Swine flu and the limited role of vaccines in initial outbreak response

The unfolding swine flu outbreak has raised considerable interest in the potential development of a vaccine against the virus. A story in yesterday's New York Times reminded us that a "Swine Flu Vaccine May Be Months Away, Experts Say," something that has long been known among public health officials considering the role of vaccines in response to a pandemic.

(This is the reason for the funding, development, and stockpiling of 'pre-pandemic' avian flu vaccines to bridge this gap for the H5N1 virus that had long been the focus of pandemic planning. Swine flu (H1N1) appeared too quickly for this to be an option for the current outbreak.)

Forbes has a similar story, and the Chicago Tribune, MSNBC, Time, and nearly every other media outlet has explored the challenges and timetable for swine flu vaccine development.

Here are the swine flu websites from CDC and WHO, which announced today it would now refer to the virus and disease as 'influenza A (H1N1)" rather than swine flu.

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There would no doubt be many issues to be discussed on this site and elsewhere if federal officials determine that a swine flu vaccine is needed, including significant questions regarding the ethics of development, production, safety testing, financing, and distribution.

In the meantime, however, vaccines are not relevant to the immediate public health challenges facing American and international health officials, even though they and antiviral drugs have dominated public discussions of pandemic preparedness over the past few years. In a piece for Science Progress titled, "When Drugs Aren't the Answer," we write:

"The limited value of pharmaceuticals and vaccines in the early stages of a potential influenza pandemic is well known to public health officials and diligent readers of the vast planning documents issued by the federal government since 2005. Instead, the severity of swine flu or any potential pandemic will be determined in large part by how quickly those infected or exposed are identified, located, and separated from the healthy. This is the decidedly low-tech but life-saving work upon which many of the achievements of public health in the past century have been based."

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"Government officials who are already justifiably concerned about creating unnecessary panic may be forced to introduce targeted social distancing, isolation, and quarantine programs to a public that has heard too little about their tremendous importance and too much about vaccines and antivirals that are barely relevant to the immediate health challenges at hand. Through the efforts of the public health community coupled with a bit of luck, swine flu may dissipate without becoming a full-blown pandemic, giving health policy-makers a second chance to revisit these critical aspects of a comprehensive, just approach to pandemic preparedness."

Court rejects alleged link between vaccines and autism

Today's decisions by the Omnibus Autism Proceeding have received widespread media coverage. The three decisions -- available here -- total over 650 pages. Together they reject unequivocally the claim that MMR vaccines, individually or in tandem with thimerosal, could plausibly cause autism. Barring possible appeals, the decisions bring an end to a two-year process including 5,000 pages of transcripts, 700 pages of post-hearing briefs, and 939 referenced medical articles, according to this background document (pdf).

Here's an excerpt from the decision written by Special Master George Hastings in the case involving Michelle Cedillo (pdf), the most publicized of the three 'test cases'. (The 'petitioners' referred to below are the Cedillo family and the 'respondent' is the government.)

"The expert witnesses presented by the respondent were far better qualified, far more experienced, and far more persuasive than the petitioners’ experts, concerning most of the key points. The numerous medical studies concerning these issues, performed by medical scientists worldwide, have come down strongly against the petitioners’ contentions. Considering all of the evidence, I found that the petitioners have failed to demonstrate that thimerosal-containing vaccines can contribute to causing immune dysfunction, or that the MMR vaccine can contribute to causing either autism or gastrointestinal dysfunction. I further conclude that while Michelle Cedillo has tragically suffered from autism and other severe conditions, the petitioners have also failed to demonstrate that her vaccinations played any role at all in causing those problems."

Here are press releases by HHS, the American Medical Association, and the American Academy of Pediatrics praising the decisions as further evidence refuting a link between vaccines and autism. Far less enthusiastic statements came from SafeMinds and Autism Speaks.

A sampling of headlines from around the web:

• New York Times: Court Says Vaccine Not to Blame for Autism
• Washington Post: Court Rules Autism Not Caused by Childhood Vaccines
• Slate: A Special Court Rejects Autism-Vaccine Theories
• Associated Press: Court Says Vaccine Not to Blame for Autism
• CNN: Vaccines Didn't Cause Autism, Court Rules
• CNN -- Dr. Sanjay Gupta: Court Rules Vaccines Not to Blame for Autism
• CBS News: Vaccine-Autism Link Ruled Out By Court

A second group of 'test cases', based on the closely related theory that thimerosal-containing vaccines could cause autism (without reference to MMR) were argued in 2008. Decisions in the cases (by the same three Special Masters) are pending, but today's decisions would suggest a different result is highly unlikely.

