September 4, 2020

National Academies of Science, Engineering, and Medicine
Committee on Equitable Allocation of Vaccine for the Novel Coronavirus
500 Fifth Street, NW
Washington, DC  20001

Re:  Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine

Dear Members of the Committee:

The undersigned cancer patient, provider, and research organizations appreciate the opportunity to comment on the Discussion Draft of the Preliminary Framework for Equitable Allocation of COVID-19 Vaccine.  We commend the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus for the way it has conducted its deliberations and developed the discussion draft for vaccine allocation.  The Committee has chosen transparency and openness to public input, important standards at a time when we need to improve public confidence in potential COVID-19 vaccines.  It is especially noteworthy that the Committee has chosen this approach, which is time-consuming and challenging, when it is facing strict deadlines for completion of its work.    

The coronavirus pandemic has affected cancer patients and health care professionals in dramatic ways.  As was true with much health care, cancer care was significantly disrupted in the early days of the public health emergency.  Health care professionals and patients have embraced safe and innovative ways to deliver and receive cancer care, and disruptions in care have been addressed substantially and delays in care reduced.  Some clinical trials are being resumed and some interruptions in research are being resolved.

Despite the hard work and commitment of the cancer community to developing safe cancer care delivery strategies, there will be lasting effects of the pandemic on cancer patients.  National Cancer Institute Director Norman E. Sharpless warned of these effects in a June 2020 editorial in Science Magazine.  Dr. Sharpless warned that delays in cancer care deemed to be elective, delays in diagnosis of cancer and resulting upstaging of cancer, and suboptimal care would contribute to excess deaths from cancer over the next decade.  He predicted a 1% increase in deaths from breast and colorectal cancer due to pandemic-associated care interruptions and delays.   He also predicted that pausing cancer research today may significantly slow cancer progress for many years in the future.^[1]

COVID-19 has also had another significant impact on people with cancer, as they have poor outcomes from COVID-19.   According to a review of outcomes of patients with cancer and concurrent COVID-19 at a US cancer center, COVID-19 mortality is higher in patients with cancer than in the general population.  Patients with hematological malignancies and lung cancer have increased COVID-19 severity.^[2]  An analysis of more than 100 cancer patients in Wuhan, China found that more than half of COVID-19 patients with cancer were susceptible to severe COVID-19. ^[3]  A retrospective, multicenter, cohort study of more than 200 cancer patients found that patients with cancer and COVID-19 who were admitted to the hospital had a high case-fatality rate.^[4]

Research continues to strengthen our understanding of the risk factors that contribute to poor outcomes among people with cancer who also have COVID-19 infection.  This research may help identify additional strategies to treat cancer patients with COVID-19 and may also inform additional means to reduce risk of infection.  In the meantime, people with cancer must take strong steps to mitigate their risk of COVID-19 infection.  They may confront challenges in their mitigation efforts if they are unable to work from home, live in multi-generational homes, or have other risk factors for COVID-19.  

In short, cancer patients are at significant risk of severe COVID-19 disease or death.  

Inclusion of People with Cancer in Phase IB of the Allocation Plan

We are pleased that the framework for the allocation of COVID-19 vaccine places people with cancer in Phase IB, in line for receipt of vaccine after high-risk workers in health care facilities and first responders.  Cancer patients are included in the Phase IB category of “people of all ages with comorbid and underlying conditions that put them at significantly higher risk.”  The Phase IB group is defined by a list developed by the Centers for Disease Control and Prevention (CDC) identifying those factors associated with an increased risk of severe COVID-19 disease.  Cancer is among those factors.  The other factors on the CDC list are chronic kidney disease, chronic obstructive pulmonary disease (COPD), immunocompromised state from solid organ transplant, obesity (body mass index [BMI] equal or greater than 30), serious heart conditions (e.g., heart failure, coronary artery disease, cardiomyopathies), sickle cell disease, and type 2 diabetes mellitus.    

The inclusion of cancer patients among those to receive vaccine in Phase IB of the allocation plan is consistent with our knowledge about cancer and COVID-19.  However, the Committee has placed a limitation on the group in Phase IB by stating that, “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.”   Although a significant portion of cancer patients have comorbidities, they may not have a second condition from the CDC list.^[5]  Cancer patients are at significantly higher risk of severe COVID-19 disease or death because of their cancer diagnosis, and they should not be required to have a second comorbid condition to receive vaccine in Phase IB.  

Although we understand the potential serious limits on vaccine supply, we nonetheless object to the suggestion that the initial group of those with underlying conditions that put them at significant risk of severe COVID-19 disease should in fact be required to have TWO of the designated conditions to be allocated vaccine.   This requirement is at odds with the efforts of the Committee, in developing the allocation framework, to rely on the best available evidence, in this case about risk of severe COVID-19 disease.  

The limited supply of vaccine – which we understand could be the situation facing the nation for some time – will of course have an impact on access.  However, we do not think that the standards for receipt of vaccine in Phase IB should be limited based on anticipated vaccine supply.

We suggest instead that the Committee rely on the CDC list of conditions that pose significant risk of severe COVID-19 disease or death without the additional standard that individuals have TWO of these conditions.

Implementation of the Allocation Framework

We understand that the Committee intends to address implementation issues in chapters to be issued later.  However, we believe that the serious implementation challenges associated with the allocation framework must be addressed without delay.  Certain implementation challenges pose a basic threat to the functionality of the framework.

If the populations identified in the framework are to receive vaccine in the phases that are recommended, the conditions that trigger receipt of vaccine must be honored.   It is unclear to us how the framework can be and will be honored.  We can make this specific with regard to cancer patients.  Cancer patients would be eligible to receive a vaccine in Phase IB.  How are patients expected to obtain access to vaccines?  Will there be a public education effort to inform Americans of the phases of vaccine availability?  And when a cancer patient is eligible to receive a vaccine, how do they confirm their cancer diagnosis for the purpose of receiving a vaccine?   Does the Committee anticipate a documentation requirement for Americans who are eligible for vaccine based on a health condition?  Will the typical immunization sites and providers be utilized as the core COVID-19 vaccine providers?  Will those sites be prepared to do the screening of Americans who are eligible for a vaccine because of a health condition?

We are concerned that implementing an allocation plan that relies in part on medical condition will be difficult and will result in discouraging patients from seeking immunization with a COVID-19 vaccine.  At a time when there is a need to strengthen public confidence in COVID-19 vaccines, it is possible that the implementation of the allocation framework will serve to discourage vaccination and undermine public confidence in the government effort.  We urge the Committee to address the implementation issues associated with and triggered by its framework as soon as possible.

We appreciate the opportunity to comment on the allocation framework and to share our concerns about how people with cancer may be affected by the framework.

Sincerely,

Cancer Leadership Council

Academy of Oncology Nurse & Patient Navigators
CancerCare
Fight Colorectal Cancer
International Myeloma Foundation
LUNGevity Foundation
Lymphoma Research Foundation
National Coalition for Cancer Survivorship
Ovarian Cancer Research Alliance
Prevent Cancer Foundation
Sarcoma Foundation of America
Susan G. Komen