MedEwok the aspect I find so depressing about this whole saga, is what appears to be the lack of data in the public domain. I am sure it is there – but where.
Graham in his post has pointed to the excellent data that has been published which is open for scrutiny.
These assertions we are seeing that the vaccine might be unsafe, just does not seem to be supported by data we can examine in the same way?
I would love to see a link please (which I am guessing there must be?)
(notwithstanding, I feel even more strongly that each nation (or the EU) must of course act as it thinks fit, but if it decides not to use a particular vaccine, then it should not stockpile the vaccine, and should release stocks to those countries that are happy to use the vaccine).
Fuji_Abound wrote:
I dont know how the system works in Germany. Can you shed any light on why your national regulator has not taken the same stance?I dont see the new recommendations here – should they be?
It looks like they did not post this in English (yet). The German press release is here
It should be noted that the latest development, that the AstraZeneca vaccine is not recommended for under-60s anymore, is not due to any regulatory initiative. It started out as an initiative by several Berlin hospitals and other university hospitals to no longer vaccinate their (female) under-55 staff with the vaccine, due to the accumulation of CVST. The STIKO then followed suit. The regulator (BfArM/PEI) did not change anything (yet) and have generally by-and-large followed EMA in this context.
The regulator only regulates wheter a pharmaceutical is safe enough for public use, while the STIKO is responsible for determining which vaccines should be given to whom. Their decisions are not legal decisions in a narrow sense, but medical recommendations which doctors may modify or disregard within the scope of their freedom to practice (but disregarding the recommendations needs to be done carefully and requires full informed consent of the patient).
So, to summarize: AstraZeneca vaccine can still be used for under-60s, it’s just no longer “recommended” and doctors must inform the patients willing to take it anyways about the risk of thrombosis.
Fuji_Abound wrote:
MedEwok the aspect I find so depressing about this whole saga, is what appears to be the lack of data in the public domain. I am sure it is there – but where.
Some official data can be found on the site of the Paul-Ehrlich-Institut (PEI), Germany’s regulator for vaccines:
MedEwok wrote:
…and doctors must inform the patients willing to take it anyways about the risk of thrombosis.
How is that ‘risk’ officially described and communicated, given that (to my knowledge) no regulatory body has concluded it actually exists?
Or do they describe it informally – e.g. some of this has been seen and we’re not sure what’s going on and if there is even a link, but you might like to know, etc?
Graham wrote:
How is that ‘risk’ officially described and communicated, given that (to my knowledge) no regulatory body has concluded it actually exists?
Well, the PEI as Germany’s regulatory body for vaccines has certainly and officially concluded it exists. See this Information for Medical Doctors release from March 19.
A combination of thrombosis and thrombocytopenia, in some cases accompanied
by bleeding, was very rarely observed after vaccination with AstraZeneca’s
COVID-19 vaccine. The majority of these cases occurred within the first seven to
fourteen days after vaccination and were seen in women under 55 years of age,
but this may reflect the increased use of the vaccine in this population. Some
cases had a fatal outcome.Medical doctors should be alert for clinical symptoms in vaccinated individuals that
may indicate a low platelet count in the blood or thrombosis.
Vaccinated individuals should seek immediate medical attention if they develop
symptoms such as shortness of breath, chest pain, arm or leg swelling in the
weeks following vaccination. Also, individuals who have small pinpoint
hemorrhages (petechiae) or bruising of the skin beyond the vaccination site in the
days following vaccination should seek medical attention immediately. A
coagulation diagnosis with blood count and determination of the platelet count
should be performed during the work-up.The leading symptoms of sinus vein thrombosis (CSVT) are persistent headache
and other neurological symptoms. However, because transient headache may
occur as a vaccination reaction in many individuals, it is not necessary to perform
further neurologic diagnosis with imaging in everyone who complains of headache
after vaccination. This should be reserved for individuals who notice severe or
persistent headaches over a period of several days in the first two to three weeks
after vaccination that do not respond, or respond inadequately, to the usual overthe-counter analgesics. In such cases, and especially if additional neurological
symptoms such as hemiplegia and/or sensory disturbances, speech disorders, or
epileptic seizures develop, further diagnostic testing should be performed
immediately.
MedEwok wrote:
has certainly and officially concluded it exists
Without wishing to be pendantic, where have they made this conclusion?
I dont read this report as a conclusion, at least in the sense there is a statistically proven link.
To paraphrases the report says this is a very rare event. Then it goes on to say the age group in which this very rare event occurred. It draws no comparison with the normally expected numbers in this age group, and it makes no observation about the statistical significance.
Are you happy to say – it has been officially concluded there is a statistically proven link between AZ and this condition based on just this evidence, or do you rely on something more?
I also dont understand how this results in the vaccine not being recommended, but never the less appropriate to the practioners discretion.
Clinically what patient presentation should the clinician base his reservations on? Do we know for example whether hypertension would be a contra indication? Do we have any medical history from those with side effects whether there is any commonality between them? Why would you effectively tell the whole population the vaccine isnt recommened with one breath, but then leave to the clinician and patient to decide? Indeed, how even is the discussion held? I assume like the UK the vaccine is not adminstered by trained clinicians (doctors), so how can there be an informed discussion?
Sorry for so many questions, but I just dont understand how this works. It sounds great on the surface, but does it stand up to scrutiny?
That’s what I’m getting it – it says ‘observed after’ – it does not state a link.
It’s not the same as writing on the packet “may cause XXX”.
LeSving wrote:
She is nurse, and had the AZ vaccine about 5 weeks ago. She is still feeling side effects like headache.
Or she believes this is a side effect.
Judging my case (and my wife’s case), there are no side effects of AZ vaccine. Literarily zero, even place of injection was invisible 5 min after being jabbed. But individual cases don’t count. It’s total number that’s important within certain group and conclusion withdrawn from wider picture.
BTW within family we got all three (Pfizer, AZ and Moderna) and nobody had any side effect at all, including my 83 year old mother who got Moderna.
Well, I finally managed to get dates for vaccination in mid April and mid May respectively. So far, AZ is not released here and so hopefully I’ll get either Pfizer or Moderna. Will see.
MedEwok wrote:
A combination of thrombosis and thrombocytopenia, in some cases accompanied
by bleeding, was very rarely observed after vaccination with AstraZeneca’s
COVID-19 vaccine.
BTW when you read the data their are lots of reports of rarely observed conditions. This true of all the vaccines.
Rarely observed conditions are one thing, and a direct statistical relationship between the two, another. Lots of these events (rare or not) occur in the population without vaccines. Are any of these events statistically more common (and by how much) after the vaccine? Produce valid data and I am sure every regulator will sit up and take note.
If the data already exists, post it up. I would argue, simple really. Why are connections be inferred, without setting out the scientific bais. I might not understand, but hell I would like to have a go.
