By Landon Gray

As the United States continues to grapple with the COVID-19 pandemic, and a new normal is embraced, leaders must prepare for future pandemics and biological events that not only threaten national security, but global security. Some in Congress are trying to do just that.

Proactive research and preparedness are critical to the capability to respond to such events.

“Mother Nature gives up its secrets grudgingly,” said Mike Leavitt, the former governor of Utah and secretary of Health and Human Services under former president George W. Bush, during a webinar hosted by the Capitol Hill Steering Committee. So, it’s difficult to respond to an emerging threat quickly.

“Solutions and pandemics don't come quickly. We take a lot of satisfaction about the fact that our development of a [COVID-19] vaccine [occurred] in the course of one year,” he said.

What people do not realize is that the messenger RNA (mRNA) technology “that underlies that ability to turn it around in a year was actually funded over the course of about 15 years through government support coming from pandemic readiness funds. Had it not been researched for 10 to 15 years, that secret of Mother Nature could never have been unfolded in a year,” Mr. Leavitt said, adding that what made the mRNA vaccine technology possible was a sustained investment in research.

The Capitol Hill Steering Committee is a bipartisan effort formed with the support of 11 congressional leaders and former administration officials, designed to better prepare the United States and the world for health security threats. The committee is managed by the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health and supported by the Open Philanthropy Project.

“The country's response to the pandemic has led to new public?private partnerships that have helped drive many of the major successes in the response to this pandemic. These partnerships have led to the development, manufacture and distribution of new vaccines, therapeutics and diagnostic tests around the world and around the country,” said Tom Inglesby, MD, the director of the Johns Hopkins Center for Health Security, in Baltimore.

These partnerships have also strengthened the United States’ capacity to domestically manufacture medical products. Sustaining these relationships to build a domestic bio-industrial base to see the country through this pandemic and others yet to come is of “clear and high importance for the health and safety of the public, for national security and for economic growth,” Dr. Inglesby said.

“Over the past year, our subcommittee has solicited feedback on how to strengthen our nation's pandemic preparedness and supply chains,” said Rep. Richard Hudson, R-N.C., the chair of the Healthy Futures Task Force Security Subcommittee. The subcommittee’s main three areas of focus are U.S. supply chains, pandemic preparedness and public health security.

“We're already taking some steps on this front. I was proud to lead H.R. 3743, supporting the Foundation for the National Institutes of Health [NIH] and the Reagan-Udall Foundation for the Food and Drug Administration Act, which I worked on along with my friend, Representative Anna Eshoo [D-Calif.], which was signed into law in March,” Mr. Hudson said. This bill allows the NIH and FDA to better their relationships with nonprofit foundations, thus increasing the collaboration with supported public?private partnerships.

To continue the success of a project like Operation Warp Speed—the public?private partnership that sped up development of the COVID-19 vaccines, Mr. Hudson said he would like to see Congress build on that model by continued and robust investments in public health security.

“The COVID-19 pandemic displayed extraordinary challenges and holes in our health security preparedness and response. It also presented many opportunities to make lasting improvements. We must use these lessons to ensure we're prepared for any future threat—whether they be chemical, biological, radiological, nuclear or other emerging infectious disease,” he said.

A key part of the partnerships is the Biomedical Advanced Research and Development Authority (BARDA), which was established in December 2006, under the Pandemic and All-Hazards Preparedness Act (PAHPA). 

“Since its inception, [BARDA] has been mobilized to respond to the H1N1 pandemic, Zika, Ebola Zaire multiple times, the COVID-19 public health emergency and now the monkeypox outbreak, as well as prepared to respond to pre-pandemic influenza outbreaks, such as H5N1 and H7N9,” said Gary Disbrow, PhD, the director of BARDA, a component of the Office of the Assistant Secretary for Preparedness and Response in the Department of Health and Human Services, in Washington, D.C.

These experiences underscore the importance of the capability to mobilize quickly, leverage partnerships and identify proven technologies that can be adapted rapidly to combat new threats, according to Dr. Disbrow.

BARDA not only provides funding, but brings to the table clinical and nonclinical expertise in manufacturing, and helps companies contract with teams that are responsive and collaborative with BARDA partners. This helps companies overcome technical challenges with the goal of bringing new technologies to licensure faster, making them available quickly to the American public, Dr. Disbrow explained.

“Our newest partnership example is BARDA Ventures. Under the 21st Century Cures Act, BARDA was provided with the authority to partner with a venture capital firm. BARDA is now partnered with Global Health Investment Corporation, a nonprofit organization, and we are provided funds that are leading to these initial investments,” Dr. Disbrow said.

This new partnering model will allow BARDA to invest in innovative technologies to address the areas of preparedness and response.

“Among the silver linings from the pandemic was the demonstrated power of cross-sector partnerships, such as Operation Warp Speed. Built on BARDA’s success and expertise, Operation Warp Speed was a triumph, delivering lifesaving vaccines and therapeutics in record time. Much of its success is due to the establishment of accelerated pathways for development, testing and approval of vaccine candidates,” said Michelle McMurry-Heath, MD, PhD, the president and CEO of the Biotechnology Innovation Organization, in Washington, D.C.

Operation Warp Speed coordinated interagency efforts to focus funding and expedited delivery of products and that mitigated the risk for industry partners, who reallocated the research and manufacturing assets to develop COVID-19 medical countermeasures. This was not something to be taken lightly, according to Dr. McMurry-Heath.

“Companies have to consider the viability of their business every time they make a research, investment or production decision. Public support was a critical factor for many—although I will note that about 1,100 biotech companies, mostly small, but small and large, initiated COVID research programs. They stopped what they were doing to help society in its moment of need,” Dr. McMurry-Heath said.

“In conclusion, let me note that mRNA technology advanced slowly for years and under the radar. Scientists labored to improve the technology with the belief that it could one day be a game changer. As a result, there was enough progress that mRNA paid off in a big way when COVID struck,” Dr. McMurry-Heath said. By investing, partnering and coordinating now, the United States can be ready for the next pathogen.

She added that now monkeypox is “knocking on our door, industry is ready to move forward. We can do the research, begin to scale up and seek greater commercialization. But we need the incentives and the guidance to make it more viable and possible.”

For more information, check out MITRE’s 10-Point Action Plan for sustaining a biopharma industrial base to increase public security from national health threats.