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Late last week, a document titled "Draft Guidance on Allocating and Targeting Pandemic Influenza Vaccine" was posted at PandemicFlu.gov.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.

Gardasil, RotaTeq sales top Merck quarterly report

As we've written previously, corporate financial reports aren't exactly our forte. However, the price of Gardasil (and, to a lesser extent, RotaTeq) have been prominent in policy discussions both in the U.S. and internationally, so this week's sales news from Merck is worth noting here.

This Merck document includes a table listing sales for various vaccines in the third quarter of 2007. Among the highlights:

• Gardasil: $418 million in sales
  
• RotaTeq: $171 million in sales
  
• Zostavax: $61 million in sales
  
• All other vaccines: $593 million in sales
  

Remembering that these numbers represent only three months of sales, we can see clearly that the days in which vaccines were not thought of as potential profit centers for the pharmaceutical industry are long over. (Moreover, most European vaccine sales are not included in these figures, making the true totals even higher.)

Here's coverage from Reuters and the Associated Press, which reports that total Gardasil sales for the first 9 months of 2007 is $1.14 billion. Also of interest is the detailed news release from Merck. According to is, Gardasil has now been approved in 86 countries (with 50 more pending) and RotaTeq is approved in 69 countries.

There's no doubt that many hope that these remarkable sales figures is the U.S. and elsewhere will encourage Merck to expand its programs (like this one) to deliver free or low-cost vaccines to those parts of the world that would benefit most from them.

"Anthrax vaccine and public health policy" in AJPH

The latest issue of the American Journal of Public Health includes a very interesting paper by Martin Weiss and colleagues examining the spectrum of issues related to anthrax vaccine development and military vaccination efforts in recent years. The extensively-cited paper, "Anthrax vaccine and public health policy,"(subscription required for full text) also details the U.S. government's relationships with BioPort (now Emergent BioSolutions, the manufacturer of the currently licensed vaccine) and VaxGen, whose failures in anthrax vaccine development have been detailed at length here and elsewhere.

The paper raises far more questions than it answers, but it is worthwhile reading for those interested in the role of vaccines in biodefense efforts and, more generally, the role of government in vaccine development.

Revised adult immunization schedule released; Hep A news and recommendations

Friday's MMWR included a newly updated adult recommended immunization schedule -- PDF available here. As the introductory material details, changes made to last year's schedule are fairly minor, notwithstanding the addition of zoster vaccine (recommended for adults 55+) and an expanded recommendation for varicella (now recommended for all adults without evidence of immunity).

The same issue of MMWR included updated ACIP recommendations on postexposure prophylaxis for those exposed to Hepatitis A virus. The recommendations address the relative merits of Hep A vaccine versus immune globulin (IG) as a postexposure strategy, the subject of a randomized clinical trial ("Hepatitis A Vaccine versus Immune Globulin for Postexposure Prophylaxis") and an editorial ("Another Success for Hepatitis A Vaccine") in this week's New England Journal of Medicine.

Roundup: Exemption rates, Health-care workers, and Shingles

Some stories and perspectives in the news of late:

• "Parents claim religion to avoid vaccines for kids: Vaccination fears fuel increase in exemptions sought, AP finds" -- This AP story published late last week received significant attention in newspapers around the country. The key finding of their analysis is this: "From 2003 to 2007, religious exemptions for kindergartners increased, in some cases doubled or tripled, in 20 of the 28 states that allow only medical or religious exemptions, the AP found." The story includes reaction from Paul Offit, Barbara Loe Fisher, and others.

• "Inoculate thyself" -- This op-ed in the New York Times, written by an epidemiologist at the New York City Health Department, raises yet another alarm over low influenza vaccination rates among health care providers. The author argues that hospital accreditation and federal funding should be tied to improving staff vaccination rates, and until then, patients should refuse care from physicians and nurses who have not been vaccinated.

• "A vaccine as an option to keep shingles at bay" -- Also from the New York Times, this story from early October introduces readers to shingles, its treatment, and prevention options, namely, the potential benefits of Zostavax. The piece feels more like an informational article from WebMD than a story published in the nation's most respected newspaper, but a useful overview regardless.
  

ACIP: FluMist OK for children 2+; 6th seasonal flu vaccine approved

There's news from this week's meeting of the ACIP that the committee's influenza vaccine recommendation for children age 2-5 now includes FluMist. Here's a story from the Associated Press and another from the Wall Street Journal. This is hardly a surprise, in light of the decision by FDA to approve the vaccine for use in the 2-5 age group. (FluMist had previously been approved for 5-49 years olds only.)

In unrelated seasonal influenza vaccine news, we haven't yet noted the FDA approval late last month of Afluria, an injectable vaccine made by the Australian company CSL Biotherapies. The vaccine, licensed for use in adults 18 and older, is now the 6th different influenza vaccine available in the U.S. Here's coverage from CIDRAP News and Forbes.com and a media release from FDA.