Military forces cannot afford to wait for the threat to emerge
The United States still treats biodefense too much as an extension of public health and not enough as a core component of military force protection. That approach must change.
As a former U.S. Army attack helicopter pilot who flew more than 300 combat missions, served as an instructor pilot and worked as a project officer for the Army’s Training and Doctrine Command, I learned that readiness is built before the threat becomes visible.
Personnel sent into dangerous environments need training, equipment, intelligence, planning and support before they are asked to accept risk. Biological threats must be approached in the same way.
A natural outbreak can create major military consequences
The history of warfare shows that a biological event does not have to result from an attack to produce serious consequences for military operations. A natural outbreak, accidental release or deliberate biological incident can affect troop deployments, base operations, ship readiness, homeland defense and the ability to operate in contested environments.
When a new virus emerges, military forces may be exposed before decision-makers have enough options to respond.
Retired Army Colonel W. Neal Burnette, Ph.D., previously summarized the challenge in Military Medicine, noting that identifying the pathogens posing the greatest risks to the military and developing an appropriate research and development portfolio of countermeasures represent major scientific, medical and fiscal challenges.
Biological threats move faster than institutions
The central vulnerability is speed. Biological agents can spread faster than policy development, procurement, budget approvals, interagency coordination, government-use authorizations and strategic stockpile decisions.
By the time a new viral crisis becomes visible, defense institutions may already be behind. Surveillance systems may need to be adapted, diagnostic methods modified, and therapeutics and vaccines may still be under evaluation without approval from the U.S. Food and Drug Administration.
Manufacturing capacity may also be limited. All these factors can delay the availability of countermeasures and leave commanders with fewer response options than they need.
Broad-spectrum antivirals should become part of military planning
For that reason, broad-spectrum prophylactic antiviral countermeasures should be included from the outset in force protection planning.
Serious evaluation of promising prophylactic technologies must begin long before a novel virus outbreak. Scientific research requires evidence, discipline, regulatory compliance and honest assessment of results.
Broad-spectrum antiviral prophylactics often require government support because access to lethal virus samples, high-containment laboratories and emergency-use planning mechanisms is strictly controlled.
Preparing for unknown future viral threats is difficult without government approval, partnership and support. Government and industry must act proactively, pursuing FDA-regulated pathways before an outbreak creates operational urgency.
The Ebola lesson: lost time can cost lives
I have viewed this challenge from two perspectives: as a combat veteran who understands the human importance of readiness and as the chief executive of a biotechnology company involved in antiviral research.
During an emerging outbreak, a broad-spectrum prophylactic antiviral could help protect service members operating in close quarters or deployed to affected areas, as well as medical personnel exposed to infection. A properly evaluated tool could help limit the spread of a novel virus for which no approved vaccine or specific treatment yet exists.
The Ebola virus provides a relevant example. The recent emergence of a new Bundibugyo strain highlights the scale of the existing gaps. There is currently no licensed or effective vaccine and no approved specific treatment for Bundibugyo virus disease.
Vaccine development, evaluation and deployment take time. A broad-spectrum prophylactic could provide a valuable buffer while specific solutions are being developed.
Preliminary results require further evaluation
Government-funded preclinical research conducted in the U.S. Army Medical Research Institute of Infectious Diseases’ Biosafety Level 4 laboratories produced encouraging results involving Ampligen, also known as rintatolimod, as a potential prophylactic or early-onset treatment for Ebola.
A study published in the scientific journal Antiviral Research reported 100% survival in one rintatolimod-treated cohort in a lethal mouse model, compared with 100% mortality among controls.
The findings justify further evaluation of rintatolimod’s mechanism of action and its potential role as a broad-spectrum antiviral against multiple Ebola variants, including Bundibugyo. AIM ImmunoTech is currently seeking government support for such studies.
The results remain preliminary and require additional confirmation. They nevertheless illustrate a broader problem: if promising antiviral platforms are not advanced through appropriate government-supported and regulatory evaluation processes, research findings may remain on the laboratory shelf instead of becoming tools available for emergency planning.
Promising countermeasures must be evaluated and prepared before a crisis requires rapid action, not after the crisis has begun.
The COVID-19 lesson and the USS Theodore Roosevelt case
The COVID-19 pandemic offered another clear example. Between the 2003 SARS outbreak and the emergence of COVID-19, researchers at Utah State University’s Institute for Antiviral Research examined potential antiviral treatments for coronaviruses.
The results were published in Antiviral Chemistry & Chemotherapy and Virology. The preclinical studies supported further evaluation of Ampligen as a possible early-onset antiviral against SARS-related coronaviruses. However, the research did not advance into a government-approved countermeasure ready for use before the next crisis arrived.
SARS-CoV-2 is genetically very closely related to SARS-CoV. The lesson for military readiness is straightforward: potential countermeasures must be evaluated before a related threat becomes a global emergency.
The COVID-19 outbreak aboard the aircraft carrier USS Theodore Roosevelt infected approximately 1,200 sailors and disrupted the operations of one of the U.S. military’s most important assets.
Had the government-funded research been followed through to an available countermeasure, a powerful prophylactic might potentially have been available to the ship’s commander. The broader conclusion is that military leaders need more evaluated and approved options before an outbreak occurs.
Biodefense must be treated as force protection
Promising science should not remain outside military readiness planning until an outbreak forces action.
Defense planners should integrate prophylactic antiviral countermeasures directly into force protection plans, alongside diagnostics, detection systems, protective equipment, decontamination and operational planning.
Promising prophylactic and early-onset antiviral platforms should be evaluated, approved by the FDA where appropriate, manufactured at sufficient scale and stockpiled against priority biological threats capable of affecting deployed forces.
For service members, readiness means protection before exposure. For commanders, it means having options before a mission is compromised. For policymakers, it means building systems capable of moving before the threat dictates the terms.
Biodefense is force protection.
If that principle is accepted, medical countermeasures must be treated as part of defense readiness—not merely as public health tools that authorities hope to mobilize after the fact.
In Army Aviation, there was a slogan that applies here: “Ready today means prepared for tomorrow.”
The next biological threat will not wait for a procurement cycle, a budget cycle or a perfect moment of consensus. Neither should we. Preparation must begin now so that vulnerabilities are not discovered only tomorrow.
Disclosure of the author’s interests
Thomas K. Equels is the chief executive officer of AIM ImmunoTech, a biotechnology company involved in immunomodulation and antiviral research.
Ampligen, also known as rintatolimod, is not approved by the FDA for Ebola virus disease, Bundibugyo virus disease, coronavirus infections or any biodefense indication.
Forward-looking statements and data limitations
This article contains forward-looking statements subject to risks and uncertainties. These include, among other matters, statements regarding the potential of Ampligen to serve as a broad-spectrum prophylactic or early-onset treatment for viral threats, including Ebola virus disease and coronaviruses.
They also include statements concerning preclinical proof-of-concept findings, which do not constitute evidence of FDA approval or clinical efficacy; the possibility that Ampligen’s mechanism of action could apply across Ebola variants, including Bundibugyo; and the timing and outcome of potential clinical trials, regulatory approvals, government funding decisions or government-supported evaluation programs.
Words such as “believe,” “may,” “will,” “estimate,” “anticipate,” “intend,” “expect,” “should,” “potential,” “plan” and “project,” together with similar expressions, identify forward-looking statements.
These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially. The company does not undertake to update forward-looking statements except as required by law.
For risk factors and additional information, readers may consult AIM ImmunoTech’s filings with the U.S. Securities and Exchange Commission, as well as information published on the official websites of the relevant institutions.
