So significant in a good way. Nice!
also - thank you for the explanation & link
The vaccines | vaxxed boosted unvaxxed? New poll
- Thread starter Badunk
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also - thank you for the explanation & link
They were locked out of the US for a long period over the safety concerns - the country with the best conditions for collecting lots of infection data.
Ah. Good point.
Even in the UK they were trialling in the wrong parts of the country to get the big September/October case numbers and they lost a couple of weeks to product holds. I'm not sure what case numbers they're looking for either, but they may have decided if they can't be first then they might as well wait until they can give some numbers that are more like the ones they'll use for an approval pack.
For people who are curious about what clinical trials look like from the guinea pig's point of view – a first look at the Novavax trial that I’ve just joined. First, I'll declare my background - I've been on both sides of a trial (30 years back) and also just on the guinea pig side before - but always in much more leisurely, non-pandemic circumstances, without the need for masks, social distancing or involving the sheer volume of volunteers/medical personnel being used over a short period.
The trial centre they were using was the sport’s hall of a leisure centre. Big car park and lots of space indoors – ideal for the job really. The venue was set up as series of stations/zones that you go through in sequence. We’d already completed an online questionnaire and had a telephone interview, and received a trial information pack to read a few days before the session. The appointment is for a specific start time – the whole thing took around 2 hours with no waiting, other than those implicit in the process (like the vaccine warm-up time and the monitoring period)
What did the trial say it would do if a vaccine gets approved?
If it’s approved and available (to your age group etc) – then you can ask for your status in the vaccine trial – placebo or vaccine. If you’re in the placebo group, then you’ll be advised to go and get the approved vaccine. If you’re in the vaccine group, they’ll give you the choice – and give you whatever efficacy and other data they’ve got as guidance.
What happens in the trial group after the Day 0 start?
A checkup, to review side effects, give you another jab, and do a couple of bloodtests etc, 3 weeks after jab1.
A checkup 2 weeks after the second jab, including a bloodtest and a review of any side-effects/health changes.
A checkup 3 months after the second jab.
A checkup 6 months after the second jab.
A checkup 12 months after the second jab.
What if you get covid symptoms, serious side effects or some major health change happens?
You have a phone number for the team doctors, they give immediate advice on what to do and arrange for a follow-up appointment.
An email address in case you want to send them any new information.
Incidentally, the trials are just as labour intensive as they sound. It takes a lot of resources to run a trial.
The trial centre they were using was the sport’s hall of a leisure centre. Big car park and lots of space indoors – ideal for the job really. The venue was set up as series of stations/zones that you go through in sequence. We’d already completed an online questionnaire and had a telephone interview, and received a trial information pack to read a few days before the session. The appointment is for a specific start time – the whole thing took around 2 hours with no waiting, other than those implicit in the process (like the vaccine warm-up time and the monitoring period)
First stop, right on the door – a temperature check, a mask change (they want you to wear their disposables) and a quick “do you have any symptoms”, “have you met anyone who has tested positive recently.” Then on to the next stop.
Reception – they get your name, and give you your personal documentation pack, and a pen, that you’ll be wandering around with.
Consent – they were working on small groups of volunteers, up to 6 at a time (all socially distanced) etc. The group listen to one of the trial leads explaining the basics of the trial, how the vaccine works, what the trial is looking for (side effects, efficacy) and the role of the placebo/blind trial, side effects observed so far (and typical side effects of vaccines) and what they’ll do if another vaccine gets approved and rolled out (in your age group or whatever) before the trial completes. Also a chance to ask questions – though it looked like the group I was in had already read the paperwork.
Medical history – we were then sent to our next station, 6 doctors at 6 well-distanced tables, doing the one to one interviews. More questions to check on obvious safety hazards (allergies, autoimmune disease etc – that might mean they don’t put you in the trial) + a general set of questions on pre-existing medical conditions/medicines/or food supplements etc, that were mostly gathered for info/reporting rather than for exclusion purposes.
Medical – the same doctor then gives you a basic checkup, working on you in a screened booth assigned to that doctor. Temperature, blood pressure, pulse O2, height/weight, a stethoscope to listen to the heart/lungs, a look into the throat and a manual inspection of the glands in the neck. A final chance to ask any questions, express any worries, add any undocumented comments/background you think of to the file – and a final go, no-go from you and the doctor.
