Growing support for health care worker flu vaccine mandate

The Infectious Diseases Society of America released a report on Thursday calling for mandatory influenza vaccination of all health care workers. Here's the press release from the IDSA. An excerpt:

"'It’s our professional duty to first do no harm,' said Andrew T. Pavia, MD, chair of IDSA’s National and Global Public Health Committee. 'Voluntary systems haven’t brought immunization rates up far enough. For the sake of our patients, all health care workers must get a flu shot every year or they must be required to opt out in writing.'"

This position was part of a larger report looking at many aspects of seasonal and pandemic influenza planning and response. There's an important caveat, however. The IDSA recommendation allows for health care workers to decline vaccination, provided they do so in writing, a provision likely motivated by practical reasons rather than sound medical or public health reasoning.

CIDRAP News covered the announcement, quoting our own Art Caplan and David Curry's op-ed in the San Jose Mercury News, which he previously noted here.

Today's Boston Globe picked up on the IDSA position in an editorial today titled "The best shot at fighting the flu." They write:

"One step in getting all health providers at or close to 100 percent is the new policy of the Joint Commission on Accreditation of Healthcare Organizations to require that they at least offer flu shots to all workers. But full compliance will come only through action by Congress and Health and Human Services. A flu shot mandate is one of the most effective steps the nation could take to prepare for a pandemic and, at the same time, reduce the annual toll of the flu virus."

Offit on vaccine exemptions

Our colleague Paul Offit published an op-ed in the Wall Street Journal last week titled "Fatal Exemption" (Unfortunately, subscription is required for full access). In it, Offit notes the findings published in JAMA last month showing a significant increase in the number of vaccine exemptions and the corresponding increase in vaccine-preventable illnesses. The chief culprit, says Offit: the growing use of 'philosophical exemptions'. He writes, in part:

"When it comes to issues of public health and safety, we invariably have laws. Many of these laws are strictly enforced and immutable. We don't allow philosophical exemptions to restraining young children in car seats, to smoking in restaurants or to stopping at stop signs. And the notion of requiring vaccines for school entry, while it seems to tear at the very heart of a country founded on the basis of individual rights and freedoms, saves lives. Given the increasing number of states allowing philosophical exemptions to vaccines, at some point we will be forced to decide whether it is our inalienable right to catch and transmit potentially fatal infections."

Sanofi 5-in-1 pediatric vaccine receives FDA recommendation

News late last week that Pentacel, a 5-in-1 vaccine manufactured by Sanofi Pasteur, received a recommendation from an FDA advisory committee that typically signals imminent licensure in the U.S. Here's the story from Bloomberg.com and the Sanofi press release. According to it, the vaccine could reduce the total number of recommended pediatric vaccine doses by seven.

Pentacel provides protection against diphtheria, pertussis, tetanus, polio, and Haemophilus influenzae type B (Hib). It has been licensed and used in nine countries, including Canada, since its introduction in 1998. If licensed for U.S. use, the vaccine would be the second 5-in-1 vaccine available, joining GSK's Pediarix, which contains four common constituents to Pentacel (Pediarix includes hepatitis B vaccine instead of Hib).

For advocates of vaccination, there is great value in these kinds of combination vaccines, which reduce the number of doses (and office visits) necessary to complete the increasingly longer pediatric vaccination schedule. More visits mean an increased likelihood of missed appointments, missed doses, and incomplete vaccination series. Critics of U.S. vaccination policy, however, express concern about 'overloading' infants' immune systems with multiple vaccines at a single visit, and resulting in a variety of known and unknown adverse effects. At present, there isn't evidence that supports this hypothesis.

Updates on HPV vaccination outside the U.S.

Those looking for information on the policy discussions and implementation of Gardasil worldwide will be very interested in the latest issue of HPV Today, an international newsletter on all things related to HPV research, policy, and practice.

Among the items in the issue: a short piece by Dr. Luisa Lina Villa, a Brazilian cancer researcher, updating the international regulatory landscape for Gardasil. She notes that more than 40 bodies around the world have approved the vaccine thus far. Australia, New Zealand, Peru, and Mexico are among the few to approve the vaccine for males as well as females. Dr. Villa also describes some of the implementation challenges faced by her native Brazil, among them cost and the absence of an adolescent vaccination infrastructure.

