Last week, the UK’s regulatory agency approved Pfizer/BioNTech’s COVID-19 vaccine (BNT162b2) for emergency use. Quietly, the UK’s Joint Committee on Vaccination and Immunization (JCVI) also published priorities for populations to be vaccinated.
Like the United States, the UK is in a unique position. It will be among the first countries to roll out the highly effective Pfizer/BioNTech vaccine. However, it will be unable to vaccinate its entire populace with the first, or even the entirety of its Pfizer/BioNTech supply agreement in 2020-2021. Eventually however, many months from now, with a combination of Pfizer/BioNTech, Moderna, and possibly other vaccines currently undergoing phase 3 trials, the USA and the UK will be able to vaccinate its entire population.
In the meantime, how will the UK and USA allocate its limited resource of COVID-19 vaccines?
A couple months ago, the National Academies of Science, Engineering, and Medicine (NASEM) published a framework for equitable allocation of COVID-19 vaccine.[i] Per their website, NASEM is a nonprofit, operating outside of the US federal government, that provides objective, straightforward answers to difficult questions of national importance.
In its hefty, 252-page report, NASEM offered the following order of vaccinations:
The UK’s approach is consistent with NASEM, although the UK prioritizes older adults to a greater degree than NASEM. The primary goal in the UK is to reduce deaths and maintain the healthcare system. The secondary goal in the UK is to reduce hospitalizations. The order of vaccinations is as follows:
The US, specifically the CDC’s Advisory Committee on Immunization Practices or ACIP, places a lower priority on older adults and clinical vulnerability, and a higher priority on racial & social vulnerability. Ezekiel Emanuel, a prominent bioethicist at University of Pennsylvania, states, because early death correlates with disadvantage, prioritizing all patients 65 years and older is likely to exacerbate disadvantage […] 30% of all non-White COVID-19 decedents are younger than 65 vs. only 13% of White COVID-19 decedents.[ii] Although Ezekiel Emanuel is not affiliated with ACIP, his ideas are well-represented at ACIP, whose meeting documents state, “Hispanics and non-Whites are under-represented among COVID-19 deaths in adults >65 years of age”.
|Priority 1||Healthcare workers||Healthcare workers||Long-term care facility residents|
|Long-term care facility residents|
|Long-term care facility residents|
|Priority 2||Long-term care facility residents|
Older and clinically vulnerable adults
|Long-term care facility residents|
Older and clinically vulnerable adults
|Older and clinically vulnerable adults||Essential workers||Essential workers|
|Priority 3||Essential workers||Essential workers||Essential workers||Older and clinically vulnerable adults||Older and clinically vulnerable adults|
The CDC recommends delaying vaccination of older and clinically vulnerable adults, in favor of vaccinating essential workers? So what?
Originally, the USA’s vaccine rollout would adhere to the prioritization of the CDC’s ACIP. Instead, the HHS offered to allow individual states to decide their own priorities for vaccine rollout. Still, individual states look to the CDC’s ACIP for guidance. Indeed, New York State priorities for “who will be first to be offered the COVID-19 vaccine” closely mirror the CDC’s priorities.
The CDC’s meeting documents acknowledge that older and clinically vulnerable adults account for the majority of hospitalizations and over 80% of COVID-19 deaths. With 60 million essential workers, older and clinically vulnerable adults will wait for an additional 6 weeks for COVID-19 vaccines. If we assume that during these 6 weeks, two thousand COVID-19 deaths occur per day (the 7-day moving average is 2250 deaths per day as of December 6, 2020), over 67,000 deaths will occur among older and clinically vulnerable adults. These 67,000 deaths are preventable, simply by giving the old and infirm their proper place in the line for a COVID-19 vaccine.
Let’s look at some of the CDC’s reasons for prioritizing essential workers over the old and infirm.
MIT Technology Review and Wired recently printed articles on vaccine prioritization. Initially, I read the articles with curiosity, but as I learned more, I become concerned that the ideas in the articles could be misused. The articles discuss vaccination strategies to either:
Targeting the old and infirm is a simple strategy to lower hospitalizations and deaths from COVID-19.
