Pandemic flu vaccine allocation plan released

Late last month, HHS and the Department of Homeland Security released its latest prioritization strategy for allocating limited vaccine doses in the early stages of a possible influenza pandemic. The report, "Guidance on Allocating and Targeting Pandemic Influenza Vaccine," (.pdf), incorporates public feedback and comments made in response to draft versions of the plan released over the past few years.

As the accompanying HHS press release notes, the general framework for the allocation strategy is based upon four primary objectives:

• Protect persons critical to the pandemic response and who provide care for persons with pandemic illness
• Protect persons who provide essential community services
• Protect persons who are at high risk of infection because of their occupation and
• Protect children
  

Here's coverage some CIDRAP News, including some unanswered questions and criticisms from infectious disease and public health experts. As the report itself acknowledges, a vaccine is only one part of a comprehensive response strategy for pandemic flu, and considerable challenges would be faced in implementing this or any vaccine allocation strategy consistently in the midst of a public health emergency.

Draft of federal pandemic flu vaccine allocation plan released

Late last week, a document titled "Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine" was posted at PandemicFlu.gov. The plan, far more elaborate than any released to date, offers a detailed scheme of how limited vaccine doses should be allocated. (Interesting, nowhere in the 31-page document do the words "ration" or "rationing" appear.)

The specifics of the draft plan are difficult to summarize, but, generally, the plan identifies four categories of individuals, based on their occupations: 1) homeland and national security, 2) health care and community support services, 3) critical infrastructure, and 4) general population (everyone else). Within each category, there are multiple levels of priority (e.g., in 'critical infrastructure,' EMS workers receive priority over postal personnel). Finally, five 'tiers' of priority are identified according to severity of a potential pandemic.

Among the "general population" -- a group that includes nearly 280 million Americans -- pregnant women and children receive first priority, and the estimated 121 million healthy 19-64 year olds are last in line.

The release of this draft plan is timed with a request for comments. The request notes a specific interest in comments on "the extent to which the guidance is likely to lead to fair and ethical allocation and targeting of pandemic influenza vaccine across the population."

Here's coverage of the report's release from CIDRAP News, USA Today, and the Associated Press. Several of the stories correctly note the major logistical questions that remain as to how to implement a national vaccination strategy and ensure the process is conducted fairly.

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In related news, a WHO announcement last week projects a major increase in pandemic influenza vaccine supply. Here's a story on the announcement from Reuters and a particularly interesting story from the Canadian Press about potential drawbacks of such a surge in worldwide capacity.

Request for comments on pandemic flu vaccine allocation; federal planning update

A few noteworthy items regarding the federal government's pandemic flu activities over the last month...

First, HHS is seeking public comment regarding prioritization strategies for limited supplies of pandemic flu vaccines. The request for information (RFI) is available here. Quoting from this document, the questions of particular interest are:

"What objectives, principles, strategies, criteria, assumptions and rationales should be considered in pandemic vaccine prioritization determinations?

What is the relative importance of the three goals described above and what are the associated implications for vaccine prioritization?

Which population group(s) should have priority for receiving pre-pandemic vaccine? Which should have priority for receiving pandemic vaccine? What is the rationale?

How can fairness, equity, efficiency and related principles be reflected in the determination of priority groupings for receipt of pre-pandemic or pandemic vaccine?

For priority groups, how should vaccine be allocated, distributed and administered? Who (federal, State or local authorities) should determine when and how the vaccine is distributed and administered?"

The deadline for sending comments is January 18. Comments will be posted here once they are made available. The goal of this RFI, aside from being an excellent opportunity to assemble a variety of perspectives on this very complex issue, is to contribute to efforts to formulate guidance at the federal level to assist state and local policymakers.

Speaking of the federal government, on December 18, a report was issued and posted at pandemicflu.gov summarizing steps taken in response to items outlined in the National Strategy for Pandemic Influenza Implementation Plan (the document released in May 2006). This CIDRAP News story reviews the report. Overall, an impressive amount of progress seems to have been made.

