Canada pauses AZ vaccines for under 55s (and says women most at risk)

[Boringlynormal]

Please tell me this isn’t something to worry about: www.google.com/amp/s/amp.theguardian.com/world/2021/mar/30/canada-suspends-use-of-astrazeneca-covid-vaccine-for-those-under-55

Speaking as a woman in her 30s who was immunised 4 days ago (article tells us the risk is for young women 4 - 20 days after vaccination), I’m panicking now. Yes I know it’s rare but so is dying of Covid in my age group so I’m wondering if I’ve made a huge mistake.

By the way I’m very pro vaccine and leapt on the chance to get one. I’m just feeling so anxious now.

And weren’t the initial trials only on healthy people?
Trials started for some other groups in September and as far as I know more groups are being added until the trials end in 2022/2023

@Canigooutyet yes, I think they can only do initial trials on healthy people anyway, for obvious reasons. The problem is (as I understand it) that the Covid vaccines had to be developed so fast that the usual, more extended trials haven't (yet) been completed. Or rather, the rollout itself forms part of the trials.

[quote Fieldofmemes]@Canigooutyet yes, I think they can only do initial trials on healthy people anyway, for obvious reasons. The problem is (as I understand it) that the Covid vaccines had to be developed so fast that the usual, more extended trials haven't (yet) been completed. Or rather, the rollout itself forms part of the trials.[/quote]
You understand it incorrectly. Phase 3 trials have completed for all the approved vaccines. This may be useful in explaining the temporary use: brodies.com/insights/healthcare-and-life-sciences/the-mechanics-of-medicines-regulation-shining-a-spotlight-on-the-mhra-vaccine-approval-decision/.

I’m even more confused now as this one suggests trials are still ongoing

www.clinicaltrialsarena.com/comment/ongoing-covid-19-vaccine-trials-continue-to-advance-steadily/

[quote Canigooutyet]I’m even more confused now as this one suggests trials are still ongoing

www.clinicaltrialsarena.com/comment/ongoing-covid-19-vaccine-trials-continue-to-advance-steadily/[/quote]
There are new variant trials, child vaccine trials, other vaccines still in development, trials for vaccines that can be sniffed instead of jabbed.
Not very confusing?

@MrsIsobelCrawley

There are reports this morning that the US is probably not going to use the AstraZeneca vaccine.

The US is sitting on tens of millions of AZ doses. These could be used to boost the UK's vaccination programme.

That’s been in doubt for some time tbh. They’ve been in no hurry to approve it cos they don’t really need it. They’ve just been sitting on a huge stockpile that they can’t/won’t export. They really just do need to make a decision and export it to wherever needs it most.

Have there been any reports about whether the people affected are also on anything like the pill, HRT etc?

Chances of dying from COVID if under 40 2,500 in 2.5 million
Ie 1000 times greater risk

These aren't the same risks though, because the clot risk is completely unknown as what indicates it, it's a simple risk to everyone. However the covid risk is not, we know the conditions which change the risk, and yes the overall average is 1000 times greater, but then the individual risk from covid differs by more than 1000 times between individuals, which would imply that for some the vaccine is indeed more risk.

Either way it's extremely low risk, but portraying risks in that way is not helpful to an argument.

@anyoldtime

Is it ethical to offer a vaccine not deemed good enough for Americans to Brazilians?

Brazil has already authorised the Astrazeneca vaccine and is using it. That's their decision. They just can't get as many as they need. Which is kind of crappy if the US is sitting on a bunch of doses they don't plan to ever use.

Have there been any reports about whether the people affected are also on anything like the pill, HRT etc?
The EMA said they hadn’t identified a common factor relating to medications for the cases it was investigating (so not including the U.K. cases or any after March 24th).

Has the age or sex of the UK deaths been reported?

@lonelyplanet

Has the age or sex of the UK deaths been reported?

Only that the first 5 were male and there's a mix of age/ sex.

I'm not sure people fully comprehend the odds of statistical mathematical probability here.

I'm not going to debate what the odds are of a blood clot from the Oxford vaccine as I'm not a dr but let's say it was a million to one chance ( 1 in 1 million). We aren't talking about one shot, we are talking of two and further shots in the future with boosters lined up for October. The odds therefore switch from 1 in 1000000 to 1 in 333 thousand. Still tiny but for younger people the dynamics shift in assessing whether the odds of taking the vaccine outweigh the virus the more vaccination shots you have. We also have no comprehensive studies on the " tweaked" vaccines for later this year so the 1 in a million may not remain that

Day 13. Of course it’s not a nice feeling but on listening to more experienced and qualified opinions I think I did the right thing. There are risks everywhere and the risk of Covid 19 or long Covid is far greater to me at 50 and working in classrooms across the school so I’m glad I had the jab and won’t hesitate to have the second. I don’t smoke, drink small amounts of alcohol, Have a healthy bmi and get 10k steps in a day. That I can control, the rest I’ll leave to the experts.

@Susan333 - In most cases your hypothesis is likely to be incorrect. If the cause is related to a genetic issue with handling the vaccine, then it is likely to occur on the first dose only. If it's due to previous covid infection then it's likely to occur on the first dose only. If it's due to taking aspirin or other NSAIDs alongside the vaccine (but more likely aspirin as it's a blood thinner), then it'll occur only if someone gets a headache so more likely first dose only when side effects are stronger with AZ. Etc etc.

