Updates: HIV vaccine reassessment; 2nd rotavirus vaccine approved; Avian flu vaccine supply

Here are a few updates on topics we've been covering over the past several months:

• HIV vaccine research -- Several months after the failure of what was billed as the 'most promising' HIV vaccine candidate, NIAID organized a meeting late last month to reassess the state of HIV vaccine research and plans for the future. The "Summit on HIV Vaccine Research and Development" garnered significant media attention from the Washington Post and New York Times, among other outlets. The apparent take-away message from the meeting was that renewed effort must be directed toward basic research and novel ideas. A subsequent Times editorial argued that the potential benefit of a vaccine is too great to give up hope. A webcast of the meeting is available at the NIAID summit website.

• Rotavirus vaccines -- As expected, on Thursday, FDA approved GSK's Rotarix, now the second rotavirus vaccine available in the United States. Here's a story from the Associated Press, the FDA press release and the GSK release. The major difference between Rotarix and Merck's RotaTeq is that Rotarix requires two doses compared to three for RotaTeq. No word yet on the price of Rotarix, which had already been licensed in over 100 countries. It is expected to be available in the U.S. later this year.
  

• Pandemic flu planning -- Another update on the federal government's pandemic flu planning was released by HHS Secretary Michael Leavitt late last month. Updates on vaccine development and stockpiling figure prominently in the report. It notes that enough pre-pandemic vaccine for 13 million people was stockpiled by the end of 2007. This CIDRAP News story has more details.

Journal roundup: Racial disparities and school requirements, Parental comprehension, MMR media coverage, and more

As we do periodically, here are some papers of note published recently in the medical literature. (Most require a subscription in order to view the full text.)

• "Effect of a School-Entry Vaccination Requirement on Racial and Ethnic Disparities in Hepatitis B Immunization Coverage Levels Among Public School Students" (Pediatrics, Vol. 121, No. 3); Included in an issue with several papers on vaccination, this study analyzes racial/ethnic differences in Hepatitis B vaccination status among adolescents in Illinois before and after the establishment of a school-entry requirement. The authors conclude, "There was a dramatic decrease in the disparity of hepatitis B vaccination coverage between white and black or Hispanic students. School-entry requirements effectively increased hepatitis B vaccination coverage levels regardless of race or ethnicity and should be considered for other recently recommended adolescent vaccines."

• "Parents' vaccination comprehension and decisions" (Vaccine, Vol. 26, No. 12, 1595-1607); Based on a series of in-depth interviews with parents, the researchers report on the attitudes and mental frameworks that shape feelings about vaccination. They conclude that the parents were generally favorably toward vaccination, but "many had limited understanding of how [vaccination] works, making them potentially vulnerable to misinformation (or disinformation)."

• "Media Coverage of the Measles-Mumps-Rubella Vaccine and Autism Controversy and Its Relationship to MMR Immunization Rates in the United States" (Pediatrics, Vol. 121, No. 4); This paper published by our colleagues at Penn and The Children's Hospital of Philadelphia examines changes in U.S. vaccination rates in the wake of papers published in the scientific literature suggesting a link between MMR vaccine and autism compared to mainstream media coverage of the same controversy. The authors conclude, "There was a significant increase in selective MMR nonreceipt that was temporally associated with the publication of the original scientific literature, suggesting a link between MMR and autism, which preceded media coverage of the MMR-autism controversy."

• "On message, off target: Official advice on vaccination is too often poorly transmitted" (Nature, Vol. 452, No. 128); An editorial published in response to press reports noting presumptive Republican presidential nominee John McCain's sympathy toward arguments suggesting a link between vaccines and autism. The editors argue that new, enhanced communication strategies from CDC and other agencies are necessary to counter allegations of vaccine safety concerns.

Belgian parents face jail over non-vaccinated children

The Associated Press today reported on a fascinating story out of Belgium, where two sets of parents were sentenced to five months in prison as a result of failing to vaccinate their children against polio. The story notes that Belgium and France are the only two countries to require polio vaccination as a matter of national law. (Recall that U.S. vaccination requirements occur at the state level, and include various exemption protocols.) The parents' jail terms have been delayed to allow them another opportunity to vaccinate their children. Fines equivalent to approximately $8,000 were also assessed.

