Preparing for Pandemics and Streamlining Vaccine Development

We live in a world where diseases are emerging and re-emerging, and spreading at an accelerating rate. Several recent outbreaks, including those fueled by the Ebola and Zika viruses, may be a harbinger of a devastating pandemic. “Some of the emerging and re-emerging infectious diseases are trivial but others are transforming,” said Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases, Bethesda, Maryland.

Preparing for what seems only a matter of time was the theme of his talk during a special plenary session at ID Week being held in San Diego, California.

One prominent example was severe acute respiratory syndrome (SARS). In 2003, from its ground zero at the Hotel Metropole in Hong Kong, jet travel by the infected person and the 12 hotel guests he had infected spread the virus globally within days. The toll was 8096 cases and 774 deaths. The good news from this pandemic was the speed of the response, with the timetable of virus discovery, genome sequencing, and vaccine development of less than 2 years, “the fastest in history at that time,” according to Dr. Fauci.

The H1N1 ‘swine flu’ virus outbreak several years later proved frustrating to handle, with vaccine development lagging behind spread of the infection. “The lesson here is the inadequacy of the vaccine response to a disease,” said Dr. Fauci. This experience inspired the thinking around pandemic preparedness, where plans are in place to cope with a pandemic that has yet to emerge, as would happen in 2014 with Ebola.

The Ebola outbreak of 2014-2016 was devastating, with 28,616 cases and 11,310 deaths. One ray of optimism, however, was the PREVAIL 1 phase 2 clinical placebo-controlled trial of 2 vaccine candidates that was conducted during the outbreak. “You can do good clinical research during an outbreak,” said Dr. Fauci. Indeed, a 2017 report by the National Academy of Sciences on the outbreak stressed that core principles of science and ethics should not change during an epidemic, and thus work toward a vaccine continued.

Preparing for a pandemic in the best way is not a single-pronged strategy. Multiple factors are the rule. Given this reality, the threat must be detected early and the response must be swift and effective.

Biomedical research is crucial to this process, as is vaccine development. Approaches to vaccine development include the priority-pathogen approach, platform approach, and prototype-pathogen approach.

Taking a cue from the World Health Organization’s blueprint for action, a handful of diseases were identified as requiring urgent action in terms of preparedness. The action can utilize a number of platforms, including nanoparticles, microbial vectors, DNA-based technologies, and others. The DNA-based approach has sped up vaccine development. In the recent Zika virus outbreak, the timing from virus discovery to vaccine development was less than 4 months.

And, finally, the prototype-pathogen approach selects an organism to test concepts and treatment strategies. This approach can speed up research. “Even though the organisms may differ, there are common denominators, and there are things you can learn from these denominators,” said Dr. Fauci.

Another tact to combating infectious disease outbreaks has been realized with the formation of the Coalition for Epidemic Preparedness Innovations (CEPI). CEPI was launched earlier this year at the Davos Economic Summit and now has nearly $900 million in funding with the mission to provide, according to the CEPI website, a “global insurance policy to defend against future infections.”

The partnership of public, private, philanthropic, and civil society organizations that is CEPI aims to stimulate, finance, and coordinate vaccine development and stockpiling. When an outbreak does occur, CEPI along with partners will be able to get the vaccine where it is needed.

One of the inspirations for CEPI was the “successful but suboptimal” response to the recent Ebola epidemic. Among the shortcomings were the need for research as part of a response strategy, the need for a new means of financing research and development for epidemic emergencies, and the financial impediments to vaccine developments. “We need to develop an ecosystem approach to ensure that we have vaccine needed to benefit people who are most at risk from epidemic diseases,” said Margaret Hamburg, MD, The National Academy of Science, Engineering, and Medicine, Washington, DC, and former head of the United States Food and Drug Administration.

Thus, 3 infectious disease targets have been identified: Middle East respiratory syndrome (MERS) coronavirus, Lassa virus, and Nipah virus. A proposal for vaccine development has already been issued. “Outstanding academic institutions, biotechnology firms, and established multinational corporations responded to the call,” said Dr. Hamburg.

If the CEPI model is successful, the hope is that it can be scaled-up and applied to other epidemic innovations that include drugs, diagnostics, and personal protective equipment, to work on quelling a pandemic of these disease before they can occur.

DISCLOSURES

Anthony Fauci: None

Margaret Hamburg: none

PRESENTATIONS

Special Opening Plenary Session

Evolution and Revolution: Infectious Disease Promise and Challenges in the 21st Century

• The Challenge of Pandemic Preparedness; Anthony Fauci, MD; Director of the National Institute of Allergy and Infectious Diseases, Bethesda, MD
• A New Strategy to Stop Future Epidemics: Role of CEPI in new Vaccine Development; Margaret Hamburg, MD, The National Academy of Science, Engineering, and Medicine, Washington, DC, and former head of the United States Food and Drug Administration.

Brian Hoyle, PhD, is a medical and science writer and editor from Halifax, Nova Scotia, Canada. He has been a full-time freelance writer/editor for over 15 years. Prior to that, he was a research microbiologist and lab manager of a provincial government water testing lab. He can be reached at hoyle@square-rainbow.com.