Exploring legal liability for parents of unvaccinated children

The current issue of First Impressions, the online companion to the Michigan Law Review, is titled "Liability for Exercising Personal Belief Exemptions from Vaccination." The issue consists of six commentaries from physicians, lawyers, public health scholars, and ethicists writing on the following topic:

"With the increased risk that the use of personal belief exemptions will limit the effectiveness of vaccination, this symposium addresses whether parents who refuse to vaccinate their children should be liable in tort to individuals who are infected and injured by the unvaccinated children."

We were asked to contribute to this symposium -- our article is available here (pdf). As a policy solution, advocating legal liability for parents of unvaccinated children seems inadvisable. From the paper, here's our conclusion...

"Efforts should be aimed at ensuring school-entry requirements are implemented only when a compelling public health need exists, as well as strengthening requirements for nonmedical exemptions so that they include only those with deeply held beliefs against vaccination. A program of research and public education should strive to demonstrate the continued safety of vaccination and inform parents about its importance to their children’s health. Holding parents of unvaccinated children liable to those whom their children infect would greatly exacerbate tensions, confusion, and controversy over vaccination, jeopardizing the public trust that vaccination has long deserved and on which the success of U.S. vaccination policy relies."

Vatican bioethics document discusses vaccines derived from fetal tissue

In June 2006, we wrote an item titled, "Catholic medical group speaks against vaccines originally derived from fetal tissue," noting a statement on the topic by the Catholic Medical Association. On Friday, the Vatican issued its most significant document on biotechnology and bioethics in two decades. While the instruction titled Dignitas Personae received attention mainly for its statements on cloning, stem cell research, and in vitro fertilization, the morality of certain types of vaccines was also addressed.

First, the background. As we wrote in 2006:

"Several vaccines, particularly those for rubella and hepatitis A, were initially developed by research that involved tissue from fetuses that had been voluntarily aborted. In some cases, the research in question occurred as long as 40 years ago. (It should go without saying that there is no fetal material in the vaccines actually administered, nor has there ever been.)

Catholic groups have been among the most vocal critics of these vaccines' origins, raising questions about the morality of receiving them in light of the teachings of their religion. The question becomes particularly difficult for them when there is no alternative vaccine available in the U.S. not derived from fetal tissue. (This is the case with rubella and Hep A, although alternative vaccines are available internationally)."

The latest Vatican document echoes a 2005 opinion issued by the Pontifical Academy of Life. Section 35 of Dignitas Personae reads, in part:

"Thus, for example, danger to the health of children could permit parents to use a vaccine which was developed using cell lines of illicit origin, while keeping in mind that everyone has the duty to make known their disagreement and to ask that their healthcare system make other types of vaccines available."

More on the Vatican's views on these vaccines appears in this Catholic News Service story.

Positive early results for GSK malaria vaccine candidate

Last week's news about the clinical trial results of GSK's malaria vaccine candidate garnered significant media coverage. As this Reuters story explains, two different Phase II trials -- one each in Kenya and Tanzania -- enrolled slightly more than 1200 infants and children. Both trials showed substantial protection against malaria (between 50-65%) when comparing those receiving the vaccine versus the placebo groups. Here's another account from Time magazine.

Papers reporting on each trial (Kenya and Tanzania) were published in the December 11 issue of the New England Journal of Medicine, along with an editorial bearing the appropriate title, "A Hopeful Beginning for Malaria Vaccines." The editorial details the significance of the results thus far and some of the many questions that must be explored by future, larger clinical trials to begin in 2009.

The implications of the results were addressed in an editorial in yesterday's New York Times, "The Glaxo-Gates Malaria Vaccine."

In addition to GSK, organizations involved in the studies include the PATH Malaria Vaccine Initiative, the KEMRI-Wellcome Trust Program in Kenya, and the Joint Malaria Programme in Tanzania. Information about both trials is available at ClinicalTrials.gov: Kenya and Tanzania.

Vaccines figure prominently in Time's "Year in Medicine"

The December 1 issue of Time magazine included several stories on health and medicine, including a feature titled "The Year in Medicine: From A to Z". Of the 33 items listed (some letters had multiple entries, others were skipped), three were related to vaccination:

• A -- "Autism: Debate Rages over a Rare Case". Reviews the Hannah Poling case; the links among vaccines, mitochondrial dysfunction, and autism; and the implications for the overall vaccine-autism debate.

• G -- "Gardasil: Vaccine Battle". Discusses the reports earlier this year about serious side-effects, including deaths, linked to Gardasil. As the item notes, governmental officials are working to assure the public of the vaccine's safety, including through this CDC website.

• H -- "HIV: The Hunt for the Elusive Vaccine Goes On--and On". Details the ongoing failures of HIV vaccine clinical trials and current plans for smaller-scale testing of novel ideas.
  

