Stacey Burling, Tribune News Service
Whenever a vaccine for the coronavirus becomes available, one thing is virtually certain: There won’t be enough to go around. That means there will be rationing.
Someone will have to decide which of the world’s 7.8 billion people gets first crack at returning to a more normal life. Infectious disease experts and medical ethicists say this exceptionally complex decision must weigh not only who is most at risk from the virus and who is most likely to spread it, but also who is most important for maintaining the medical and financial health of a nation as well as its safety.
This pandemic has also added a new quandary: how to address the fact that people of colour have suffered higher rates of serious illness and death than white people.
“It’s going to be very, very hard,” Harald Schmidt, a University of Pennsylvania bioethicist, said of the priority-setting process. There will likely be more than one type of vaccine. One may work better in certain groups, say, older adults, than another.
“We don’t only have to make this decision once, but multiple times for multiple vaccines,” Schmidt said. “They won’t all be there at the same time, and they will have different profiles.”
Arthur Caplan, a bioethicist at New York University, said the rush to bring vaccines to market likely will leave many questions unanswered at first about how well they work in different groups. He sees the first public doses as an extension of clinical trials. That will require careful tracking of recipients. “We keep acting as if the race to get FDA approval is the end of things,” he said. “I would say it’s just the start.”
Vaccine development has been moving at lightning speed, and a handful of candidates have had promising results. Experts say the best-case scenario is that a vaccine could be available to the public by the first quarter of 2021.
Traditionally, the US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommends who should get vaccines, and it has been discussing since April how to divvy up a new coronavirus shot. It is unclear whether officials from the Trump administration’s Operation Warp Speed on vaccine development will want in on the decision as well. “It’s a black box,” said Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. He thinks Warp Speed will probably focus on distribution. The National Academy of Medicine, at the behest of the National Institutes of Health, has also created an expert panel to study the issue.
At the panel’s first meeting on Friday, Victor Dzau, the academy’s president, said he expected final recommendations by late September to early October. CDC Director Robert Redfield stressed that it was important for Americans to see vaccine allocation as “equitable, fair, and transparent.”
National Institutes of Health Director Francis Collins, who has faced some criticism for potentially adding to decision-making confusion, said this issue is so thorny, we can benefit from extra “deep thinkers.”
“This is going to be controversial,” he said. “Not everybody is going to like the answer.”
Caplan favors an independent commission that includes both scientists and representatives of affected communities, such as people with disabilities and children. Whoever makes the decisions, he said, “it’s got to be trustworthy.”
Eddy Bresnitz, a former deputy commissioner of the New Jersey Department of Health who is now advising the department on coronavirus response, said he expects that the White House Coronavirus Task Force will also weigh in, but that the ultimate decision will rest with officials at the US Department of Health and Human Services.
The federal government is purchasing vaccines and will allocate them to states, said Bresnitz. States usually have some flexibility in interpreting federal guidance. New Jersey already is planning how the vaccine will be distributed, but that will depend on how many doses are available and characteristics of the vaccine itself.
During the H1N1 influenza pandemic in 2009, ACIP developed a five-tiered priority list for vaccine distribution that frames the current discussion. First came critical health care and public health personnel, pharmacists, emergency responders, police and firefighters, along with “deployed personnel.” The second tier included essential military support, the National Guard, intelligence services and other national security personnel as well as mortuary workers, and those in communications, IT and utilities. High-risk adults were in the fourth tier and healthy adults, aged 19 to 64 were in the last group.
Children were a high priority in that plan, because H1N1 hit them harder. They will be a lower priority this time, Schaffner said, because they are not involved in current vaccine trials. In addition, young children seem to be less likely to spread the virus than older children or adults. Older children rarely develop serious complications. Pregnant women, however, could remain a high-priority group.
In it’s June meeting, ACIP held preliminary discussions about what new tiers might look like, Schaffner said, keeping in mind that officials will need to know how many doses are available and who responds well to the vaccine. Among those considered for the top tier were high-risk medical, national security and essential workers. Below that might be other health care and essential workers along with people age 65 and older, those who live in long-term care settings and those at high medical risk for severe COVID-19. Those groups include 122 million people.
Future discussions will likely focus on how to slice the various categories.
John Zurlo, an infectious diseases doctor at Jefferson Health, said he would prioritise health care workers most likely to have direct contact with COVID-19 patients and people who live in settings like nursing homes and assisted-living facilities. Low-wage workers with a lot of exposure to the public would also be high on his list, as well as those with conditions like obesity, diabetes and heart disease that raise the risk of hospitalization from COVID-19. The elderly would get priority over the young.
Schmidt says race must be considered. Minority groups are at higher risk in part because they have higher rates of chronic medical problems, but socioeconomic conditions like crowded homes, low-wage jobs without sick leave and the need to take public transportation make things worse. Black and brown workers also often toil in essential businesses like hospitals, nursing homes and grocery stores.
“We have to understand that social justice will loom large in allocating vaccine,” the Penn bioethicist said. While legally, governments could not prioritise by race, they could by “social deprivation,” a measure that combines income, education, employment, and housing-quality data to rank neighbourhoods.
It’s clear, he said, that the vaccine should not be dispensed on a first-come-first-served basis. That would help the “well connected and better off.”
Bresnitz tells friends and family not to think a vaccine will change everything — it will be a while before their effectiveness is proven. “Whatever vaccines we have,” he said, “it is not going to obviate the need for continuing to practice social distancing and hygiene and even mask wearing.”