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
Some may go into “not related” but even if they don’t it will make no difference because regulators will be left with a handful of cases either way. 4/n
Scientists will do maths and “risk” may increase from roughly 0.0002% for a rare thrombotic event for an individual to at very highest 0.002% or more realistically 0.0004%. Some might call this 2-10x risk but don’t be fooled by relative vs absolute risk. 5/n
2-4 weeks. Programmes will then be opened up again- how can they justify any other course of action vs a disease with a 1%+ mortality, 30% readmission rate and 25-50% persisting long term symptoms. 6/n
Regulators/scientists/politicians making these calls will now be on defensive again (see over 65s). They have sunk costs in justifying these actions. Public effect will be complete opposite of desired effect. Vaccines will go to waste, roll out will slow further. 7/n
4-6 weeks. Attempts to shift blame and they will try to move story back to lack of supply or to some nationalist or local political angle as this always plays well to someone. 8/n
Next cluster of rare things happens. Remember there are literally hundreds of rare things that can happen and they happen stochastically (at random). When we look for patterns, we see patterns (observer bias). What do they do now? 9/n
Having set the template twice (over 65s and now rare events), do they shut down again? Not doing so will be an admission they got it wrong last time (more sunk costs). Politicians not great at admitting mistakes (neither are scientists!). 10/n
At this point everybody is confused. Cases will be going back up. 8-12 weeks. New variants are now embedding but cavalry is arriving with updated vaccines. Safety needs established again and we are back to the start. 11/n
We need to break this cycle at some point. We need better international co-operation and to start listening to the WHO, the only organisation that can carry this. They are not perfect but they have been right on nearly all the big things and have clear vision on vaccines 12/n
We need better message discipline and communication. We are so distracted by this that we haven’t even started to put serious energy into developing countries with no vaccines yet. This is where the big battle lies.
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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
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