Jul 23, 2008 (CIDRAP News) – Federal health officials today released their official guidance on allocating vaccine during an influenza pandemic, with few changes from a previous draft that put military personnel, critical health and emergency workers, pregnant women, and small children at the head of the line.
The 25-page guidance document is intended to help state and local leaders allocate scarce vaccine supplies in a pandemic, especially the early stages. The goals are to blunt the effects of a pandemic on public health and the economy and to limit general social disruption.
The new document, issued by the Department of Health and Human Services (HHS) and the Department of Homeland Security (DHS), is a revision of one that was released in October 2007. It was developed by a federal interagency working group, which gathered two rounds of input from the public and various stakeholders, including business and community organizations.
In a news release, HHS Secretary Mike Leavitt called the guidance "the result of a deliberative democratic process."
"This guidance was developed to ensure that our nation's critical infrastructure remains up and running and we address the needs of all of our citizens, enabling the country to recover from a pandemic more quickly," added Dr. Jeffrey Runge, DHS assistant for health affairs and chief medical officer.
Once a pandemic emerges, "it could be on the order of 20 weeks before matched vaccine begins to flow," and production capacity will be limited, said Dr. William Raub, Leavitt's science advisor, at a press conference today. "So we need a plan to target the successive batches as fairly as we can. These guidelines are the instrument to do that."
Consensus on four objectives
Federal officials said all the public and stakeholder input produced a consensus on four objectives for vaccine allocation:
- Protect people who are critical to the pandemic response and care for those who are sick with the flu
- Protect providers of essential community services
- Protect those at high risk for infection because of their jobs
- Protect children
The working group settled on five tiers, or vaccination priority groups. To facilitate the assignment of people to the different tiers, the authors sorted the population into four broad categories: homeland and national security, healthcare and community support services, critical infrastructures, and the general population. They also defined several "target groups" on the basis of occupation, type of service, age-group, or risk level.
In making their recommendations, federal officials looked at three levels of pandemic severity: severe, moderate, and less severe. Some occupational and risk groups move to a higher or lower tier depending on pandemic severity, but tier 1 is the same for all levels of severity. The following classifications assume a severe pandemic.
In tier 1—those first in line for vaccine—are several "critical occupations": deployed military forces, critical healthcare workers, emergency medical services workers, fire fighters, and police. Also included are pregnant women, infants, and toddlers. Those groups total an estimated 24 million people.
Among the health workers assigned to tier 1 are an estimated 300,000 public health personnel, 3.2 million hospital employees, 2.5 million outpatient and home healthcare providers, and 1.6 million workers in long-term care facilities.
Tier 2, totaling an estimated 15 million people, includes the following occupational groups: military support, border protection, the National Guard, intelligence services, other national security, community services, utilities (energy and water), communications, "critical government" workers, and two groups not previously included in this tier: pharmacists and mortuary workers. Also included in tier 2 are two high-risk groups: contacts of infants, and children with certain medical conditions.
Tier 3 includes several more occupational groups: other active duty military; other healthcare workers; other critical infrastructure sectors, including banking and finance, chemical, food and agriculture, pharmaceutical, postal and shipping, and transportation workers; and other government workers. Also in tier 3 are healthy children ages 3 to 18 years. Tier 3 is estimated to include 64 million people.
Tier 4, an estimated 74 million people, consists of two high-risk populations: adults between the ages of 19 and 64 who have chronic medical conditions that increase their risk of severe flu, and everyone age 65 or older.
Tier 5 is defined as all other healthy adults between 19 and 64 years old who don't fall into one of the other tiers, estimated at 123 million people.
The guidance says that all groups within a given tier should be vaccinated at the same time, but "sub-prioritization" may be necessary if the vaccine supply is very short, which may be the case through the first wave of a pandemic. The guidance gives recommendations about how to rank groups within tier 1 in this situation, putting front-line inpatient and hospital-based healthcare workers first.
Another case of sub-prioritization is in tier 4, which includes 19- to 64-year-old adults with medical conditions and adults 65 and older. If the vaccine supply is limited, the 19- to 64-year-olds should be vaccinated first, HHS advises. The reason: elderly people have a lower immune response to flu vaccines, so putting high-risk younger adults first makes better use of the available vaccine.
Protecting essential workers
The main reason for vaccinating workers in critical infrastructure sectors, the report says, is not to reduce general absenteeism, but rather to protect workers whose absence would slow or stop critical functions and also to protect workers at especially high occupational risk.
At the press conference, Dr. Ben Schwartz of the Centers for Disease Control and Prevention responded to a question about why transportation workers were not ranked higher than tier 3.
