I get the need to make sure medicine is safe and effective, and we absolutely should follow those to a T when it comes to new medicines on the market in non-emergency situations.
However, that's not the case here. vaccines are well studied in general and J&J is one of the more "normally developed" vaccines on the market. After generally ensuring that it's safe (Phase I/II tests), there should have been a damn good reason to pull it even temporarily. The "we are seeing a small increase in blood clots" really doesn't seem like a valid reason to pull a vaccine.
Personally, I lay the blame primarily on anti-vaxxers. They've made us far too cautious around vaccinations. It has screwed up our risk management rules. I've no doubt that this pull back will result in anti-vaxxers publishing BS about the safety of J&J vaccinations to try and scare people away from it.
This has nothing to do with "anti-vaxxers". Vaccines usually take years to develop precisely because we give them to everyone, and rare, long-tail risks matter. This was the case well before the MMR autism scare defined "anti-vax" as it has come to be known today.
In this case, we bypassed that standard development process. It was the right choice, in my opinion, but it's not the right attitude to start claiming that our standard level of risk mitigation for vaccines is excessively cautious because "anti-vaxxers" exist. That's simply reactionary.
If anything, we've tossed out all of our usual standards of evidence in 2020, and did a bunch of stuff willy nilly, with no supporting evidence or rational consideration of trade-offs. We tore off all the safety belts. We don't need lower bars for evidence, we need less reactionary hysteria.
The vaccine trials were limited in their power to detect rare events. The Pfizer trial [1], for example, explicitly said that events rarer than 0.01% are less likely to be detected:
> This trial and its preliminary report have several limitations. With approximately 19,000 participants per group in the subset of participants with a median follow-up time of 2 months after the second dose, the study has more than 83% probability of detecting at least one adverse event, if the true incidence is 0.01%, but it is not large enough to detect less common adverse events reliably. This report includes 2 months of follow-up after the second dose of vaccine for half the trial participants and up to 14 weeks’ maximum follow-up for a smaller subset. Therefore, both the occurrence of adverse events more than 2 to 3.5 months after the second dose and more comprehensive information on the duration of protection remain to be determined. Although the study was designed to follow participants for safety and efficacy for 2 years after the second dose, given the high vaccine efficacy, ethical and practical barriers prevent following placebo recipients for 2 years without offering active immunization, once the vaccine is approved by regulators and recommended by public health authorities. Assessment of long-term safety and efficacy for this vaccine will occur, but it cannot be in the context of maintaining a placebo group for the planned follow-up period of 2 years after the second dose.
Even a 0.001% risk is not small, when you're talking about giving the vaccines to billions of people.
(I don't mean to single out Pfizer here. It's just the one I've read most recently.)
Anti-vax hysteria has been around for longer than MMR and autism.
> rare long-tail risks matter
I agree, but at the same time I also think that it's an overblown problem with vaccinations. We aren't talking about medication that screws around with the metabolism in unusual ways. Vaccines (other than the newer mRNA stuff) are by and large large enough chunks of whatever we are vaccinating against to trigger an immune response when the real thing comes along + preservation/delivery medium.
At the end of the day, the worst case for vaccination is that you might be infected with the disease you are vaccinated against (when live viruses are used).
That's not the case for J&Js vaccine.
So the next question is, if the worst case scenario is you get a disease you were attempting to prevent, then what is the next real biggest threat from a traditionally developed vaccination?
> If anything, we've tossed out all of our usual standards of evidence in 2020, and did a bunch of stuff willy nilly, with no supporting evidence or rational consideration of trade-offs. We tore off all the safety belts. We don't need lower bars for evidence, we need less reactionary hysteria.
I'd argue that pulling a vaccine over a very minor number of reports of increased blood clots is overly reactionary.
Edit: And... reading this it makes it sound like I'm skeptical of mRNA vaxxes. Just to be clear, I'm not and I've gotten the pfizer vaccine myself. I do think they'd have more justifiable scrutiny to make sure they are safe as it's a new technique for mass vaccinations (even though it's been used in immunotherapy for a while now).
The worst case for vaccination isn't that you get the illness. It is that you are one of the unlucky ones that gets some severe reaction and gets killed.
However, keep in mind we are continuing the vaccinate people are a really high rate, we just are not using the JJ vaccine. No one is stopping all of vaccinations. A brief pause in JJ while they relabel is just a minor hiccup in our overall vaccination plans
I think some people would choose the J&J vaccine if it meant getting vaccinated faster. Some people would choose Moderna / Pfizer, later.
It really depends on things like whether or not you can work from home, how depressing it is not interacting with people, or how concerned you are about the risk of long COVID19. That's not something we can answer for anyone centrally.
From a public health perspective, vaccinating people now with Johnson is an obvious win.
I think this is unrealistic for medical application, not only for vaccinations but in general for anything related to side effects of drugs.
First of all, most people don't have the data and in this case part of the risk management is to get more data or consolidate and evaluate existing data more thoroughly. Second, while you might be an exception, the vast majority of people do not have the knowledge and skills to properly assess risks or perform multiattribute cost-benefit analyses. Layman cannot even compare small probabilities correctly and frequently mix up risks that differ from each other by multiple orders of magnitude. Even people with fairly good knowledge of probability theory will have a hard time judging small risks without extensive comparison data and maybe some didactic tools like "micromort" comparisons.
So do public health professionals. The passive death and disability from COVID19 is weighed far less than the active death of side-effects. Providing J&J to everyone in the US would obviously reduce spread and reduce the thousand-or-so deaths we're continuing to see in the US every day by far more than blood clots.
In general, doctors leave medical decision making to patients, is central to medical ethics. This even applies to patients with incomplete capacity.
And the damn good reason was that there's a bunch of people out there who don't want to take the vaccine for political reasons. And there's a smaller amount of people who don't want to take the vaccine because they're uninteresting in taking a new vaccine. They're looking for reasons to validate their fears.
If you just keep pushing the vaccine even though a bad thing happened to a small number of people, then there will be people who use this as an excuse to avoid all of the vaccines completely.
Take down the vaccine and make a bunch of lab coats spend a hectic two weeks double checking some figures and people will feel listened to and they'll have less arguments to not get the vaccine. The vaccine that you're taking is as safe as it can be. After all when we saw a problem we did something about it.
This is 100% about optics and PR AND that's 100% necessary right now in order to get the job done.
> I lay the blame primarily on anti-vaxxers
Don't even talk about anti-vaxxers right now. The only thing bringing up anti-vaxxers will do is grow that movement. The people who don't want the covid vaccine are not anti-vaxxers. They get the flu vaccine and they get their children vaccines. They're only afraid of the new covid vaccine. They don't like anti-vaxxers any more than you do, BUT if you call them that then some of them are going to decide they might as well join the anti-vaxxer movement.
These are two groups of people who I do not want to join forces. Covid hasn't exactly been a fun time, but I'm really not interested in seeing polio and friends come back.
Have rational debates, quit the name calling, go the extra mile to convince people who don't like your position to do something for the greater good. Otherwise, we're not going to see enough vaccinations to make a difference.
