NIH’s Top Vaccine Maker Wants Warp Speed ​​to Be the New Standard

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Are you concerned about the effect that the use of the new vaccines will have on current and future trials? I think the ethics of continuing trials even when a vaccine is available is probably developing now. But what about just losing potential volunteers because they are already receiving other vaccines?

This issue will be at the center of concerns in the coming weeks. And I think that’s a good problem to have. We have a more effective vaccine than we hoped for. And that means we now have these ethical issues to deal with. How long can you really continue in a placebo-controlled study if you have good evidence that your vaccine works?

So what do I consider good proof? Not a press release from a company, but the FDA looking at the data and saying, “Yes, we agree that you have 95% effectiveness because we looked at the primary data” – what the FDA will – and the FDA approval, an emergency use application. We then have to confront the following questions: When do we offer this vaccine to people participating in the placebo arm of the study? And I think that will be part of the discussions over the next several weeks at the FDA Advisory Committee on Vaccines and Related Biologics. The idea will be to vaccinate most of the population, and it will become difficult to conduct studies. Whether it is January, February, March, April or whatever, we don’t know, but it will happen. This is a good thing.

Now that you’ve watched this process unfold over the past year, what do you think are the implications for vaccine development – not just for the next pandemic, but for infectious diseases in general?

If you think back to the beginning, there was a lot of concern that we were using technologies that had never been used before for a licensed vaccine. And now we have the validation that mRNA vaccines can work and that they can be implemented quickly. I think it is 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 work as well.

The other really encouraging implication is that we’ve proven that science-based vaccine design works, that knowing how to manipulate a viral protein into a good vaccine antigen has worked for Covid. It’s tested for respiratory viruses, children and other cases, but Covid has sort of taken the lead and has proven the concept to work.

Now we need a much better, global, integrated global surveillance system that uses modern technology to do testing, so we know what is out there. We need a better capacity for global clinical trials so that we can withstand these large trials more quickly. The US government can put $ 10 billion or $ 12 billion on the table and incent the business. But, you know, what about the rest of the world? And how do you create the infrastructure to prepare for and conduct clinical trials?

When people say it only took a year to get a Covid vaccine, I know that’s not entirely true. It took nearly two decades to fully understand coronaviruses to work on them. But what if the next one isn’t coronavirus?

There is a reasonable possibility that a virus would emerge from a different virus family, and we wouldn’t be so prepared. We know that there are about 20 major families of viruses around the world that infect humans, and almost every outbreak that we have seen in the past 50 years or more has come from one of those 20 families of viruses. What if we made a concerted effort to study each family in detail, to make vaccines for each family, and to do what we did for the coronavirus? Make some prototypes. So, if a cousin of this family emerges, a virus that we’ve never seen before, we’ve at least laid the groundwork for designing a vaccine. It could be done for what was once considered a lot of money, but what would now be considered a small investment compared to what happens in 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 isn’t quite accurate, but we could, for $ 20 million per virus family, make a prototype vaccine and test it in the clinic. You talk about a few billion dollars over five years for this type of project. It didn’t seem to be tenable. But now it’s like I can be prepared for the next pandemic, it’s probably a pretty good investment.


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