Hundreds of COVID-19 treatments are currently ineligible for funding from the Biomedical Advanced Research Development Authority (BARDA), the federal program specifically created to support the development of pharmaceutical remedies for public health emergencies. The ineligibility of these treatments is not due to questions surrounding efficacy. Rather, since October 2020, eligibility became limited to diagnostic tests and vaccines, neglecting therapeutic options.
Although the rate of SARS-CoV-2 vaccinations continues to increase and the Centers for Disease Control and Prevention relaxed mask requirements for vaccinated people, we hear about the emergence and increasing spread of variant strains as well as breakthrough cases of COVID-19 in fully vaccinated individuals. Moreover, the risk of severe illness and hospitalization from COVID-19 will persist among individuals who remain unvaccinated.
As of May 14, 2021, there were thousands of COVID-19 therapy-related trials globally and 849 active studies in the United States according to clinicaltrials.gov. Immunomodulators, medications that help regulate the immune system, are examples of the class of drugs that could mitigate admissions to the intensive care unit (ICU), reduce hospitalization times, and decrease mortality. Their efficacy in treating COVID-19 patients is currently under clinical evaluation, and this crucial work requires further funding.
In a February 22, 2021 White House press briefing, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, highlighted the role that immunomodulators could potentially play in treating COVID-19 because of their ability to block a variety of cytokines and cytokine receptors. By inhibiting the so-called “cytokine storm,” the overactive immune response triggered by the COVID-19 virus
these treatments have the potential to prevent acute lung injury and the progressive damage that often leads to ICU admittance and the need for mechanical ventilation.
People with chronic lung conditions, including the nearly 16 million Americans and more than 300 million people worldwide living with chronic obstructive pulmonary disease (COPD), are at an increased risk for death and are more likely to have worse outcomes as a result of COVID-19 infections. On March 1, 2021, the COPD Foundation asked U.S. Department of Health and Human Services Secretary, Xavier Becerra, to eliminate the new BARDA restrictions on funding for lifesaving immunomodulators and related anti-inflammatory COVID-19 treatments.
The National Institutes of Health (NIH) is supporting research on immunomodulators and other therapeutics that could prevent or repair damage to the lungs and other organ systems in patients with COVID-19. Under the NIH, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership has evaluated hundreds of potential drugs and prioritized candidates for their master protocols, with an emphasis on repurposed drugs. However, NIH’s larger Adaptive COVID-19 Treatment Trial (ACCT) studies have recently closed to new drug candidates, including those that are being investigated for the treatment of hospitalized COVID-19 patients.
Funding for this class of medications would greatly accelerate the delivery of essential treatments to hospitalized COVID-19 patients.
These therapeutics are not COVID-19 specific, which means that they can also be applied to treat SARS, MERS, and influenza cases as well as other causes of acute lung injury. Undoubtedly, this would be a significant contribution for individual patients and in the event of a future pandemic.