In effort to develop coronavirus vaccine, outbreak expert sees ‘hardest problem’ of his career

As China struggles to contain an epidemic caused by a new coronavirus, science is racing to develop vaccines to blunt the outbreak’s impact. Central to the effort is CEPI — the Oslo, Norway-based Coalition for Epidemic Preparedness Innovations — a global partnership created to spearhead development of vaccines in just this type of emergency.

Two weeks after China announced on Jan. 7 that a new coronavirus had ignited a fast-growing outbreak of pneumonia cases in the city of Wuhan, CEPI announced funding for three efforts to develop a vaccine to protect against the virus, currently known as 2019-nCoV. A week later, it added a fourth. Just days after that, it announced major vaccine manufacturer GSK would allow its proprietary adjuvants — compounds that boost the effectiveness of vaccines — to be used in the response.

But to date, most of the CEPI-funded efforts are focused on partners that don’t have the production facilities to make a commercial product in bulk. They include Inovio, a partnership between Moderna and the National Institute of Allergy and Infectious Diseases; CureVac; as well as the University of Queensland, in Australia. All use innovative approaches that offer the promise of unprecedented speed to the development of a vaccine candidate. But none of the companies has yet licensed a vaccine.

STAT asked CEO Richard Hatchett — who formerly held leadership roles at the U.S. Biomedical Advanced Research and Development Authority — about CEPI’s strategy for helping the world develop a vaccine for the masses in the midst of an emergency, a challenge he called “the hardest problem that I have ever dealt with in my career.”

The conversation was lightly edited for length and clarity.

What’s the task in front of you?

There’s so much that we don’t know about this virus. Its epidemiology, its transmission patterns, who the vulnerable populations really are. It appears at this point in time that older individuals, probably immune-compromised individuals, individuals with other medical conditions seem to be the ones who are affected the most by the severe disease.

The vulnerable population may not be something that is geographically defined, it may be something that is demographically defined. And it may be that each country needs to prioritize whatever vaccine becomes available for those who are identified as being at the highest risk.

Most countries have laws that are analogous to the Defense Production Act in the U.S. that allows the government to requisition stuff manufactured within their borders if it serves the purposes of national defense or national security — which is understandable. But what we do not want to have happen in this epidemic is to have vaccines be developed in the places where vaccines are currently developed and manufactured — which is mostly in developed countries — and then used exclusively in those countries. That would be a disaster.

So we are working very closely with the World Health Organization and we are fully aligned with the WHO about the importance of access.

The vaccine development platforms offer promise in terms of speed. But the partnerships CEPI has forged so far are with biotechs, a government scientific agency, and a university. If any of them succeed in developing a candidate vaccine, can they actually produce mass amounts of vaccine? If they cannot, can someone else take their candidate and run with it?

We’re having conversations with a broad array of potential partners. And critical to those conversations is: What’s the plan to make very large quantities of vaccine within a time frame that is potentially relevant to what people seem to be increasingly certain will be a pandemic, if it isn’t already there?

It is part of the evaluation of the partners. It’s a part of the evaluation of their current capability and how quickly those capabilities could potentially be scaled. We’re still in the process of assembling an array of candidates. And you’re only seeing part of the picture right now. But we are acutely conscious of what is actually required.

A lot of the mass production capacity rests with the big pharmaceutical companies, players like Sanofi and Merck and GSK. These companies have been burned in previous health emergencies, when they have raced to develop new vaccines the world ultimately decided it didn’t need. Of the big players, only Johnson & Johnson has announced it will try to make a vaccine. What about the others?

I’ve been talking to a number of the global multinational partners, all of whom are extremely concerned and interested in understanding how they can help. Nobody has said, “Sorry, we’re sitting this one out.” It’s a question of what they can do, how they can help, what capabilities they have internally.

These are conversations that I’ve had in confidence, and I don’t want to put words in anybody’s mouth. But I have been well-received by everyone that I’ve reached out to. I would just say: Watch this space.

Is there a disconnect between the types of vaccines CEPI is supporting and the bulk vaccine production lines that exist?

What I observed in the U.S. government was that there was often technical success in developing [bioterrorism countermeasure] products without a plan for the sustainability of those products without a vast expenditure of government resources to keep these noncommercial products and manufacturing lines around.

So we have been thinking about how could we design sustainability into the programs from the beginning. And part of that was doing a global survey of manufacturing capacity to think about where we wanted to plant the manufacturing of any successful products we were able to bring forward. We did that in the last year or so.

We are using the information that we have collected and have that team now thinking about opportunities for scaling vaccines of various different types. That is a work in progress. For some of the technologies the tech transfer [to a manufacturer] may be something that could be done in a time frame that was pertinent to the epidemic, potentially.

What do you mean by pertinent in this context?

It’s really difficult to predict the duration of what’s in front of us.

We know that in the very near term communities are going to have to depend on infection prevention and control and nonpharmaceutical interventions because that’s literally all that they have.

By pertinent I mean is it going to be possible to scale production, assuming we can move a vaccine through the development process to the point where regulators are comfortable with it being used broadly. Let’s assume that that takes — under the best possible case — a year. Is this epidemic still going to be going on in a year?

Possibly. In which case we want to have the ability to produce vaccine that has succeeded to that point, to produce as much of it as we can as quickly as we can so that those who haven’t been infected by the epidemic can actually be protected.

If the major producers don’t get involved, it’s hard to imagine that there could be vaccine in mass quantities. Am I wrong?

I think it is going to be really important to engage those folks who have access to really substantial production capacity. And having the big producers at the table — because of their depth, because of their experience, because of their internal resources — would be very, very important.

The candidate vaccines will be very, very quick. Dr. Anthony Fauci, director of NIAID, is out in public as saying he thinks the clinical trial for the Moderna vaccine may be as early as the spring.

I think part of the general strategy is to have a large number of candidates. Because you don’t know what’s going to slow down any particular candidate, and it might be something that surprises you. But you want to have enough candidates that at least some of them are moving rapidly through the process.

And then for each candidate, you need to ask yourself the question: How do you produce that? How do you get that candidate to a point where regulators are comfortable with it being used widely and how are you going to get to that point with production at a scale that is meaningful in the context of a disease that is going to infect the whole of society?