NIH Director Francis Collins shares his best-case scenario for a coronavirus vaccine: We could have a shot by fall but mass-producing it will be 'a heck of a stretch' by the end of the year.

• A top US public health official told Business Insider it's possible that we'll have not just one but several effective coronavirus vaccines this year.
• Dr. Francis Collins, director of the National Institutes of Health, said his "best-case scenario" is that four or five vaccines will get through clinical trials, and at least one will be ready for emergency use by the fall
• Collins has led the NIH, the top US agency for biomedical research, since 2009. Previously, the physician-geneticist led the Human Genome Project in the late-1990s, successfully sequencing the human genome for the first time.
• In a wide-ranging interview on vaccines, Collins discussed how the NIH plans to quickly test candidates, realistic timelines, the "underappreciated" manufacturing challenge, and the threat of the antivax movement.
• Visit Business Insider's homepage for more stories.

Having an effective coronavirus vaccine is possible by the end of 2020, but achieving a goal of 300 million doses by January will be "a heck of a stretch," Dr. Francis Collins, the leader of the National Institutes of Health, told Business Insider.

In a Monday evening phone interview, Collins explained how health officials plan to test vaccines quickly. He cautioned that finding one that works is only part of the challenge. Manufacturing the huge number of doses needed to inoculate the world will require tremendous investment, starting now, he said.

Since 2009, Collins has been director of the NIH, the top US agency for biomedical research with an annual budget exceeding $40 billion. Previously, he oversaw the Human Genome Project, a historic scientific achievement that successfully sequenced the human genome for the first time.

Now, he is helping lead perhaps an even bigger task: ending this pandemic. Last month, the NIH launched a sweeping partnership bringing together government agencies, nonprofits and the drug industry. Called Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV for short, the group includes some of the largest vaccine drugmakers in the world, including Pfizer, GlaxoSmithKline, Sanofi, and Merck.

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On Monday, Collins along with other NIH officials including Dr. Anthony Fauci and a vaccine expert at the Fred Hutchinson Cancer Research Center published a roadmap for testing vaccines quickly by having biotech and pharma companies design late-stage vaccine trials that are similar to one another. That would make it easy to compare their results, speeding up research.

"My best-case scenario is that we will see four or five of these vaccines run through very effective, well-designed trials in the course of the coming months, and we will by the fall have at least one and maybe more of those that has been granted emergency use authorization by FDA," Collins said.

Read more: Scientists are racing to create a coronavirus vaccine that can halt the pandemic in its tracks. Here are the top 3 candidates aiming to be ready this fall.

"The hair stands up on the back of my neck" thinking about this ambitious timeline, he said, given all the potential uncertainties these vaccines will face.

The challenge of scaling up manufacturing for a coronavirus vaccine is underappreciated by many people, Collins said. Building this production capacity has to happen now, and Collins said the US Biomedical Advanced Research and Development Authority (BARDA) is prepared to spend at least $3 billion on this.

That means "a lot of money's going to get wasted," Collins said, likely resulting in some manufacturing capacity built for vaccines that wind up not working. But that's the only way to prevent a time gap between knowing a vaccine works and mass-producing it, he said.

The antivax movement is a real threat, Collins said, but he said he's optimistic science can win over some vaccine skeptics with transparency and openness.

He called the next eight months "a national adventure of a scientific sort" as researchers progress toward a widely available vaccine. It will be critical to be transparent and open about what we know and don't know he said.

Read more: Here's how 13 top drugmakers are sprinting to develop a coronavirus vaccine or treatment that can halt this pandemic

Here's the full transcript of Collins interview with Business Insider's Andrew Dunn. Collins discussed how the NIH plans to test vaccines with historic speed, what a realistic timeline is for having a vaccine, the manufacturing challenge and the threat of the antivax movement. The interview has been lightly edited for clarity and length.

The NIH is seeking a radically different way to test vaccines. Collins says he's seen 'no resistance' so far between industry rivals now working together.

Andrew Dunn: The ACTIV partnership strikes me as radically different than traditional vaccine development. What do you see as the key benefits from this plan compared to traditional vaccine testing testing?

Francis Collins: The goals are to be sure we're sharing information as openly as possible, which has not traditionally been the case with competitive vaccine platform development.

We want to make sure that every lesson that can be learned is learned. We want to actually make some of these steps more efficient by not having them duplicated. If we have a shared database, that we have a shared [data and safety monitoring board], we could potentially move these whole enterprises along a lot more quickly.

And I think also organizing the way in which the clinical trials are put together so that you can take maximum benefit of where the patients are and get them signed up is also something we can do together better than doing it separately.