The test and vaccination – Another desk and a different nurse or doctor. Another couple of checks on allergies/current symptoms etc. They collect a blood sample, then do a (swab) covid test and give you an explanation of how to do a covid test on yourself. They also gather together all the paperwork including the consent form, crosscheck the numbers and get it copied. If you’re going ahead with the jab – they request a dose for you (to the dispensing staff working behind a partitioned area at the back of the room - to help preserve the placebo/vaccine blinding). Twenty minutes later (to give it time to reach room temperature) – you get the jab – name, patient ID and vaccine code get cross checked.
Monitoring – they send you to the comfy (socially distanced) chairs to wait for half an hour. One of the nurses tries to keep you entertained by offering you bottled water and packets of biscuits. They give you a bag containing your copy of your signed consent, a patient ID card (with your patient code and the trial team phone numbers etc), three Covid test kits, a thermometer, and a ruler (in case they want you to measure a rash). They give you a reminder to phone the trial doctors if side effects are worrying or you get covid symptoms and help you register in a clinical trials reporting app. Finally, a check on your pulse O2, blood pressure, temperature – to check they’re back to (your) normal.
Checkout – a final desk where you get schedule your appointment for the next mini-medical and second jab.
Reception – they get your name, and give you your personal documentation pack, and a pen, that you’ll be wandering around with.
Consent – they were working on small groups of volunteers, up to 6 at a time (all socially distanced) etc. The group listen to one of the trial leads explaining the basics of the trial, how the vaccine works, what the trial is looking for (side effects, efficacy) and the role of the placebo/blind trial, side effects observed so far (and typical side effects of vaccines) and what they’ll do if another vaccine gets approved and rolled out (in your age group or whatever) before the trial completes. Also a chance to ask questions – though it looked like the group I was in had already read the paperwork.
Medical history – we were then sent to our next station, 6 doctors at 6 well-distanced tables, doing the one to one interviews. More questions to check on obvious safety hazards (allergies, autoimmune disease etc – that might mean they don’t put you in the trial) + a general set of questions on pre-existing medical conditions/medicines/or food supplements etc, that were mostly gathered for info/reporting rather than for exclusion purposes.
Medical – the same doctor then gives you a basic checkup, working on you in a screened booth assigned to that doctor. Temperature, blood pressure, pulse O2, height/weight, a stethoscope to listen to the heart/lungs, a look into the throat and a manual inspection of the glands in the neck. A final chance to ask any questions, express any worries, add any undocumented comments/background you think of to the file – and a final go, no-go from you and the doctor.
The test and vaccination – Another desk and a different nurse or doctor. Another couple of checks on allergies/current symptoms etc. They collect a blood sample, then do a (swab) covid test and give you an explanation of how to do a covid test on yourself. They also gather together all the paperwork including the consent form, crosscheck the numbers and get it copied. If you’re going ahead with the jab – they request a dose for you (to the dispensing staff working behind a partitioned area at the back of the room - to help preserve the placebo/vaccine blinding). Twenty minutes later (to give it time to reach room temperature) – you get the jab – name, patient ID and vaccine code get cross checked.
Monitoring – they send you to the comfy (socially distanced) chairs to wait for half an hour. One of the nurses tries to keep you entertained by offering you bottled water and packets of biscuits. They give you a bag containing your copy of your signed consent, a patient ID card (with your patient code and the trial team phone numbers etc), three Covid test kits, a thermometer, and a ruler (in case they want you to measure a rash). They give you a reminder to phone the trial doctors if side effects are worrying or you get covid symptoms and help you register in a clinical trials reporting app. Finally, a check on your pulse O2, blood pressure, temperature – to check they’re back to (your) normal.
Checkout – a final desk where you get schedule your appointment for the next mini-medical and second jab.
What did the trial say it would do if a vaccine gets approved?
If it’s approved and available (to your age group etc) – then you can ask for your status in the vaccine trial – placebo or vaccine. If you’re in the placebo group, then you’ll be advised to go and get the approved vaccine. If you’re in the vaccine group, they’ll give you the choice – and give you whatever efficacy and other data they’ve got as guidance.
What happens in the trial group after the Day 0 start?
A checkup, to review side effects, give you another jab, and do a couple of bloodtests etc, 3 weeks after jab1.
A checkup 2 weeks after the second jab, including a bloodtest and a review of any side-effects/health changes.
A checkup 3 months after the second jab.
A checkup 6 months after the second jab.
A checkup 12 months after the second jab.
What if you get covid symptoms, serious side effects or some major health change happens?
You have a phone number for the team doctors, they give immediate advice on what to do and arrange for a follow-up appointment.