Seasonal flu: Examining school-based vaccination; Debating health-care worker mandates

A few recent items related to seasonal influenza vaccination:

-- Lisa Schnirring at CIDRAP News published an interesting story last week examining the potential use of school-based flu vaccination efforts in order to increase coverage in the under-18 population for whom vaccination is now recommended by the ACIP. Optimism for these in-school vaccination programs seems to be in short supply given the various pressures -- funding, staffing, and performance -- faced by school districts around the country.

-- Each flu season, the amount of attention grows regarding the astonishingly-low influenza vaccination rates among health-care workers grows. Two recent papers join the discussion about the use of mandates to boost coverage in this group:

• "Requiring Influenza Vaccination for Health Care Workers" (American Journal of Public Health, online pre-publication -- subscription required); Reviews the ethical arguments for and against mandating vaccination, concluding that a program providing small incentives for compliance and requiring active refusal is ethically superior to mandated vaccination.
  

• "The Ethics of Mandatory Vaccination against Influenza for Health Care Workers" (Vaccine, Vol. 26, No. 44, 5562-5566 -- subscription required); Focuses primarily on the ethics of mandatory vaccination for those working in long-term care facilities, and concludes that mandates are only justifiable if voluntary programs fail to achieve 50% coverage among health-care workers.
  

Positive results for Gardasil trial in males

News came from Merck last week that results from its clinical trial of Gardasil in males showed the vaccine's efficacy in preventing HPV-related genital warts and other lesions. No serious safety concerns were found. Here's coverage from the Associated Press and the Merck press release detailing the (as yet unpublished) results which were presented at this European conference last week.

The trial included nearly 4,000 males between the ages of 16 and 26. The vaccine was 90% effective at preventing external genital lesions, the most common of which are genital warts.

Dr. Bernadine Healy, in the news earlier this year for comments seen as supporting a possible link between vaccines and autism, was pleased by these research results about Gardasil, writing about the many benefits of vaccinating males against HPV.

These findings will be part of Merck's eventual application to the FDA to license the vaccine for use in males in addition to females, a decision that has been widely expected for some time.

More interesting, however, will be the decision faced by the Advisory Committee on Immunization Practices regarding its recommendation for Gardasil in males. In particular, it remains to be seen if the direct protection provided against genital warts in males will be sufficient to recommend broad use of the vaccine, and/or what role the indirect benefits of male vaccination (i.e., aiding in the prevention of HPV-related disease in women) will play in the ACIP's recommendation.

No timetable has been set for these actions, but they are sure to be in the news in 2009.

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One other item related to HPV vaccines: The November 15 supplement to the journal Cancer is titled, "Assessing the Burden of HPV-Associated Cancers in the United States". It has a number of papers examining the burden of cervical cancer and other HPV-related conditions as well as several papers on the potential impact of HPV vaccination programs. Very interesting reading.

St. Pete Times story reviews vaccine-autism debate

The November 23 edition of the St. Petersburg Times has a very good feature reviewing the enduring controversy over vaccine safety and alleged links to autism. Written by Lisa Greene, the story, "Debate rages over need for vaccines," interviews prominent voices on both sides of the issue, including proponents of current vaccine policy such as Paul Offit and Amy Pisani, and critics including J.B. Handley and Vicky Debold.

Among other topics addressed in the story is the challenges faced by Autism Speaks in representing its diverse constituencies of autism advocates -- many of whom reject links between autism and vaccines. The piece also explores how media coverage by journalists may contribute to ongoing public confusion over the safety of vaccines.

Greene writes, "This is no longer principally a debate about science. The real question is whether Americans still believe in science — or at least, in the nation's scientists."

Also accompanying the story is a collection of graphs and figures about the history of vaccination efforts and autism trends.

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Speaking of Paul Offit, his new book, "Autism's False Prophets: Bad Science, Risky Medicine, and the Search for a Cure," has attracted considerable attention this fall, including a profile on NBC's "Today" and a story in Newsweek, among many others. The overwhelmingly-favorable coverage of Offit, his book, and his arguments has triggered online rebuttals from leading critics of U.S. vaccine policy, including Barbara Loe Fisher and J.B. Handley, who refers to Offit as a 'lying jerk.'

Journal roundup: Assessing parental doubts; Cost-effectiveness models in vaccine policy-making

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

• "Parents with Doubts about Vaccines: Which Vaccines and Reasons Why" (Pediatrics, Vol. 122, No. 4, 718-725); A survey of nearly 4,000 parents aimed at understanding the factors contributing to doubts over vaccinating their children or decisions to delay or reject vaccines. The authors note the impact of vaccine safety concerns -- some specific, others general -- on parents with doubts about vaccines and the role of information from physicians in causing parents to change their minds and proceed with vaccination.

