> 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 only part of the safety process we bypassed was 6 moths of phase-3 data, we decided 2 was good enough. Everything else was just bypassing all the time where we were doing nothing at all because there wasn't money to run the next study.
That's not really true. The phase 1 trials were a good bit faster than they'd normally be. Also, even if you ignore that, having years of phase 2 and phase 3 trials gives you a lot of additional safety data, in the form of larger trials with longer duration. Also, better cross-tabs, so that it's possible to assess safety by age, gender, race, pregnancy, etc.
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.)
> 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.
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).
Read the post by timr above. The studies are very limited and can't reliably detect problems that occur with small part of population. This can be hundreds of thousands of people.
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.
Has that ever happened in vaccine studies? What would the biological path be that would cause you to have a severe reaction from the vaccine but not from the disease itself? Why wouldn't that already be present the data around the millions of people that have already been infected by the disease?
The type of severe reactions you'd expect are allergic reactions. They would show up right away, not as an event 2 weeks later. Given that J&J has already done 6 million dosages it seems pretty safe to say that those allergic reactions are pretty much non-existent.
I see a lot of maybe and mights, yet never any actual evidence or example of the fear around vaccine safety or a cogent explanation of HOW these things could happen. That's because you'd have to explain how proteins from the vaccination are somehow more dangerous than the same proteins present in the diseases.
The linked explanation would have been a reason for a longer and wider phase II/III study. However, now that the cat is out of the bag and we've got millions of people who've been dosed for multiple months, that's the study. Until we start seeing severe negative side effects in the 100s or 1000s of individuals, it doesn't make sense to pull a vaccine.
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.