How long would another Phase III take?
The vaccines | vaxxed boosted unvaxxed? New poll
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Several months, at least. They might be able to shorten that by extending one of the studies already underway (focussing on a cohort who got the optimal dose/dose interval)
An interesting snapshot of the way countries are pre-buying vaccines, and just how fundamental the other vaccines are. So far only Pfizer has approval in the UK (and now Canada). It also illustrates just how important some of the vaccines who haven't yet got/released Phase3 data (like Novavax) could turn out to be.
India went all in on Novavax ... has there been update regarding it? I hear news just about Pfizer, Moderna and the Oxford one..An interesting snapshot of the way countries are pre-buying vaccines, and just how fundamental the other vaccines are. So far only Pfizer has approval in the UK (and now Canada). It also illustrates just how important some of the vaccines who haven't yet got/released Phase3 data (like Novavax) could turn out to be.
An interesting snapshot of the way countries are pre-buying vaccines, and just how fundamental the other vaccines are. So far only Pfizer has approval in the UK (and now Canada). It also illustrates just how important some of the vaccines who haven't yet got/released Phase3 data (like Novavax) could turn out to be.
UK have signed up for 265m doses with a population of 67m, so pretty much exactly 4 doses per person on average. Is it safe to assume it’s intentional? Most vaccines are 2 doses so we are hedging our bets that if one doesn’t work we have a backup option?
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A good tactic from a purely UK perspective. The vaccines aren't that expensive compared to the other costs of the pandemic so buying a range is no bad thing, particularly as they cover multiple technologies and delivery schedules are likely to be unreliable over the next year. There's probably a resale market (and a "humanitarian gift" variant) for the unwanted options as well. I think they were hoping to meet the bulk of the Q1/Q2 rollout using Astra Zeneca, but they must be glad they did pre-purchase their place the in other vaccine queues.
That's not a complete list either. The UK has bought 30m doses of Johnson & Johnson (and an option of 20m more) as well. The J&J may even be available as a single dose vaccine. Efficacy data expected in January apparently.
I presume they'll have ordered enough for 2 jabs for everyone initially. The surplus can be stored for future/aid and I also suspect a chunk will go into research.
I react but not as badly to European wasps.
I had 6 months of immunology treatment which has hopefully helped but I was meant to keep going for 5 years but it was killing me pumping myself full of venom every week.
I have always swelled up when stung by wasps but nothing too severe until a decade or so ago. I was driving a 4x4 along the beach on Fraser Island when a massive wasp (3+ cm long) somehow came through the ventilation system and stung me on the arm. I got a hard lump the size of half a golf ball which went away over a week and I thought no more about it.
A few weeks later I was working at home alone and I was putting a ladder back into the garage and I bumped a small paper wasp nest that I hadn't seen and I got stung about 20 times on my shoulder and neck. They are fecking painful and after swatting them off, killing a few with my hand and swearing vigorously I went into the house to get insect spray to kill the rest. I then sprayed the small nest and ran for it to avoid getting stung again and after about 5 steps felt a bit odd. I sat down on the steps for a minute then felt fine. Stood up and rapidly didn't feel fine. I then realised I was going unconscious and tried to roll onto my side on the grass as I went down. Then went fully out.
I was then unconscious for an unknown length of time before my son's mate from across the road saw me. Came over, prodded me with his foot and then ran off to tell his folks. He had a bit of form for tall tales so his folks didn't immediately believe him but after a while did and came over, found me and called the ambulance. After the ambulance arrived I started to come round a bit (not sure if they gave me anything or if I just came round) at which time I tried to stand up quite a lot and they had to almost sit on me to stop me. At this point my wife and son came home and her first thought was that I'd had a heart attack, because her friend's husband had dropped dead the week before. It quickly became apparent I wasn't dead but my eyes were totally bloodshot and my breathing was slightly impacted (airways were fine) and I still groggily REALLY wanted to stand up. An ambulance ride with added saline and I was fine. A hour's nap at emergency, where my wife took the opportunity to post a picture of me unconscious to Facebook, and they sent me home.
The diagnosis was that the stings had stimulated the vagus nerve and that I was dehydrated due to working in the summer sun.
