Whenever a vaccine for the SARS-CoV-2 virus that causes Covid-19 becomes available, one thing is virtually certain: there won’t be enough to go around.
And 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,” says University of Pennsylvania bioethicist Assistant Professor Dr Harald Schmidt 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,” he says.
“They won’t all be there at the same time, and they will have different profiles.”
New York University bioethicist Prof Dr Arthur Caplan says the rush to bring vaccines to market will likely 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 (US) FDA (Food and Drug Administration) approval is the end of things,” he says. “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 (CDC’s ACIP) recommends who should get vaccines (in the United States), and it has been discussing since April (2020) how to divvy up a new SARS-CoV-2 virus 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 Children’s Hospital of Philadelphia vaccine expert Dr Paul Offit.
He thinks Warp Speed will probably focus on distribution.
The US National Academy of Medicine, at the behest of the US National Institutes of Health (NIH), has also created an expert panel to study the issue.
At the panel’s first meeting on July 24 (2020), the academy’s president Dr Victor Dzau said he expected final recommendations by late September to early October (2020).
US CDC director Dr Robert Redfield stresses that it is important for Americans to see vaccine allocation as “equitable, fair, and transparent”.
US NIH director Dr Francis Collins, who has faced some criticism for potentially adding to decision-making confusion, says that this issue is so thorny, we can benefit from extra “deep thinkers”.
“This is going to be controversial,” he says. “Not everybody is going to like the answer.”
Prof Caplan favours an independent commission that includes both scientists and representatives of affected communities, such as people with disabilities and children.
Whoever makes the decisions, he says, “it’s got to be trustworthy”.
Prof Dr Eddy Bresnitz, a former deputy commissioner of the New Jersey Department of Health who is now advising the department on coronavirus response, says 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.
According to him, the US federal government is purchasing vaccines and will allocate them to states.
States usually have some flexibility in interpreting federal guidance.
New Jersey is already planning how the vaccine will be distributed, but that will depend on how many doses are available and the characteristics of the vaccine itself.
Pennsylvania Department of Health spokesperson Nate Wardle says the state is preparing to give vaccines to the public and high-risk groups in a variety of settings, including doctors’ offices, pharmacies and other community distribution points that will “ensure the entire population gets coronavirus vaccination”.
Priorities need to consider the multiple public health roles vaccines can play, says Vanderbilt University Medical Center infectious diseases specialist Prof Dr William Schaffner.
Typically, younger people mount the strongest immune response, says Prof Schaffner, who represents the US National Foundation for Infectious Diseases as a liaison to ACIP.
They are currently catching Covid-19 at higher rates and spreading it to other more vulnerable populations.
Vaccinating them could weaken the chain of transmission.
Older people and those with chronic health problems are clearly getting sickest, but vaccines tend to be less effective in these groups.
A third group are “the people in society that are responsible for its most essential functions”, he says, i.e. medical workers, police, firefighters, and those who make, sell and distribute food.
He says it’s important not to create such narrow categories that the vaccine sits unused in refrigerators.
“Vaccines do not prevent disease,” he says. “Immunisation prevents disease.”
During the A(H1N1) influenza pandemic in 2009, ACIP developed a five-tier priority list for vaccine distribution that frames the current discussion.
First came critical healthcare and public health personnel, pharmacists, emergency responders, police and firefighters, along with “deployed personnel.
The second tier included essential military support, the US National Guard, intelligence services and other national security personnel, as well as mortuary workers and those in communications, IT (information technology) 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 A(H1N1) hit them harder.
They will be a lower priority this time, says Prof Schaffner, 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 its June (2020) meeting, ACIP held preliminary discussions about what new tiers might look like, Prof Schaffner says, 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 healthcare and essential workers, along with people aged 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 (in the US).
Future discussions will likely focus on how to slice the various categories.
Jefferson Health infectious diseases specialist Dr John Zurlo says he would prioritise healthcare 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 hospitalisation from Covid-19.
The elderly would get priority over the young.
Prof Caplan’s list is similar to Dr Zurlo’s, with a priority tier that includes first responders, healthcare workers and nursing home staff and residents.
But he would also add representatives of groups that were not well studied in clinical trials.
Then he’d start looking at hot spots. Maybe Houston, Texas, will need the vaccine more than Boise, Idaho.
He’d want to make sure that key foreign locations are under control so that travellers don’t reintroduce the virus.
Racial and political considerations
Because Blacks and Latinos have been more likely to become seriously ill with Covid-19 and to die of it (in the US), ACIP members have discussed whether some racial groups should get preference for the vaccine.
Assist Prof 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 a vaccine,” he says.
While legally, American state governments cannot prioritise by race, they can by “social deprivation”, a measure that combines income, education, employment and housing quality data to rank neighbourhoods.
It’s clear, he says, that the vaccine should not be dispensed on a first-come-first-served basis. That would help the “well connected and better off”.
Prof Schaffner thinks that prioritising essential workers and those with risk factors will benefit non-white Americans.
“I don’t like vaccine allocation by race,” he says. “I think doing it by risk is much the better method.”
Should political leaders jump the line?
Prof Bresnitz thinks that should be on the table. “We don’t want our leadership to be decimated,” he says.
One could make a case, he says, that career government workers may sometimes be more important than elected officials.
Prof Caplan says we can assume that not everyone will follow the rules. There will inevitably be a black market.
“There will be people buying access,” he says. “This is America.”
It’s a safe bet that no one, save possibly those critical healthcare workers, will be completely satisfied with the eventual rationing scheme.
Prof 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 says, “it is not going to obviate the need for continuing to practice physical distancing and hygiene, and even mask-wearing.” – Stacey Burling/The Philadelphia Inquirer/Tribune News Service