Dear CEOs of Pfizer, Moderna, and AstraZeneca,
Thank you for rapidly mobilizing your scientific resources and your vaccine clinical trial networks. (We also thank Operation Warp Speed and others for organizing and underwriting your efforts to tame Covid-19.)
Your vaccines are on the brink of crossing the finish line of approval, but the confusion surrounding the presidential transition has brought great uncertainty to the distribution plan.
The National Academies of Sciences, Engineering, and Medicine developed an ethical framework for equitable distribution of Covid-19 vaccines, as have others. But national plans based on these frameworks are problematic. They recommend giving the vaccine first to Phase 1a front line high-risk health workers and first responders. That stretches the supply chain to include workers in every hospital, nursing home, long-term care facility, as well as all ambulance, fire rescue, and police first responders.
The National Academies estimate that 5% of the U.S. population, or about 16.5 million people, will fall into the Phase 1a category. Pfizer and Moderna have estimated they will have 45 million doses, or enough to vaccinate 22.5 million Americans, by January. For the first few months, though, we would not have learned whether the vaccine can break the chain of transmission and control the fires raging in local hot zones. Effectiveness in the real world can be determined only if the vaccine is given to a large percentage of people within a localized hot zone.
We propose a different approach: target several hot zones with high numbers of Covid-19 cases, especially those zones with rising Covid-19 hospitalization rates. In these areas, surge care means high death rates, medical staff burnout, cancelation of elective surgery, and limited space for regular emergencies.
In concert with the federal government, vaccine makers should work directly with state governors who will designate the boundaries of the hot zones, the population sizes of which would be dependent on the total number of vaccine doses that are available. Vaccination within each hot zone would begin with Phase 1a individuals and then move on quickly through Phases 1b, 2, 3, and 4.
This approach allows the vaccine to be given in rapid sequence to frontline health care workers, first responders, vulnerable patients, essential workers, those with relevant comorbidities, minority groups at high risk, children, and others — essentially vaccinating everyone in the zone. When everyone in the four phases within the hot zone has been vaccinated, the state can decide whether to then vaccinate all Phase 1a candidates in the state or expand the hot zone approach to a wider region. By then there should be sufficient doses of vaccine to do both.
Within a few months, we would know if the vaccine breaks the local epidemic. At the same time, enough people from diverse groups would have gotten the vaccine so we would be able to tell how safe it is in a real-world setting.
During this widespread vaccination program, it would be important to be on the lookout for rare neurological side effects, comparing mRNA vaccine platforms (Pfizer and Moderna) to the altered adenovirus vector platforms (AstraZeneca, Johnson & Johnson, and many others). In the 1976 swine flu epidemic, an uptick of Guillain-Barré syndrome, a type of paralysis, occurred following a vaccination program. What better way to assure the public about safety than by looking for rare events such as Guillain-Barré syndrome in a regional population. But that means employing just one vaccine in each regional hot zone.
One candidate zone could be El Paso County, Texas, with a population of 839,000. It is experiencing a significant surge of Covid-19, with 177 cases per 100,000 people as we write this. By comparison, Worcester, Mass., has 33.6 cases per 100,000. Since El Paso is a border county, with a lot of traffic coming from Mexico, the vaccine should also be given to frequent visitors coming in and out, such as truck drivers, as well as undocumented immigrants.
The advantage of this focused approach is that it would allow for more rapid mastery of the learning curve. And it would be easier to find people for the second booster shot in a localized area where many people would be ready for the booster at the same time. Finally, since only one vaccine would be used in a zone, comparisons of the performance of the different vaccines should be possible across zones.
Currently, there is little clarity in the national vaccine distribution plan, but states will likely have an expanded role in determining priorities. Companies making Covid-19 vaccines should work with governors to target at least one hot zone per state to receive the first available doses. We believe that our approach offers the best way to break the chain of transmission. The first 60 days will be key in showing the results. Our plan has many advantages over the “phase” plan proposed by the National Academies.
In a pandemic, all ideas need to be considered. We stand ready to help.
Daniel Teres is a critical care physician and a clinical instructor in public health and community medicine at Tufts University School of Medicine in Boston. Martin A. Strosberg is emeritus professor of health care policy, and bioethics at Union College in Schenectady, N.Y.