An email address in case you want to send them any new information.
Incidentally, the trials are just as labour intensive as they sound. It takes a lot of resources to run a trial.
I've had Covid, and 3 very close members of our family have passed away over the last few weeks in the UK and India. This is not something to be taken lightly. If Muslims have suspicions then they should listen to the words of the Prophet Muhammad when making a decision on the vaccine. I quote two sayings which are authenticated according to Islamic theologians.
Prophet Muhammad SAW The Last Messenger & Prophet of God Said:
“Allah SWT (God) did not send down any disease but that he also sent down the cure.” (Sahih Hadith Bukhari & Muslim)
Usamah ibn Sharik (may Allah be pleased with him) narrated:
I came to the Prophet (peace and blessings be upon him) and his Companions were sitting as (quiet as) if they had birds on their heads. I saluted and sat down.
The desert Arabs then came from here and there. They asked: Messenger of Allah, should we make use of medical treatment?
He replied: “Make use of medical treatment, for Allah has not made a disease without appointing a remedy for it, with the exception of one disease, namely old age.” (Abu Dawud)
I wonder what approach Anti-Vaxxers will take if they make it mandatory to be vaccinated in order to board a plane (which will most likely happen). There’s even talk of it becoming mandatory to enter an office workplace!
Sorry to hear that.
At least in India, it isn't widespread among Muslims either. I heard of a few cases in Kerala some years ago, but nothing more. Pakistan had a problem with the polio vaccine after Osama.
Thanks, @jojojo
Brave souls like yourselves are a credit to humanity. God knows with your help how many lives will be saved.
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The only country I can see this actually becoming an issue in would be America, where there's simultaneously a lot of anti vaxx idiots, and a lot of people that love litigation.
We've been waiting for a year for a vaccine and all of a sudden within a few weeks they're all claiming to be successful. I very much hope this is not about mine is bigger and better.
@jojojo interesting! Do they test you for virus at the checkups? I am wondering how/if they are looking for prevention of infection at all.
They do tests on day 0 (jab 1) and day 21 (jab 2) - but I think those are to deal with the confusing problem of people developing new antibodies early in the trial due to the real virus not to the vaccine.
I don't know if they do them at any other sessions, but I think the "infection prevention" element is in one of the sub-studies, not in the mass trial.
Sorry to hear about your loss. I hope you’re back to full health, if not now, then very soon.
I don’t think I’ve ever looked into how phase III vaccine studies are usually designed (never been an area of interest for me, until now!) but I would assume the endpoint has always been symptomatic cases, so this is probably a standard trial design. Antibody titres can be very misleading and the diseases you usually vaccinate against will always reveal themselves.
I also don’t think there’s ever been a vaccine against an illness that is often asymptomatic. So it would seem they’re missing a trick to not at least try to screen for asymptomatic cases.
So what's the current thinking for the rollout of these vaccines? Or timeline?
Is it feasible that by next summer, travel within Europe won't be considered a crazy idea?
Is it feasible that by next summer, travel within Europe won't be considered a crazy idea?
If the efficacy is as high as they are seeing now and doesn't wear off too fast, the virus doesn't mutate too much and the manufacture scales up as hoped then, barring failure in the rollout...
In my opinion, basically yes. Between the (hopefully several) vaccines, and a slicker set of testing options, leisure travel within Europe at least should be back on again sometime in the summer. It probably still means masks in airports, and on planes and other indoor areas, some social distancing precautions etc in force and maybe a need to take up an extra insurance option (even if you don't need the health cover you may need something to cover a sudden quarantine or similar situation) - so maybe not normal but close enough that people will be on the move again.
But then I enjoyed my week's holiday in Spain in September, and happily did my two weeks quarantine on return - so I might not be the best guide
Cool, sounds good! ThanksIf the efficacy is as high as they are seeing now and doesn't wear off too fast, the virus doesn't mutate too much and the manufacture scales up as hoped then, barring failure in the rollout...
In my opinion, basically yes. Between the (hopefully several) vaccines, and a slicker set of testing options, leisure travel within Europe at least should be back on again sometime in the summer. It probably still means masks in airports, and on planes and other indoor areas, some social distancing precautions etc in force and maybe a need to take up an extra insurance option (even if you don't need the health cover you may need something to cover a sudden quarantine or similar situation) - so maybe not normal but close enough that people will be on the move again.
