Over the last three months, the world has witnessed a series of historic global health milestones: regulatory agencies approved Merck & Co.’s Ebola Zaire vaccine, ERVEBO® (pronounced er-vee-boh). ERVEBO is the world’s first Ebola vaccine approved by the FDA and EMA, prequalified by the World Health Organization, and approved in an initial set of African countries, including the Democratic Republic of the Congo. The Pulse sat down with Anant Shah, global new product lead for Merck’s Ebola vaccine, to discuss the world’s effort to make this innovative vaccine.

The Pulse: How did this vaccine originate and how did Merck become involved in its development?

Anant Shah: In a way – through a mix of mother nature, scientific serendipity, and match-making. It was the West African Ebola outbreak in 2014-2016, the largest Ebola outbreak in history, that catalyzed the world to pursue new medical innovations against the disease with an increased sense of urgency, including, but not limited to, what is now Merck’s Ebola Zaire vaccine, ERVEBO®. The world was fortunate that well before that outbreak ever happened, scientists from the Public Health Agency of Canada had already performed the early science and engineered the original vaccine construct, which was subsequently licensed to an American biotechnology company, NewLink Genetics. As the outbreak grew, Merck was approached by the FDA [U.S. Food and Drug Administration] asking us to leverage our expertise and work with partners to take forward the early science and drive a full research and development effort toward an approved vaccine. Merck acquired the rights for the vaccine from NewLink Genetics in late 2014, and thus began Merck’s journey as part of what remains an unprecedented global collaboration involving so many people and organizations. Through it all, it was a shared purpose, a strong sense of urgency and unique partnership that brought the world together and helped make this vaccine a reality.

The Pulse: What made Merck a particularly well-qualified company to develop ERVEBO? How does it fit in with your broader vaccine or global health strategy?

Anant Shah: Everyone involved in the effort brought their own, complementary expertise. Our specific role was driven by having relevant technical capabilities, combined with a longstanding culture of commitment and partnership. Technically, we could bring-to-bear commercial-scale expertise in process research, clinical development, regulatory affairs, and manufacturing, along with experience in live-virus vaccines. Our technical expertise was able to supplement the expertise of others, which together was a formidable combination. Beyond that, and perhaps more fundamental, we are a company that believes in the power of public-private partnerships and are inherently committed to tackling some of the world’s most urgent health threats. It’s part of our culture and is reflected in the decision by our leadership to embark on this journey along with partners. In many ways, the Ebola program speaks to the core of who we are: a purpose- and science-driven organization seeking to serve patients and help protect public health.

The Pulse: You mentioned that the Ebola outbreak kicked off a large public-private partnership. Which organizations are involved in this partnership?

Anant Shah: So many, and too many to list here. Individuals and organizations of all shapes and sizes, from across the world and from multiple sectors came together to make this vaccine possible. Just to name a few: governments, across Africa, the United States, Canada, and Europe; the World Health Organization; companies; Gavi [the Vaccine Alliance]; Médecins Sans Frontières; academic institutions; research organizations; community-based organizations, including for example, Alima and the International Federation Red Cross and Red Crescent; and importantly, individual patients, volunteers, and frontline responders. The list goes on – it’s truly remarkable, and a partnership that will help write a new chapter in the history of public health. It’s a partnership that continues today focused on the important work ahead, following regulatory registrations. Beyond the vaccine itself, partnership was really the hero and breakthrough of the entire effort.

The Pulse: How do you coordinate partnerships with so many different types of organizations around the world?

Anant Shah: We, Merck, are not officially coordinating any specific partnership on our own, per se. But in terms of the spirit and nature of partner coordination – it’s as much art as it is science. Fundamentally, I think successful coordination and collaboration comes down to a shared mission and human relations. Other ingredients include trust, transparency, open lines of communication, determination, and in this case, a particular sense of urgency. Admittedly, these types of partnerships are not easy or inevitable. They require intentional effort and an “eyes wide open” approach, often times involving divergent perspectives and disagreement. In the words of our CEO: “A great partnership means finding ways to work around, beyond, or beside your differences to find common ground.” In the end, when you do that, together you can achieve greatness.

The Pulse: How do you think the vaccine will change how we respond to future outbreaks?

Anant Shah: Over time, a vaccine – any vaccine – should help fundamentally change-the-game and transform the way the world can prepare for and respond to Ebola outbreaks. Certainly, a vaccine is only one component of a complex collection of solutions required. Great products require great systems to succeed. But I would argue there are few, if any, interventions as discrete, elegant and disruptive as a new vaccine. I’d like to believe that a vaccine brings new hope and meaning to global public health preparedness against Ebola. In our case, a much-needed new tool in the global fight against Zaire ebolavirus.

The Pulse: What major lessons have you learned?

Anant Shah: We’ve learned so many lessons and are still learning so many lessons. We’re working with partners to share those lessons to help inform other, similar endeavors being pursued by others.

As mentioned earlier, one major lesson is about partnership: they are necessary and powerful but are not inevitable or easy. Another major lesson is about sustainability and a so-called business mode: how do partners make efforts like this possible in a way that is attractive and sustainable to everyone involved? How does one balance doing the right thing and ensuring equitable access while not placing disproportional burdens on any one entity? Developing and bringing-to-market a vaccine for a relatively rare, unpredictable disease with unpredictable demand is not always a naturally viable scenario. The entire global health community – across government, non-government organizations, and companies – are working to better dissect these challenges and pursue improved solutions, while recognizing there is no one-size fits-all template either.

We’re also learning about process efficiency: there is a fundamental tension between the need for fast and flexible epidemic preparedness and the heterogeneity of procedures to research, develop, manufacture, and make available a vaccine. For vaccines against relatively rare, outbreak-prone diseases, you don’t necessarily know where, when, and in what amount you’ll need the vaccine, so it’s not clear where and how to register, supply, store, or ship the vaccine. Every country has different regulatory, legal, and logistical requirements. Before you know it, you’re doing lots of atomized work, when instead, you need something more uniform so you can be fast, responsive, and flexible. Developing more fit-for-purpose, or so-called “harmonized” procedures and systems is a critical area that requires more innovation.

We all have to continue challenging the status-quo and pursing creative solutions that make similar, future endeavors even more successful. The Ebola vaccine experience offers incredible insights on both, successes on which to build and challenges to continue solving.

The Pulse: What major themes have you taken away from being involved in this process?

Anant Shah: There are many inspiring themes. Believing in the “art-of-the-possible” stands out for me. When the world puts its mind to a problem and acts with a serious sense of urgency, imagination, compassion, and cooperation, anything is possible. Forty-plus years after the discovery of the Ebola virus and only about five years after the world united following the West African outbreak, we now have at least one vaccine. And the world is on the verge of other important interventions against this terrible disease as well. Ebola Zaire disease is now vaccine preventable, and with new medicines on the horizon, Ebola will hopefully soon be treatable too. Imagine that. Now, imagine if the world tackled other major problems with the same shared mission and relentless determination with which we are tackling Ebola. The possibilities are endless.

Interviewed by Michele Dragoescu, December 2019