The next cataclysmic threat to our national security may not be delivered in the form of bombs, cyber-sabotage or Paris-style attacks. Unlike the preparations the US has taken to defend against such acts of violence, we are woefully unprepared to deal with an equally serious menace.
A recent report by the bipartisan Blue Ribbon Study Panel on Biodefense concluded that the United States is not prepared to deal with biological threats from bioweapons or pandemic diseases.
“Simply put,” the panel, led by former Sen. Joe Lieberman and former Secretary of Homeland Security Tom Ridge said, “the nation does not afford the biological threat the same level of attention as it does other threats.”
Biomedical research is the first line of defense against biological threats, be they terrorist in origin or resulting from outbreaks such as the 2014 epidemic of Ebola in West Africa. However, the decade-long process of developing, testing and manufacturing new medical countermeasures – in the form of vaccines and medicines – is rarely part of the national dialogue on homeland security. This needs to change.
The Blue Ribbon Study Panel on Biodefense recommended high-level leadership in three key areas: coordination, collaboration and innovation. On this last point, the panel concluded that, “The innovative process of scientific discovery is inherently fraught with uncertainty. Yet biodefense efforts urgently call for a much greater focus on innovation than ever before – because biological threats are imminent, biological vulnerabilities have existed for too long, and the complexity of the threat requires equally complex solutions. Biodefense also requires sustained prioritization and funding to ensure that success realized thus far is maintained, and that opportunity and innovation are pursued.”
Our company has maintained a long-standing collaboration with the US government to develop, manufacture and stockpile medical countermeasures – in our case a vaccine for smallpox – a virus that could be weaponized against large population centers. Millions of doses of our vaccine are now available should a need arise anywhere in the world. But the question remains: What is to be done about the dozens of emerging threats where countermeasures do not currently exist?
The Blue Ribbon Study Panel on Biodefense’s report has put forth an innovative model for addressing this challenge. The report recommended using broadly applicable platform technologies to advance the initial development of select countermeasures, focusing on the threats with the greatest potential to cause a pandemic. This process involves identifying promising drug or vaccine candidates for high-priority threats, conducting initial safety and efficacy evaluations, and creating plans for large-scale production that could be called upon when needed. Having an “accelerator” model in place strengthens the pharmaceutical industry’s ability to respond effectively to biological threats. Importantly, we have experience with this model.
During the Ebola crisis, for example, industry leaders collaborated to meet the challenge of dealing with an infectious disease for which no approved treatment or vaccine existed. A promising vaccine candidate was quickly brought forward into large-scale manufacturing and phase 3 studies, all in less than 12 months, producing some 2 million doses for large-scale evaluation and implementation if necessary.
The process would have taken many years had it not been for the early development work previously undertaken with government-funded support.
It is essential that we learn from this experience and further develop this model so we are prepared to produce a high volume of vaccines and other treatments for future biological threats. Responding to the next biological threat from a standing start could have disastrous effects.
We are more prepared than ever to confront large-scale terrorist attacks on the scale of 9/11. We should be just as ready to prevail over biological delivery systems that are harder to see, but equally threatening to global health security.
Paul Chaplin is president and CEO of Bavarian Nordic. Prior to joining the company, Chaplin worked for several years both in the UK and Australia developing vaccines against infectious diseases. Chaplin is co-chair of the Alliance for BioSecurity, and holds a Ph.D. in Immunology from Bristol University.