The website of the Belgian Federal Public Service includes information on polio and notes that it is the only mandatory vaccine in Belgium.

The story brings to mind the controversial jail threat levied against parents of unvaccinated children in Prince George's County, Maryland, last fall. (Our coverage here.)

According to this WHO website, there have been a total of three confirmed cases of polio in Belgium since 1980, the last occurring in 1989. (For comparison, there were 1307 cases worldwide in 2007 according to the Global Polio Eradication Initiative, the vast majority found in India and Nigeria.) Authorities in Belgium would likely point to the scarcity of polio cases as evidence supporting a strong vaccination requirement.

Threatening (or imposing) imprisonment is perhaps the most forceful tool at the disposal of public health authorities. It is unclear from the AP story whether such action is appropriate here or whether these measures should be reserved for more imminent threats to public health than the comparative minor threat of polio in Belgium given the very high vaccination rate overall.

Flu vaccine recommendation expanded through age 18

News out of this week's ACIP meeting in Atlanta that the committee voted today to expand its influenza vaccine recommendation to include all children and teenagers up to age 18. Previously, the recommended pediatric population only included children between 6 months and 5 years of age. Here's the CDC announcement about the expanded recommendation; it notes that approximately 30 million children are affected.

Here's coverage from the New York Times, CIDRAP News, and the Associated Press. The AP story reports that of the 36,000 annual influenza deaths in the U.S., only 25-50 occur in the 5-18 population. (Of course, preventing deaths is only one goal of expanded vaccination efforts.)

With some in the medical and public health communities advocating a universal recommendation, i.e., that all Americans receive the vaccine annually, the new recommendations (once fully implemented) will include essentially all Americans under age 18 and over age 50, in addition to a host of specific groups at higher risk of influenza morbidity or mortality.

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Today's announcement follows several weeks of bad news about the severity of the current flu season and issues with this year's vaccine failing to match a significant percentage of the circulating strains. Earlier this month, WHO recommended a wholesale redesign of the composition of the 2008-9 influenza vaccine -- replacing all three strains in the current season's vaccine. Here's the WHO report (pdf) and a CDC Q&A explaining the process by which the annual composition of the vaccine is determined. As is standard practice, the identical three strains were also recommended by the relevant FDA advisory committee at their meeting last week. Here's a related CIDRAP News story.

This link includes the most recent weekly report from CDC on influenza activity in the U.S., just part of the vast amount of information and resources available at its seasonal flu website.

FDA: GSK rotavirus vaccine appears safe and effective

Rotarix, the rotavirus vaccine developed by GSK, moved closer to U.S. licensure on Friday, as an FDA staff report stated that clinical trial results suggest that the vaccine is safe and effective.

Here is coverage of the news from The Wall Street Journal, Associated Press and Dow Jones. Rates of intussusception -- the gastrointestinal condition that doomed the first rotavirus vaccine, Rotashield, in 1999 -- were not significantly different in those receiving Rotarix versus control groups receiving a placebo.

A positive recommendation from government advisors at next week's meeting of FDA's Vaccines and Related Biological Products Advisory Committee would likely be the final step prior to licensure in the U.S. Rotarix is already approved in over 90 countries, according to GSK.

Merck's rotavirus vaccine, RotaTeq, was approved in February 2006 and is currently recommended for all infants at 2, 4, and 6 months of age

N.Y. Times public editor examines coverage of vaccine-autism link

In today's New York Times, Public Editor Clark Hoyt takes a look at questions surrounding reporters' handling of contested topics (at least by some) in science and medicine, including allegations of the link between vaccines and autism.

As we wrote last month, the New York Times broke the story about the content of the premiere episode of ABC drama "Eli Stone", triggering a flurry of protest by the American Academy of Pediatrics and others. In his stories, Times reporter Edward Wyatt wrote that the issue was all but settled within the scientific and medical communities, with the possible link between vaccines and autism largely rejected. (A Times editorial published after the episode aired offered a similar point-of-view.)

