Will the FDA (A) treat Omicron-specific booster vaccines like flu shots, or will it (B) impose more requirements and slow them down?

So far, it looks like the default is (B), and it also looks like Omicron has a significant chance of making the coming months at least as painful as the debut of COVID-19 (due to its high infectiousness and potential for major vaccine escape). The hypothesis here is that switching to (A) is the most promising single way to reduce that chance, by getting a fully effective vaccine for Omicron ASAP.

There's lots of uncertainty - Omicron might turn out to be mild (at least in vaccinated people), might turn out to be less scary than expected in other ways (less infectiousness, less vaccine escape), or manufacturing might be a big enough bottleneck that we're too slow even under option (A). But still, when you think about how bad a redux of early 2020 would be, (A) vs. (B) seems to have massive stakes riding on it. If there’s anything you can imagine yourself doing to move us from a default of (B) to a world of (A), I think it would be good to drop whatever else is on your plate long enough to do that.

You're done with the important part of the post. Here's a bit more detail

This post from a Metaculus forecaster (“one of the best Covid forecasters there is” according to this tweet, which might be based on some quantitative metrics I haven’t easily found or might just not be right) reasons in detail to claims very much like the ones above. In particular, it concludes:

This variant is much fitter than Delta and, as such, will overtake it almost everywhere by sometime in early 2022. Omicron will result in a much greater decrease in vaccine efficacy than anything we've seen so far. Vaccines will probably end up being updated to target Omicron, but even under optimistic scenarios Omicron-specific boosters won't arrive until sometime after the first Omicron-driven wave hits. Omicron-driven waves will peak fast and high. There is good reason to think the drop in vaccine efficacy against severe disease won't be nearly as drastic as the decrease in efficacy against infection or symptomatic disease, but it will still be a large drop …

By far my most important recommendation is the one that is unfortunately the least likely to be heeded: given what we already know, vaccine manufacturers should immediately switch all production to begin making Omicron-specific doses — and governments should commit in advance (now!) to buying these doses. However, this doesn't seem like it'll happen …

Here are thoughts from the excellent Michael Mina over email:

We should do the least necessary checks of the new variant vaccines. Put them into 20 people and make sure they elicit the desired immune responses. Do NOT do any sort of efficacy study and these vaccines should be fast tracked like flu shots.

Unfortunately FDA has essentially no ability to balance the cost of slowness and the cost of inaction with the benefit of action. The FDA viewpoint is that inaction and whatever cost comes from that is not on them. They are used to a system where it’s better to do nothing than act with any uncertainty. But that’s Bc the FDA is not designed for emergencies. It just isn’t. It is horribly inefficient and unable to effectively make calculations around public health vs medicine.

To this day we still do not have a regulatory framework for products that have as a base use one of public health. Vaccines elicit ideas of public health but ultimately are evaluated and regulated as medicine. As far as safety this is important. But as far as efficacy and the regulatory approaches and data required, it’s entirely around individual benefit. Which at this point I hope everyone recognizes that’s the wrong angle in a pandemic.

For example, we knew that a single dose vaccine would yield 90% or more protection from severe disease for at least a few months, yet we withheld first doses in order to give people second doses and importantly we have those second doses in a suboptimal manner just Bc that’s the hard data we had. But the soft data (the data from decades of immunology research across the world) allowed us to know that spacing the vaccines months apart would have been better both for individuals and for public health. We didn’t do that.

I’m not going to give a more detailed defense of my position for now - this is a snap take, and I expect that it will hold up pretty well if one digs into the claims, but I don’t have the time to write it up thoroughly and still put it out quickly. I will just give a couple more links to clarify exactly what is at stake in the “flu-shot-style approval vs. slower approval” distinction.

• This recent WSJ article talks about studying the vaccines in “hundreds of subjects” for immune response, and also mentions that “The FDA is still determining how much the effectiveness of current vaccines would need to drop to merit authorizing new ones.” The overall process is expected to take over 3 months (it's unclear how much of that is approval vs. manufacturing).
• This is a faster process than for the original vaccines, but it is nowhere near the efficiency of the flu shot process, which goes like this: the latest flu variants are used for a vaccine, and the vaccine is approved. No studies on whether it beats last year’s shot, no studies on immune response. (Apparently it takes 6 months to scale up manufacturing for flu shots, which is longer than COVID-19 boosters should take.)
• A big question I haven't run to ground is how much delay we're stuck with (regardless of approval) due to manufacturing scale-up. I wouldn't guess it's a huge delay since vaccines are already being made at scale, but regardless, it seems like the fastest possible version is the one where vaccines are pre-ordered yesterday.

Treat new boosters like a flu shot, and we might roll them out in time. Approve them more slowly than that, and it seems like we're much more likely to be dealing with something that looks more contagious than Delta, with significant vaccine escape, and targeted vaccines arriving too late. So if you can do something to push toward the former, please do.

P.S. Most people who write takes like this get flooded with "You’re not a doctor, you don’t know what you’re talking about" type reactions. I doubt my readers are going to do that, but if you’re curious about why I feel OK saying the above as a non-expert, it is basically that over the course of this pandemic, I have decided to trust specific people and types of people more than the FDA/CDC/etc., based both on comparing what I could understand of their reasoning and on seeing how things played out over time. I'm not certain, but I'm comfortable making some bets. If you think this is ridiculous, you might be interested in this website that provides a handy way of insulting me in public - go check it out!