But then I enjoyed my week's holiday in Spain in September, and happily did my two weeks quarantine on return - so I might not be the best guide
I've had a look through the main trial protocol, but I'm not techie enough to understand it. In the secondary endpoints section, it sounds like they're looking at N-protein serology and S-protein serology separately. Is that an attempt to spot virus created antibodies? I think the Novavax vaccine only mimics the S protein.
I believe there are some sub-studies underway as well, that may be related, but I only understand what some of the words in the title mean, and not what they're actually committing to do
It is just that they started at much the same time with the same time constraints.
Glad to hear you have recovered. Hope it wasn't too severe a case.
HPV?
Oh yeah. Good shout.
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Amazing.
When Boris got out of hospital and did that speech he said we were at the end of the beginning, could we with caution say we're potentially approaching the beginning of thd end or is it too soon?
We are in the middle. The number of deaths is gonna be at least doubled till the end of the pandemic, and 2021 is gonna be as shitty as 2020.
A lot of people dying from Covid lately, or is it from other health issues. I know some here in Ireland have questioned the deaths of their loved ones who had covid written on their death certs when it was not what they died from.
Not true at all. Even if you ignore the imminent vaccine program (and why would you?) We know a hell of a lot more about prevention, treatment and diagnosis than we did at the beginning of this year. This thing isn’t going to go away suddenly (and it will get worse before it gets better) but this time next year we’l be in a MUCH better place than we are now.
An interesting story of one of the scientists who did the basic research underpinning the mRNA projects.
https://www.theguardian.com/science...hnology-pioneer-i-never-doubted-it-would-work
https://www.theguardian.com/science...hnology-pioneer-i-never-doubted-it-would-work
Well if you were being pedantic, if you have underlying health conditions its not the covid that directly kills you, but rather an exacerbation of existing ailments that results in your body shutting down. A bit like how people die from cancer due to organ failure, cardiac arrest, etc.
Mass vaccination might just allow it I guess. Australia have all but ruled out opening up international travel until at least the second half of 2021. I have acfeeling it might be longer. Hopefully it willbe possible and to return without quarantine by late Oct 2021 so I can finally get to see the offspring again. Hard to believe it will be close to 2 years
Interesting article on the creator of the mRNA technology used in the first 2 covid vaccines.
https://www.theguardian.com/science...hnology-pioneer-i-never-doubted-it-would-work
https://www.theguardian.com/science...hnology-pioneer-i-never-doubted-it-would-work
I was looking at the vaccine agreements and delivery schedule for Australia. It looks like they plan on the Oxford vaccine will be first cab off the rank with 3.8 million doses (2 doses per person) by late Dec/Jan and then about the same again every month until mid year. We will import 10 million doses of Phizer between Feb and June. If all goes well then Novavax and the UQ vaccine will be available from mid year - a combined 14 million doses per month and up to 20 million doses of a vaccine TBA as part of the Covax initiative - schedule unknown.
So if none of the vaccines fail we will have enough to give everyone a shot by mid year, sooner if we get any Covax supply before then. Not everyone will get a shot but it has to be distributed and administered so the very earliest we could have full rollout is the end of August and that is very optimistic and relies on nothing going wrong.
So what are the plans in your country? How many people will get vaccinted?
I can see that many countries are going to require vaccination before you can enter as not everywhere will have the same vaccine take-up and covid is likely to remain around in some countries for quite a while and possibly indefinitely.
So if none of the vaccines fail we will have enough to give everyone a shot by mid year, sooner if we get any Covax supply before then. Not everyone will get a shot but it has to be distributed and administered so the very earliest we could have full rollout is the end of August and that is very optimistic and relies on nothing going wrong.
So what are the plans in your country? How many people will get vaccinted?
I can see that many countries are going to require vaccination before you can enter as not everywhere will have the same vaccine take-up and covid is likely to remain around in some countries for quite a while and possibly indefinitely.
People expect 2021 to be a bit shit so expectations will be low. Few thought 2020 would be so shit because barely anyone was talking about a global pandemic.
NHS England are planning to vaccinate all willing adults over the age of 18 by April. A bit of a stretch tbh.
Do they have quantity of vaccine needed to do that by then? Assuming all goes well.
And what % of the adult population do they think will be willing?
If someone already had covid, and it was confirmed beyond any doubt with a combination of a PCR test at the time and antibody tests later, are they expected to get the vaccine?
I think they have ~100m of them - though not sure how many by April.
I'm curious to know this too. I'd be keen on a national antibody test campaign and then targeting the vaccine.
But I'm assuming the answer to your question is no. I think they'll just go with blanket mass vaccination.