In his piece today, Hoyt writes:

"Wyatt’s article made clear that there is a debate but did not give equal weight to the two sides. The Times has not since 2005, when two reporters investigated every scientific study and thousands of documents from parents convinced of a link between autism and vaccines, and came down pretty clearly on the side of the scientists.

Wyatt said he relied on that report and read extensively about autism when he got the first hint of what the “Eli Stone” episode would say. "The show seems to portray it as, ‘No one knows,’" he said. “My conclusion was that that is not the case."

Proponents of a possible link were not pleased with Wyatt's portrayal of the scientific debate last month and are likely to be similarly displeased with the concurrence of the Times' public editor today.

Rare Paraguay yellow fever outbreak prompts vaccine demand

In over 220 posts in the 24-month history of this site, we haven't mentioned yellow fever once, a disease and a vaccine that, in the United States, are largely limited to historical narratives featuring Walter Reed or requirements for international travel. In parts of Central and South America and Africa, however, the disease is still a very real health threat. In Paraguay this week, the first yellow fever outbreak there in over 30 years has prompted the rapid delivery of several hundred thousand vaccine doses from countries throughout Latin America.

As this AP story reports, Brazil, Peru, and other countries have committed to deliver vaccine supplies to Paraguay to assist vaccination efforts in effected areas. (Public demand for the vaccine has led to street protests, according to many reports.) This ABC News (Australia) story notes that one death and 10 other cases of the mosquito-transmitted disease have been confirmed to date. This Guardian story adds that 30,000 deaths are caused by yellow fever annually, according to WHO.

More information about yellow fever and the vaccine available against it can be found at this CDC site and this WHO site.

Fifth edition of "Vaccines" published

The 5th edition of Vaccines, the magisterial textbook covering all aspects of vaccines and vaccination, was published this month. Edited by Stanley Plotkin, Walter Orenstein, and Paul Offit, everything about the newly revised and expanded text is impressive: 1748 pages, 76 chapters, several hundred contributors, and tens of thousands of references to other published materials. Already long viewed as the standard reference work on vaccines, the new edition adds to this unmatched reputation.

Chapters cover every vaccine developed or in development and several dozen topics related to infrastructure, regulation, and policy considerations. We were pleased to co-author one of the chapters new to the 5th edition, one titled "Ethics". In it, we provide a necessarily brief overview of the many (largely unexplored) ethical issues that arise throughout the vaccine life-cycle -- from the earliest stages of research through the implementation of national and international vaccination programs.

Overall, Vaccines is the first place to turn for answers to just about any question about a specific vaccine or vaccination programs more generally. More information about the book can be found at the Elsevier web site.

ABC drama with mercury-autism plot creates controversy

ABC, the same network that brought us 'Fatal Impact' -- the 2006 TV movie presenting a much-criticized dramatization of an avian flu pandemic -- is drawing fire from medical groups regarding the plot of the premiere episode of 'Eli Stone', a legal drama scheduled to debut on January 31.

As this New York Times story first reported last week, the plot of the first episode involves a 'ripped-from-the-headlines' case about a mercury-based vaccine preservative (called 'mercuritol' in the show) alleged to have caused autism in Eli Stone's client. At the end of the show, the jury apparently agrees that a link exists, deciding against the pharmaceutical industry and awarding the plaintiff $5.2 million.

News of the episode's plot has generated a remarkable amount of criticism from the medical community, including campaigns demanding ABC not air the episode. Here's a follow-up by the Times, "ABC Show Will Go On, Over Protests By Doctors." Leading the opposition has been the American Academy of Pediatrics -- here's a press release demanding the episode's cancellation and a letter to ABC from AAP President Renee Jenkins. Here is more coverage from the Associated Press, Reuters, and USA Today.

