Concerned about having second jab of AstraZeneca

[LuluJakey1]

I have read all of the stuff about AstraZeneca and blood clots and felt the EU was making a fuss about something the WHO and EMA were saying was not a significant issue.
However, I have become increasingly worried over the last few days when further reports have emerged. They are all linked to AstraZeneca, not to Pfizer.
This is in The Independent which is the first time I have read of the medical profession here recognising it as an issue and warning Drs about it.
www.independent.co.uk/news/health/coronavirus-astrazeneca-vaccine-blood-clotting-doctors-b1826144.html
It raises some very interesting points.

I am worried about having the second jab. I am now feeling the government are trying to sweep it under the table' because they have bought so many doses and could not vaccinate everyone without using AZ.
AIBU to be considering not having the second jab?

What I would like to do is leave it for a while and then have two doses of Pfizer. Does anyone know if that is even medically possible?

Yanbu

I started having nosebleeds and bleeding from my gums after the jab. No previous clotting issues but 2 deaths in my family from clotting disorders.

My gp was concerned enough to do all sorts of tests. No real answers.

I'm scared to have the 2nd one and I'm very pro vaccination.

Surely bleeding is the opposite of clotting?

The nosebleeds could just be coincidence. I think it's quite common for nosebleeds not to have a known trigger, though high blood pressure is often a cause. And maybe hay fever?

Thank you to those who have explained the real risk and the potential issue, and how it is different to a "normal" blood clot. Luckily I've had my platelets checked recently and they are in the normal range.

YABVU OP

Take the second jab

Covid causes more blood clots than the vaccine. 🤦🏼‍♀️

Maybe I am wrong. Maybe you run trials and know more about this than me. I read a lot of trials, have been a PI for trials in the past in other areas and volunteered in this one.

My understanding has always been that the point of a phase III clinical trial is to determine how efficacious and how safe a treatment is and to balance the two and that no medicine would be licensed if risk outweighs benefit

Obviously the exact benefits aren't known pre trial but they are estimated from pre clinical and phase 2 studies. You then do a power calculation to determine the number of subjects required to show a statistically significant benefit and to show up any significant harm.

Very rare side effects can be and are uncovered in post market surveillance because trials are not powered to show up very rare things but commonly occurring side effects that are more common that the benefit would occur in the trial

Since there is no randomisation or blinding it is much harder to determine causation from correlation for surveillance data

This issue is not yet determined to be a side effect. It might be or it might not be and there is no reason to pause therefore

Germany were wrong about AZ not being of benefit to over 65s and wrong about a 12 week dosing gap being less effective so why are they suddenly so certain to be correct about this? They have taken a more cautious approach but that might not be the correct one. It could result in more people dying of COVID whilst unvaccinated. There is a cost to pausing the programme that outweighs any benefit of doing so at present in the opinion of both the U.K. and the EU regulators but not in the opinion of some individual countries.

When the regulators say it should be paused then I will agree it is risky but not until then.

@CovoidOfAllHumanity

Maybe I am wrong. Maybe you run trials and know more about this than me. I read a lot of trials, have been a PI for trials in the past in other areas and volunteered in this one.

My understanding has always been that the point of a phase III clinical trial is to determine how efficacious and how safe a treatment is and to balance the two and that no medicine would be licensed if risk outweighs benefit

Obviously the exact benefits aren't known pre trial but they are estimated from pre clinical and phase 2 studies. You then do a power calculation to determine the number of subjects required to show a statistically significant benefit and to show up any significant harm.

Very rare side effects can be and are uncovered in post market surveillance because trials are not powered to show up very rare things but commonly occurring side effects that are more common that the benefit would occur in the trial

Since there is no randomisation or blinding it is much harder to determine causation from correlation for surveillance data

This issue is not yet determined to be a side effect. It might be or it might not be and there is no reason to pause therefore

Germany were wrong about AZ not being of benefit to over 65s and wrong about a 12 week dosing gap being less effective so why are they suddenly so certain to be correct about this? They have taken a more cautious approach but that might not be the correct one. It could result in more people dying of COVID whilst unvaccinated. There is a cost to pausing the programme that outweighs any benefit of doing so at present in the opinion of both the U.K. and the EU regulators but not in the opinion of some individual countries.

When the regulators say it should be paused then I will agree it is risky but not until then.

Yeah, I also understand a thing or two about medical trials. I am also very pro vaccination just to be clear on this point.

If we are talking about say, a drug to treat a disease in a specific person than yeah, it is feasible to try and balance benefits vs risks to a specific person taking the drug. This is exactly what German government did when it advised to stop giving the vaccine to those under 65.

Unfortunately in the situation of this vaccine as a whole it is far less clear how to define benefits. Society clearly benefits if people continue getting the vaccine even despite this very small but serious risk to their own health, but will they take it if we don’t disclose all risks and moreover do so in time?

This issue clearly is serious enough to be investigated. Is it really ok to wait until the final decision by the regulator keeping in mind that if the final decision is to stop vaccination in some age groups then we let some people endanger themselves? Or would it be prudent to withhold the use in this population while the decision is pending? When side effects like this occur in a trial the entire trial is held (in fact exactly this happened to AstraZeneca - although the side effect was judged to be not connected to the vaccine).

Why should it be different now? It is a tough question, that has not much to do at all with science, unfortunately.

Has anyone seen any data to show the length of time between being administered AZ and the colts occurring? I've RTFT but I can't seem to spot this

*clots

Up to 20 days was what was reported I think.