Also in the issue: a very helpful table outlining the different approvals (by age, gender, condition, etc.) that Gardasil has received by various regulatory bodies around the world and a brief report on the results of a survey in Australia exploring whether the vaccine could promote unprotected sex among Australian teens. (The short answer: no)

For the bookshelf: Vaccine by Arthur Allen

A new book released this month is sure to be of interest to readers of this site: Vaccine: The Controversial Story of Medicine's Greatest Lifesaver by Arthur Allen. Allen is a journalist who has written frequently in the popular press on vaccine-related issues. We haven't yet read the book, so we can't vouch for its merits, but all accounts point to it being a comprehensive work (as any 500+ page book is likely to be) tracing the history of vaccination from Jenner to today.

Allen has published vaccine-related essays in several publications this month, providing well-timed promotion for his book. On January 15, Allen wrote a piece for Slate titled "The Autism Numbers: Why There's No Epidemic" that looks broadly at the rise in autism rates in recent years, including the alleged link to vaccines.

Last Thursday, Allen had an op-ed published in the New York Times titled "For the Good of the Herd," a strong defense of the merits of vaccination framed by some of the major events (both good and bad) of U.S. vaccination programs in the 20th century. By the end of the op-ed, there's little doubt that Allen is a strong proponent of vaccination. He writes:

"But the experts are certain that it is only a matter of time before a flu pandemic strikes. Keeping the vaccine pipeline running and building immunity against all types of flu will help us prepare. Even in apparently humdrum flu years like this one, it behooves us to join the herd and be vaccinated."

Finally, the book's website, www.vaccinecontroversy.com, includes an extended essay by the author with his take on "how to think about vaccination."

Update, 2/6/06: In this weekend's New York Times, David Oshinsky gave the book a quite favorable review.

GSK planning head-to-head comparison of HPV vaccines

Earlier this month, GSK announced its plans to conduct a head-to-head clinical trial comparing its HPV vaccine, the still-unlicensed Cervarix, with Merck's Gardasil. Here's the GSK press release and a provocatively-headlined story from the Philadelphia Inquirer, "Area drug firms go to war over vaccine."

As the story notes, such a trial design is rare in medicine and all but unheard of for a vaccine. There's little doubt that this move by GSK is an attempt to frame an argument for the superiority of its HPV vaccine, despite the numerous advantages of Merck's Gardasil at present, among them, an increasingly longer head start in the market, immense media coverage over the past year, data showing 100% effectiveness (with respect to the HPV strains included in the vaccine), and the additional protection it provides against genital warts. Whatever their motives, head-to-head comparisons are helpful to patients and physicians, and it would by no means be a bad thing for other manufacturers of pharmaceuticals and vaccines alike to follow this lead, despite the high risks.

A sidebar piece in the same issue of the Inquirer looked at cost and access issues related to Gardasil. One interesting item: According to Merck's Richard Haupt, about $80 million worth of Gardasil had been sold through October, which he describes as "an extraordinary uptake." At Merck's listed price of $120/dose, that works out to roughly 660,000 doses, or enough to fully vaccinate 220,000 girls and women. (That number is likely higher, given the discounts offered to government programs and other groups).

More states introduce HPV mandate bills

A "wave of support" is how today's Washington Post describes the growing number of states in which bills to mandate HPV vaccination have been introduced in recent weeks. This story notes developments in Maryland, Virginia, and the District of Columbia, with many comments from politicians and physicians supporting the actions but nary a quote from opponents of the bills.

On Wednesday, a Washington Post columnist offered a very critical take on the D.C. measure and his views of the assumptions underlying the need for such a law in the city. Also of note is this counterpoint to the Post columnist's views in today's Washington Times, strongly supporting the proposed mandate.

Elsewhere, this story in Wednesday's Houston Chronicle discusses the debate likely to occur now that similar bills have been filed in both of Texas' state houses.

