US federal health officials are already trying to decide who will get the first doses of any effective coronavirus vaccines, which could be on the market this winter but could require many additional months to become widely available to Americans.
The Centers for Disease Control and Prevention and an advisory committee of outside health experts in April began working on a ranking system for what may be an extended roll-out in the United States.
According to a preliminary plan, any approved vaccines would be offered to vital medical and national security officials first, and then to other essential workers and those considered at high risk – the elderly instead of children, people with underlying conditions instead of the relatively healthy.
Agency officials and the advisers are also considering what has become a contentious option: putting black and Latino people, who have disproportionately fallen victim to Covid-19, ahead of others in the population.
In private meetings and a recent public session, the issue has provoked calls for racial justice. But some medical experts are not convinced there is a scientific basis for such an option, foresee court challenges or worry that prioritising minority groups would erode public trust in vaccines at a time when immunisation is seen as crucial to ending the pandemic.
"Giving it to one race initially and not another race, I'm not sure how that would be perceived by the public, how that would affect how vaccines are viewed as a trusted public health measure," said Claire Hannan, executive director of the Association of Immunization Managers, a group represented on the committee.
While there is a standard protocol for introducing vaccines – the CDC typically makes recommendations, and state and local public health departments decide whether to follow them – the White House has pressed the agency at times to revise or hold off on proposals it found objectionable.
President Donald Trump, who has been pushing to reopen schools, fill workplaces and hold large public events, has been acutely focused on the political consequences of public health guidance.
Scarce resources
Since the beginning of the pandemic, almost every aspect of the administration’s response has involved scarce resources, high demand and claims that the privileged were receiving unfair advantage. The White House recently created Operation Warp Speed, a multi-agency effort to accelerate vaccine development that has invested billions of federal dollars in a growing number of companies.
To speed up distribution, the most promising vaccines will go into production even before they have cleared the final stages of clinical trials
At the public advisory committee hearing, held in mid-June, a defence department representative said the operation would address the distribution plans in coming weeks.
To speed up distribution, the most promising vaccines will go into production even before they have cleared the final stages of clinical trials and been authorised for public use by the Food and Drug Administration. But there will be a gap between the first doses coming off the manufacturing lines and a stockpile large enough to vaccinate the US population.
“I would say months,” Dr José Romero, the chairman of the Advisory Committee on Immunization Practices, predicted.
The committee, which reports to the CDC director, has long played a key role in determining how to implement new vaccines. The group includes 15 voting members selected by the health secretary who come from immunology, infectious disease and other medical specialities, 30 non-voting representatives from across the health field, and eight federal officials focused on vaccines. Still, it operates largely out of sight.
Romero is among four committee members who have been deliberating on the plans since this spring alongside doctors at the CDC, representatives from the health field, ethicists and other outside consultants. In June, they briefed the full committee on their work, offering a glimpse of the questions being considered.
Choices
As they come up with a multi-tiered schedule for the first 1.2 million vaccine doses and then the next 110 million, they have focused on who should be considered essential workers, what underlying conditions should be taken into account and what kinds of living environments – nursing homes, homeless shelters – put people at high risk.
Black and Latino people have become infected with the virus at three times the rate of whites, and have died nearly twice as frequently
Among the questions: what should be done about pregnant women? Should teachers go towards the front of the line? Should prisoners be in a top tier?
But for the broader committee, questions of whether to prioritise race and ethnicity sparked the most debate. Black and Latino people have become infected with the virus at three times the rate of whites, and have died nearly twice as frequently.
Many of them have jobs that keep them from working at home, rely on public transportation or live in cramped homes that increase their risk of exposure. They are more likely to suffer from underlying health problems, including diabetes and obesity, that raise the risk of hospitalisation and death. Not only do the groups have less access to health services, they also have a documented history of receiving unequal care.
The questions come amid a national uproar over the United States’s racist past, which stretches into its response to infectious disease – including the infamous Tuskegee syphilis study, when the government deliberately let hundreds of black men go untreated even when there was a known cure for the disease.
Dr Sharon Frey, a professor of infectious diseases at St Louis University, pointed to health disparities among black and Latino people at the recent meeting. "I think it's very important that the groups get into a high tier," she said. "Maybe not an entire group but certainly to address people who are living in the urban areas in these crowded conditions."
Dr Peter Szilagyi, a professor of paediatrics at the University of California, Los Angeles, said he was "really struggling with what to do about race and ethnicity".
Underlying conditions
He wondered if a lot could be accomplished for minority groups by prioritising people in general with underlying conditions and by trying to improve their access to healthcare. Romero, the chairman, was doubtful. “This will not address the problem that exists now,” he said. “I think we need to deal with this issue at this time with the information that we have. And it is: they are groups that need to be moved to the forefront, in my opinion.”
Dayna Bowen Matthew, dean of the George Washington University Law School, who has focused on racial inequality in healthcare and is serving as a consultant on the prioritisation issue, agreed.
“It’s racial inequality – inequality in housing, inequality in employment, inequality in access to health care – that produced the underlying diseases,” Matthew said in an interview. “That’s wrong. And it’s that inequality that requires us to prioritise by race and ethnicity.”
Harald Schmidt, an assistant professor of medical ethics and health policy at the University of Pennsylvania, is not a member of the committee but has been suggesting other ways vaccine prioritisation could work. He predicts that courts would strike down any guidelines explicitly based on race and ethnicity. Instead, he has proposed using an index that takes into account education, income, employment and housing quality to rank neighbourhoods by socioeconomic disadvantage that he says could serve as a good proxy.
Inequalities
“It’s imperative that we pay attention to how Covid has impacted the health of minorities differently; otherwise it compounds the inequalities we’ve seen,” Schmidt said.
There may be substantial differences in how racial and ethnic groups view vaccines. A recent Pew survey found that a little over half of black adults said they would definitely or probably get a coronavirus vaccine if one were available today, while 44 per cent said they would not. Among Hispanic and white adults, 74 per cent said they would get the vaccine, while about a quarter said they would not.
“Because of Tuskegee and structural racism within the healthcare system, you have to make a case much more strongly to the African-American population,” Schmidt said.
Whoever is prioritised for the first doses, it will not matter if the vaccines don’t work for those demographics. And that will not be determined unless the vaccine trials themselves include those groups. So far, several vaccine candidates have entered final Phase 3 trials.
At a recent Senate hearing, Dr Robert Redfield, the CDC director, and Dr Francis Collins, head of the National Institutes for Health, emphasised the need for racial and other diversity within the trials. "The last thing we want to be is trying to recommend who gets the vaccine and we don't have any data on how the vaccine works in the population that we think really needs this vaccine," Redfield said.
– New York Times
