The NIH’s Top Vaccine Maker Wants Warp Speed To Be the New Normal

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Are you concerned about the effect that use of the new vaccines will have on ongoing and future trials? I think the ethics of keeping trials going even when a vaccine is available are probably getting worked out now. But what about simply losing potential volunteers because they’re already getting other shots?

That issue will become front and center in the next few weeks. And I think it is a good problem to have. We have a vaccine that’s more effective than we even hoped for. And that means that we now have these ethical issues to address. How long can you really continue a placebo-controlled study, when you have good evidence that your vaccine works?

So what do I consider good evidence? Not a press release from a company, but the FDA looking at the data and saying, “Yes, we agree you have 95 percent efficacy, because we’ve looked at the primary data”—which the FDA will do—and the FDA granting an Emergency Use Application. Then we have to then confront the questions of: When do we offer that vaccine to the people who are on the placebo arm of the study? And I think that will be part of the discussions in the next few weeks at the FDA’s Vaccines and Related Biological Products Advisory Committee. The idea will be to get most of the population vaccinated, and it will become hard to run studies. Whether it’s January, February, March, April or whatever, we don’t know, but it will happen. That’s a good thing.

Now that you’ve seen this process unfold over the past year, what do you think the implications are for vaccine development—not just for whatever the next pandemic is but infectious disease generally?

If you think back to the beginning, there was a lot of concern that we were using technologies that have never been used before for a licensed vaccine. And now we have validation that mRNA vaccines can work, and they can be brought to bear quickly. I think it’s likely that the adenovirus technology has reasonably good protection. So we have another technology that works, and we have the more traditional technology, proteins, which I think will also work.

The other really encouraging implication is that we’ve proven that scientific structure-based vaccine design works, that knowing how to manipulate a viral protein to make it a good vaccine antigen, that’s worked for Covid. It’s being tested for respiratory viruses and children and other cases, but Covid sort of just came to the front of the line and proved that the concept works.

Now we need a much better global surveillance system that’s worldwide and integrated, and uses modern technologies to do testing, so we know what’s out there. We need better global clinical trials capacity so we can stand up these large trials faster. The United States government can put $10 billion, $12 billion, on the table and incentivize companies. But, you know, what about the rest of the world? And how do we create the infrastructure to be prepared and do clinical trials?

When people say that it only took a year to get a Covid vaccine, I know that’s not exactly right. It took nearly two decades to understand coronaviruses well enough to work on. But what if the next one’s not a coronavirus?

There’s a reasonable possibility that a virus could emerge from a different virus family, and we would not be as prepared. We know that there are about 20 major virus families in the world that infect humans, and almost every outbreak we’ve seen in the past 50 years or more has come from one of those 20 virus families. What if we made a concerted effort to study every family in detail, to make vaccines to every family, and do what we did for coronavirus? Make some prototypes. So that if a cousin in that family emerges, a virus we’ve never seen before, we at least have laid some groundwork for vaccine design. One could do that for what used to be considered a lot of money, but what now would be considered a small investment compared to what happens when you have a pandemic.

If a pandemic costs $16 trillion, you mean?

Exactly. I don’t want to pull a number off the top of my head that’s not completely right, but one could, for $20 million per virus family, make a prototype vaccine and test in the clinic. You’re talking a few billion dollars over five years for that kind of project. That used to seem like it wouldn’t be tenable. But now it’s like, well, if I could be prepared for the next pandemic, that’s probably a really good investment.


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