There may be as many as five different vaccines that are promising for COVID-19. They won't all come onboard at exactly the same point in terms of when they're ready for Phase 3 trials, but they will occur within a certain time interval and the more that we can learn from each of those in terms of how they generate an immune response and what kind of safety signals pop up, the faster we'll get to the answers the public is waiting for.

And I've seen no resistance to that concept from any of the involved parties. My hat is off to the industry partners. They have been very willing to say this is not business as usual and to put aside what traditionally would have been some firewalls and say, let's do it together.

Dunn: Global collaboration is a big part of ACTIV with plans for working with international partners. Do you think it's a mistake for the US to step back from the WHO in terms of funding and official participation, thinking of the US not participating in a global collaboration on vaccines ran by the WHO?

Collins: We may not have been involved in the fundraising that they did back on May 4, but I can assure you that we have multiple contacts with the global community about vaccine developments with WHO, with GAVI, with the Wellcome Trust, with the Bill and Melinda Gates Foundation.

The scientific community has always figured out that if we are going to be successful, it needs to be successful on a global scale. And that will be true here as well.

Why we don't need to expose people to the coronavirus to test potential vaccines

Dunn: On trial designs, what are your thoughts on human challenge studies? Do you think those could play a role in COVID-19?

Collins: I think they probably won't, to be honest.

First of all, the idea of starting a human challenge study requires you to have [Good Manufacturing Practice] material that's ready to go. None of these vaccine platforms are there yet.

When they get there, they will be ready also to start a standard efficacy trial enrolling thousands of patients, which is a much more compelling way to show whether the vaccine actually works in the real world.

For a challenge trial, traditionally, you're picking young healthy people, you're vaccinating them, and then you're exposing them to the virus and looking to see if they get sick.

How predictive is that actually? Really what we need to know is what happens to somebody with chronic illnesses or an elderly person. It's not clear that it tells you the efficacy question that you really need the answer to.

And of course there are profound ethical questions about whether it is justifiable to put a healthy person at risk when we don't have a cure for this disease that they happen to get sick anyway. So I think at the present time, the case for it is pretty weak. The case against it is pretty strong.

Dunn: Ring vaccination designs worked for Ebola recently and smallpox a few decades ago. But those studies require resources for contact tracing. Do you think a ring vaccination study would help fight COVID-19, and is the US in a position to run such a study given the need for contact tracing?

Collins: I think it would be enormously complicated. Why don't we just do this the way that would be most straightforward, which is to enroll tens of thousands of participants in areas where the virus is still circulating with an appropriate placebo control and see whether it works or not.

Dunn: Would ACTIV have one design to test five vaccines simultaneously, or would each of these companies still craft their own Phase 3 designs but with some level of harmony between the designs to compare the results with each other?

Collins: The latter seems to be the model that is the best fit for all the contingencies that are going to be necessary to think about.

What you call a harmonized master protocol, where each company has their own particular design, but they have agreed to utilize a common database, common laboratory assays and hopefully a common [data and safety monitoring board] as well, although that's still somewhat under discussion.

Let's not actually slow down the process by demanding one monolithic master protocol with multiple arms, because that could be quite complicated and it might actually slow down that fast horses. You don't want that to happen. And let's make sure we're doing everything we can to share information and learn from each of these studies simultaneously.

Collins is optimistic that one or more vaccines will be safe and effective. Mass-producing them this year will be 'a heck of a stretch.'

Dunn: President Trump has said he's "very confident" about having a vaccine by the end of this year. How confident are you in that timeline?

Collins: This is science and there's a lot about what's going to be tested in these trials that we can't predict the answer of.

I am optimistic that among these trials on four or five different platforms, we are going to find one or more that actually shows benefit that safe and effective. That is going to be a heck of a stretch to get there by the timetable that's been put forward, where we might have 10 million doses by October and 100 million by November and 300 million by January.

That is a mark that's been put out there. I know the team that's working on ACTIV will do everything in their power to achieve that. But the skeptics will say, you don't really know whether this is going to work. You don't actually even know for sure whether immunity to coronavirus lasts more than two weeks because we don't have the data to show that people who've had natural infection are immune for long periods of time.

So there's a lot of unknowns here, but I think we are doing the best we can with what we do know and a lot of resources and a lot of talents to try to achieve that very ambitious goal.

Dunn: Realistically, what do you see as the best case scenario by the end of 2020? How far along are these vaccines and what level of manufacturing should could there be by year's end if everything goes right?

Collins: We're not going to wait until the fall to gear up the manufacturing. This has got to be a circumstance where we do that at-risk. The resources to help with that from BARDA are substantial. At least $3 billion and maybe more.