"We certainly recognize the importance of including the transportation system," he said. "It's in tier 3 because it's an infrastructure where it's likely the overall demand won't increase in a pandemic and may decrease. Transportation workers are not likely to be highly exposed to ill people, and thereby won't be at high risk. A truck driver is a pretty solitary worker."
Schwartz also said demand for nonessential commodities may drop during a pandemic, which would allow workers to shift to transporting more essential goods.
In other observations, the guidance says that general population groups assume greater priority, relative to occupational groups, in less severe pandemics, ie, those ranking 1 or 2 on HHS's pandemic severity index.
During the 1957 and 1968 pandemics, healthcare and essential services were effectively maintained in the United States, the document says. "Because of this, after tier 1, occupational groups in the health care and community support services and critical infrastructure categories are not specifically prioritized and workers in these groups would be vaccinated based on their age and health status as part of the general population."
Experts welcome the plan
Many public health experts have praised HHS' hard work on the pandemic vaccine allocation guidance, particularly that of the interagency working group that spearheaded the project. They have also praised the agency for its leadership role.
Jeffrey Levi, PhD, executive director of Trust for America's Health (TFAH), a nonprofit health advocacy group based in Washington, DC, wrote in an e-mail to CIDRAP News today that the guidance represents a step in the right direction. "HHS is to be commended for the breadth of outreach that was part of developing this guidance," he said.
J. Eline Garrett, JD, assistant director for health policy and public health at the Minnesota Center for Health Care Ethics (MCHCE) in Minneapolis, told CIDRAP News that HHS and other agencies have shown strong leadership. "There's a whole lot that's good here. A range of pandemic scenarios and scalability are very important, and we value and agree with the way that multiple tracks and category tiers are used to address the practical and ethical complexities," she said.
The public health community also appreciates federal officials' recognition that there is a need for vaccine allocation, she said.
Some see serious gaps
However, some experts said the federal guidance still contains some serious gaps and raises a host of questions.
Levi said there tier 1 includes a large number of people, which demonstrates the need for more vaccine production capacity and the need to more seriously explore vaccine stockpiles.
Garrett said that despite the revisions that followed extensive input from stakeholders, the MCHCE still has a number of concerns about the federal guidance. "This is to be expected. This work is difficult and important," she said.
One of the group's concerns is that the federal guidance doesn't explicitly and consistently address vaccine efficacy among the different population groups.
In some instances, the guidance lacks rationales for the placement of groups on the priority spectrum, which makes it seem less transparent and more difficult for public health officials to grasp, Garrett said. For example, a high priority is placed on vaccinating children, but prioritization decisions might change if the pandemic virus that emerges threatens a different group.
Prioritization of workers in homeland security, healthcare, and community support acknowledges exposure levels, but it doesn't address the risk of death or serious complications, Garrett said. Allocating vaccine to critical workers who are not at risk could shortchange members of the general population who are at risk, she added.
Garrett acknowledged that it's difficult to balance flexibility with uniformity and equity.
Federal officials recommend that states uniformly apply the prioritization guidance, but she said a lack of flexibility might be impractical for some areas and in some situations. For example, authorities plan to distribute vaccine in proportion to each state's population. However, some critical jobs might not be distributed equally among states.
Also, some locations might opt to keep schools open during a pandemic and will need to factor teachers into the vaccination scheme, Garrett said.
"These questions haven't been asked or answered, but they should at least be addressed," she said.
Ignoring economic realities?
Michael T. Osterholm, PhD, MPH, director of the University of Minnesota Center for Infectious Disease Research and Policy, which publishes CIDRAP News, said the current federal guidance falls far short of what's needed to address critical infrastructure and economic realities.
During a pandemic, failure to adequately protect workers in sectors such as power, water, food, transportation, and pharmaceuticals could cause collateral damage that could rival deaths from the virus, he said.
For example, Osterholm said the transportation sector is incompletely addressed in the vaccine prioritization plan and that coal workers aren't listed as a priority, even though half of the electricity in the United States is generated by coal.
Also, he pointed out that several lifesaving drugs in the United States are generics that are made offshore. Written stakeholder comments that Osterholm and some of his colleagues submitted to HHS suggested that the federal plan should prioritize some offshore workers who help produce goods, such as generic drugs, that are critical to the United States.
Jul 23 HHS news release
HHS guidance document on allocating vaccine
Dec 12, 2207, CIDRAP News story on public response to draft HHS plan
Oct 24, 2007, CIDRAP News story on draft HHS guidance