As chairman of the Advisory Committee on Immunization Practices, Romero may be the single most influential person deciding who will get a coronavirus vaccine — and when — in the coming months.
People know it, and they’ve been lobbying Romero, and other members of the committee, which guides the US Centers for Disease Control and Prevention on vaccine allocation.
It was ACIP that decided frontline health care workers and the frail, vulnerable residents of long-term care facilities should be the at the front of the line for the scanty first vaccines.
On Sunday, they meet to decide who comes next.
In the mix: essential workers, people over age 65, and people with chronic conditions that put them at higher risk of severe disease if they get infected. There are tens of millions of people in each group, and there won’t be enough vaccine to cover everyone right away. Choices must be made.
“We are dealing with these decisions knowing there is not enough vaccine,” said Romero, a pediatric infectious diseases specialist who is also secretary of health for the state of Arkansas.
ACIP has been tasked with setting out a four-phase rollout of vaccine, but there’s still so little vaccine available that Phase 1 has been subdivided into Phases 1a, 1b and 1c. Phase 2, Romero said, may not even be discussed until February.
Phase 1b is likely to include essential workers — but that’s a group that includes 87 million people. US Health and Human Services Secretary Alex Azar estimates the United States can vaccinate 50 million people by the end of January — including the 20 million or so the US hopes to have vaccinated in December.
So who goes next?
The CDC outlined a list that included the food and agriculture sector, transportation, energy, police, firefighters, manufacturing, information technology and communication, water and wastewater.
But how about camp counselors?
“Childcare staff in out-of-school educational and recreational settings such as camps and community centers are critical for continued support to serve the nation’s health care, first responders, frontline and essential workers, as well as in assisting in the continued economic recovery of our country,” the American Camp Association argued in its letter to Romero.
“Our workforce represents a central and critical link in the nation’s supply chain, and will play an essential role in the imminent COVID-19 vaccine distribution process. As the trucking industry is called upon to deliver vaccines across the country, it is imperative that truck drivers have prioritized access to the vaccine to minimize the potential for supply chain delays and disruptions,” Bill Sullivan, Executive Vice President of Advocacy for the American Trucking Associations, wrote in a letter to ACIP.
“We are not asking for aviation workers to be on top of the list, but we need governments to ensure that transportation workers are considered as essential when vaccine roll-out plans are developed,” said International Air Transport Association CEO Alexandre de Juniac.
Teachers do not want to be left out.
“Our public schools are vital to California’s full recovery from this pandemic and we cannot safely and fully return to face-to-face instruction without putting our public-school workers at the top of the priority list,” the California Teachers Association said in a statement.
“The vaccine rollout should include school-based vaccination sites where school staff and students’ parents, guardians, and household members who are essential workers have the option to be vaccinated, providing greater wrap around protection for our public school communities.”
But how can these people, many of them young and healthy adults, be put in front of the elderly and sick, who are at much higher risk of severe illness if they do get infected?
These will include people with obesity — more than 40% of the US population — diabetes, heart conditions, lung disease, kidney disease, cancer, sickle cell disease and other conditions.
Should patients with rare diseases go first because they are both vulnerable and few in number? Should smokers have to wait because their lifestyle choice is not technically a disease?
“We understand that our decisions are going to be scrutinized,” Romero said. “I expect that people are going to criticize me for my decision.”
In deciding to include residents of long-term care facilities in Group 1a, the committee looked at data that showed these patients made up 40% of deaths from Covid-19. Romero said ACIP will similarly look for data in deciding who to recommend goes in Groups 1b and 1c.
“I go into these meetings with an open mind. I just want to see the data,” he said.
A team of cancer experts say they’ve got that data, having reviewed 28 different studies showing the risk of dying from Covid-19 is higher in cancer patients.
“After reviewing 28 publications that included relevant information on fatality rates of patients with cancer who developed COVID-19, we conclude that patients with an active cancer should be considered for priority access to COVID-19 vaccination, along other particularly vulnerable populations with risk factors for adverse outcomes with COVID-19,” they wrote in a position paper published in Cancer Discovery Saturday.
And then there’s the issue of disparities.
“The idea is that we want to minimize harm from the vaccine and maximize its benefits. We want to address health care disparities. We want to make sure there is equity,” Romero said.
The National Council on Disability makes its argument for people with intellectual and developmental disabilities. “Individuals with intellectual and developmental disabilities (I/DD) should be included in the list of high-risk diagnoses used to determine vaccine priority. Compared to individuals without I/DD, individuals with I/DD face alarmingly higher complication and mortality rates from COVID-19, with mortality rates up to 15 percent,” the group argued in a statement.
The committee has been charged specifically to think about these factors in deciding.
“How do characteristics of the vaccine and logistical considerations affect fair access for all persons?” the committee was asked in an initial document at the start of its round of meetings in November.
“Does allocation planning include input from groups who are disproportionately affected by Covid-19 or face health inequities resulting from social determinants of health, such as income and health care access?”
For Romero, it’s good guidance.
“It is a complex decision to make. Yes, everything counts. You don’t discount one factor.”
And states have the flexibility to adapt the guidance. Legally, they don’t have to follow it at all.
“The states have the option to not use our recommendations,” Romero said. But he hopes they will.
“If we document that our decisions are based on the current epidemiological disease data that we have, they will be sound and they will allow the governors to accept them.”