I don't disagree. But I will observe that many people in the low(er) risk tier are going to be traveling, eating out, having parties, etc. sooner rather than later--vaccine or not. In my very Blue state people are very obviously relaxing a whole lot more. So the question isn't whether things open up or not. It's whether people are vaccinated when they do. (Which doesn't mean all vaccines are equally safe.)
J&J is also widely used in the US for people who might have issues with scheduling a second shot, for example people who are homeless, or are home-bound.
I don't think the drug safety system is set up to effectively evaluate the cost/benefit of the pause itself in a pandemic scenario.
“Don’t wear masks.” “No, no: wear masks.” “COVID kills over 10%.” “COVID kills less than 0.1%.” Once we realized the difference in makeup between the over-10% and sub-0.1% populations, we still couldn’t bring ourselves to make data-backed differentiations for many, many months (and still today have many small businesses closed or restricted based on what they do rather than the risk profile of their owners and employees).
These are difficult decisions to be sure, but when being seen as on the “safe side” confers benefits without a commensurate charge for the risk of the “safe” action, you get a society which moves in the direction of perceived safety (and where perceived safety may be strongly sub-optimal).
yes, security theater abounds. it's a multidimensional optimization problem with no absolutely safe side in the long run, only relatively, but often initially unintuitively, safer non-linearly intertwined sets of actions. it's hypocritical to discount the tiny risk of vaccines while dramatizing the tiny (but larger) risk of death by covid. further, it's myopic to look at the risks of covid in isolation (which is what all the frenzy around it has been doing for over a year) rather than in relation to all the similar risks in our lives and couching our responses now within our existing responses to those other ongoing risks.
How does one do that math ethically? There are risks if you do and risks if you don't. The FDA is the wrong group to make that call, because they're only concerned with the first kind of risk.
In Canada we reserved the Astra Zenica vaccine for people over 55 because of the blood clot issue. I think that's probably the right call.
This is a highly unusual situation insofar as phase III monitoring is far from complete and there is no 'phase IV' (confirmatory) trial data at all yet. In the normal course of research, this is how we'd catch rare but consistent adverse effects.
So, if we had complete trials on a normal timeframe, then obviously there's a different calculus to apply.
But given what we know at this moment, these six incidents might actually be far more normal than the crude use of six as numerator and seven million as a denominator.
A pause to assess the data and allow any lag to resolve seems prudent.
And, while this will be very difficult to quantify until much later, if then, I surmise that this will only create temporary vaccine hesitancy and only outside the high-risk tier, which is perfectly rational.
For people in the low-risk tier, there's nothing wrong with waiting until the conclusion of the RCT monitoring in the first place, even if adverse events weren't the basis of that decision.