While all accounts suggest that 'Eli Stone' is a light-hearted series rather than a serious courtroom drama (commercials for the show prominently feature a singing-and-dancing George Michael, the 1980s pop singer who appears in 'visions' of the lead character), the medical community is still concerned that the show's plot will impact parents' decisions regarding vaccination. Today, the Immunization Action Coalition -- among the nation's most prominent advocates of vaccination -- encouraged readers of its e-mail newsletter to contact ABC and request that they cancel the episode.

Recent papers on vaccine-autism history, mandates, vaccine law, and YouTube

There have been an exceptional number of papers published in medical journals over the past several weeks that are worth mentioning...

• "Mercury, Vaccines, And Autism: One Controversy, Three Histories" -- American Journal of Public Health (subscription required for full text; published online ahead-of-print). From Jeffrey Baker, a physician and historian of medicine at Duke, an examination of the multiple histories that have contributed to the nature of current arguments linking vaccines to autism. Baker traces the parallel histories of thimerosal as a vaccine preservative, mercury as a health risk, autism as a diagnosis, and the relatively recent intersection of these stories.

• "Mandating Vaccination: What Counts as a "Mandate" in Public Health and When Should They Be Used?" -- American Journal of Bioethics (subscription required for full text). By Matthew Wynia of the American Medical Association, a commentary on the imprecise usage of the term 'mandate' (with respect to both vaccination and other public health activities) and the implications thereof. A nice introduction to a topic that deserves more attention from scholars.

• "Vaccine Law 101" -- Journal of Law, Medicine, and Ethics (subscription required for full text). Exactly what the title suggests, a high-altitude overview of the many laws, regulations, and types of litigation related to vaccines. A summary of a conference panel session of the same name. Short on insights and argument, but a very useful starting point for those interested in legal aspects of vaccination.

• "YouTube as a Source of Information on Immunization: A Content Analysis" -- JAMA (subscription required for full text). From a research team at the University of Toronto, a review of vaccine-related content posted on YouTube, examining claims made about vaccines and vaccination as well as the general attitude expressed toward vaccines. Slightly more than half of all videos were not expressly positive about vaccination, and those critical of vaccination tended to receive higher ratings from YouTube visitors. Here's a press release about the paper.
  

More evidence against thimerosal-autism link; critics disagree

This paper in the Archives of General Psychiatry, part of the JAMA family of journals, reports that data "do(es) not show any recent decrease in autism in California despite the exclusion of more than trace levels of thimerosal from nearly all childhood vaccines. The DDS data do not support the hypothesis that exposure to thimerosal during childhood is a primary cause of autism."

Seemingly yet another piece of evidence refuting the thimerosal-vaccines-autism hypothesis, the paper led to coverage from ABC News, the Associated Press, the San Francisco Chronicle, and elsewhere.

Advocates of the link between thimerosal and autism were not swayed, as this Baltimore Sun story explains. SafeMinds, perhaps the most prominent organization focusing on mercury-related vaccine risks, published its own analysis of the paper arguing that the imprecision of the data in the study prevented any variable (including thimerosal) from being ruled out as a cause of increasing autism rates.

Research updates: meningococcus, dengue, and cocaine(!?!)

While we were away, there's been news on several fronts related to research on new vaccine candidates, some much farther along than others:

• Meningococcus -- The Jan. 9-16 issue of JAMA reported positive Phase II clinical trial data for a new meningococcal vaccine for infants manufactured by Novartis. The vaccine, called Menveo, would be the first available for infants, a population not covered by two meningococcal vaccines currently licensed in the U.S. Phase III trials are underway. An editorial on the results accompanied the paper in JAMA. Here's the Novartis Press Release and coverage from USA Today and HealthDay News.

• Cocaine -- There's been a great deal of attention to stories like this one on preliminary research at Baylor University that aims to develop what its (media-savvy) researchers generously describe as a "cocaine vaccine." Similar to reports of a "nicotine vaccine" that made the rounds a few years back, more interesting than speculation about a therapy that is many, many years away (if ever) is the continued broadening of the meaning of 'vaccine' by researchers working on just about any strategy that involves the immune system. Nevertheless, the media strategy worked, as one newspaper headline (originally in the Houston Chronicle) proclaims, "Researchers develop cocaine vaccine." Time magazine was on top of the story as well, publishing a news story as well as a bioethicist Q&A with the rather sweeping headline, "The Ethics of Vaccination."
  

