When Swati Gupta, MPH ’97, was pursuing her degree at the Yale School of Public Health, she had no idea that one day she would be involved in the development of one of the most important vaccines of the early 21st century.
Now, as the world celebrates the success of Merck’s Ebola Zaire Vaccine known as Ervebo, Gupta is part of a select group of scientists, clinicians, administrators and other collaborators whose innovation and persistence is being lauded for making the life-saving vaccine a reality.
“The conditional authorization of the world’s first Ebola vaccine is a triumph for public health, and a testimony to the unprecedented collaboration between scores of experts worldwide,” said Tedros Adhanom Ghebreyesus, WHO Director-General following the European Medical Agency’s marketing authorization of the vaccine in mid-October. The full European Commission granted authorization a few weeks later and the WHO awarded the vaccine critical prequalification status on Nov. 14.
Gupta was executive director of Merck’s Office of Public Health and Science during the largest Ebola outbreak in recorded history. In 2014, more than 11,000 people died in West Africa and over 28,000 were infected. She led a number of external partnerships in helping coordinate an international response to the public health crisis including the WHO, CDC, and other U.S. government institutions such as the National Institutes of Health, the U.S. Department of Health and Human Services and the Department of Defense.
At the same time, Gupta kept in close contact with Merck’s vaccine development team, constantly updating researchers on the rapidly evolving situation on the ground in West Africa as the deadly epidemic spread rapidly.
Developing a new vaccine is a long and complex process under the best of conditions; developing a vaccine at the height of a severe outbreak is a different challenge altogether, said Gupta, who holds an MPH in infectious disease epidemiology from the Yale School of Public Health and a Dr.PH in epidemiology from the Johns Hopkins Bloomberg School of Public Health.
“Conducting vaccine development during an outbreak required a tremendous amount of collaboration, coordination, and communication among the organizations involved as well as building trust rapidly among partners with different expertise and who may not traditionally work together,” Gupta said in a recent email interview. “An additional challenge is that once an outbreak subsides, oftentimes so does the commitment to see the vaccine development through to its completion. It is important that people understand this reality and stay committed even after the public health crisis is over (like Merck has) in order to make sure these life-saving interventions are available when needed for outbreaks that are unpredictable in size, location, duration and frequency.”
Now the vice president for research integration and innovation at the nonprofit international scientific research organization IAVI, Gupta said the training she received in infectious disease epidemiology at Yale forged the foundation on which her professional career was built.
“The training and mentorship I received from leading researchers at the school provided a solid foundation for my subsequent career in public health, including conducting research in tuberculosis control, HIV surveillance and ultimately now to conduct vaccine development for infectious diseases,” said Gupta. “I am grateful for the exposure to and my training in international health that the Yale School of Public Health provided.”
An Extraordinary Challenge
Gupta is not the only YSPH alum associated with the recent Ebola vaccine. Anant Shah, MPH, ’07, currently serves as Merck’s Global New Product Lead for the vaccine. Shah is working with the WHO, Gavi (the Vaccine Alliance), UNICEF, the U.S. government and others to design a model for how the new vaccine will be stored and distributed so that it is ready and available for those who need it.
Shah said he is both “humbled and proud” to be part of the Merck team working with national and international partners in addressing the deadly virus, which is named after the Ebola River in the Democratic Republic of Congo, one of the places of origin for the disease.
“These decisions (to authorize the new vaccine) represent a monumental step forward in the global fight against Ebola and the result of an unprecedented global effort,” Shah said in an online interview. “The vaccine, and the effort overall, is an extraordinary proof point in the power of science, innovation and public-private partnerships.”
Developing the vaccine was an extraordinary challenge. There is little precedent to guide research, development, manufacture and supply of a vaccine of this kind, Shah said.
“There were challenges around every corner,” said Shah. “How do you conduct clinical trials for a disease that appears relative rarely? Can an unlicensed, investigational vaccine be used to support outbreak response prior to having an approved product? Everyone had to constantly learn, adapt and problem-solve along the way.
“The beauty of this was that for every challenge, the partners stepped-up,” Shah continued. “We stretched our imaginations and paved a way forward. And by working with organizations like the Coalition for Epidemic Preparedness Innovations (CEPI), we’re sharing the lessons being learned to inform similar, future endeavors. Hopefully, the next time the world embarks on this kind of effort, there will be a few less challenges.”
Shah praised the Yale School of Public Health for teaching him critical thinking and encouraging him to engage with other disciplines around campus to broaden his experience, knowledge and views.
“The Yale School of Public Health offered me a terrific environment to learn, hone technical skills and be exposed to new ways of thinking and problem-solving,” Shah said. “Beyond YSPH, I relished the opportunity to be part of a broader Yale community–interacting with incredible people from all over the world and engaging with other schools.”
While at YSPH, Shah merged his passion for public health and public policy by sitting in on courses at the Yale Law School and serving as managing editor of the Journal of Health Policy, Law and Ethics.
“Ultimately, the Yale School of Public Health is a world-class institution with an intimate, approachable style that was attractive to me,” Shah said.
Special Delivery
Yale’s role in the development of the Ebola Zaire Vaccine extends far beyond the School of Public Health.
No vaccine is effective unless it can successfully reach its target. Yale Professor Emeritus of Pathology and Senior Research Scientist John “Jack” Rose is credited with developing the vaccine’s important delivery system.
Rose and colleagues genetically modified the vesicular stomatitis virus (VSV), making it possible for Canadian scientist Heinz Feldmann to connect a key Ebola protein to it. The resulting vaccine, identified as rVSV-ZEBOV-GP and later Ervebo, targets the Zaire species of Ebola, the most dangerous of the five viruses of the genus Ebolavirus and the species responsible for most outbreaks. A 2016 study found the vaccine to be 95% to 100% effective in fighting the Ebola Zaire virus.
Ervebo is currently deployed in the Democratic Republic of Congo (DRC) under a “compassionate use” research protocol in response to an outbreak that the WHO has deemed a “world health emergency.” More than 236,000 people have been inoculated with the vaccine to date, including more than 60,000 frontline workers in the DRC, Uganda, South Sudan, Rwanda and Burund.
“It is thrilling to see the first licensing of a VSV-based vaccine vector system for use in humans where it has already saved many lives,” Rose told the online health news website STAT in an Nov. 11 article. “Numerous scientists worked for many years in my laboratory at Yale to develop this potent vaccine platform.”