With a potential COVID-19 vaccine moving closer to reality and the U.S government signing contracts for millions of potential doses, an unresolved question is who should be at the front of the line to get those first doses.

A National Academies of Sciences, Engineering and Medicine committee provided a possible answer when it released a discussion draft Sept. 1 of a preliminary framework for the equitable allocation of a vaccine. Sponsored by the NIH and the CDC, the framework follows a four-phase approach, in the recognition that initial supplies of a COVID-19 vaccine will be tightly constrained – perhaps enough to vaccinate just 3% to 5% of the U.S. population.

When finalized within the next month or so, the framework is expected to help health authorities, including the CDC’s Advisory Committee on Immunization Practices, as they create and implement national, state and local guidelines for allocating a SARS-CoV-2 vaccine. But first, the National Academies is holding a public listening session on the draft from noon to 5 p.m. Eastern Time Sept. 2. It also will accept comments through Sept. 4.

It should come as no surprise that those first in line, according to the draft, should be frontline health workers, based on their actual risk of exposure to the coronavirus, followed by first responders. Together, those two groups make up about 5% of the population. The second part of phase I would extend the vaccine to an additional 10% of the population – people with significant co-morbidities and older adults living in long-term care facilities or crowded settings.

Phase II would include teachers and school staff, people with moderate co-morbidities, all older adults, people in homeless shelters or group homes, incarcerated or detained individuals along with staff at those facilities, and workers in industries essential to the functioning of society and at high risk of exposure.

The third phase would kick in once vaccines are more widely available. In that phase, the vaccines would be given to young adults, children – provided a vaccine has been adequately tested in kids – and other workers essential to fully restoring economic activity. The final phase opens immunization to anyone who wants it.

While it didn’t specify the phase, the draft said the thousands of volunteers who participate in the vaccine trials should be given early access to the vaccine, as is the practice with most clinical trials. It also said legal status of individuals shouldn’t be a consideration and the vaccines should be provided with no copays, regardless of whether a person is covered by Medicare, Medicaid or private insurance.

Fine-tuning needed

When it comes to implementing such a framework, some of the categories in the phases will have to be better defined as more data become available, the committee acknowledged. For instance, what’s the age threshold for “older adult”?

“As of Aug. 1, nearly 80% of all COVID-19 deaths in the U.S. have occurred in people over the age of 65, and a significant proportion of these deaths were individuals living in long-term care facilities,” the National Academies said.

However, the framework noted that morbidity and serious illness and death from COVID-19 rises substantially at about age 50, but it is most prevalent in people older than 70.

“Current knowledge of the relative risks stemming from specific underlying risk factors is evolving quickly and will be better known by the time vaccines actually become available,” according to the draft. The hope is that emerging information would allow decision makers to more effectively target those at greatest risk of serious morbidity and mortality, including younger people, than they can today.

Also, the development of life-saving drugs and early detection and treatment could avert much of the serious morbidity and mortality being seen today, which could change the prioritization outlined in the framework.

In preparing the draft, the National Academies committee acknowledged that one-third or more of the U.S. population may pass on the vaccine due to uncertainties that likely will compound significant doubts many people already have about the COVID-19 vaccine, or vaccines in general. The committee said that, no matter how well thought out its framework is, it “cannot address the general lack of confidence in vaccination.”

How much of the framework is adopted by federal and state agencies will remain to be seen, as other groups also are proposing allocation plans. So far, the Trump administration has been mum about how it will distribute a vaccine, despite pressure to reveal its plan. With drugs, devices, diagnostics and personal protection equipment needed to treat COVID-19 patients, the federal government dispersed them to the states and then let the states take it from there.

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