We're not generally in the business of forecasting the future, but it seems very likely that this momentum will lead to the passage of HPV vaccination mandates in at least some states in 2007. The fact that the exemptions (for medical, religious, and philosophical reasons) already available for other vaccine mandates are all but certain to apply to HPV requirements will likely play a significant role in how politicians react to the concerns of opponents of these bills. As a result, policy discussions of HPV mandates will be able to avoid entirely the difficult ethical questions raised by the exemption policies themselves, or, for that matter, the overall principle of mandating vaccination.

Michigan HPV mandate bill fails; similar bill introduced in Kentucky

This story from the Grand Rapids Press reports on the rejection of the bill in the Michigan legislature that would have mandated HPV vaccination for sixth-grade girls (while keeping the exemption system common to other vaccines). The bill, which passed the Michigan senate in September, was rejected by the state house during its last day in session prior to the holidays. The story above notes the intentions of two legislators to reintroduce the bill during the new session that has just begun.

Similar efforts are underway in Kentucky, according to this story from Friday's Lexington Herald-Leader. A bill that would require vaccination of girls prior to entering middle school was introduced by Rep. Kathy Stein and currently is being evaluated by the house's Health and Welfare Committee.

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.

Posts now viewable by topic

Thanks to the new version of Blogger, our posts now include long-desired subject/topic labels, which allow visitors to see with a single click all posts addressing a specific topic. We've gone back and labeled all of the nearly 150 posts written during our 10 months of existence; we think this will be a useful addition to the site and for its readers.

2007 Pediatric & adolescent immunization schedules released

Yesterday, the American Academy of Pediatrics released the 2007 recommended immunization schedules for children, adolescents and catch-up immunization. (As always, the schedules are a joint production of the ACIP, AAP, and American Academy of Family Physicians, but it appears that the AAP website is first to release it publicly.) The new schedule includes, among other changes, the new recommendations for rotavirus and HPV vaccination, as announced in 2006.

The traditional one-page schedule covering all vaccine doses from birth to 18 years had grown increasingly complex and crowded in recent years, a multi-colored sea of bars, shaded boxes, dotted lines, abbreviations, and minuscule print. The chief solution to this problem is the expansion of the single-page schedule to three pages, one for birth-6 years, another for ages 7-18, and a third for catch-up immunization spacing. Many of the more confusing design elements from years past have been eliminated and the fine-print footnotes are now bullet points.

While this update is marked improvement over previous versions with respect to comprehensibility, most parents will still be far better served consulting their physician to understand clearly which vaccines are recommended for their children and when.

Update, 1/5/06 -- The latest issue of CDC's MMWR also announces the newly revised schedules.

Gardasil: Profile of Merck Vaccines president; feature on early HPV-cancer link proponent

Two items worth reading for those interested in background content related to Gardasil's development and arrival:

• "Making her mark at Merck" (Business Week, 8 January) -- A profile of Margaret McGlynn, the president of Merck Vaccines. An interesting item in the story: "Analysts are counting on McGlynn to drive much of Merck's growth: Some predict revenues from her division will triple by 2010, to $6 billion." While the business of vaccines is not our area of expertise, this is point underscores the period of explosive growth for vaccines that we're just entering, one in which ethical considerations will demand that much more attention.

• "Cancer quest: How ex-Penn scientist's hunch led to cervical vaccine" (Philadelphia Inquirer, 24 December) -- A very lengthy feature (two pages in the print edition) on
  Dr. Harald zur Hausen, described in the story as a very early proponent (i.e., the 1960s) of a link between HPV and cervical cancer (the credit for proving such a link has gone to others in the early 1980s). A very interesting, seemingly well researched piece.
  

Seasonal flu: Healthcare workers, surplus doses, and more

A number of items in the news recently regarding seasonal (i.e., 'regular') influenza:

• Following up on our earlier post about the importance of vaccinating healthcare workers against seasonal flu, this story in the Houston Chronicle details CDC efforts to increase vaccination rates among this group.

• Regarding flu supply, we've noted several times this fall the very large supply of vaccine doses expected to be available this year -- as many as 20 million more doses that have ever been administered in a single season. This New York Times story ("After Shortage, Vaccine for Flu Goes Unused," 12/16) and this Cox News Service story examine the problems posed by the early delays in vaccine shipments this fall and the doses likely to be wasted as a result.