A week later my wife was telling our neighbor about it, who was a nurse at the main NSW allergy treatment center at Westmead Hospital, and she flagged that the registrar at emergency was almost certainly wrong and that I'd suffered an anaphylactic event and these events tend to escalate so I could die next time. The clinic confirmed and I then had the immunology treatment which involved them pumping ever increasingly large quantities of venom into me every week to train my body not to react. Makes you feel like shit and very achy, which is why I stopped after the inpatient part as I was written off for every weekend.
Stripy paper wasp bastards
Jaysus. That sounds scary. I was actually mainly cracking a dad joke about wasps made out of paper. I can’t help myself. It’s an age thing.
Bugger. Not concentrating. I'm so tired I missed a dad joke. I think I really need my weekend after what will be 19 days work on the run.
However paper wasps create paper cuts. The struggle is real.
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Novavax may well have interim trial data this month as (in theory at least) they should be hitting the right number of covid cases in the UK trial group round about now, certainly they're expecting to have enough efficacy data to go for regulatory approval early next year.
Unfortunately their trial in the US and Mexico has been delayed (pending approval of their manufacturing procedures) - so they may not have sufficient people in their trial to convince everyone on the safety front. That said, they've done a manufacturing deal with the Serum Institute, so they may also start producing doses in India, at risk, based on the UK data - maybe even with a view to running another clinical trial in India or elsewhere.
As expected, FDA have doubts over Oxford data.
Man, they have really dropped the ball with this haven't they? They are definitely going to have to wait for more data from the US at the very least to get any sort of reliable data and even then, the dosing regimens mistake means they are going to certainly have to extend the trials to include this specific dose.
Will be interesting to see what the MHRA makes of the data.
We all knew about the low dose “serendipity” stuff but the shocking/surprising news to me on reading the paper was that there was no consistency in the timing of the second dose. Because they started the trials not anticipating the need for a second dose. Then couldn’t manufacture additional doses quickly enough for consistent timing of the boosters. All of which adds up to so many variables it’s almost impossible to make sense of all the data.
The whole thing is a clusterfeck tbh. What’s frustrating is that they still might have developed a great vaccine. It’s just that they’ve made a pigs ear of proving this. With all the crazy haste to get vaccines across the line there were always going to be some cock ups in development plans. And it’s not surprising that the companies with more experience at developing vaccines ran a tighter ship. Just a pity that the AZ candidate is the cheapest/easiest to distribute. Because it sure as shit won’t get approved as easily/quickly as the Pfizer/Moderna ones.
What I don't understand is, what is the person in charge thinking when at some point they decided "Let's just give the 2nd jab as and when it arrives"?
How did they anticipate they'd get approval for that? What did they think would be their conclusions? That is really pub standard. I understand Oxford is academics and Pfizer are giant corporations with more experience, but your average data scientist at any organisation would know there's no conclusion you can get out of that.
Pausing the trial and waiting for enough doses would've been a far superior option.
UQ/CSL vaccine trial abandoned due to some trial participants having “aberrant results”, more details to come. Not great news for Aus as we were hoping for 50m doses.
Due to some people in the trial returning false positive HIV tests after being vaccinated.They were not at any risk but developed to an antibody response to part of the UQ/CSL vaccine known as the “molecular clamp” that is taken from HIV.
Apparently they were aware this might be a problem and were actively looking for it. The trial was terminated despite the vaccine producing a robust immune response to SARS-CoV-2 because losing the ability to test people for HIV is obviously a pretty big problem!
Sad news for all the people that worked so hard developing it in such a short space of time.
https://www.theguardian.com/austral...unt-scott-morrison-health-politcs-latest-news
Due to some people in the trial returning false positive HIV tests after being vaccinated.They were not at any risk but developed to an antibody response to part of the UQ/CSL vaccine known as the “molecular clamp” that is taken from HIV.
Apparently they were aware this might be a problem and were actively looking for it. The trial was terminated despite the vaccine producing a robust immune response to SARS-CoV-2 because losing the ability to test people for HIV is obviously a pretty big problem!
Sad news for all the people that worked so hard developing it in such a short space of time.
https://www.theguardian.com/austral...unt-scott-morrison-health-politcs-latest-news
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Apparently the vaccine was causing false positives in HIV (yes, really) tests. Talk about a problem coming out of leftfield!
