So Germany followed suit today in what appears a bit like vaccine hysteria, but not based on PE. Instead based on 7 cases of sinus venous thrombosis in 1.6 million people. I’m going to put this in context below of 1/n
Normal annual rate is apparently anywhere 2-15 per million. link.springer.com/article/10.100…
In UK 3 have been reported (I am told) in 11 million 2/n
So in the UK in the vaccine time window we are square within expected rates having vaccinated 10x the amount they have (so our sample size is much better). In Germany they have a much smaller sample size and so at risk of random chance but let’s give benefit of doubt 3/n
Let’s say for argument sake there is a 10fold increase. This would still change almost nothing about the risk/benefit calculation of vaccinating a population (where risk of Covid-19 still easily outweighs risk of vaccine) or for that matter an individual (for same reasons) 4/n
Now some individuals may choose to not have a vaccine because of this risk and that should be their choice, made with the best of information available. However by suspending vaccine programmes for single figure side effects Europe is dooming its programmes 5/n
By definition every single statistically underpowered but emotive “cluster” of events will logically follow the same stop/start process. Achieving proper power to define if any of these are real will take them forever, confidence in vaccines will struggle to recover 6/n
and the slow pace of vaccination will ensure any small chance we had of getting cases low enough to reduce chance of viral escape will evaporate (though this is probably happening anyway regardless). 7/n
Part of our job here is to communicate risk. I have consistently said vaccines are “safe” but clarified this does not mean they are without risk. Specifically I have tweeted about the difficulty in defining rare event risks and that once we get to this level it means 8/n
Regardless if any emerge, the balance of risk vs benefit must always be in favour of a vaccine. This is where we sit now with all the vaccines. Rare effects may emerge and take a while to confirm or refute. By definition they should not affect our programmes 9/n
And by going down this route based on tiny event numbers, Europe is storing a long term problem it will come to regret (and so will we)
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Never make predictions. Especially about the future...
Here’s what will happen with vaccine clots reporting in next few weeks 1/n
1-2 weeks of loud noises about need for high safety bar. I’ve spent some time assessing causality of events for drugs- at least half of the reported cases will be complicated and best the European regulators will be able to say is 2/n
“Possibly related”. Even if a handful are more clear cut it is hellishly difficult to be definitive for individual cases so these will go into “probably” column. 3/n
I have tweeted about likely over-reporting of side effects of vaccines extensively in the past but will have another go again for pulmonary embolism as it is my area of expertise 1/n theguardian.com/society/2021/m…
Firstly this was always going to keep happening. Take any intervention rolled out to whole populations and there are going to be a lot of spurious associations made and links touted that eventually quietly get shelved 2/n
We have already seen it a few times in the trials and in the post roll-out stage and it will happen again. The PE one seems weaker than usual given the high volume of vaccinations and lack of any suggestion in any other population, but as with all of the previous dramas 3/n
Quick tweetorial on why the design of the different vaccine studies is important. I'm also going to talk about how reporting has coloured the debate.
My disclosures- Minor investigator on ChAdOx trial. No funding to declare. 1/n
First thing is funding/ sponsorship (who is responsible for trial). Most western vaccines are commercially sponsored and funded though with variable govt involvement. Exception was ChAdOx which was sponsored by Oxford Uni (with some trials yet to report further from AZ) 2/n
Why is this important? Because you may want to know how independent the studies are. E.g. Some concern about Russian Sputnik because it clearly isn't. Some people don't trust drugs companies so those ones may come under different scrutiny. 3/n
@BijuCherianDr really important point in thread (and thanks for nod). We saw early in ChadOx that BAME underrepresented. This is panning out also in vaccine rollout. We need to urgently address complex, difficult community concerns. 1/n
Valid and deeply held concerns about govt, institutions and medical scientists that have not always had their back. These are added to the normal mix of mostly addressable safety concerns. I’m white and pretty privileged. Hard for me to walk a mile in their shoes. 2/n
We need community voices, strong leadership from trusted sources to stand up and join us. By definition this will not be won by public health/govt or even NHS and independent scientist voices because 3/n
Thought a longer thread on the Pfizer delayed dose in UK might be useful. 1/n
Firstly important to keep local UK context clear. Pfizer will end up a minority vaccine in UK so this will not have much of a long-term effect on population coverage. However because of the way we are prioritising, it will disproportionately land in 2 groups. 2/n
Those are HCWs and over 80s. HCWs are as a population low risk for serious complications. They are at the front of the queue for the same reason you put your O2 mask on yourself first before your child on an airplane. Right now we are generally pretty critical. 3/n
However most of this data pertains to younger HCWs. I still think for HCWs the UK calculated gamble to delay second jab is reasonable and one I am personally comfortable with having had only one. I haven’t seen any older population data... 3/n