HHS Sample Framework For Vaccine Distribution
#15,578
While there are still no currently approved COVID-19 vaccines in the United States, early clinical trial data has been encouraging on both safety and effectiveness, and so one or more will likely receive an EUA (Emergency Use Authorization) before the end of the year.
A tremendous accomplishment, given it has been less than a year since SARS-CoV-2 emerged. But creating a vaccine may end up being the easy part. Getting two doses into the arms of enough people to significantly impact the spread of the virus my prove the far greater challenge.
Not only will initial vaccine supplies be limited, there is a huge amount of vaccine skepticism - or downright resistance - among the general population. A recent Gallup Poll found only 58% of Americans would be willing to take the vaccine - up from 50% two months ago - but well below the ideal uptake for the vaccine.
And this is before the expected full-court press on social media channels by the anti-vaccine brigade, once a vaccine is approved.
As I pointed out last August in Remembering An Emergency Pandemic Vaccine Program That Went Awry, demand for the 1976 Swine flu Shot was very high until the newspapers began highlighting several (elderly) recipients who died within days of getting the jab. Their deaths were likely unrelated to the vaccine, but it was a `good' story, and so the papers ran with it.
Today, between 24-hour cable news networks and scores of social media outlets, any deaths that occur within days or a couple of weeks of receiving a COVID vaccine will probably get a lot of adverse attention.
Much like what we saw last month in South Korea (see South Korea's Flu Vaccine Investigation) after reports emerged of dozens of deaths (out of millions of flu shot recipients), even though their CDC could find no link to the vaccine.
When you vaccinate large numbers of an elderly population, a small percentage will die due to other causes within days. While expected, it is nevertheless a public relations nightmare.
While early clinical trials suggest these COVID vaccines are safe, they are somewhat notorious for producing brief, and self-limiting side effects in many people, including fever, `flu-like' symptoms, and general malaise. It reportedly isn't pleasant.
How this will affect uptake is unknown, but many who opted for the first jab may decide against taking the booster 28 days later.
And then there is the thorny problem of who to prioritize for the vaccine, when supplies do become available. Healthcare workers are likely to be at or near the front of the line, but deciding who to vaccinate next is much tougher.
- The elderly in nursing homes are at greatest risk of death from COVID - but they are also the frailest cohort - and some percentage will inevitably succumb in the days and weeks after the receiving the shot, potentially eroding confidence in the vaccine. We also don't know how effective the vaccine will be in the elderly.
- Essential workers are - by the very nature of their jobs - at greater risk of viral exposure, and often belong to ethic groups that have been disproportionately impacted by the pandemic. They often have less access to medical services, and arguably have a better chance of spreading the virus than nursing home residents.
Further down the line will be those over 65 (but not in nursing facilities), and adults under 65. As we discussed a month ago in A COVID Vaccine Reality Check, pregnant women and children probably won't be offered the jab in the beginning due to a lack of safety data (see CDC: 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans).
While the U.S. government has not finalized their plans, yesterday the CDC's MMWR carried a lengthy report from ACIP (The Advisory Committee on Immunization Practices) on the ethical principals that will be used to guide their decision.
Their four guiding principals and associated criteria are listed as:
Maximize benefits and minimize harms
- What groups are at highest risk for SARS-CoV-2 infection, COVID-19 disease, hospitalization, and death?
- What groups are essential to the COVID-19 response?
- What groups are essential to maintaining critical functions of society?
- What are the important characteristics of these groups (e.g., size or geographic distribution) that might inform the magnitude of benefit based on the amount of vaccine available or its characteristics?
Promote justice
- Does the allocation plan result in fair and equitable access of the vaccine for all groups?
- How do characteristics of the vaccine and logistical considerations affect fair access for all persons?
- Does allocation planning include input from groups who are disproportionately affected by COVID-19 or face health inequities resulting from social determinants of health, such as income and health care access?
Mitigate health inequities
- Does the plan identify and address barriers to vaccination among any groups who are disproportionately affected by COVID-19 or who face health inequities resulting from social determinants of health, such as income and health care access?
- Does the allocation plan contribute to a reduction in health disparities in COVID-19 disease and death?
- What health inequities might inadvertently result from the allocation plan, and what interventions could remove or reduce them?
- Is there a mechanism for timely assessment of vaccination coverage among groups experiencing disadvantage and the possibility for course correction if inequities are identified?
Promote transparency
- How does development of the allocation plan include diverse input, and if possible, public engagement?
- Are the allocation plan and evidence-based methods publicly available?
- Is the allocation plan clear about what is known and unknown and about the quality of available evidence?