EDIT: Actually, not totally out of leftfield considering how the vaccine is designed but still. Seems a shame, seeing as there’s no real harm done, but can you imagine how the antivaxxers would react?!
Yep. Safe and effective (as far as we can tell from phase 1) but would make HIV testing unreliable. It can be reengineered but that would push the delivery date out by 12 months at least.
Bet the Federal government wished that they had ordered from Modern now to complement the other vaccines they have ordered as it looks to me like they planned for the Oxford vaccine to be the main 1st response and the UQ vaccine to do the heavy lifting in the second half of next year. We only have 10m does of the Phizer vaccine ordered as well which will only be enough for 25% for of the population assuming 10m doses needs dividing by 2 as you need 2 shots each.
I always thought they were putting too much faith in the UQ vaccine because it was being developed in Australia and our vaccination plans will be delayed for sure if the Oxford vaccine doesn't get approved (which we manufacture here). We'd also really need the Novavax vaccine ASAp and/or the COVAX initiative to give us a hand.
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Yeah, with major doubts over Oxford vaccine too this is a kick in the balls. It’s a strange one, I know for a fact that I will never need an HIV test. You’d think people like me could sign some sort of a disclaimer and take the vaccine at our own risk.
They'll be hoping the Novavax comes through now. It emphasises again just how important the Astra Zeneca variant is globally, and why the messy Phase3 is such a disappointment. At any rate I suspect we'll hear about a new manufacturing contract being made with one of the companies still at trial - picking up the capacity left spare by the loss of the Queensland vaccine. J&J, Sanofi and Novavax may move in to fill these gaps in Q3/4.
For anyone interested in such things there are some lovely infographics on who's bought what at:
https://www.bloomberg.com/graphics/covid-vaccine-tracker-global-distribution/
I think the problem is that if everyone was vaccinated you might as well stop testing for HIV as it would be almost meaningless. The prevalence of false positives was quite high apparently.
Wait until tomorrow - Facebook will be full of plebs claiming the vaccine gives you Aids.
Australia buys in some replacements...
As usual our Federal Government try to snatch defeat from the jaws of victory. They really are a bunch of clowns (Pennywise style). They have been forced by the states to virtually eradicate covid and shut state borders which they fought in the courts until they realised late in the game it was the right thing to do and backed down. Fingers crossed for approval of the Oxford vaccine and that Novavax gets through ASAP as well.
We make the Oxford vaccine and have already ordered enough to vaccinate nearly the whole population (subject to approval). We also already have 40 million doses of Novavax ordered for delivery in 2021 which is almost enough to vaccinate the entire population, so again it is a bit meaningless. They want to distract from putting so much emphasis on the UQ vaccine when it was known from day 1 that HIV false positives were a risk. In essence this is just PR bullshit
I know. I hate them.
In fact this should be the best demonstration that vaccine testing is rigorous. But morons will moron.
Yeah, true.
I see. I understand now. Thanks for the clarification.
I agree with the latter bit but the thing that jumps out at me is the number of frontline medical staff and law enforcement who would be told they have HIV after, say, a needle stick or the breaking of the skin in an incident. Lawyers would, sadly, have a field day, given how avoidable that would be. It's so difficult to say never when it comes to needing a test like that even before the sexual transmission side of things is factored in.
More UQ vaccine news
"The University of Queensland and CSL are holding a media briefing on the decision to abandon the trial. It’s a webcast.
There were 216 participants in phase 1 of the CSL/UQ clinical trial.
The trial began on 13 July with 120 participants, five groups of 24, and all participants are healthy adults aged 18 to 55. Ninety-six participants received the vaccine, 24 received the placebo.
It was expanded on 15 September with an additional 96 participants, 72 of whom got the vaccine and 24 got a placebo.
Monitoring of those participants will continue."
"The University of Queensland and CSL are holding a media briefing on the decision to abandon the trial. It’s a webcast.
There were 216 participants in phase 1 of the CSL/UQ clinical trial.
The trial began on 13 July with 120 participants, five groups of 24, and all participants are healthy adults aged 18 to 55. Ninety-six participants received the vaccine, 24 received the placebo.
