A silver lining is defined as: a sign of hope in an unfortunate or gloomy situation; a bright prospect. As in the old saying “every dark cloud has a silver lining.”
With the recent announcements of multiple COVID-19 vaccine candidates showing efficacy of greater than 90 percent and with an apparently acceptable safety profile, we can begin to see an end to our current nightmare.
And of course, the COVID-19 death toll has been devastating, with more than 280,000 people who have died and estimates that another 250,000 lives may be lost this winter. Lost in the statistics is the human toll; not one life in this world can be replaced. The grief of losing a loved one is not assuaged by numbers going up or down.
However, as we deal with both the continuing chaos of the current pandemic and simultaneously put it behind us, we would be remiss if we did not seek the silver linings in this dark cloud. We can draw on another historically relevant disease, HIV/AIDS, to provide guidance.
In the 1980s through the mid-90s, HIV was gradually converted from a certain death sentence to a chronic manageable disease. As a young translational molecular virologist, clinical researcher and physician, I bore witness to the challenges we faced in bringing life-saving diagnostics and treatment to the public. And yet, in looking back, we realized that so many of the research advances we made had a tremendously positive spillover or “halo” effect on other life-threatening and rare diseases.
One notable example is the treatment of deadly HIV/AIDS-associated opportunistic infections. Prior to HIV/AIDS these were rare infections. But during the HIV/AIDS pandemic these infections were seen as daily occurrences. Over the long run, this research had a direct impact on the improvements in the prevention and treatment of opportunistic infections in cancer patients. We have learned that with drugs that selectively suppress the human immune system, we can positively impact many chronic human diseases such as rheumatoid arthritis and issues for recipients of organ transplants such as kidney, liver and heart transplants. The downside of using these drugs is the increased risk of these opportunistic infections that we can now prevent and treat, having learned from the lessons of treating HIV/AIDS patients.
Today, during the COVID-19 pandemic, we are witnessing an unprecedented number of innovations, many disruptive. In the realm of vaccine development, it has been accepted for years based on first principles that an mRNA vaccine would be a logical platform advance to prevent viral infections. And yet this technology languished in development due to a variety of forces that disrupters of innovation see as barriers to bringing breakthrough commercial products to market.
However, COVID-19 will lead to the first mRNA vaccine ever approved, which will undoubtedly be a platform for vaccine development in the future. Without the COVID-19 pandemic, this may have taken years and possibly may never have occurred.
Critical in the realm of diagnostics and drug development for COVID-19 as well as vaccines has been the Food and Drug Administration’s the use of the Emergency Use Authorization established in 2004 due to the Project BioShield Act. This section of the law permits FDA to authorize the use of unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat or prevent serious life-threatening diseases.
Recently, as CEO of a start-up biotechnology company with E.U.-approved COVID-19 molecular diagnostic products using the EUA process to commercialize in the United States, I witnessed firsthand the incredible potential of collaborative interactions between FDA and developers. The highly interactive EUA process, including weekly town hall teleconferences, enabled manufacturers and academics to advance molecular diagnostic tests to be developed, validated, and deployed within weeks and months rather than years or possibly never.
Many other life-threatening, rare and ultrarare diseases — other than COVID-19 — may benefit from an EUA process that allows developers to develop, validate and deploy tests while generating more data to support their continued use in the real-world setting. While these life-threatening diseases may not rise to the level of being a national security threat, they are most certainly a real threat to the affected individuals and their families.
Now is the time to look more closely at the application of EUAs in other life-threatening, rare and ultrarare conditions. The investments our country has made, and continues to make, in science and technology allow us to lead the world in medical technological innovations. Crisis, because it is disruptive, can force regulatory change.
Together, and with the strength of the incredible work being conducted in our research universities, we can increase the speed by which we turn inventions into innovations — namely, the commercially successful use of an invention as defined by Bacon and Butler. Despite the dark cloud imposed by the COVID-19 pandemic, I have hope and confidence that the breakthroughs discovered and applied in battling COVID-19 will have a positive impact on all of our health and well-being.
Dr. Anthony Japour is an infectious disease specialist and former CEO of AdvancedDx Biological Laboratories USA.
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