SALT LAKE CITY — Nearly 60 million Americans are non-health care essential workers — truck drivers, meat packers, building cleaners and grocery clerks. Because they can’t work from home and often work closely with others, experts believe they should be near the top of the list to receive a hoped-for COVID-19 vaccine.
However, more than 100 million Americans have at least one medical condition that puts them at risk for COVID-19 complications, and older Americans represent 16% of COVID-19 cases but nearly 80% of COVID-19 deaths.
Whose risk is riskiest? And how do experts narrow down such a massive pool of need?
Those are the questions before the Advisory Committee on Immunization Practices, a Centers for Disease Control and Prevention committee tasked with determining a vaccination order during the first wave of a hoped-for COVID-19 vaccine.
The group met Wednesday in a online meeting and was expected to vote on a recommended lineup, but instead outlined many of the crucial details that still remain unknown — which vaccine will be approved (if any), storage/handling requirements, potential efficacy levels in different populations, how many doses will be available and when, not to mention the public confidence in a vaccine — all facts that could dramatically impact the group’s recommendations.
Though no date was set for an expected recommendation, “if and when FDA authorizes or approves a vaccine, then ACIP will have an emergency meting and vote on recommendations and populations for use,” Dr. José Romero, chief medical officer for the Arkansas Department of Health and ACIP chairman, instructed the ACIP group near the close of the hourslong meeting.
Building a framework
While the group didn’t offer an official recommended lineup, they did share a new ethics/equity framework that will guide them as they create such a list.
The framework centers on five key ethical principles: maximize benefits and minimize harms, equity, justice, fairness and transparency.
With transparency as a foundation, and evidence-based practices as an overarching standard, the group emphasized that any vaccine recommendation framework should minimize death and serious disease while also serving as an approach that “reduces rather than increases health disparities,” and commits to “fair stewardship in the distribution of a scarce resource,” according to the presentation by Dr. Sara Oliver with the CDC’s National Center for Immunization and Respiratory Diseases. COVID-19 has been especially devastating among racial and ethnic minorities.
“We want to ensure that everyone has a fair and just opportunity to be as healthy as possible,” Oliver said.
The advisory committee’s ethics/equity framework comes after reviewing three other recommendations from the World Health Organization, the Johns Hopkins Bloomberg School of Public Health and the National Academies of Sciences, Engineering and Medicine.
The groups all agreed that front-line health care workers topped the list, including long-term care facility workers, although after that, opinions diverged. (The WHO didn’t offer rankings.)
Johns Hopkins
- Tier 1: Front-line health care workers including long-term care facility workers, public transport, food supply workers, teachers, pandemic support and public health officials, adults over 65, those with serious diseases and individuals of social groups experiencing “disproportionately high fatality rates.”
- Tier 2: All other health care workers and pharmacists, deployed military, police, TSA and border security, fire, front-line infrastructure workers and workers in high-density/high-contact jobs.
The National Academies
- Phase 1a: Front-line health care providers, police and firefighters
- Phase 1b: Older adults in congregate settings and adults with two or more high-risk health conditions.
- Phase 2: Other health care personnel, teachers, school staff and child care workers, adults with only one health risk and older adults not in congregate settings.
Yet because tier 1 or phase 1 groups comprise 50 million-plus individuals, said Oliver, additional subprioritization is needed.
The advisory committee showed how they’re using their new ethics/equity framework to consider each subgroup, exploring how to maximize benefits, provide equity, justice and fairness, while being transparent through the entire process.
Safety monitoring
If and when a vaccine is distributed to front-line health care workers, the Vaccine Safety Assessment for Essential Workers, or V-SAFE, will immediately go into action, said Dr. Tom Shimabukuro, on the CDC COVID-19 Vaccine Planning Unit Vaccine Safety Team.
The CDC will text or email recipients of the COVID-19 vaccine daily for a week following their vaccination and weekly for the next six weeks to document any adverse effects.
The new program augments the existing Vaccine Adverse Event Reporting System, (VAERS), which is co-managed by the CDC and FDA to document any issues with vaccines.
With the VAERS reporting system, anyone — a patient, parent or health care provider — can report a concern about a vaccine, even if they’re not sure if the reaction was caused by the vaccine, said Shimabukuro.
Since 2015, the reporting system has received around 50,000 reports a year, with serious reports being reviewed by FDA scientists, who also consult a person’s medical records.
The vaccine playbook
The CDC also recently released a 57-page “interim playbook” — an instruction manual to help cities, states and jurisdictions develop their vaccine distribution plans — both the immediate plans for reaching high priority groups as well as subsequent plans for reaching the broader population.
The playbook was created with help from officials in North Dakota, Florida, California, Minnesota, Philadelphia who were tapped by the CDC to start thinking about a plan more than a month ago and share what they were learning.
Thus far, officials have learned that a COVID-19 vaccination rollout will be more expensive than other vaccine campaigns, and more complicated due to social-distancing requirements. Technology concerns are definitely an issue and the need for clear federal guidance is key.
But settling on the right level of federal guidance is also a work in progress.
ACIP member Dr. Robert Atmar, a professor of infectious diseases at Baylor College of Medicine, argued for a little more national guidance, noting that often provides the greatest transparency, compared to guidance that “trickles down” through state channels.
Others echoed his comments, while also emphasizing the need for state flexibility and preserving the autonomy of local leaders.
“We need to be careful that the level of guidance is not too granular that it bogs down or paralyzes vaccination campaigns,” said Dr. Sharon Frey, clinical director of the Center for Vaccine Development at St. Louis University School of Medicine and ACIP committee member.