September 4, 2020
Committee on Equitable Allocation of Vaccine for the Novel Coronavirus; National Academy of Medicine; National Academies of Sciences, Engineering, and Medicine
RE: Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (2020)
Dear Ms. Gayle, Mr. Foege and Committee Members:
It is with great interest that the Foundation attended a session of the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus and read the Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine. We would like to commend the Committee for their thorough review of historical vaccine distribution frameworks and the sensitive inclusion of the need for ethical and transparent public planning. We are commenting about the Discussion Draft to encourage expansion of the definition of Chronic Obstructive Pulmonary Disease (COPD) to include Alpha-1 Antitrypsin Deficiency.
The Alpha-1 Foundation supports individuals who have the genetic condition Alpha-1 Antitrypsin Deficiency, or Alpha-1 for short. Alpha-1 can cause liver disease in infants, children, and adults often leading to liver transplantation. In addition, Alpha-1 causes severe COPD (emphysema) and bronchiectasis in the lungs of adults with this condition, often appearing during an individual’s prime earning years. The majority of adults identified with Alpha-1 have significant lung impairment and have been demonstrated to have an increased risk of severe disease and death should they develop COVID-19 infection. While many individuals with Alpha-1 have remained free of COVID-19 because of careful adherence to recommended preventive measures, those who do become infected are more likely to spend time in the hospital and intensive care. A significant number of those with Alpha-1 and COVID-19 have died.
As an organization that represents individuals with genetic COPD we are particularly interested in the vaccine allocation criteria that is aimed at mitigation of negative effects on those with pre-existing conditions. This rare disease population is amongst the most vulnerable for severe outcomes because of the comorbid condition of lung tissue loss and decreased immunity. We also represent individuals who have had end stage treatment for Alpha-1 which is transplantation of the lung or liver.
While every effort is being made to secure millions of doses of vaccines even before proof of safety and effectiveness is demonstrated there will not be sufficient doses to vaccinate all that need the vaccine as the vaccination process begins and even if there were sufficient doses available, the vaccination program will likely take months to years to perform.
Studies show that there are over 100,000 individuals with the U.S. with Alpha-1. Many remain unidentified even though testing for Alpha-1 involves a simple blood test or cheek swab. Many risk factors for severe COVID-19 disease have been identified already including advanced age, obesity, diabetes, and hypertension. We propose that Alpha-1 Antitrypsin Deficiency be included in the definition of COPD and be prioritized for COVID-19 vaccination.
Our recommendation is that Alpha-1 Antitrypsin Deficiency be inserted into “Phase 1b Population: People of All Ages with Comorbid and Underlying Conditions That Put Them at Significantly Higher Risk”, as noted below.
“Phase 1b Population: People of All Ages with Comorbid and Underlying Conditions That Put Them at Significantly Higher Risk. It remains unclear precisely which comorbid and underlying conditions put individuals at a significantly higher risk of severe COVID-19 disease or death. CDC continues to gather evidence on this topic, and lists the following as factors associated with an increased risk of severe COVID-19 disease: Cancer, chronic kidney disease, chronic obstructive pulmonary disease (COPD) and Alpha-1 Antitrypsin Deficiency, immunocompromised state from solid organ transplant, obesity (body mass index [BMI] ≥30), serious heart conditions (e.g., heart failure, coronary artery disease, cardiomyopathies), sickle cell disease, and type 2 diabetes mellitus (CDC, 2020d). Vaccinating all individuals with the above comorbid conditions in Phase 1b would prove unmanageable, as the group includes hundreds of millions of people in the United States. In a highly constrained vaccine scenario, the initial group of recipients with comorbid and underlying conditions could focus specifically on individuals with two or more of these designated conditions. It should be noted that as the relationship between severe COVID-19 disease and certain comorbid conditions becomes clearer, this list is subject to evolve. ACIP and CDC will play a key role in assessing relevant evidence on this topic, and in the process of prioritization, it will be critical to recognize that not all comorbid conditions are equal when it comes to their 1391 placement in an allocation framework. “
Thank you for your good work and the opportunity to comment on behalf of individuals with Alpha-1 Antitrypsin Deficiency.
Miriam O’Day Robert A. Sandhaus, MD, PhD, FCCP
President & CEO Clinical Director
Alpha-1 Foundation Alpha-1 Foundation