Now um this is the paul ehrlich institute and as i say a transparent report now um these are reports received between the 27th of december 2020 which is when the german authorities started their vaccination campaign all the way up to the 31st of march 2022 so we’ve got a pretty big data set
A total of 172 million vaccinations now this is vaccination 172 million this is vaccinations not people vaccinated so this is doses of vaccine given and i like the way that they they do this because that’s what we want to know we want to know the risk per dose given
Is very useful and they’ve received 269 233 reports of suspected adverse events now we are going to unpack this a bit later suspected adverse events what that means but for now let’s just look at the rates overall rate of reporting for all vaccines now this is the overall rate
Of serious and less serious events 1.7 reports per thousand vaccines and according to my maths that is 0.17 um higher than i uh suspected it might be but that’s the data from germany so that’s overall reporting rate for all vaccines but when we look at the more serious events
Reporting rates for serious events is 0.2 per thousand doses according to my math 0.02 or one serious um adverse event per 5 000 doses of vaccine given now given that we are in omicron times now and for the vast majority of people not all but for the vast majority of people
This is a much less serious infection the risk benefit analysis has changed and i really feel it’s time for the risk benefit analysis to be taken fully into account before we uh carry on with further interventions we need to know the risk benefit analysis and the paul early institute is
Very aware of this and we’ll point that out in a minute now let’s just look at the um the side effects that have been reported here now these are per hundred thousand uh vaccine doses so pulmonary embolism clearly quite serious a clot in the lungs um then erythema is redness pain palpitations
Aware of the heartbeat hypoaesthesia lack of feeling um itching myocarditis all of them are there i’m not going to go through them all in detail but they’re all detailed then coming on to the more common ones again we see vomiting cardiac arrhythmias pain and extremities difficulty breathing
Rash malaise you can look through these they’re all there so they’re the actual uh headache of course very common fatigue very common pain at the injection site obviously these are the more common ones so they’re they’re the actual adverse events per 100 000 doses of of vaccine so that’s quite that’s quite um
I think that’s quite useful to know what the particular the particular events are now just before we go and i will show you the site that this comes from so you know this is um directly from the paul eric institute this is the site here um it does have the safety padlock at
The top of the site you can go onto it the information’s there you can click on it you can get the full reports it’s very transparent very clear what they’re talking about and there’s the full uh the there’s foot there’s full details of the full safety report for example i
Think is under this one here so again full details very clear and of course it might not have escaped you notice i’m sure back to you it hasn’t that this is german so this is the full english language version that the german authorities have uh kindly supplied for international uh enlightenment so um
Get getting back to the report definitions adverse events are noxious and unintended reactions to the medicinal product that’s their definitions now um the vaccines that we used uh 73 pfizer 17 modernist 7.4 percent astrazeneca 2.1 janssen and uh 0.1 nova vaxx um you can get the full details on those again from the
From the site where that is supplied now um before we go on i think we should notice that um this is the overall these are the overall figures this is the amount of uh adverse events reported now these are reported after the vaccine has been given so
You could say that these are simply temporal correlations vaccine given adverse event reported it does not demonstrate causality so the real number of adverse events could be less than this but there again we can assume that not all adverse events were reported or recognized as such so that number could actually that would
Tend to increase that number or vaccine adverse effects might be delayed for a period of time outside the time frame and have not yet manifest so that could be higher than that number so this is the number that’s actually reported temporal correlations may actually be lower than that that
The fact some some people are going to have these adverse events after the vaccine which would tend to lower that number but as we say lack of reporting could actually increase that number but that’s the data that we have and we’ve looked at the particular effects now further things to notice from this
Report um reporting rate after the booster pfizer of pfizer and moderna was lower than after the primary immunization so it seems that with pfizer and moderna um the primary immunization was associated with a higher rate of these um these adverse reactions i’m just looking for the precise term yeah
Adverse events is what we call them i don’t want to get this wrong these are described as adverse events serious adverse events and uh overall reporting rates for all vaccines so um paul ehrlich institute will closely monitor continue to investigate cases of myocarditis pericarditis of course thrombosis which is the blood clots
Immunologically mediated adverse events such as immune thrombocytopenia where there’s not enough platelets in the blood that can lead to bleeding complications and can actually as the platelets are used up can actually lead to clotting complications as well it can lead to both occurring after administrations of approved vaccine so we see the temporal
Correlation not necessarily caused by the vaccine but of course not all vaccine adverse events necessarily identified full detailed report there now this is the full detailed report here that is the link for it um it’s very very very readable um given that this is written this is the english language version
It’s much easier to understand than um certain other authorities uh might uh present their data personally i find it a lot easier to read than cdc information for example that’s just me um maybe i have difficulty with the american uh modality of expression but i did find this particularly easy to understand
Um other things to notice the german paul ehrlich institute authority responsible for monitoring and safety of vaccines and bio medicines good uh institute’s division of pharmacovigilance collects uh and reviews reports on adverse drugs effects so this is the paul ehrlich institute of pharmacovigilance this this is post trial post-trial data collecting and of
Course this is good i mean most countries collect this but the the germans present it very very clearly uh in in maya or clearly in a way that i’m able to understand anyway reporting suspected cases of adverse events is a central pillar for being able to judge safety of medicines of course
We need to know the data new signals anything cropping up can be detected in a timely manner early hopefully and the risk benefit profile of vaccines can be continuously monitored this is what we need to look at the risk benefit analysis and personally i’m interested in the risk benefit analysis for me
This should be done i believe on an individual basis what is the risk benefit analysis for the individual and this data allows us more accurately to make these kind of assessments even reactions with a timely relation to a vaccine do not necessarily have a causal relationship so these are temporal correlations
Therefore it may represent over-reporting but as we said not all adverse events may be reported safety reports um open communication of risk includes potential ones is the prerequisite for high acceptance rates of vaccine amongst the population we have to have trust the benefits of the covered 19 vaccination for
The health of individuals and the population as well as their affecting combating pandemic pandemic essentially depends on confidence in the vaccine is essential to get the benefits of the vaccine so we have to have confidence and we can only have confidence when we have transparent data paul ehrlich institute publishes continuously
Or suspected cases reported in germany excellent this is an ongoing basis this is a summary report and adverse events of vaccination and complications in a temporal relationship with a covid19 vaccine and of course it’s up to uh hopefully the further aspects of pharmacovigilance that clinicians can evaluate the probability that any adverse events
Is actually caused by the vaccine or it’s the temporal correlation that they can they can hopefully be in a position in a specific case by case basis to evaluate causality reporting suspected cases for adverse events healthcare providers of course marketing authorization holder and persons vaccinated or their relatives
So um there we go um that’s the report um this is the the bottom line which is really the uh the top line is the overall numbers and uh just to close and summarize that’s what they are there 172 million vaccines 296 000 reports of suspected adverse events
0.17 percent of overall adverse events and for the more serious adverse events it was no point 0.92 one per 5 000 doses of vaccine so come on other countries let’s have similar transparency in reporting so even someone like me can understand it that would be great thank you and thank you for watching