Targeting super-spreaders is, in theory, elegantly seductive. If we can vaccinate the super-spreaders (“social butterflies”) with surgical precision and lower R-naught (R0) to below 1, then we can quickly halt the COVID-19 pandemic. And who doesn’t love mathematical models?
Unfortunately, it’s bunk.
Because here’s the rub, neither the Moderna or the Pfizer/BioNTech vaccine trials assessed the effect of their vaccines on reducing COVID-19 transmission. To study transmission, they could have (for example), regularly tested every participant after vaccination for SARS-CoV-2. Instead, they looked for participants developing clinical symptoms of COVID-19, and then tested these participants for SARS-CoV-2 to confirm a “case” of COVID-19. Pfizer’s CEO also agrees it’s “not certain” that its vaccine prevents viral transmission.
The mathematical models on vaccine prioritization look at R0 and transmission.[iii],[iv],[v] It is possible, even likely, that the Moderna and Pfizer/BioNTech vaccines lower SARS-CoV-2 transmission. However, it is inappropriate to design a real-life vaccine rollout strategy based on guesswork.
So, does it make sense for the USA to design a COVID-19 rollout on the assumption that vaccines reduce COVID-19 transmission?
Why does viral transmission hold such prominence in the minds of epidemiologists?
In 2009, a mathematician and epidemiologist published an influential paper in Science.[vi] Because schoolchildren are most responsible for transmission of seasonal influenza, and their parents serve as conduits of the virus to the rest of the population, optimal vaccination ought to prioritize schoolchildren and their parents. Slowing viral transmission is critical to annual rollout of flu vaccines.
However, it’s unclear how readily flu vaccination strategy extrapolates to COVID-19 vaccination strategy.
• Flu vaccines are 40-60% effective, whereas the COVID-19 vaccines are 94-95% effective
• Flu mortality is much lower than COVID-19 mortality
Many epidemiologists do agree that the old and infirm should be among the first to receive COVID-19 vaccines. Marc Lipsitch, professor at Harvard University, said that the vaccines prevent SARS-CoV-2 infection in the old and infirm from becoming life-threatening COVID-19 disease. He said, “if we vaccinate the very old and the people with significant comorbidities, that would be the quickest way to get back towards a more normal life.”
If we look again at the ACIP’s rationale for prioritizing essential workers, we see that racial and social equity drives part of its decision-making. That’s commendable. However, I am concerned that ACIP’s policies will disenfranchise the socially vulnerable populations it’s looking to protect.
While minorities may be overrepresented in “subsets” of essential workers, minorities are also overrepresented among the unemployed, before and during the COVID-19 pandemic.[vii] From my personal experiences as a physician for disenfranchised minority populations in one of the most diverse cities in the country, many patients can’t work because of short- or long-term medical disabilities.
These medical disabilities, predominantly cancer in my clinic, also predispose my patients to hospitalization and death from COVID-19. And, if my patients require in-person medical care, they can’t shelter in place without significant risks, including death.[viii] Urgent (i.e. timely) and/or extended in-person medical care is required for many conditions:
Unfortunately, many patients, particularly Blacks and Hispanics, delay medical care due to their fears of contracting COVID-19.[ix],[x] Delays in diagnostic or therapeutic care during the pandemic have led to substantial increases in non-COVID-19-related deaths.[viii],[xi]
According to the ACIP, medically disabled minorities who can’t work will wait in line for a COVID-19 vaccine, behind healthy minority and non-minority essential workers. That seems inequitable.
A few days ago, Uber Technologies asked the CDC to designate its ride-hail and delivery drivers as essential workers entitled to early COVID-19 vaccination. It’s interesting that Uber is taking a sudden interest in the health of its drivers, since as independent contractors, they do not get health insurance from Uber. No, instead, it’s more likely that Uber sees a COVID-19 immune driver fleet as “good for business.”
With Uber’s ask of the CDC, it seems that big business is aware of the CDC’s prioritization of essential workers, and Uber (among others) is seeking to classify itself as “essential.” Given the ambiguity of the term, the CDC current prioritization seems ripe for abuse by special business interests at the state and national level.
