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+1 TiRed
I’ve worked in QA, alongside Qualified Persons Pharamcovigilance (QPPVs) and in injectables most of my career so agree with that assessment.
Years ago there was an issue with injectable EPO. When given as an injection not an infusion, some patients developed anti-EPO antibodies. These neutralised their own EPO and then their red blood cells started tanking. After much investigation, the effect was traced to the rubber in the stoppers, not the actual drug, causing the effect.
Rings a bell.
The UK may not have seen cases of ITP
Have we not then?
https://www.hematology.org/covid-19/covid-19-and-itp
"Should I immunize my ITP patient to SARS-Cov2 and influenza?
Even though vaccine administration in general can occasionally result in a drop in the platelet count in otherwise stable ITP patients, the expected benefits of receiving the influenza vaccine and a SARS-CoV-2 vaccine likely outweigh this concern. A case of new onset severe acute ITP, complicated by a fatal intracranial hemorrhage, was diagnosed three days following vaccination with the Pfizer COVID vaccine was recently made public. Best available knowledge from all phases of the vaccine clinical trials and individuals vaccinated to date suggests that post-COVID vaccine ITP is either extremely rare or unrelated coincidental event. ITP onset or worsening has been reported with some frequency following viral infections and anecdotally following other vaccines. Based on current knowledge, the risks associated with COVID-19 disease appear to outweight risks associated with SARS-CoV-2 vaccination in ITP patients. It may be appropriate to obtain baseline and post vaccination platelet counts in certain ITP patients, particularly in those with ongoing thrombocytopenia or a history of unstable platelet counts."
Relevant or not?..
Apologies – individual national agencies working for varied governments have gone against the advice of their own European body (EMA). Pardon my confusion
It’s the individual bodies that contribute and help design EMA policy - in the past that has included the MHRA who are as respected and if not more respected than the EMA. TiRed will quite happily give you his opinion of the EMA.
It wouldn’t be the first time that individual regulatory agencies have gone against the EMA and it won’t be the last.
Back to TiReds point about this vaccine being produced in different factories, there is that, there is also the fact that a lot of these facilities are operating in what is essentially a “surge” capacity - site heads won’t tell you they are but the manufacturing technicians will. This increases the propensity for manufacturing error. Which is partly why I have been very worried about the ability to keep this up. Europe’s pivot to Sputnik somewhat validates my thoughts on the matter.
I was vaccinated this morning. After hearing about the issues on the news this morning I'll admit to being a little concerned but I decided to go ahead with it regardless. As it turns out, I received the Pfizer vaccine.
I'm getting mine on Friday - AZ.
I posted a few days regarding my mums friend who developed platelet issues a few days after AZ vaccination, she originally developed clots but now her platelet count is non existent, she's went seriously downhill since and is currently receiving multiple iv platelets and plasma and other stuff, been in intensive care for the previous 3 weeks, i'll find out her current status later and come back to this thread
I don't see a problem with delaying for long enough to elimate any doubt. Vaccination capacity is so far above vaccine availability catch up will be very fast.
Two weeks in a nine month programme is nothing but another "sang contaminé" scandal would seriously reduce vaccine uptake and compromise the whole strategy. Better to takee a couple of extra months to vaccinate 85% than get stuck at 60%.
And question, even if they know there is an issue do you think the UK authorities would make the information public? I find it curious that the issue has been raised by countries that have injected a tiny number of doses compared with the UK.
I totally get the overall benefit of vaccination outweighs a tiny number of vaccine related deaths (if they are),but public confidence relies on transparency. So I'm happy with decisions being made.
The MHRA would let us know, as TiRed alluded to you - it could quite easily be a batch related issue.
Relevant or not?..
Refers to a case following Pfizer vaccine...
Relevant though. Indicates it’s not a problem with az vaccine per se, possibly a vaccination risk in general. This is a massive worldwide program and things are going to happen. Decision makers need to make good decisions if they are t going to undo the good work of the vaccine program
I'm 53, got a text from local doctors this afternoon. after 29 minutes in their phone queue, booked in for Thursday. Not bothered by the latest issues over AZ, I'll take whatever is being offered. Wife (NHS district nurse team) happens to be booked in for 2nd jab (Pfizer) same day, but thats tagging onto 2nd vacinations at a local care home.
