Accelerating Vaccine Development

Developing a new vaccine and getting it approved is a slow and tedious process. With the current coronavirus vaccines, it seems, it was the careful testing that took longest.

Allegedly, it took the pharmaceutical company Moderna two days in January to develop the vaccine. I am not sure how much we should take this claim at face value. Think about pharma companies that have thousands of potential drug candidates in their data bases. Is it fair to say “we already had the treatment for this cancer ten years ago”? In this instance it is more appropriate to say that having the virus sequence is very much similar to having the mRNA vaccine against it. After all, what the mRNA vaccine does is code for the exact same protein that the virus also codes for. Given that no mRNA vaccine was ever approved before, that, however, is only the first step. And there were many more to come.

Still, it does make sense to ask: Could we have gotten a vaccine earlier? Perhaps, or maybe even probably. A lot has been said about the confusing amount of time it took the FDA to get the approval process for the BioNTech/Pfizer vaccine going. Britain managed to approve the same vaccine quite a bit earlier, probably saving several thousand people from death. We could also already have started with vaccine roll-out (like China and Russia did) before all phase III results were in. 1 Day Sooner alone has more than 35,000 people who signed up to participate in human trials – I believe many more would have been willing to take the vaccine even before its efficacy were proved all the way.

Cutting phase III trials shorter (those are the ones were efficacy and rare side effects are the main focus) is the intuitive way to accelerate vaccine development. Why not give the vaccine to a wider audience after phase I and phase II trials have already established that the vaccine should be safe in most cases? Of course, there is a risk associated with that. But given that we allowed health care workers to work without sufficient protective equipment in spring, given that we allow young people (who are still almost children) to volunteer to die in Iraq – it seems ridiculous not to allow people to volunteer for an untested vaccine.

Cutting Phase I trials

Some researchers, however, argue that it’s not the Phase III trials, but instead the Phase I and II trials we should focus on. From an article in the NY magazine:

More precisely, they thought it would be possible to do all the research, development, preclinical testing, and Phase I trials for new viral pandemics before those new viruses had even emerged — to have those vaccines sitting on the shelf and ready to go when they did. They also thought it was possible to do this for nearly the entire universe of potential future viral pandemics — at least 90 percent of them, one of them told me, and likely more.

As Hotez explained to me, the major reason this vaccine timeline has shrunk is that much of the research and preclinical animal testing was done in the aftermath of the 2003 SARS pandemic (that is, for instance, how we knew to target the spike protein). This would be the model. Scientists have a very clear sense of which virus families have pandemic potential, and given the resemblance of those viruses, can develop not only vaccines for all of them but also ones that could easily be tweaked to respond to new variants within those families.

“We do this every year for influenza,” Rasmussen says. “We don’t know which influenza viruses are going to be circulating, so we make our best guess. And then we formulate that into a vaccine using essentially the same technology platform that all the other influenza vaccines are based on.” The whole process takes a few months, and utilizes a “platform” that we already know is basically safe. With enough funding, you could do the same for viral pandemics, and indeed conduct Phase I trials for the entire set of possible future outbreaks before any of them made themselves known to the public. In the case of a pandemic produced by a new strain in these families, you might want to do some limited additional safety testing, but because the most consequential adverse effects take place in the days right after the vaccine is given, that additional diligence could be almost immediate.

According to Florian Krammer, a vaccine scientist at Mount Sinai, you could do all of this at a cost of about $20 million to $30 million per vaccine and, ideally, would do so for between 50 and 100 different viruses — enough, he says, to functionally cover all the phylogenies that could give rise to pandemic strains in the future. (“It’s extremely unlikely that there is something out there that doesn’t belong to one of the known families, that would have been flying under the radar,” he says. “I wouldn’t be worried about that.”) In total, he estimates, the research and clinical trials necessary to do this would cost between $1 billion and $3 billion. […] When he compares the cost of such a project to the Pentagon’s F-35 — you could build vaccines for five potential pandemics for the cost of a single plane, and vaccines for all of them for a fraction of the cost of that fighter-jet program as a whole — he isn’t signaling confidence it will happen, but the opposite.

I find this highly intriguing and exciting. One to three billion is an amount that multilateral organizations could easily spend. It is even something that a single individual like Bill Gates could invest to tackle this problem. Let’s hope they do.

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