It was expanded on 15 September with an additional 96 participants, 72 of whom got the vaccine and 24 got a placebo.
Monitoring of those participants will continue."
Dr Andrew Nash, the chief scientific officer of CSL, said that there is no safety issue identified in the vaccine — it’s just a diagnostic issue. He says:
"I want to emphasise there’s no adverse health reactions and there’s no possibility the vaccine causes HIV infection. I want to highlight through the study no serious adverse events or safety concerns were reported in the 216 trial participants.
Now, over the past few weeks, we’ve worked closely with experts in HIV and pathology to potential management solutions. In consultation with the Australian government, CSL and the University of Queensland have now concluded that while there is not a safety issue, there are a number of challenges in rolling out the vaccine and that these challenges might have an impact on public confidence in vaccination programs more broadly. At this stage, and without more data, significant changes would need to be made to the well established HIV testing procedures and the healthcare setting would need to change to accommodate the rollout of this vaccine. Therefore, CSL won’t be proceeding with the further development of the program and the phase two and three study will not go ahead.
The phase one trial will continue with scheduled follow-up and monitoring of participants and in due course the University of Queensland plans to submit full data for peer review publication.
Now, from the very beginning of this project, we have highlighted there’s a risk of failure associated with early vaccine development. This decision emphasises the rigorous assessment involved in vaccine development and the myriad considerations that must be taken into account in order to produce a vaccine that’s safe and effective, logistically viable and publicly acceptable. And while there’s still many challenges along the way to produce a vaccine against Covid-19, we remain steadfastly committed to our work protecting the Australian population against this pandemic to.
This end, manufacture of approximately 30 million doses of the Oxford AstraZeneca vaccine candidate is under way with first doses planned to be released for use in Australia early next year. In addition, CSL has now agreed at the request of the Australian government to manufacture an additional 21 million doses to ensure that there’s enough of this vaccine, should it be approved by the regulators, to cover the entire Australian population. And on behalf of everybody at CSL, I like to acknowledge that we are very proud to be able to step up and make this additional commitment."
"I want to emphasise there’s no adverse health reactions and there’s no possibility the vaccine causes HIV infection. I want to highlight through the study no serious adverse events or safety concerns were reported in the 216 trial participants.
Now, over the past few weeks, we’ve worked closely with experts in HIV and pathology to potential management solutions. In consultation with the Australian government, CSL and the University of Queensland have now concluded that while there is not a safety issue, there are a number of challenges in rolling out the vaccine and that these challenges might have an impact on public confidence in vaccination programs more broadly. At this stage, and without more data, significant changes would need to be made to the well established HIV testing procedures and the healthcare setting would need to change to accommodate the rollout of this vaccine. Therefore, CSL won’t be proceeding with the further development of the program and the phase two and three study will not go ahead.
The phase one trial will continue with scheduled follow-up and monitoring of participants and in due course the University of Queensland plans to submit full data for peer review publication.
Now, from the very beginning of this project, we have highlighted there’s a risk of failure associated with early vaccine development. This decision emphasises the rigorous assessment involved in vaccine development and the myriad considerations that must be taken into account in order to produce a vaccine that’s safe and effective, logistically viable and publicly acceptable. And while there’s still many challenges along the way to produce a vaccine against Covid-19, we remain steadfastly committed to our work protecting the Australian population against this pandemic to.
This end, manufacture of approximately 30 million doses of the Oxford AstraZeneca vaccine candidate is under way with first doses planned to be released for use in Australia early next year. In addition, CSL has now agreed at the request of the Australian government to manufacture an additional 21 million doses to ensure that there’s enough of this vaccine, should it be approved by the regulators, to cover the entire Australian population. And on behalf of everybody at CSL, I like to acknowledge that we are very proud to be able to step up and make this additional commitment."
Here’s the summary of the Pfizer trial submitted to the FDA. If you have a sneaky peak you’ll see how much faith/respect I have in the FDA/MHRA/EMEA etc. Clinicians think they’re fully clued in if they read/understand every nuance of a study as published in a peer reviewed journal but that’s the tl;dr ELI5 version of what the regulators have to go balls deep in. Anyone who digests every line of this tome gets nothing but respect from me. I’ll be waiting for the journal before I try and get my head round this trial, that’s for damn sure (although I did read the executive summary of this document and all the evidence looks solid as feck, in sharp contrast to the Oxford omnishambles).