Back towards end of Jan, I worked out that us Group 9'ers would be 3rd-4th week in March based on vac rates, group sizes, and North Yorkshire setting a good pace, even though offical line was "before May". Well Pleased.
I think I maybe had a brush with Covid (or another virus) end of last March, 5 days feeling a bit of a chill, but no temperature or other symptoms, then short period of tight chest, minor breathing problems, followed by 6 months of intermittent sky-high heart rate and occasional dizzy spells.
52 in April, text came through at 4.15 this afternoon when I was driving, appointment booked online half an hour later when I was home, for Friday at 5pm.
I cannot wait, though I was due to do a 100km road ride on Saturday with a mate now we've figured a local route, and I've put him on warning I may have to bail out if I get one of the weird reactions (that aren't blood clotting).
mrlebowski, more than 30% of the adult population have been vaccinated...
Great to see the steady stream of forum members being offered the vaccine. Happy for you and your families.
It’s brilliant that the over 50 group are now getting jabbed. I don’t think Scotland is nearly as advanced unfortunately. I’m banking on hopefully getting mine by the the end of April at earliest (I’m 44), although probably may more likely. Hopefully I’ll be vaccinated a few weeks before things open up here.
Someone told me they were now aiming for everyone before end of June which is a month earlier than I’d thought?
Turns out Notts accidentally (?) opened up their booking system to all over 40s.
tpbiker
Someone told me they were now aiming for everyone before end of June which is a month earlier than I’d thought?
I think on this one single issue the government has finally learnt to under promise, over deliver.
Anything else relating to Covid/Brexit though.... It's BS as normal obviously.
@mrlebowski here's the EPO story https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2730535/ . It wasn't the product per se. The Vaccine is likely different. Perhaps a batch contains something at levels high enough to induce auto-antibodies - or not? But ITP is relevant and can be a serious adverse event.
Mrs TiRed is experiencing the effects post-Pfizer. Nothing to book yet for me, but she's vulnerable and younger. I'm just old and sick!
The Vaccine is likely different. Perhaps a batch contains something at levels high enough to induce auto-antibodies – or not?
You'd think QC would pick that up, but who knows - I've seen some almighty **** ups caught post-release in my time (which is admittedly not that long).
I don’t think Scotland is nearly as advanced unfortunately.
It's patchy - both across Scotland and across the UK.
https://i.postimg.cc/Y06tFsVr/Screenshot-2021-03-15-210415.jp g" alt="" />
Two weeks in a nine month programme is nothing but another “sang contaminé” scandal would seriously reduce vaccine uptake and compromise the whole strategy. Better to takee a couple of extra months to vaccinate 85% than get stuck at 60%.
Makes sense to me.
Turns out Notts accidentally (?) opened up their booking system to all over 40s.
Not for the first time, iirc
57 first jab last Saturday, arm sore as hell, feel a bit shit but not bedridden. I know that I have not had covid as i had a proper test a few weeks ago so maybe i got off lightly.
I made the mistake of opening up the Guardian tab earlier to be greeted with the headline "Chaos in Germany and Italy after suspension of Oxford vaccine" along with a pic of a vaccination center with nobody in sight.
Since when was nothing happening chaos? The bias in reporting on Covid in Europe is disappointing. How about doing some investigative journalism Guardian people rather than publishing more sensationalist nationalistic shite. You're becoming more and more part of the problem.
@Edukator - sadly they are increasingly guilty of low quality journalism nowadays. They still do some good articles but it's becoming quite hit & miss.
What you are saying with that post I’ve quoted is that we should stop all vaccinations until the people who have already been injected are studied for years? ... You spreading the ‘information’ that the vaccine is dangerous when it plainly isn’t puts you in the same group as the anti-vaxxers and conspiracy nutjobs like Lawrence Fox.
Um, did I say any of that?
Ok, silly of me to expect any humility on here, but given the ravaging I got a few weeks ago for asking (yes, asking) about the safety of a vaccine tested so briefly, I do feel somewhat inclined to blow a raspberry at the lot of you.
