I keep hearing about small delays in the vaccine development process that I don’t understand given how urgent the need is. I read a perfect example today. A New York Times article sharing good news about the effectiveness of the Pfizer vaccine mentioned that the company would be applying for emergency use authorization “within days”. A similar article cited a period of weeks for the Moderna vaccine. This progress is great news. It made me wonder, though, why not today? What prevented these companies from being ready to file with the FDA right away?
By all accounts, the rapid progress of COVID-19 vaccine candidates has been miraculous. Still, I’m confused by the apparent lack of urgency in certain parts of the process. Most of the vaccine development work is probably difficult to speed up. For example, it isn’t possible to speed up the rate at which trial participants get exposed to the virus so that effectiveness can be proven1. But what prevents Pfizer and Moderna from pre-writing their application to the FDA while the trial is running and netting a few days or weeks? Even just a few days has serious value. Of course, the data is still coming in so there would be some uncertainty about what should be written in the application. But they must have a pretty good sense of how the trial is going. They could even pre-write two or three versions to cover the most likely scenarios. And of all possible trial outcomes, why would these companies both be unprepared for best-case scenarios where their vaccines are proving to be highly effective?
Getting a bit more speculative, why aren’t scientists at Pfizer and Moderna already in conversation with decision makers at the FDA so that the evaluation process can be started based on preliminary data? Then they could be possibly be ready to issue emergency use authorization immediately once the trial concludes. If there is an unexpected change in the latest data regulators should of course be prepared to reassess. To be clear, I am not suggesting that the approval process be less rigorous. I just want it happening in parallel with the trial as much as it can. Given how ridiculously destructive this pandemic is, I sure hope COVID vaccines are the FDA’s top priority.
This possibility reminds me of the mechanics of my thesis defense. My adviser, the main decision maker, was already very familiar with my work. Little information was actually transmitted to him that day. He already knew what he needed to know to make his decision. In fact, we wouldn’t have even gone forward with the defense if he wasn’t ready to pass me. He didn’t take a month after the defense to closely read my thesis, consider all the arguments, check the math, and then deliberate. That process occurred while the data was coming in. Maybe some parallelization of the approval process like this is happening for the COVID vaccines, but I’ve never read anything that gives the sense that it is.
Possible answers to my own questions:
Why weren’t the EUA applications ready?
Maybe a document like this is way more complicated than I’m imagining and the drug companies are writing them as fast as possible. This sort of suggests that writing the application is a similar challenge to developing the vaccine. I hope that’s not right.
Maybe the drug companies are already working with the FDA, and the timing of the application isn’t important. As I mentioned above, I’ve never seen anything that suggests this.
Maybe these companies aren’t incentivized to actually get the vaccine to market as fast as they can. Off the bat this didn’t seem right to me, but could the advance purchase agreements that Moderna and Pfizer signed with governments eliminate their urgency?
Why aren’t the drug companies working with the FDA?
Maybe this just isn’t the way the FDA usually works and they weren’t able to adapt to this extraordinary situation.
Obviously scientific integrity is important here. Maybe the scientists are intentionally kept separate from other parts of Pfizer and from the FDA to prevent some kind of academic dishonesty. I wonder about the relative dangers involved, but I could imagine an explanation like this.
Answers that other people have suggested:
Commenters on Hacker News and Reddit have suggested that the things I want to happen are already happening. I’ve looked into this a little bit, and I’m unsure. Both Moderna and Pfizer have been granted the FDA’s Fast Track status. This sounds great. It apparently means these companies have the opportunity for closer collaboration with the FDA, at least on clinical trial design. Some have suggested that the companies would also already be sharing advance results from their studies, but I haven’t found any reference saying that.
Fast Track also gives them the opportunity to participate in Rolling Review, which allows them to submit sections of their applications as they become ready. The references I’ve found discussing this are mostly press releases by the companies or closely based on them. They discuss participation in Rolling Review in Europe and elsewhere, but I haven’t seen that they are doing this in the US.