- What is the process for revision of allocation plans based on new information?
- Is there a mechanism to report demographic data elements for vaccine recipients (e.g., age, race/ethnicity, and occupation) to support equitable vaccination coverage?
Just the logistics required to roll out a 2-jab emergency vaccination campaign to over 300 million Americans next year are staggering, even assuming everything goes right with the vaccine.
I've posted the summary and some excerpts from the MMWR report below, but you'll want to follow the link to read it in its entirety. I'll have a brief postscript when you return.Trying to do so fairly and equitably - particularly with limited resources - is an unenviable job.
Early Release / November 23, 2020 / 69
Nancy McClung, PhD1; Mary Chamberland, MD1,2; Kathy Kinlaw, MDiv3; Dayna Bowen Matthew, JD, PhD4; Megan Wallace, DrPH1,5; Beth P. Bell, MD6; Grace M. Lee, MD7; H. Keipp Talbot, MD8; José R. Romero, MD9; Sara E. Oliver, MD1; Kathleen Dooling, MD1 (View author affiliations)View suggested citation
Summary
What is already known about this topic?
During the period when the U.S. supply of COVID-19 vaccines is limited, the Advisory Committee on Immunization Practices (ACIP) will make vaccine allocation recommendations.
What is added by this report?
In addition to scientific data and implementation feasibility, four ethical principles will assist ACIP in formulating recommendations for the initial allocation of COVID-19 vaccine: 1) maximizing benefits and minimizing harms; 2) promoting justice; 3) mitigating health inequities; and 4) promoting transparency.
What are the implications for public health practice?
Ethical principles will aid ACIP in making vaccine allocation recommendations and state, tribal, local, and territorial public health authorities in developing vaccine implementation strategies based on ACIP’s recommendations.
(SNIP)
Discussion
During a pandemic, ethical guidelines can help steer and support decisions around prioritization of limited resources (3,4). Consideration of ethical values and principles has featured prominently in discussions about allocation of COVID-19 vaccines. This consideration is particularly relevant because the COVID-19 pandemic has highlighted long-standing, systemic health and social inequities. Although various frameworks for COVID-19 vaccine allocation demonstrate differences in their structure (e.g., based on varying combinations of different goals, objectives, criteria, and other structural elements) and emphasis (e.g., inclusion of global and national considerations), nearly all reference values and principles similar to those which ACIP considers fundamental (5–8). ACIP viewed the following characteristics as critical for its ethical approach to COVID-19 vaccine allocation when supply is limited: simplicity in structure and definitions; acceptability to stakeholders; and ease of application, both at the national and state, tribal, local, and territorial levels.
Allocation of limited vaccine supplies is complicated by efforts to address the multiple goals of a vaccine program, most notably those related to the reduction of morbidity and mortality and the minimization of disruption to society and the economy. If the goals of a pandemic vaccination program are not clearly articulated and prioritized, drawing distinctions between groups that merit consideration for allocation of vaccine when supply is constrained can become difficult. The unanimity in opinion for early vaccination of health care personnel indicates that maintenance of health care capacity has emerged as a high priority in the context of a severe pandemic. This perspective aligns with ethical considerations for pandemic influenza planning (3,4). If vaccine supply remains constrained, it might be necessary to identify subsets of other groups for subsequent early allocation of COVID-19 vaccine.
At the national, state, tribal, local, and territorial levels, such decisions should be guided, in part, by ethical principles and consideration of essential questions, with particular consideration of mitigation of health inequities in persons experiencing disproportionate COVID-19 morbidity and mortality. In the setting of a constrained supply, the benefits of vaccination will be delayed for some persons; however, as supply increases, there will eventually be enough vaccine for everyone.
In addition to ethical considerations, ACIP’s recommendations regarding receipt of the initial allocations of COVID-19 vaccine during the period of constrained supply will be based on science (e.g., available information about the vaccine’s characteristics such as safety and efficacy in older adults and epidemiologic risk) and feasibility of implementation (e.g., storage and handling requirements). Thus, ACIP’s allocation recommendations will be made in conjunction with specific recommendations for the use of each FDA-authorized or licensed COVID-19 vaccine. Although the ethical principles in this report are fundamental for stewardship of limited vaccine supply, they can also be applied when COVID-19 vaccines are widely available, to ensure equitable and just access for all persons.
Even assuming everything goes extraordinarily well with the vaccine's launch, we still have this winter and spring to get through.
All of which means that face covers, social distancing, and scrupulous hand hygiene remain our best defense against the virus for the immediate future (see CDC Scientific Brief: Community Use of Cloth Masks to Control the Spread of SARS-CoV-2).