Follow-up on Minnesota pandemic vaccine report

Following up on Sunday's post about a Minnesota group's report on pandemic flu allocation strategies, the folks at CIDRAP published a story on the same topic earlier this week featuring some perspectives on it from us, for those who are interested.

WHO and state reports on ethics and pandemic flu planning

The folks at CIDRAP News report in this story that the WHO plans to issue a report in January on ethical issues associated with pandemic flu planning. Among the topics to be explored: access, the ethics of quarantine and related actions, health-care worker responsibilities, and international collaboration. All are important topics will ethical aspects that merit attention alongside the relevant science and public health considerations.

Speaking of WHO, yesterday's New York Times included an editorial, "Preparations for a Flu Pandemic," that questions the current pace of pandemic planning, particularly vaccine development and supply issues that are certain to complicate mass vaccination efforts.

Thinking about limited vaccine supply and the ethics of allocating those doses, a number of scholars and organizations have offered ethical perspectives on how best to do so. (The most notable: the Emanuel/Wertheimer essay in Science back in May, which we wrote about here.) This week, the Minnesota Center for Health Care Ethics released a very interesting report titled "Allocating Pandemic Influenza Vaccines in Minnesota." Growing out of a multi-disciplinary working group of state-wide stakeholders, the report offers a different model for prioritizing specifics groups than the current HHS plan. While the report is written for Minnesotans in particular, the discussion of ethical concerns and priorities is relevant everywhere. The report is well worth reading for anyone interested in the ethical priorities that will influence these difficult decisions.

The Minneapolis Star-Tribune wrote a story ("A Tough Call Awaits if a Killer Flu Breaks Out," October 23) on the report that includes a few quotes from us, among others.

"Who lives? Flu crisis may make us pick"

Yesterday's St. Petersburg Times was the latest publication to run a feature talking about which groups should receive vaccines first in the event of a shortage in the early stages of an avian flu pandemic. It's another of the stories surfacing in response to the Emanuel/Wertheimer piece in Science earlier this month (which we've discussed here and here.)

The story includes the perspectives of Greg Poland, director of the Mayo Clinic Vaccine Research Group and a member of ACIP, Bruce Gellin, director of the National Vaccine Program Office at HHS, and our own Art Caplan.

Philadelphia Inquirer on avian flu vaccine allocation strategies

In an editorial today titled "Who gets the shots?", The Philadelphia Inquirer reflects on the paper in Science this month by Emanuel and Wertheimer (which we wrote about on May 12) challenging the current paradigm for avian flu vaccine distribution when supplies are limited.

The Inquirer's four-sentence summary of the Science paper does not quite do justice to the authors' argument in favor of vaccinating those in the middle of life (roughly, 13-40 years old) ahead of the very old or very young. The original paper is very much worth reading, but a subscription is required to access it here.

The editorial's position? "Ultimately, the country will need one set of priorities, designed federally, implemented locally. The discussion needs to happen now, long before a crisis arrives."

Agreed. The key question, however, is how to determine the aforementioned set of priorities, particularly when analyses based on public health and ethics don't necessarily lead to the same conclusions. Should the first goal be to minimize loss of life in absolute terms, thereby valuing the life of an 85-year-old with a host of other medical problems as equal to (or perhaps greater than) that of a healthy teenager? Or should the first goal be to minimize the virus' spread, thus prioritizing those groups known to be better vectors for transmission (e.g., young schoolchildren). These and other questions are difficult enough when thinking in general terms, but become all the more wrenching when the generic '85-year-old' or 'schoolchild' are more accurately thought of as someone's grandmother or grandson.

Discussion is vital, but reaching any degree of consensus on these topics seems to be, at best, an uphill battle. More difficult still will be ensuring widespread public buy-in once it becomes clear who is at the bottom of the list to receive the vaccine. As if this weren't tall enough a task, the agreed-upon system must then somehow be faithfully adhered to even in the worst days of a potential crisis, when the best, non-controversial disaster plans typically fail amid the chaos.

Much to be done, and The Inquirer is right to shine a light on the urgency and importance of the work.