It is indeed Logic 1 Science 0. Logic (me) said you can’t pick up all side effects in a few months. Science (you lot) told me unequivocally and aggressively that you can.
It will be interesting to see what other unexpected effects crop up in the coming months and years with these vaccines.
It is indeed Logic 1 Science 0. Logic (me) said you can’t pick up all side effects in a few months. Science (you lot) told me unequivocally and aggressively that you can.
It can.
For a properly manufactured batch.
Getting my first jab on Saturday.
Berkshire & I’m just 50!
They still do some good articles
Yup, Marina Hyde and Simon Jenkins though very different styles usually get me reading to the end.
German regulator has released info on their decision to pause
The German authorities have provided more details of what motivated their decision to suspend vaccinations with the Oxford/AstraZeneca jab, saying they had recorded three new cases of cerebral venous thrombosis since last Friday in people who had received the shot.
In a statement, the health ministry said there had been a total of seven cases of CVT since vaccinations with the AstraZeneca jab started, three of which resulted in death. It said the cases were in conjunction with thrombocytopenia, a condition characterised by abnormally low levels of platelets.
“Despite the high number of vaccinations with AZ (1.6m in total), that [the seven cases of CVT] is above average.” It said one would normally expect about 1-1.4 cases in the population over 14 days after vaccination, not seven.
I've noted that the AZ people are quick to point out blood clots are common and not exceptional. What they're not saying is whether the blood clot victim within a few days of vaccination fit in with the long term risk or short term risk. What is chance of having blood clots in any week in the year rather than in any year.
Fatal traffic accidents due to fog might not appear to change annual road fatality statistics much as they only happen when it's foggy. You can't however dismiss fog as being a cause of road fatalities and say they'd have happened anyhow.
They need to look for signs of cause and effect, nad from what I can gather that's just what the various EU health authroities are doing while vaccination is paused.
It is indeed Logic 1 Science 0. Logic (me) said you can’t pick up all side effects in a few months. Science (you lot) told me unequivocally and aggressively that you can
Science has never said that all possible adverse events will be detected within the duration of a clinical trial. Not for any drug. That is why participants will continue to be monitored after the study has finished. It's also why the surveillance of safety of a medicinal product carries on for as long as the product is licensed (and years thereafter, should it be withdrawn for any reason).
What science has said is that the probability of adverse events (and especially serious ones) is sufficiently low that the benefit of the treatment outweighs any harm it could possible do - with vaccines the scales really need to tip very far in the benefit direction, even for COVID-19.
It can.
For a properly manufactured batch
Manufacturing process knowledge is not complete at the time of registration. Process understanding increases with each batch made. Over time, things change - equipment wears/is replaced, new operators are trained, raw material supplies change etc. etc. A batch can be 'properly manufactured' to all current controls and still have an undetected issue.
We are yet to see AZ or a competent authority issue a batch recall notice... Hopefully this won't be the case.
Science has never said that all possible adverse events will be detected within the duration of a clinical trial. Not for any drug. That is why participants will continue to be monitored after the study has finished. It’s also why the surveillance of safety of a medicinal product carries on for as long as the product is licensed (and years thereafter, should it be withdrawn for any reason).
Yes, absolutely. I’m just messing with the armchair experts on here like ElShithead who are so damning of anyone who has the temerity to question the party line.
I'm unlikely to get offered a vaccine any time soon but here's my personal league table at present.
1: Johnson and Johnson. One jab, under three weeks to almost full cover, Brazilian and South African covered.
2: Biontech pfizer
3: Moderna
4; the rest: AZ, Sputnik... .
Any ecperts who have more insight than the press care to comment and/or correct? Who knows, I might even be given a choice.
Most medicines have listed side effects in the hundreds, with incident rates in the 1 per 100 not 1 per million. NICE lists the common or very common side effects of codeine phosphate as
Arrhythmias; confusion; constipation; dizziness; drowsiness; dry mouth; euphoric mood; flushing; hallucination; headache; hyperhidrosis; hypotension (with high doses); miosis; nausea (more common on initiation); palpitations; respiratory depression (with high doses); skin reactions; urinary retention; vertigo; visual impairment; vomiting (more common on initiation); withdrawal syndrome
Yet I bet most of the people saying they wont take the vaccine because a few people got a blood clot would be begging for some opioids if they suddenly had a painful injury.
