply for non-specialists.
The adjuvants are something different - they are just something that encourages the reaction, like vit C improves the gluten in flour to make bread rise better. Many of them are natural substances and have been used in all sorts of vaccines for many years so they know they are safe. It will be the same as with the flu vaccine - it still works for us though possibly, like bread without vit C, it won't "rise" as much. Either you need a lot of vaccine or you add a pinch of adjuvant - so it makes the vaccine go further.
Why would the Oxford one be safer? They all went through safety trials right at the start - the data hasn't been published but the MHRA were obviously convinced when they saw it. We don't know the numbers for the Oxford one yet and they are having to repeat part of the Phase 3 but we already know the BioNTech vaccine has been used in well over 20,000 people in the Phase 3 studies plus some in the earlier stages. All the usual stages of development have been carried out but have been done either in parallel or one immediately after another instead of there being months between each stage. Lots of money was thrown at this and there were plenty of subjects available - recruitment is one of the slowest stages of drug development. Also it has all been targeted at the genetic model that was worked out within a few weeks of the virus being identified - that wasn't an option until relatively recently. They had started working on a vaccine for SARS-1 but it practically died out and the work was put in a drawer and dug out again now so a lot of basic work had already been done.
And why this one and not the Oxford one? Very simple: it was finished and available. And the UK got first dibs because they chose the slightly shorter method of approval than the one the EU is using and the MHRA also worked on things in parallel. The trials for the Oxford vaccine are still underway so the information about numbers is not complete.
the part that really surprises me is that people accept the 95% effective number, which is derived based on 170 cases out of 42000 people, or 0.40% of participants. One way to look at the same number is to say that chances of contracting Covid-19 is only 0.4% vaccinated or not. Does that sound realistic compared with what current numbers are? Not to me...For example:
US has ~330m population and has confirmed 14.5m Covid-19 cases and 283K morbidity rate. Using those numbers gives 4.4% infection rate ( 11x of Pfizer study) with death rate of 0.09%.
or UK #s are population 66.5m, confirmed 1.674m and 60k death ==>2.53% infection rate ( 6x then in the study) and same 0.09% death rate.
Perhaps the study was too short to reflect real world, but then the question is what else was missed.
Like them all - the true figures will out after Phase 4: being in use. So I suppose we have to decide if WE want to be part of the long term effects research. Not that different from choosing to take Actemra for GCA is it?
Thanks! At the end of the day, until studies are done on people with AI (excluded from all Phase 3 unfortunately for these vaccines) we’ll have to rely on those who come before us and our rheumie’s risk assessment. Mine is saying no to any vaccines yet - but it’s up to each person I suppose. Having “lived through” Shingrex, I’m waiting. 7 of my rheumie’s 10 patients had serious side effects (one had kidney failure) and we all took a course of prednisone to get the second dose, which likely decreased efficacy. I can’t wait to get vaccinated, but will follow her advice on which and how. My healthy husband will be going for Pfeizer - best outcomes and fewest adverse events of all. I also look forward to cheaper tests that monitor your immune antibody response so that whichever I get, I can see what my own level of protection is, accounting for the drugs I’m on, etc.
It’s reassuring you have a sensible rheumatologist. I fear quite a few will recommend patients have the vaccine when in fact, in certain cases, it might be very dangerous. Where do you live? I will ask my rheumatologist when I speak with him next week but somehow I don’t think he knows enough. Will see.
It’s my Stanford University rheumie. I live in London, but was shocked to see the NHS only sees me once a year so she agreed to monitor me on the side for free. No one I know who has an AI disease in the US (3 close friends and 2 family across the US seen by different doctors) is being told to get the vaccines yet. And they are all clear that more data is needed to determine which is the best vaccine to take for their patients and how those should be taken. There won’t be one blanket vaccine forced on everyone. Fight for yourself on this, I say!
When you say your rheumatologist says NO to any vaccine yet, I take it it is your CA consultant, not your UK NHS consultant? Also when you mentioned that 7 out of 10 patients had serious side effects and that you all (does that include you, sorry am a little confused here) took a course of prednisolone to get the second dose which likely decreases efficacy, where was that in California or in the UK or? Thank you if you feel able to clarify this.
Thanks for this. I am trying to ignore the hype and this was very easy to understand. Both my son and I have had reactions to past vaccines. Given the gift of hindsight they were probably live vaccines as this was more than 30 years ago. Therefore I am a bit nervous about having any new vaccines. I've only ever had one flu vaccine (which again I think was a live vaccine at the time) followed by having a really bad infection in the injection site and a dose of flu which was the worse I ever had. I am not an anti-vaxxer and have had all the usual jabs except the shingles, MMR or HPV. My son had all his too including MMR but not the whooping cough. I want to be well informed on the risks and so am happy to wait to see the results of the Oxford vaccine trails. I wouldn't think we will be offered it until mid 2021 anyway so time to keep an eye on the science.
