President Donald Trump and the Food and Drug Administration (FDA) this week announced the emergency use authorization of convalescent plasma as a treatment for hospitalized COVID-19 patients, a major breakthrough in the fight against coronavirus that will make the therapy widely available than before.
Convalescent plasma is a blood product obtained from persons who have been exposed to the virus, who have recovered, and whose plasma has been determined to contain antibodies that may be sufficient to confer immunity and treat covid-19.
On April 22, 2020, we published an opinion, “An Immune Registry for America” in US News & World Report, highlighting its importance. Today, we re-emphasize that if convalescent plasma is to be used as a treatment it is imperative that we create a national COVID-19 immune registry of potential donors to help those suffering from COVID-19 and permit those who have been determined to be immune to safely return to work.
The authorization of the use of convalescent plasma — now assessed at improving the survival of COVID-19 patients, when administered within three days of diagnosis, who were not on mechanical ventilation and were under the age of 80 years, by 35% — is encouraging. The greenlight came from the National Institutes of Health (NIH) which has examined data from researchers, including the Mayo Clinic, evaluating thousands of COVID-19 patients given convalescent plasma as a treatment.
However, while the FDA has relied on a limited analysis of the data, it’s confident in the safety of convalescent plasma as it creates a bridge to save lives even as other treatments are developed.
But this addresses only part of the problem. The other half of the equation is the distribution of the convalescent plasma to patients in need.
We strongly urge Congress to immediately pass and send to Trump legislation establishing an immune registry. Under such legislation, the immune registry would collect and maintain data sufficient to identify and locate persons who may benefit from treatment with convalescent plasma, and it would contain information about persons who can donate plasma beneficial to those persons. It would enable the management and distribution of convalescent plasma to hospitals to assure rapid access to patients in need. It would also address the complex issues of costs and priority of usage of the convalescent plasma serum.
There are several uncoordinated efforts to establish a registry. They include the HHS initiative to collect convalescent plasma, the convalescent plasma program launched by the American Red Cross at the request of the FDA, a testing program launched by the Centers for Disease Control and Prevention, plasma-testing protocols at Mount Sinai Hospital and the Mayo Clinic, and the Plasma Protein Therapeutics Association’s collection of information on plasma donors.
We believe that the Covid-19 pandemic requires a federal legislative response to coordinate the various disparate efforts that have been launched pursuant to a single federal contract, particularly with regard to distribution of the convalescent plasma.
One of the reasons for the poor performance of the U.S. in controlling the novel coronavirus has been the lack of a coordinated national response. The pandemic is a problem that affects all 50 states, and convalescent plasma should be an article in commerce that is regulated by the federal government under the Commerce Clause of the U.S. Constitution.
Moreover, there is ample precedent for federal legislation establishing a national health-related registry. The National Organ Transplant Act of 1984, for example, established federal legislation for solid organ transplants and bone marrow transplants.
Reliance on the governing authorities in 50 states to respond separately to the coronavirus pandemic has resulted in chaos thus far, and it is time for Congress, working with the Trump administration, to establish a coordinated federal response. A national COVID-19 immune registry program run by the federal government, which would provide a mechanism for treatment of the COVID-19 disease and act as a screening process for putting Americans back to work, would further this effort.
Bart S. Fisher, JD, PhD, is a lawyer in Washington, D.C.
Dr. Rashid Chotani, MD, MPH is a public health physician and an infectious disease epidemiologist and the Medical Director at IEM, in Washington, D.C.