They feel the need for opioids, it's an immediate problem . Vaccination is different, most people have got this far without catching Covid or surviving it with varying levels of symptoms. Most people can look at the stats and not feel concerned, they might not get it and even if they do it's not an issue for most people.
Most of the people I know who are hoping to get vaccinated are doing it more for the general good than their own health. They want life to return to normal and see getting vaccinated as contributing to that.
But, big but, if they think they are taking a risk by getting vaccinated all that changes. They start comparing the risk of getting vaccinated with the risk of not getting vaccinated. That's where we are now. We need to give people some numbers: at age 50/60 with a,b,c comorbidities you have X risk of blood related issues which might kill you and Y risk of dying if you catch the virus.
I'm sure the numbers will come out vastly in favour of getting vaccinated but people need to be properly informed if they are to persuaded to line up for a jab.
This has got me a little worried, and I will need to speak to the GP, but I'm 50 and currently on Clopidrogel (anti-platelets) and asparin (blood thinning) under the orders of the stroke clinic.
So is the AZ going to have an adverse effect, or be "more" risky* re blood clots?
*if there is a risk.
Or should I aim for another manufacturer's version?
Chance of dying of Covid = 1 in 1000
Chance of Long Covid = 1 in 10
Chance of serious reaction to vaccine = 1 in 225,000
I know what I'm more worried about.
Chance of serious reaction to vaccine = 1 in 225,000
Where does that come from? That's supposed to be the number we don't know yet. As for 1 in a 1000, not if you're skinny and otherwise healthy. And 1 in 10 for long Covid, that needs referencing too.
You don't need to reassure me, you need to reassure the millions who are already sceptical. That needs more convicing numbers than I've seen so far. AZ is bungling it with their dismissive sweeping approach. The devil is in the detail, the Italian cases aren't just the fruit of coincidence. That number of health workers within a very limited time frame needs detailed investigation and explanation. They're doing it, be patient not dismissive.
Patience costs lives too.
I agree, Mefty. I think that impatience will cost more because of a lack of confidence leading to a lack of take up. Vaccination isn't obligatory, you're relying on good will. A two week break wil change nothing, withijn a week of resuming vaccination EU countires will run out again.
A two week break wil change nothing,
More people will die.
Or should I aim for another manufacturer’s version?
Talk to your clinic. The only other "version" available to you right now (BioNTech) is circumstantially linked to more cases of pulmonary embolism here in the UK than the AZ one.
A two week break wil change nothing
It may well feed the anti-vaxxers, who'll be shouting "I told you so", and infecting more sensible people with their logic fails. If this means a serious reduction in people taking the vaccine over the rest of the year, just as our gift of the Kent variant takes hold across Europe... it'll mean many extra unnecessary early deaths. It's not just about the pause.. it's about the effect of the pause on confidence in the public. While it would be nice to imagine everyone will think, "they are being super cautious, that feels me with confidence", I fear that it is more likely that, "my mate was right, he said it can't be safe when it's so new", is a more likely response.
I made the mistake of opening up the Guardian tab earlier to be greeted with the headline “Chaos in Germany and Italy after suspension of Oxford vaccine” along with a pic of a vaccination center with nobody in sight.
The pic emphasises the chaos in the background of all the last minute cancellations having to be done, wasting peoples time and delaying unnecessarily something that'll save lives.
Yo're one liners make you appear to be a number of things I hipe you're not Mefty. Discussions in provacative unrelenting one liners which are demonstrably false isn't constructive.
The total number of deaths will be more closely related to vaccine take up than the speed of vaccination. That is easy to demonstrate, so easy I'll let you do it for yourself.
We have differeing definations of chaos, Larry Lamb. Chaos is what happens when Harrods opens the doors in the sales, not when they are closed due to lockdown.
Chaos suggests a lack of organisation, everything is being very well organised.