"Only that the first 5 were male and there's a mix of age/ sex."

Thanks MRex, do you have a link for the information? I can't find it anywhere - thank you.

[quote MRex]@Susan333 - In most cases your hypothesis is likely to be incorrect. If the cause is related to a genetic issue with handling the vaccine, then it is likely to occur on the first dose only. If it's due to previous covid infection then it's likely to occur on the first dose only. If it's due to taking aspirin or other NSAIDs alongside the vaccine (but more likely aspirin as it's a blood thinner), then it'll occur only if someone gets a headache so more likely first dose only when side effects are stronger with AZ. Etc etc.[/quote]
There is no evidence to back that up, you're guessing pulling figures out of a hat- no one knows not even the experts which is why some countries have suspended it for some age groups and some haven't.

Perhaps the sensible option is to allow individual choice in assessing the personal risk to your own health instead of a " vaccine passport" meaning you cant function in society without taking risks you aren't comfortable with

Nice summary yesterday from some scientists assessing the MHRA reports: www.sciencemediacentre.org/expert-reaction-to-latest-weekly-summary-of-yellow-card-reporting-following-covid-19-vaccination-published-by-the-mhra-including-updated-numbers-of-cerebral-venous-sinus-thrombosis-cvst-and-other/

@Susan333 - no, you are the one stating unknowns as facts. You posited that the risk must be multiplied, and I explained why that is not likely with a range of different hypotheses.

@lonelyplanet

"Only that the first 5 were male and there's a mix of age/ sex."

Thanks MRex, do you have a link for the information? I can't find it anywhere - thank you.

Not necessarily the most reputable, but the first I found: www.standard.co.uk/news/uk/astrazeneca-germany-europe-pfizer-b924970.html

@MRex
You are talking rubbish. The phase 3 studies are ongoing for all these vaccines have NOT completed. The fully study designs are listed on www.clinicaltrials.gov and do not complete until end 22/early 23.

They have been granted conditional approval for emergency use only. Full safety data has NOT been collated, duration of efficacy remains unknown, and further data are required for full license.

To suggest otherwise is irresponsible and verging on criminal.

[quote confuseddotcom090]@MRex
You are talking rubbish. The phase 3 studies are ongoing for all these vaccines have NOT completed. The fully study designs are listed on www.clinicaltrials.gov and do not complete until end 22/early 23.

They have been granted conditional approval for emergency use only. Full safety data has NOT been collated, duration of efficacy remains unknown, and further data are required for full license.

To suggest otherwise is irresponsible and verging on criminal. [/quote]
Ah, you're in the USA. The USA requested an additional phase III trial, that doesn't affect MHRA approval but only FDA.

The Oxford AZ UK phase III trials completed with the interim reports; continuing immunogenicity blood tests are not the same as saying a vaccine has not been tested.

What worries me from the Sciencemediacentre Experts' Reaction to the Summary of Yellow Card Reporting by the MHRA is that it describes CVST as "affecting predominantly younger people with an estimated incidence for adults of 3-4 per million, and for children 7 per million… [It] is characterized by a highly variable clinical spectra, difficult diagnosis, variable etiologies and prognosis.” So higher risk in younger people and children... AND difficult to diagnose. More reasons, I would think, to use AZ in a predominantly older cohort, as other countries have done, where the risks of CVST are lower. Use other vaccines for the youngest people where the risk of Covid is low. And the argument about risking a greater number of lives if we pause the rollout... well, Boris always said lifting restrictions depended on data not dates. Here's some data.

t hadn’t occurred to me that the U.K. has also stopped giving it to most under 50s as of tomorrow. For a reason that nobody seems to know. That really is worrying

I should imagine that's because all those who had their first dose in January are coming up to needing their second, and with supplies of AZ at the moment, they're reserving all the AZ for second doses

Most people who had first doses in January had Pfizer and need Pfizer for the second one. The slowdown isn't because of second doses - they were always factored in. They said there was a shortfall of 5 million AZ doses from India - fine, but that is around 10 days' doses at the rates we were vaccinating at. What is happening for the other 20 days in April?

Hopefully the Moderna vaccine will come on stream when they "officially" start doing the healthy under 50s and anyone concerned can maybe have that one instead. But if I had already had the AZ vaccine and was fine, I wouldn't be at all concerned about having the second dose.

However, this is a very good illustration of why vaccination should never be compulsory. People always have the right to decide what goes into their bodies.

@poppycat10

t hadn’t occurred to me that the U.K. has also stopped giving it to most under 50s as of tomorrow. For a reason that nobody seems to know. That really is worrying

I should imagine that's because all those who had their first dose in January are coming up to needing their second, and with supplies of AZ at the moment, they're reserving all the AZ for second doses

Most people who had first doses in January had Pfizer and need Pfizer for the second one. The slowdown isn't because of second doses - they were always factored in. They said there was a shortfall of 5 million AZ doses from India - fine, but that is around 10 days' doses at the rates we were vaccinating at. What is happening for the other 20 days in April?

Hopefully the Moderna vaccine will come on stream when they "officially" start doing the healthy under 50s and anyone concerned can maybe have that one instead. But if I had already had the AZ vaccine and was fine, I wouldn't be at all concerned about having the second dose.

However, this is a very good illustration of why vaccination should never be compulsory. People always have the right to decide what goes into their bodies.

Uk started vaccinating in January with az as well so some people will be having their second doses now