I couldn’t imagine having to read through something like it and sign it off or put my name to it. Takes some dedication
It’s amazing. I’m arrogant enough to think I’m a smart bloke but documents like this always make me feel like I’ve got the attention span of a five year old child.
Tbf I probably do have the attention span of a five year old child. I blame this place and my smartphone.
New England Journal of medicine has got the phase III trial results too and an editorial if you guys fancy a comparatively lighter read
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577
https://www.nejm.org/doi/full/10.1056/NEJMe2034717?query=recirc_curatedRelated_article
The full FDA briefing document is here, in case anyone here cares to read it. haha
https://www.fda.gov/media/144245/download
https://www.fda.gov/media/144245/download
Disappointing for Australia but I think this might help from a global vaccination perspective. You need some failures to reassure people that the system is working. The fact that Pfizer jumped through those hoops wasn't just a formality but exceptional work with a dose of good fortune. I'm sure some folks will start saying that the vaccine causes AIDS but for the people on the fence, I think it'll be helpful. They can see the process is transparent and it is difficult to get approval, even when the vaccine doesn't harm people and does protect them.
I got to the abbreviations page and then my mind went blank
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Bad news on the Sanofi/GSK vaccine. As @Brwned said, this really just confirms what I’ve been saying all along. Developing new drugs is tough. With lots of failures to be expected. Which makes the successes more impressive and gives us less reasons to doubt them.
Thanks for that. Waaaaaaay more digestible than FDA submission. The editorial covers all the key points. Not much to criticise but need to keep an eye on serious cases. Currently higher % in vaccine arm than placebo but numbers far too low to draw any conclusions. Good to see they’ll be screening for asymptomatic cases at a later date.
Vaccine clinical trials - guinea pig's eye view - part 2.
Novavax trial. 21 days after jab 1 (of something), it's time to return to base for jab 2 (of something). The trial is based in the sports centre again - the sports hall is kitted out with a series of socially distanced stations - laid out as a numbered circuit of activities, you stick to your table number loop as you move.
Summary: a brief medical - as with jab1 day this is actually a longer "hands on" physical checkup than I've had from a GP in the past 30 years
- medical history, any changes in medications/conditions, any after effects from jab 1. A trip to the nurse to get jab 2. A stay in observation, with another check of bp, pulse O2, temperature, vaccination site then release.
What's striking from the guinea pig side is just how smooth and professional the whole thing feels - and how seriously they take their responsibility for the volunteers. It's slick, the only pauses/waits are part of the trial - wait for the jab to warm up because it's in the fridge, then wait in observation - and that gives you time to talk to doctor for longer, or chat with the nurses as you wait together. It's also very labour intensive, which is a reminder why "normal" clinical trials don't get done this fast. They require lots of funding, clinical support and volunteers.
The staff are clearly enjoying the trial (as odd as that might sound). They believe in what they're doing. They're also very aware of what they aren't doing. One of the nurses I spoke to is normally involved in new cancer treatment trials, but has spent most of the year dealing with covid patients and then later with covid treatment trials on hospitalised patients. The vaccines come as a huge relief to them and running the trial has given them a boost.
And me? Well I don't know what I got - placebo or vaccine. I had a pain in the injected muscle after jab 1 (not bad, but enough that I couldn't sleep on that side on that first night). Same again after jab2, but for a couple of nights. Placebo or vaccine - it's an injection into the deltoid muscle (high on the arm) - maybe I just don't like them at all, maybe it's a coincidence. It won't change anything in my behaviour but obviously I hope I had the vaccine. I'll happily admit that I've become bizarrely committed to the Novavax vaccine - I want it to be the +90% efficacy, fridge storage, low side-effect vaccine of choice! But who knows.
Novavax trial. 21 days after jab 1 (of something), it's time to return to base for jab 2 (of something). The trial is based in the sports centre again - the sports hall is kitted out with a series of socially distanced stations - laid out as a numbered circuit of activities, you stick to your table number loop as you move.
