Earlier this month, the Biomedical Advanced Research and Development Authority, or BARDA, part of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS), apparently notified companies and researchers that it was transitioning funding away from therapies targeting Acute Respiratory Distress Syndrome (ARDS), a severe and potentially deadly outcome of the novel coronavirus. Rather, the administration would place all big bets on a vaccine. COVID-19 has turned the global economy upside down, potentially devastating a generation’s economic prospects. Consequently, the U.S. federal government appears to favor a home-run vaccine stopping the pandemic over incremental improvements in the war against COVID-19.
BARDA has pledged more than $2.2 billion in deals with five vaccine manufacturers for the coronavirus, compared with about $359 million toward potential Covid-19 treatments, as reported by Sheryl Gay Stolberg with the New York Times.
This emphasis on the development of a vaccine evidences the administration’s deeper, more profound concerns about societal normalcy with a particular emphasis on economic sustainability. A case is to be made at tripling down on vaccine development because without a vaccine, America faces a fundamentally bleaker economic reality: perhaps an economic contagion worse than the 1930s Great Depression. But at what cost? Some of the most at-risk groups may now face even graver risk without sufficient federal funding targeting novel ARDS therapies.
The Debate Between Research and Finance
The decision to suspend investment in lung treatments blindsided academic researchers and executives at certain companies, who report spending months pitching proposals to BARDA. Some clinicians and bioethicists contend that BARDA should continue supporting research into treatments for lung conditions, while other experts argue the policy is a sensible way to spend limited federal dollars.
Vaccines are universally considered the world’s best hope for stopping the virus, but scientists and doctors treating patients hospitalized with COVID-19 caution that there is no guarantee a vaccine will be ready by the end of the year, as President Trump has promised. TrialSite News covered with optimism the Operation Warp Speed announcement. By orchestrating, marshalling and directing federal resources toward the goal of producing vaccines as well as therapies and diagnostics (countermeasures) the timing, intensity, and intentions made sense. Although the argument for a concentrated focus certainly has merit, as recently as a week ago the Department of Health and Human Services (HHS)’s Fact Sheet on Operation Warp Speed didn’t preclude therapies and diagnostics. Does it have to be an either/or proposition?
Given the horrific number of ARDS-based fatalities, especially among the elderly, people with health comorbidities and other at-risk populations, the consideration to move funding away from therapies targeting this potentially grave condition raises considerable concern.
But other experts believe that BARDA’s shift away from lung treatments make sense, given that vaccines or broad-based antiviral drugs would do the most to stop the global spread of the virus, and experimental treatments like stem-cell therapies are far from proven.
“It’s not unreasonable, what they are doing,” said Dr. Luciana Borio, who oversaw public health preparedness for the National Security Council in Mr. Trump’s White House and had been the acting chief scientist at the Food and Drug Administration under former President Barack Obama. “It’s important to bring discipline to the process because the resources are finite, both financial and human.”
The Risk: Calculated or Not?
In the case of the coronavirus, Congress has allocated more than $6.5 billion to BARDA to develop vaccines, treatments and other products to address the pandemic. Representatives for academic researchers and biotech companies contend that BARDA should disperse funds to a wider variety of research initiatives. The argument goes that because the course of COVID-19 is relatively short, funding targeted therapies makes more sense.
The coronavirus outbreak has killed more than 118,000 people in the United States, and those who die often succumb to respiratory failure after the lungs become unable to provide the body with enough oxygen. In some cases, people’s immune systems go into overdrive and cause critical damage from the so-called Cytokine Storm. This is an extremely difficult topic, given what is in the balance here. What are the probabilities associated with a successful vaccine? What happens if these vaccines turned out to be rushed, and therefore not as effective or safe? Are there measures to mitigate risk and incrementally move society back towards normalcy? There are some examples around the world where it appears particular societies are prepared to learn how to live with the virus. Is America ready for this reality?
Call to Action: While federal funding has boosted research efforts and provided resources for investigators studying the coronavirus as well as the most potential treatments, the politicization that comes with that support has, in some cases, barricaded advancements in the war against COVID-19. Sign up for our Daily Newsletter to get updates from TrialSite News on the status and direction of “Operation Warp Speed.”