• Dengue -- This commentary in the Jan. 9-16 issue of JAMA co-authored by NIAID Director Anthony Fauci reviews public health risks related to dengue and hemorrhagic fever in the United States. The essay reviews the progress and unanswered questions related to dengue vaccine development.
  

2008 recommended vaccination schedule; Paper on historical changes in disease rates

Last week's issue of MMWR included the recommended vaccine schedule for children and teenagers (i.e., birth to age 18). The familiar color-coded tables incorporate changes made in the joint recommendations of CDC, AAP, and AAFP over the past year. (The updated schedule was also published nearly simultaneously in the journal Pediatrics earlier this month.)

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Speaking of CDC, a paper by a group of researchers at its National Center for Immunization and Respiratory Diseases was published in JAMA in December titled, "Historical Comparisons of Morbidity and Mortality for Vaccine-Preventable Diseases in the United States."(free abstract; subscription required for full text). From the abstract, here is what the researchers report:

"A greater than 92% decline in cases and a 99% or greater decline in deaths due to diseases prevented by vaccines recommended before 1980 were shown for diphtheria, mumps, pertussis, and tetanus. Endemic transmission of poliovirus and measles and rubella viruses has been eliminated in the United States; smallpox has been eradicated worldwide. Declines were 80% or greater for cases and deaths of most vaccine-preventable diseases targeted since 1980 including hepatitis A, acute hepatitis B, Hib, and varicella. Declines in cases and deaths of invasive S pneumoniae were 34% and 25%, respectively."

A table showing this 'before-and-after vaccines' disease incidence data is a mainstay of Powerpoint presentations by vaccine policy-makers and researchers. While the numbers are impressive, such analyses of historical disease rates are fraught with challenges, particularly when attempting to isolate the impact of a certain variable (such as a vaccine) over many decades. To their credit, the authors of the paper note some of the many other factors that also contributed to the changes in disease rates during the 20th century, such as improvements in health care, standards of living, and many others.

The major decline in disease rates is impressive, and there's no doubt that vaccines play a major part in these successes. However, without being given comparisons to rates of other infectious diseases for which vaccines are not available, the reader of this paper could not be faulted for forgetting that vaccines are part of a much larger story of changes in medicine, health, and disease during the 20th century.

Jail threatened for parents of unvaccinated children in Maryland

It's a rare day when the same story gets noticed by both the Drudge Report and our site, but this story in today's Washington Post is already raising eyebrows. Titled "Get Kids Vaccinated or Else, Parents Told," the story reports that 2,300 parents in Prince George's County, Maryland, could be fined $50/day or be jailed for 10 days if their children are not vaccinated against hepatitis B and varicella, as required by the state.

The parents have received a letter from a state prosecutor and judge ordering the parents to attend a court hearing this weekend where free vaccinations will be available. The action comes after several months of failed efforts by local officials to resolve this issue which has resulted in the 2,300 children being barred from attending school.

As this excerpt from Maryland state law details, medical and religious exemptions from vaccination requirements are permitted, but Maryland is not one of the 20 states that allows philosophical exemptions.

There's certainly more to this story than today's Post account suggests. At first glance, however, it would seem that threatening to jail parents of unvaccinated children in the absence of a public health emergency is, to say the least, a dramatic action. While state officials are presumably well intended, it is unclear that such rhetoric is the best strategy to promote widespread support for the value of vaccination.

Lessons from the Failure of HPV Vaccine State Requirements

That's the title of a paper written by a group from the Penn Center for Bioethics -- including the editor of this site -- and the Johns Hopkins University Berman Institute of Bioethics. The article, a review of the events surrounding Gardasil state requirement proposals and their impact on long-term HPV vaccination efforts, will appear in the December issue of Clinical Pharmacology & Therapeutics but is already available on its website.