I would be interested in an antibody test first though as I think I may have had the virus early in the year just before the first lockdown.
Maybe I am too cautious but having had so many health problems in the past I want to be as informed as I can be for when my turn comes around.
I think like you. It is quite right to be fully informed about these vaccines, yet we don't know enough. I too feel very nervous about any possible debilitating side effects or worse because of my very suppressed immune system by the AI diseases and the strong immunosuppressants I take and prednisolone. My main concern is that no vaccine has been tested on people falling in that category, therefore no data to reassure us in having the vaccine or warning us it is to be avoided. Naturally, I would love being able to be inoculated if it is proven to be safe. That will take time. So it will be difficult managing this virus safely until we can get vaccinated. Take care.
I won’t be - my husband will because he’s healthy, 18-55 which has been well tested. I actually work with academic researchers involved in the various trials so I have confidence in them for healthy folks. Great work has been done and healthy people should go for it. Also I believe cancer and diabetes patients were included in Pfeizer’s and I’d do that one. AI folks are NOT being included in any trials - you are right. I will say that there will be a vaccine that’s good for us, but it’s critical we watch the data (or anecdotal evidence from AI patients who go for it anyway) so we know what to do. In the past inactivated vaccines (old tech) have been ok for AI. China is in phase 3 with a couple of those and a research unit in Scotland is working on one, expected to be reviewed in the fall, 2021. Bottom line - I haven’t followed UK govt guidelines so far and I won’t going forward. I follow California where the political leaders are guided by science. I was shielding 3 weeks before the UK called for it - I followed CA. I will follow my CA rheumie because I don’t trust my NHS rheumie. I don’t want what’s good for “health economics,” I want what’s good for me. I don’t doubt I will be vaccinated - I just want to wait and see which is best for me. That might take 6-12 more months.
It’s reassuring you’re working with academic researchers who are actually involved with the trials. So I think I was right in assuming these vaccines are not really safe for people with AI problems. I so much would like to be inoculated because it would perhaps put an end to the loneliness of shielding but it needs to be safe, I need to have evidence it would not be dangerous. This is lacking at the moment.I don’t have much faith in the rheumatologists here either because they’re told what to do by the government.... and most don’t have any knowledge about COVID-19 and the vaccines, it’s too soon yet.
Interestingly, I spoke with 2 GPS at my surgery, on the phone. When I asked them if they would gladly be inoculated, one said umm, probably to which I replied that sounds like no then and she laughed, so she won’t be rushing to be vaccinated and she’s in her 30s. The other one is very young and she said she will definitely have the vaccine because she’s young and healthy.
I find it rather bizarre that doctors should not be expected to be vaccinated when consultation will return face to face, even recently I had to go and see a doctor at the surgery. So if some refuse to be vaccinated how safe is it likely to be for their patients? No one seems to have thought of that. Yet, it’s most important. If a doctor doesn’t think it’s safe for her/him, how can it be justified it’s safe for very vulnerable patients with multiple AI problems?
Please let us know any important information you might get and when you will be inoculated. I am dreading receiving a call saying I am on the list to receive the vaccine when I really don’t think it’s safe just yet for me.
"Pfizer chairman Albert Bourla admitted that there is one aspect of the coronavirus that he is not sure the pharmaceutical company's COVID vaccine can mitigate which raises questions about how it could impact the spread of the virus.
Clips from the upcoming Dateline prime-time special titled, "Race for a Vaccine" have highlighted Bourla's remarks regarding the Pfizer vaccine's effectiveness in mitigating the spread of the virus. He admitted to host Lester Holt that he was "not certain" if the COVID vaccine would prevent the coronavirus from being transmitted.
"Even though I've had the protection, am I still able to transmit it to other people?"
"I think this is something that needs to be examined. We are not certain about that right now with what we know," Bourla responded.
It is HUGE negative, because even if you got a jab, it does not prevent one to spread the virus, which means that it does nothing to stop the pandemic.
They do not yet KNOW whether it prevents you spreading the virus. It may turn out that it does, that it reduces the viral load far enough for the hygiene measures to slow the spread or even without them. What it does seem to do so far is reduce its effect to that of a common cold, for example, for a lot more people and that makes it livable with. We don't have our medical facilities overloaded because of the common cold and normal life continues. Many people have either no or only minor symptoms with Covid, the vaccine brings that for almost everyone. And THAT is a major POSITIVE.
Absolutely! Anything that mitigates the effects has to be a massive positive. I found the following article by an immunologist at the Crick Institute interesting and easy to read.
Do you think that CEO of one of the largest companies in the world accidentally disclosed the fact that their vaccine does not prevent spread of the virus? Not a chance. He is doing this for his own protection and the protection of the company from lawsuits. Not from people who got vaccine - they are s*it out of luck because of immunity law, but shareholders and investors are free to sue for misleading information. So, you can assume with 95% certainty ( ) that vaccine does not prevent spread of the virus, so there will not be group immunity to protect the weakest, one of the main purposes of vaccination.