Vangogh

Its thrombocytopenia. It's rare but can be fatal. Causes bleeding but also clotting issues. Its acknowledged as a rare but recognised risk.

I've never had a nosebleed in my entire life until the morning after the jab. It just wouldnt stop. From my gums too. I'm on no medication and bp is fine. I dont have allergies. My gp yellow carded it.

I've had jabs all my life and never reacted like this. I think there's something to the concerns being raised.

Covid-19: France enters third national lockdown amid ICU surge www.bbc.co.uk/news/world-europe-56622471

Risks of pausing vaccination programmes are starting to be evident in France and Germany who are going into lockdowns

Willyoujustbequiet

I assume your GP checked your platelet count and your D dimer for clotting issues. If they did that it will easily rule out it being VIPIT. It sounds like they did take it seriously and report it.

I don't think bleeding is indicative of the rare vaccine induced clotting disorder (VIPIT) but obviously it can be something else eg ITP

I can understand you not wanting another one and it's a personal decision in discussion with your Gp. You do get a pretty good level of immunity from 1 jab but the problem is we don't know how long that would last.

"This is very very unfortunate however you cannot expect people to risk their own health even though on the population level this would be clearly advantageous."

We do expect 'people' to do this though, or rather, we risk CHILDREN, because no vaccine, including those commonly, or almost universally, given to children do carry some risk. We accept this risk (or more likely we don't even think about it) because it's known that the risk of adverse effects of diseases (which are usually overcome by healthy children) is more than the the risk of adverse effects by vaccine.

Stop thinking of vaccines as 'safe' or 'not safe'. None of them is entirely either of those two things. Learn to weigh up risk.

because ALL vaccines, including those commonly, or almost universally, given to children do carry some risk. (typo)

Covid

Thanks. Yes it was ITP that was the concern as there was sudden onset causing a tragic fatality in a young person in my immediate family.

I'm still pro vaccination. I just dont want to risk oxford again. I need to see if its possible/advisable to try a different one.

There are always going to be worriers when they read about some new information about the vaccine issues., But it seems silly to avoid the second jab, when you have already had your first one..

I am more concerned, that I have lost my little card that was given to me, stating the time and date for my second jab in MAY. !!

A medical internist explains the nature of the rare side effects linked to AZ:

twitter.com/sharkawymd/status/1378147622997929984?s=21

(My jokey new username seems in bad taste on this thread. Sorry)

And his conclusion about the demographic affected based on what we know to date:

“IF you're a WOMAN < 55 & no other (vaccine) options, risk of Covid-induced clots, getting very sick/death vastly outweighs risk of VPIT. In this case, makes sense to take AZ no question. If options exist, doesn't make sense to limit use to AZ only.”

No-one in tbe world has ever had a blood clot before, all that pesky vaccines fault.

Hollowgast

As someone on here said: if nobody had a blood clot after the vaccine, it would have been a cure for blood clots.

Well, yes, if it was a positive effect possibly linked to vaccines then nobody would even bother investigating it...they’d just market it as a wonder cure....but if a possible negative effect we get the standard “correlation doesn’t equal causation” nonsense.

Any effect (positive or negative) needs to be investigated. These rare blood clots are being seen (certainly on this thread) as a binary outcome (you have the jab and you are fine (very common outcome) or you have the jab and get very very rare low platelets with bleeding and blood clots). There must be a sliding scale of effects relating to this issue (in the same sense anaphylaxis is a rare but severe reaction but there are also many milder allergic reactions such as rashes, hives, itchy skin). And in the same sense that people react mildly, moderately or severely to the virus itself. You don’t have a binary outcome of healthy or dead when you catch covid. There are many mild, moderate and severe side-effects such as headache, body pain, loss of taste/smell, lung damage, pneumonia, death, among others. We don’t yet know what underlying effects any of these vaccine might be causing, and these blood clots have only been flagged because they are obvious (much like deaths). When people say the vaccines haven’t had enough testing this is exactly why.

There should really be follow up blood tests on a large sample of vaccine recipients to check for unusual signs such as low platelets even in the absence of severe clot events. This may or may not be happening, but I haven’t heard of anyone having post vaccine follow ups other than the original trial participants (briefly) and specific trials (AZ effects in type 1 diabetes patients).

I have a blood clotting disorder and one thing I have learned is that blood is weird. How it behaves in the body is not necessarily how it behaves in a test tube.

The problem when looking at possible rare side effects is that you are dealing with the statistics of small numbers. One more, one less skews the numbers and can make something seem significant when it isnt.

@FrancesSaid

No, they wouldn’t be allowed to make claims on its efficacy as a wonder drug for blood clots without medical trial evidence. The rules around advertising are surprisingly strict (in this country at least).

The vaccine very likely (certainly if you ask me based on published information) has a potentially fatal side effect

So do a lot of other vaccines and medicines but people still take those without question.

@Willyoujustbequiet

I've never had a nosebleed in my entire life until the morning after the jab. It just wouldnt stop. From my gums too. I'm on no medication and bp is fine. I dont have allergies. My gp yellow carded it.

I've had jabs all my life and never reacted like this. I think there's something to the concerns being raised.

I'm the opposite. My gums have bled for years when I clean my teeth, in spite is scrupulous dental hygiene. I'm also on blood thinners for a heart condition, but that is not the cause. When I had my first AZ jab the bleeding stopped. It may have been a coincidence, but it's all very weird. I've now had my second jab which I'm very grateful for.