From a Penn news release on the paper:

“The arrival of Gardasil was a major achievement for cervical cancer prevention efforts worldwide,” says Jason Schwartz, MBE, Researcher, Penn’s Center for Bioethics and Department of History & Sociology of Science, and lead author. “Much of the initial enthusiasm for the vaccine was lost amid the controversy surrounding state proposals that would require teenage girls to be vaccinated in order to attend school. The events of the past year reveal important lessons regarding ways to introduce new vaccines successfully and in an ethically responsible manner."

In the months leading up to the June 2006 approval of Gardasil, there was unprecedented media coverage and support from even socially-conservative groups. However, this support for the vaccine began to slow in September 2006 following the introduction of a bill in the Michigan state legislature that would require the vaccination of girls attending public schools. Additional states also were quick to propose similar legislation. In response to the legislation, numerous groups expressed their opposition by arguing that it was either too soon to consider an HPV requirement, or that the sexual transmission of the virus did not warrant requiring the vaccine in schools.

The opposition grew when the governor of Texas issued an executive order requiring HPV vaccination for all girls entering the sixth grade. Critics of state HPV requirements called attention to how these policies violated obligations to respect parental autonomy. However, many critics often overlooked opt-out provisions, implying that the proposals made vaccination compulsory.

The authors note that, “Quite apart from whether it was prudent public health policy to implement state requirements for HPV vaccination so soon after the vaccine’s licensure, these attacks on the state initiatives may have exacted a very real ethical price in terms of the public’s understanding of the justifications for state vaccination requirements generally, as well as the public’s understanding of the merits of the HPV vaccine itself.” Additionally, they suggest that issues of price gouging, corporate profits, and political motives, may have also added to the opposition.

In order to move forward with cervical cancer prevention efforts, the authors suggest that attention be focused on assessing the long-term safety of the vaccine, while implementing effective patient and provider educational programs about HPV and the HPV vaccine, as this is the model that other successful vaccination programs have followed. "With a second HPV vaccine expected to be approved in early 2008, it is vital to understand the strategies that are most likely to lead to the long-term success of this remarkable weapon against cervical cancer," says Schwartz.

The authors also discuss the importance of designing and implementing HPV vaccination programs in developing countries. "Cervical cancer is a worldwide concern, but its impact is particularly severe in the developing world,” says Schwartz. “It would be tragic if the negative attention created by the debate over HPV vaccine ‘mandates’ in the U.S. hamper efforts to make the vaccine available to those internationally who could benefit most from it."

Only the abstract is available free. Those without access to the full text are welcome to contact us to receive an offprint.

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.

Study reports no link between thimerosal and neuropsychological outcomes

In what is sure to mark a new round in the debate regarding the impact of thimerosal in vaccines, a paper published in the latest issue of the New England Journal of Medicine reaches the following conclusion:

"Our study does not support a causal association between early exposure to mercury from thimerosal-containing vaccines and immune globulins and deficits in neuropsychological functioning at the age of 7 to 10 years."

The paper by CDC's William Thompson and (many) colleagues -- "Early Thimerosal Exposure and Neuropsychological Outcomes at 7 to 10 Years" -- is available for free at the NEJM website. The study compared children's performance on a battery of neuropsychological tests to their total exposures to thimerosal during vaccination as infants. The paper repeatedly states that autism was not a focus of this study, but there's little doubt that the findings here will find their way into the vaccines and autism debate, even despite efforts from CDC officials at today's teleconference to emphasize this distinction.

Tomorrow, we'll link to some of the media coverage that this news will surely receive -- it was already prominently featured on several of the national evening news broadcasts tonight. For now, here's coverage from the Associated Press, US News & World Report, and Reuters.

The New England Journal also published two related perspectives on thimerosal and vaccines. Paul Offit writes in "Thimerosal and Vaccines -- A Cautionary Tale" (free full text),

"The thimerosal controversy should stand as a cautionary tale of how not to communicate theoretical risks to the public; otherwise, the lesson inherent in the collateral damage caused by its precipitous removal will remain unlearned."