Summary: a brief medical - as with jab1 day this is actually a longer "hands on" physical checkup than I've had from a GP in the past 30 years
- medical history, any changes in medications/conditions, any after effects from jab 1. A trip to the nurse to get jab 2. A stay in observation, with another check of bp, pulse O2, temperature, vaccination site then release.Front door - a new (disposable) mask as they prefer you to wear theirs, a temperature check, and "have you had any symptoms, met anyone who has tested positive?"
Reception - check-in, they give you your paperwork to carry round with you.
Introduction - a brief status report to the group in your timeslot on the trial from one of the senior trial doctors and a chance for questions. Mostly focused on the question, "what if I get a call to go for a (real) vaccine" again.
Doctor - go to your numbered station to see your doctor. Quick checkup of bp, temperature, pulse O2. Medical history update, including any changes. Any reactions to the jab. Physical checkup (in screened privacy booth) concentrating on lymph nodes, but with a quick "no changes" look at other things. A final check that you're willing to continue the trial.
Nurse - next numbered station. There's a pause now, while you wait for your jab to warm up (the vaccine is kept in the fridge) and dispensed in a screened pharmacy area. We had a nice chat and then it was jab time. Dose labels, name date of birth, patient number, checked by pharmacist, nurse and second nurse. Again, I don't actually feel the vaccination at all, there's not really even any mark beyond a tiny pinprick dot of blood.
Observation - 30 minutes in the comfy chair, with the coffee and biscuits. Choice of biccies available today I got the lemon cream. Another nurse checks your bp, pulse O2, temperature and asks how you're feeling, and makes sure you've still got your covid test kits at home and that the app is on your phone. Then you're done.
Appointments - book your next session in 14 days for a checkup
Reception - check-in, they give you your paperwork to carry round with you.
Introduction - a brief status report to the group in your timeslot on the trial from one of the senior trial doctors and a chance for questions. Mostly focused on the question, "what if I get a call to go for a (real) vaccine" again.
Doctor - go to your numbered station to see your doctor. Quick checkup of bp, temperature, pulse O2. Medical history update, including any changes. Any reactions to the jab. Physical checkup (in screened privacy booth) concentrating on lymph nodes, but with a quick "no changes" look at other things. A final check that you're willing to continue the trial.
Nurse - next numbered station. There's a pause now, while you wait for your jab to warm up (the vaccine is kept in the fridge) and dispensed in a screened pharmacy area. We had a nice chat and then it was jab time. Dose labels, name date of birth, patient number, checked by pharmacist, nurse and second nurse. Again, I don't actually feel the vaccination at all, there's not really even any mark beyond a tiny pinprick dot of blood.
Observation - 30 minutes in the comfy chair, with the coffee and biscuits. Choice of biccies available today I got the lemon cream. Another nurse checks your bp, pulse O2, temperature and asks how you're feeling, and makes sure you've still got your covid test kits at home and that the app is on your phone. Then you're done.
Appointments - book your next session in 14 days for a checkup
What's striking from the guinea pig side is just how smooth and professional the whole thing feels - and how seriously they take their responsibility for the volunteers. It's slick, the only pauses/waits are part of the trial - wait for the jab to warm up because it's in the fridge, then wait in observation - and that gives you time to talk to doctor for longer, or chat with the nurses as you wait together. It's also very labour intensive, which is a reminder why "normal" clinical trials don't get done this fast. They require lots of funding, clinical support and volunteers.
The staff are clearly enjoying the trial (as odd as that might sound). They believe in what they're doing. They're also very aware of what they aren't doing. One of the nurses I spoke to is normally involved in new cancer treatment trials, but has spent most of the year dealing with covid patients and then later with covid treatment trials on hospitalised patients. The vaccines come as a huge relief to them and running the trial has given them a boost.
And me? Well I don't know what I got - placebo or vaccine. I had a pain in the injected muscle after jab 1 (not bad, but enough that I couldn't sleep on that side on that first night). Same again after jab2, but for a couple of nights. Placebo or vaccine - it's an injection into the deltoid muscle (high on the arm) - maybe I just don't like them at all, maybe it's a coincidence. It won't change anything in my behaviour but obviously I hope I had the vaccine. I'll happily admit that I've become bizarrely committed to the Novavax vaccine - I want it to be the +90% efficacy, fridge storage, low side-effect vaccine of choice! But who knows.