Ultimately, COVID-19 is predominantly a clinical disease, not a social, racial,[xii] or cultural disease. Social vulnerability,[xiii] which some have suggested as a way to prioritize the COVID-19 vaccine, certainly increases the risk of contracting COVID-19. As I’ve argued, “essential workers” excludes some of the most socially vulnerable populations who are also very clinically vulnerable. In addition, with COVID-19 case-fatality varying by orders of magnitude, I argue that social vulnerability should not supersede clinical vulnerability in prioritizing populations for COVID-19 vaccination.
To illustrate the stark differences in the UK and the USA’s vaccination priorities:
A. 25 year old male; police officer; healthy
B. 48 year old female; homemaker; recently diagnosed with early-stage breast cancer
In the UK, person B would be vaccinated much earlier than person A. In the USA, with current CDC guidelines, person A would be vaccinated earlier (potentially much earlier) than person B.
By prioritizing those at highest risk of developing severe COVID-19, the CDC can not only save lives, it can bring the pandemic under control more rapidly. After all, who is admitted to the hospital or ICU, if not old and infirm adults? While the occasional news story illustrates that even the young and healthy can die of COVID-19, the vast majority of severe and critically ill patients with COVID-19 are old and infirm. By vaccinating this population sooner, we can reduce hospitalizations, ICU admissions, and deaths.
In many ways, the response to the COVID-19 pandemic has been a race. A race to genetically sequence the vaccine, a race to rollout SARS-CoV-2 testing, a race of drug & vaccine clinical trials. Time is of the essence. Why make the most vulnerable Americans wait 6 more weeks for vaccination?
[i] Stephenson, Joan. “National Academies Report Advises on Allocation Priorities for a COVID-19 Vaccine.” JAMA Health Forum. Vol. 1. No. 10. American Medical Association, 2020.
[ii] Persad, Govind, Monica E. Peek, and Ezekiel J. Emanuel. “Fairly prioritizing groups for access to COVID-19 vaccines.” Jama 324.16 (2020): 1601-1602.
[iii] Moore, Sam, et al. “Modelling optimal vaccination strategy for SARS-CoV-2 in the UK.” medRxiv (2020).
[iv] Matrajt, Laura, et al. “Vaccine optimization for COVID-19, who to vaccinate first?.” medRxiv (2020).
[v] Bubar, Kate M., et al. “Model-informed COVID-19 vaccine prioritization strategies by age and serostatus.” medRxiv(2020).
[vi] Medlock, Jan, and Alison P. Galvani. “Optimizing influenza vaccine distribution.” Science 325.5948 (2009): 1705-1708.
[vii] Galea, Sandro, and Salma M. Abdalla. “COVID-19 Pandemic, Unemployment, and Civil Unrest: Underlying Deep Racial and Socioeconomic Divides.” JAMA (2020).
[viii] Woolf, Steven H., et al. “Excess deaths from COVID-19 and other causes, March-July 2020.” Jama 324.15 (2020): 1562-1564.
[ix] Czeisler, Mark É., et al. “Delay or avoidance of medical care because of COVID-19–related concerns—United States, June 2020.” Morbidity and Mortality Weekly Report 69.36 (2020): 1250.
[x] Rosenbaum, Lisa. “The untold toll—the pandemic’s effects on patients without Covid-19.” (2020).
[xi] Maringe, Camille, et al. “The impact of the COVID-19 pandemic on cancer deaths due to delays in diagnosis in England, UK: a national, population-based, modelling study.” The Lancet Oncology 21.8 (2020): 1023-1034.
[xii] Yehia, Baligh R., et al. “Association of race with mortality among patients hospitalized with coronavirus disease 2019 (COVID-19) at 92 US hospitals.” JAMA network open 3.8 (2020): e2018039-e2018039.
[xiii] Garcia, Odalys Estefania Lara, et al. “Application of Social Vulnerability Index to Identify High-risk Population of Contracting COVID-19 Infection: a state-level study.” medRxiv(2020).
[xiv] Kuderer, Nicole M., et al. “Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study.” The Lancet (2020).
[xv] Pastor-Barriuso, Roberto, et al. “Infection fatality risk for SARS-CoV-2 in community dwelling population of Spain: nationwide seroepidemiological study.” bmj 371 (2020).
[xvi] O’Driscoll, Megan, et al. “Age-specific mortality and immunity patterns of SARS-CoV-2.” Nature (2020): 1-9.