Stephen Sugarman also contributes a piece titled "Cases in Vaccine Court -- Legal Battles over Vaccines and Autism."

Autism advocates and proponents of a link between thimerosal and autism are already raising questions about the researchers, the study and its conclusions (despite the standards required for publication in the world's premier medical journal). For examples, here are statements from Autism Speaks and SafeMinds (which calls the study 'wrong').

More to come...

"Most promising" HIV vaccine trial stopped; vaccine not effective

In what a colleague at Penn--an HIV researcher--describes as "very big and very disappointing news", Merck announced Friday that it was halting clinical trials on what was viewed as a highly promising HIV vaccine candidate, the most advanced vaccine that employed a new strategy attempting to stimulate T-cell immunity against the virus. An interim analysis of research data found that the vaccine was not effective.

Here's the front page story from Saturday's New York Times -- Failure of Vaccine Test is Setback in AIDS Fight, and more coverage from Scientific American, The Associated Press, and The Washington Post. Here are official statements from Merck, NIH, and IAVI.

Also of note is this editorial in today's Philadelphia Inquirer, "Starting fresh for an HIV vaccine."

More good news on Gardasil cross-protection?

An Associated Press story published last week began with what seemed to be remarkable news:

"New data show that a vaccine against the virus that causes cervical cancer partially blocks infection by 10 strains of the virus on top of the four types targeted. That boosts protection - at least partially - to 90 percent of strains causing the deadly cancer, according to data presented yesterday at a medical conference by Merck & Co., maker of Gardasil."

90% protection? Recalling that 70% had long been the number used to quantify the percentage of cervical cancer-causing HPV strains covered by the vaccine, this would be a major development.

As is often the case with unpublished data presented at medical conferences, specifics on the research results are difficult to come by. However, this WebMD story published at CBSNews.com adds more detail, explaining, "The new study, which involved about 11,000 young women aged 15 to 26, shows that the vaccine is also 38% effective against 10 additional HPV types, which are responsible for an additional 20% of cervical cancers."

The fact that the vaccine is only 38% effective against these additional strains is never clearly stated in the AP story. (Research has shown the vaccine to be 100% effective against the 70% of cancer-causing strains included in the vaccine.)

The findings are still good news, but readers of the AP story -- published in our hometown Philadelphia Inquirer and no doubt many other newspapers -- could be excused for thinking it was even more noteworthy.

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In other Gardasil news, Merck announced today plans to donate 3 million doses of the vaccine for use in the developing world. Here's coverage from the Associated Press and a Merck press release.

Seasonal flu: Record supply expected; FluMist approved for 2-4 year olds; Data shows low coverage in past

In what is becoming an annual tradition, CDC announced last week that a record supply of seasonal influenza vaccine is expected to be available for the approaching flu season. Once again, however, barring a massive increase in the number of Americans seeking the vaccine, millions of doses will very likely go unused.

As this AP story reports, current estimates are for 132 million doses to be available this year, an increase over last year's total of 121 million doses (itself a record). Despite the vaccine being recommended for 218 million Americans, 18 million doses were not used last year and were destroyed. Here's more coverage from CIDRAP News and the Washington Post.

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Last Wednesday, FDA approved FluMist -- the only flu vaccine that is administered nasally -- for use in children between the ages of 2-5. Previously, the vaccine had been approved for those age 5-49. Here's the FDA announcement, coverage from CIDRAP News, and a particularly detailed story from the Washington Post.

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Last week's MMWR included several papers detailing flu vaccination coverage in recent seasons. Here's state-by-state data of adults 18 and older, children age 6-23 months, and early data on children age 6-59 months (reflecting the new ACIP recommendation of June 2006). The editorial notes for all three papers explain that the observed vaccination rates are well below CDC goals.

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In related news, CDC announced a new-and-improved seasonal influenza website available at www.cdc.gov/flu/. The site contains extensive information for health professionals and the general public about the virus, prevention, and treatment.