In a normal time, this vaccine would be rejected, not hailed as a solution.
I don't see it is that much different from the annual flu vaccine since that also does not necessarily stop you catching flu nor from shedding virus having caught it.
so the statement from CDC is misleading claiming that
"...Getting vaccinated yourself may also protect people around you, including those who are more vulnerable to serious flu illness, like babies and young children, older people, and people with certain chronic health conditions...."
I also recall that many people on this site did get vaccine to protect family member...
Not entirely. If the vaccine reduces the severity of the illness it is most likely to be because the viral load is much lower - and in turn that means you are going to not be shedding as much virus into your environment and over vulnerable people close to you. If you were one of the people who has no symptoms - that could well mean you shed even less. It also is not yet known whether it STOPS you shedding virus because they haven't the proof yet, that isn't the same as it doesn't stop you shedding virus. I shan't reject an option that hopefully will improve the situation for others and will definitely improve the situation for me.
What is being said is that we can't assume that we are 100% safe having had a vaccine and the hygiene options must be continued in the meantime. After all, they have contributed to reducing case numbers when used properly - just another layer to belt, braces, velcro and an elasticated waistband!!
Seems that you are much more positive on fast tracked vaccine then me... Another bit of info...
China Prepares Large-Scale Rollout Of Coronavirus Vaccines - More than 1 million people China have already received experimental vaccines under emergency use permission.
Too bad that politics is in a way to find out more on this. They have 4 different vaccines, all using traditional methods..
I happen to think the "fast tracked" descriptor is being misunderstood.
The technology was already in use, aimed previously more in the direction of cancer therapies. They weren't starting from scratch. But what the uninitiated heard was "never been used for a vaccine" - first time for everything. Nor did they have to find the genetic material they needed - that was worked out within a few weeks of the strange pneumonia appearing, not only in China but also in various western countries including Italy and made public knowledge - like a vast amount of the Covid research. Normally that just doesn't happen. There was already a solid basis of knowledge about SARS and MERS and which bit of the viral protein was key - the spike - but the SARS research had died back as it didn't appear to be a pandemic-like problem.
They didn't have to write grant applications for funding - money was thrown at it. That probably cut a couple of years off the normal process. And the clinical trials process usually takes months to recruit enough subjects - no such problem with Covid - and then each stage has weeks of analysis and waiting around before the next stage can be started. That bit was fast-tracked - partly by doing things in parallel rather than one after the other. The speed it is available is also favoured by the way the stuff is made and that, too, has been shared in a way that is rarely seen.
If all pharmaceutical companies shared what they know without keeping the lid on what they are doing, then drug development would be a far faster and (probably) less expensive process. But they wouldn't make as much money either.
"The European Medicines Agency (EMA) said on Tuesday its human medicines committee was evaluating the first batch of data on the vaccine, and would continue to do so until enough data is available for a final decision. (bit.ly/34mAHiI)
Pfizer and BioNTech said in a joint statement the start of the review is based on data from laboratory and animal testing, as well as early testing on humans, while continuing talks to submit data as it emerged."
"Pfizer and BioNTech didn’t wait for lengthy tests on monkeys and mice ..." doesn't mean they didn't do them - it was part of the in parallel approach.
it is not about liking or not liking vaccine... it is about risk/benefit assessment, which is highly personal ( depends on your risk to exposure, external contacts, location, etc., combined with risk from vaccine's side effects short and long term. My risk of contacting Covid-19 in Japan (160K total since the begining of pandemic out of 130m population, so almost 1 in a million)is quite different from say person in US.
BTW I see you are more active on this forum, so I assume things are better in your life. I enjoy discussions, it would be terrible if we all agree on everything, then there would be nothing to talk about :).
Nothing has changed in my life - and I am ALWAYS active on the forum. I think I had a couple of days not on the forum in May last year when in hospital!
You can only make risk benefit assessments on the basis of correct information. And the US and UK/Europe are in very different positions from Japan when it comes to immediate need for the vaccine. The current approval in the UK is for EMERGENCY use, not the longer term approval which will be in the same sort of time scale as all the rest. YOU may not be willing to have the vaccine at present - but by claiming that animal testing has not been done/taken into account and the process is rushed, you are sowing doubt in the minds of others who are at greater need of protection.
Have been following this discussion closely, and agree with PMRPro’s considered and knowledgeable responses to you.
I appreciate you have specific personal concerns about any vaccine, and agree there should be open discussions - but please remember that there are members on here who are very vulnerable and some of your opinions are likely to make them distressed and even more confused about the way forward for them.
I am glad that you have followed our discussion closely and hope that you have learned by doing so. I did. I would imagine that discussion that brings out more subtle details about vaccine would help people, not make them distresses ( as you say). I was presenting facts, not my opinion.
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) that vaccine does not prevent spread of the virus, so there will not be group immunity to protect the weakest, one of the main purposes of vaccination. 
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