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National Academies of Medicine releases draft of proposed guidelines for COVID-19 vaccine, seeking public feedback

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On Tuesday, September 1, the National Academies of Medicine (NAM) released a draft of their proposed guidelines for the distribution of a potential COVID-19 vaccine once it becomes available.  The public has been given the opportunity to provide their thoughts on this document until 11:59 ET on Friday, September 4, 2020.  

We at the Child Neurology Foundation recognize that should a vaccine become available for COVID-19, it could affect our community in many ways. And while the National Academies would not be the arm distributing the vaccine, nor does it have the power to enact or enforce any legislation, the National Academies has been the Federal government’s most trusted, evidence-based, unbiased advisor for almost two centuries. For that reason, we encourage you to share your comments with the National Academies at nap.edu/vaccine. If you have questions about the comment process, the draft, or below summary, please contact Jessica Nickrand at jnickrand@childneurologyfoundation.org. 

Background: 

  • This draft is only designed to provide guidance on the distribution of a potential vaccine. Other issues, including communication about risk and efficacy, ideas to reduce people’s hesitancy to take the vaccine, and international considerations will be addressed in the final report. 
  • This proposed framework is intended to “inform the decisions by health authorities…as they create and implement national and/or local guidelines for SARS-CoV-2 vaccine allocation.” 
  • The authors thoroughly studied other vaccine efforts and the ethical discussions over the allocation of other scarce resources in the COVID-19 effort. By examining this historical evidence, the authors can better identify a path forward for this potential vaccine, which will almost certainly be another pandemic-related scarcity. 

Lessons Learned from Other Vaccine Efforts: 

  • Even if a vaccine became approved for use and available against COVID-19, it “most certainly” will only be available in limited supplies. Those most affected and/or those from the most vulnerable populations should be prioritized. 
  • Previous efforts, like against H1N1, Ebola, and the Flu, inform NAM’s thinking in this paper. 

A Framework for Equitable Allocation of COVID-19 Vaccine 

  • The public seems uncertain about a COVID-19 vaccine, with some studies demonstrating that about one-third of Americans may decline an FDA-approved vaccine for the novel coronavirus. A mass vaccine campaign will fail with this level of mistrust. The National Academy believes that an efficient, effective, and scientifically-backed allocation effort can help to regain the public’s trust to ultimately benefit the most community members in our fight against COVID-19. 
  • NAM identified the following foundational principles as its guide for determining “equitable allocation”: 

    • Maximization of benefits 
      • This means both maximizing the health of the individual, but also the role an individual plays in society. The National Academy notes physicians, nurses, health care providers, teachers, etc., and others who work in high-risk environments that serve many people are good candidates for early allocation. 
    • Equal regard 
      • People at equal level of health and in equal roles should be treated equally. If there is a scarcity among people at particular levels, random or weighted lotteries should select recipients. 
    • Mitigation of health inequities 
      • COVID-19 disproportionately affects Black, Hispanic/Latinx, and American Indian populations due to socioeconomic factors. These socioeconomic factors, as well as populations’ preexisting conditions and other health factors, should be a strong consideration when identifying vaccine allocation. Additionally, a plan for distributing the vaccine must also include a plan to “ensure that people who are allocated a vaccine actually receive it” by providing transportation and other social assistance if necessary 
    • Fairness 
      • NAM does not advocate age itself as an allocation criterion. Because current data demonstrate that children do not transmit the virus as well as older adults, they may not be candidates for prioritization. 
    • Evidence-based 
      • Vaccination phases must be based on the best available science and public health data available. 
    • Transparency  
      • Open communication about this program is central to its success 

Risk-Based Criteria for Vaccine Allocation 

  • The NAM identifies the below criteria for evaluating high-risk in a vaccine allocation program, therefore having higher priority in the allocation process: 
  • Risk of Acquiring Infection: Individuals who have a greater probability of “being in settings where COVID-19 is circulating”  
  • Risk of Severe Morbidity and Mortality: Individuals with a higher probability of severe complications or death 
  • Risk of Negative Societal Impact: Individuals who, if they got sick and/or died, would negatively impact many people. NAM specifically says that this “does not consider their wealth or income,” or “how readily an individual could be replaced in a work setting.” 
  • Risk of Transmitting Infection to Others: Individuals with close contact to others in their material, physical, and social lives. 
  • NAM chose specifically to not consider the following issues for vaccination allocation prioritization: 
  • Political context: Level of government or lead government official should have no bearing on the prioritization process. 
  • Public Health Changes: It is impossible to predict future public health measures, including mask mandates, etc., and the allocation framework allows for these changes 
  • Advances in Treatment: As treatments and even potentially cures for the novel coronavirus become available, the allocation procedure should allow for these changes 

Phases of Allocation 

  • The NAM identifies four distinct phases of allocation, with further prioritization for geographic areas with greater vulnerability: 
    • Phase I includes “frontline” health workers, based not on title but on actual proximity to COVID-19. For example, NAM doesn’t wish to say “physicians” are included in Phase I when many doctors may work in specialties or in settings far removed from high-risk patients, whereas nursing home workers and home health aides experience, on average, higher risks of this virus. Also included in Phase I include older adults living in community living facilities, and “individuals with select high-risk comorbid and underlying conditions,” although NAM does not indicate what these conditions may be, nor if age of the individual with the comorbidity affects their allocation. 
    • Phase II includes individuals with underlying conditions not vaccinated during Phase I and older adults not included in Phase I. School teachers and staff should be included in Phase II, as well as individuals working in group homes, homeless shelters, and those who are incarcerated. Also included in Phase II should be any other essential workers who are at high risk of exposure to COVID-19. 
    • NAM anticipates that the vaccine will be more widely available by Phase III of allocation, allowing for vaccination of workers unable to work from home to “restore full economic activity.” NAM anticipates the widespread vaccination of children and young people in this phase, but acknowledges that vaccine trials may not include children, making their participation in this allocation at all difficult. 
    • Phase IV would see vaccination for all other individuals “interested in receiving the vaccine for personal protection.”