So we want to be sure that we don't end up with a long lag after we see that a particular vaccine turns out to be safe and effective.

My best-case scenario is that we will see four or five of these vaccines run through very effective, well-designed trials in the course of the coming months, and we will by the fall have at least one and maybe more of those that has been granted emergency use authorization by FDA.

And that the manufacturing capabilities will have been thought about ahead of time and will at that point be scalable aiming for exactly what's been put out there is this very ambitious mark of having 300 million doses by January.

When I say that, that the hair stands up on the back of my neck because there's a lot of uncertainties that could knock this off of its hoped-for trajectory. But that's what we're going to do with everything in our power to achieve.

Dunn: Bill Gates has spoken about the need to invest billions in manufacturing at-risk right now. Do you think the manufacturing challenges are underappreciated in the broader dialogue about a vaccine?

Collins: I think they are underappreciated by most people, including me.

Hey, I'm a scientist who ran the Human Genome Project and now oversees NIH, but I never had to think about manufacturing a vaccine, 300 million doses before.

There are all these things that I'm learning about that cause me some anxiety in terms of exactly where's this going to get done? How are you going to be sure of the supply chain? Even for things like medical glass, are you going to have enough vials to put the vaccine in once you've prepared it? How are you going to make sure that the vaccine is working, can be manufactured in a plant that is already prepared to do that, even if it happens to be a different company than the one that has designed the vaccine. There's a lot of things that have to be paid attention to.

I am reassured that people who know more about this seem to believe that those are surmountable. But it's going to take a heck of a lot of planning and a lot of money.

And let's be clear, a lot of money's going to get wasted because if we are going to be prepared for a vaccine that succeeds to already have manufacturing capacity in place, that means we will have also done that for some vaccines that fail and that will have all gone down the drain. But it is the only solution we have to be sure there's not a long gap as many lost lives from next fall.

Collins agrees that the antivax movement is a real threat. But he sees an opportunity to give skeptics a second look at the science behind vaccines and is optimistic some can be convinced.

Dunn: Throughout your career, you've been a preeminent communicator in explaining science clearly to the public. With the antivax movement, given how fast-moving this research is, are you concerned at all that parts of the public might not trust a resulting vaccine. They might believe the testing is too rushed. Do you take that threat seriously?

Collins: I do, and I think already you can see some evidence that those forces are beginning to appear, because I would not have expected those who had strong objections to vaccines for other things would suddenly decide that vaccines are fine for COVID-19.

We hope to win them over. We hope to be as transparent as we possibly can about what we know and what we don't know. My colleague Tony Fauci is probably the best communicator that the world has seen in this space. And I hope he continues to be out there in every way explaining all of this.

I will do what I can in the same vein, but ultimately people will have to decide when the vaccine becomes available. Are you going to fall into the kind of conspiracy arguments which are still out there about vaccines and what their motivation is, or are you going to see this as a way to save lives because we've lost already more than 80,000 lives in the United States and we don't want to keep losing anymore.

Dunn: If there is a level of resistance to a vaccine, would that impact the timeline that everyone wants on ending the pandemic and reaching a level of herd immunity?

Collins: It could if that resistance is allowed to really take root and become widespread.

But I think this might be a great moment for the scientific basis of vaccines to get a second look by people who may have been a little on the fence about whether this is risky or not because many people have taken the antivax approach because what the immunizations were for didn't seem all that present in their personal life.

If you've never seen a child with measles, you might have a more comfortable time saying maybe the natural infection is just fine.

When you've seen 80,000 people die all around you of COVID-19, it's harder to say that the natural infection is just fine and if you have a vaccine that could save lives, I think people are going to look at very carefully. We have the science to put forward and this is our moment maybe for a scientific basis of vaccines and immunology to be better understood by more people. We should not squander that opportunity either.

Dunn: So how do you build that trust with the public, as far as someone who might be skeptical? I'm hearing from you the idea of transparency being key. Is that fair?

Collins: Absolutely, and admitting the things that we're not sure about and helping people all the way along.

We've got a great opportunity here as a national adventure of a scientific sort. Here we are in May looking forward to what we will be an end to this pandemic once and for all because of a widely available vaccine in something like eight months from now.

If we could figure out a way to use that adventure over those eight months to raise everybody's consciousness about what the science is behind the development of a vaccine and what we know and what we don't know. When the ultimate data comes out that says it's safe and effective, how safe and how effective, that would be a great moment to really raise consciousness about an issue that I think is still pretty blurry in a lot of people's minds.

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