Friday round-up: HPV vaccine parental acceptance, bird flu vaccine allocation, and more

• The May 2006 issue of Pediatrics includes an interesting study of parental beliefs and attitudes on HPV and HPV vaccination, comparing groups receiving an information sheet on the topic versus those without it. The paper, from Dempsey, et al., is titled "Factors that are associated with parental acceptance of human papillomavirus vaccines: A randomized intervention study of written information about HPV." (117:1486-1493; free abstract, subscription required for full text) Their findings, in short: those receiving the information sheet performed better on a knowledge assessment, but there was no statistically significant difference in vaccine acceptability between the two groups. Here's the press release on the paper from the University of Michigan (the lead author's institution.)

• This story from National Geographic's website discusses a paper in the current issue of Science on how best to ration limited vaccine supply in the event of a pandemic. The paper, titled "Who should get influenza vaccine when not all can," is written by Ezekiel Emanuel and Alan Wertheimer of the NIH, though they note the opinions expressed are solely their own. (312:854-855; subscription required for full text.) In the paper, the authors challenge the current plan to allocate limited supplies of vaccine, which they refer to as the 'save-the-most-lives principle.' Their alternative? A modified 'life-cycle principle' that values giving everyone a chance to pass through various life stages while, overall, still maintaining public order. It's an interesting idea, and one that leads to a radically different ranking of which groups would receive vaccines first. Well worth reading.

• Another paper of note in this week's Science: "Is polio eradication realistic?" by Arita, et al. (312:852-854; subscription required). The authors propose that "the time has come for the global strategy for polio to be shifted from 'eradication' to 'effective control.'"

Strategies for distributing limited supplies of avian flu vaccine

One of the most difficult public health and ethical questions a potential flu pandemic raises is how best to allocate limited supplies of vaccine (which will only be of limited effectiveness at first, as we've written previously). There's general consensus that first responders or other 'essential personnel' (the definition of which varies widely) should be a top priority, including hospital staff, police, firefighters, top government leaders, etc.

Eventually, though, the focus shifts to larger segments of the population, and the key question becomes how to equitably distribute vaccine supplies while most effectively combating the virus' spread. According to this story in today's Seattle Times, flu researches Ira Longini and Elizabeth Halloran have an answer: school-aged children...

"At school, kids are close together, they don't practice the best hygiene, and they help germs spread like pollen in spring. At home, they do the same with their families.

Giving them the best available vaccine at the earliest sign of a major epidemic might fend off a deadly pandemic, say two of the nation's most prominent influenza researchers, newly arrived at the Fred Hutchinson Cancer Research Center.

'A lot of people believe kids are the best transmitters of the virus, and with a limited supply of vaccine, this might work,' said Elizabeth Halloran, who has studied epidemics for decades.

Halloran and her colleague, Ira Longini, believe using available vaccine would buy time for manufacturers to create a vaccine that matches the pandemic flu virus exactly and would protect millions of people worldwide."

Ask any teacher and they (and their immune system) will agree that school-age children are highly effective vectors of bacteria and viruses. This public health strategy is not new in itself and has implications reaching well beyond avian flu. As in most discussions of vaccines, the challenge is weighing individual benefits versus societal good. Children may be a common vector of transmission, but their immune systems are (generally) better equipped to fight off infections. Thus, alternative strategies suggest vaccinating the elderly, the immunocompromised, pregnant women, and other groups that individually are more susceptible to the effects of infections.

The story in today's Seattle Times actually references a Science paper published by Halloran and Longini back in February. (Science, 3 February 2006, 311:615-616 -- subscription required). In the paper, the authors call for increased research of vaccinating schoolchildren against seasonal flu in order to better understand the impact of such a strategy in limiting transmission.

Speaking of Science, the current (April 21) issue is devoted entirely to influenza and is available free (with registration). In an introduction to the issue titled "Influenza: The State of Our Ignorance," Caroline Ash and Leslie Roberts write,

"An energetic response to H5N1 does not have to be alarmist. We can marshal existing concern about this particular strain of avian influenza to build a long-lasting international infrastructure to monitor and thwart threats from such emerging infections."

Agreed.