• The December 14 issue of the New England Journal of Medicine included three papers on flu vaccination. One article compares the efficacy of live attenuated flu vaccines (i.e., FluMist -- the nasal vaccine) vs. inactivated vaccines (the others that are injected). Another paper studies school-based vaccination programs, and a third is an editorial titled "Different approaches to influenza vaccination". All three papers are nicely summarized in this story by CIDRAP News' Lisa Schnirring.
  

Coming in 2007: A bigger, better vaccineethics.org

Thanks to the very generous support of The Greenwall Foundation, plans are underway for a major expansion of this website in 2007 and beyond. We'll be working on the specifics of these improvements in the weeks and months ahead, but look for more frequent blog posts, short essays on topics related to the ethics of vaccines, comprehensive bibliographic material, and much more. Stay tuned.

If you have suggestions for content you'd like to see, feel free to email us. Feedback and comments are always welcome. Thanks again for visiting.

$877m VaxGen anthrax vaccine contract cancelled

Since early last year, we've been covering the bad news related to VaxGen's anthrax vaccine development efforts (funded by Project Bioshield). In March 2006, we discussed a Washington Post story reporting a 'major setback'. Then in May, we noted the new government contract issued to Emergent Biosolutions, the manufacturer of the current vaccine. In October, the New York Times took a closer look at the story, as we wrote here, and a month later, we linked to the announcement that the FDA had halted further testing of the VaxGen project on account of insufficient data.

With that background, perhaps the news announced just before Christmas that HHS had cancelled its $877.5 million contract with VaxGen for 'default' should not come as a great surprise.

Here's the story from the New York Times and CIDRAP News. Also: the VaxGen press release and an interesting story from the San Jose Mercury News titled "What demise of anthrax vaccine contract means for VaxGen, U.S."

Here's an excerpt from the Times story:

"'This is a great disappointment and a very real setback,' said D. A. Henderson, the former director of the Department of Health and Human Services office that helped create the BioShield program.

By the end of this year, VaxGen was supposed to have delivered its first 25 million doses to the stockpile. But as it was testing the vaccine, the company noticed that it was breaking down too quickly, apparently because of an unexpected interaction with an additive intended to bolster the vaccine’s effectiveness, said Lance Ignon, a company spokesman."

With the development of a next-generation anthrax vaccine nearly back to step one, efforts now appeared directed at stockpiling the old vaccine as a stopgap measure while rerouting support to other manufacturers at much earlier stages of the development process, making a new vaccine years away.

Updates on measles epidemics in U.S. and worldwide

A few items of note regarding measles outbreaks during the past few years:

• We've written several times about the 2005 measles outbreak in Indiana that sickened 34 (such as here and here). This AP story from late last month confirms what was widely speculated to be the cause of the outbreak: a 17-year old unvaccinated girl who traveled to a Romanian orphanage as part of a church mission trip, according to CDC.

• Farther from home, PLoS Medicine published yesterday a paper with the provocative (but accurate) title: "Unacceptably high mortality related to measles epidemics in Niger, Nigeria, and Chad," looking at mortality rates in three epidemics in 2004 and 2005. Accompanying the paper is an editorial titled "Measles still has a devastating impact on unvaccinated populations." To those close to global vaccination programs, the title will likely seem laughably obvious, but the paper is a noble effort to draw attention to the continued suffering caused by a completely preventable disease.
  

Assessing pediatrician attitudes on rotavirus vaccine

The January issue of Pediatrics has a number of items discussing RotaTeq, Merck's rotavirus vaccine. Most interesting to this group is a paper titled "Will pediatricians adopt the new rotavirus vaccine?," a survey of attitudes among 431 physicians (free abstract, subscription required for full text). Much of the data was presented at the February 2006 ACIP meeting at which RotaTeq received a universal recommendation.

Here's a portion of the results section:

"Of the respondents, 52% strongly agreed and 37% somewhat agreed with the need for a rotavirus vaccine. If recommended for routine use, 50% would strongly recommend and 34% would recommend but not strongly; 52% would begin to use within 6 months and 27% from 6 months to 1 year. The top 3 "definite" barriers to implementation included concerns about uniform coverage of vaccine by insurers, lack of adequate reimbursement, and parental reluctance because of withdrawal of previous rotavirus vaccine."