• "The Role of Economic Information in Decision-making by the Advisory Committee on Immunization Practices" (Vaccine, Vol. 26, Iss. 42, 5389-5392); A survey of ACIP members' views regarding the use and importance of economic data -- principally cost-effectiveness analyses -- in the development of ACIP recommendations. (While published this fall, the study interviewed the 2006 ACIP membership. This summer, guidelines regarding presentations of economic data were issued by CDC, attempting to address suggestions raised in this survey and elsewhere regarding the standardization of economic presentations.)

• "Funding of Drugs: Do Vaccines Warrant a Different Approach?" (Lancet Infectious Diseases, Vol. 8, No. 11, 727-733); Another paper on the impact of population-level economic analyses on vaccine policy. The authors detail some of the unique characteristics of vaccines and vaccination programs (compared to pharmaceuticals) that make cost-effectiveness analyses more complicated for vaccine policy-makers. Includes examinations of several specific vaccines and the challenges they raise for economic analyses of their impact across populations.

New content now available at VaccineEthics.org

A variety of new materials are now available at VaccineEthics.org:

• Several new Issue Briefs have been added, examining risk and benefit in vaccine policy, vaccine research related to neglected tropical diseases, bioterrorism vaccines, and the vaccine industry.
  
• A new primary-source based curriculum unit is also available, examining key moments in the history of the Salk polio vaccine through documents from the Eisenhower presidential library.
  
• Finally, our bibliography has been updated with over 150 new references, bringing the total number of entries to more than 1,000.

As always, your feedback about the site is welcomed and appreciated.

Protest in NJ over flu vaccine requirement

This Associated Press story on a protest yesterday in Trenton, NJ, regarding the state's expanded childhood immunization requirements has been distributed widely throughout the media. (It even earned a coveted place on the website of the widely-visited Drudge Report.)

The newly-enacted state requirements in New Jersey -- available here and effective as of this past September 1 -- include, among other vaccinations, that all children between 6-59 months attending day-care or preschool be vaccinated annually against influenza. This requirement mirrors the CDC recommendation for influenza vaccination, (which was recently expanded through age 18). New Jersey is the first state in the nation to require influenza vaccination in this population, a policy that has been widely supported by medical and public health organizations in the state and nationwide.

According the media coverage of the protest, those in attendance support a bill introduced in the state legislature that would allow the variously-termed 'philosophical,' 'personal-belief', or 'conscientious' exemptions to state vaccine requirements, available in approximately 20 states but not currently permitted in New Jersey. (Presently, only medical and religious exemptions are allowed in the state.)

The Newark Star-Ledger also sent reporters to cover the event, as did the Camden (NJ) Courier-Post. The Star-Ledger published an editorial arguing against the personal-belief exemption bill.

WSJ on meningococcal vaccine for adolescents

Today's Wall Street Journal has a story about meningococcal vaccine -- the cause of many cases of bacterial meningitis -- and the obstacles faced by efforts at vaccinating adolescents. The story, "Quelling a Killer: The Case For the Meningococcal Vaccine," uses the stories of a few victims of bacterial meningitis to illustrate the rapid and severe course of the rather rare disease in the U.S. Estimates vary, but the WSJ story says that 1,400 to 2,800 cases occur annually, roughly 10% of which are fatal.

Routine vaccination (with SanofiPasteur's Menactra) is recommended for all 11-12 year olds, many colleges and universities require vaccination for students living in dormitories (a high-risk group), and now states such as New Jersey are adding the vaccine to those required for school entrance. Despite these efforts, vaccination rates among recommended populations have ample room for improvement.

As these types of stories tend to do, the article includes back-to-back quotes from Paul Offit and Barbara Loe Fisher on the merits and possible concerns, respectively, associated with routine vaccination of adolescents.

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Speaking of the Wall Street Journal, a lengthy story appeared in July -- "Get Your Shots: Adults Need Vaccines, Too" -- detailing the growing number of vaccines recommended for another population, adults, for which awareness of vaccination efforts lags in comparison to pediatric vaccination programs.

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.

HPV Roundup: Gardasil safety worries, Cervarix FDA delays, more on mandates

There's been a flurry of media coverage this week about possible safety issues related to Gardasil. It appears that the attention was initiated by this report released by Judicial Watch, the conservative watchdog group. Like its previous reports alleging numerous deaths and illnesses caused by vaccine, this Judicial Watch report is based on unconfirmed submissions to VAERS, the government's clearinghouse for reports of possible vaccine-related adverse events. Reports to VAERS -- widely described as a 'hypothesis-generating mechanism' -- are later examined by government officials to determine what, if any, role a vaccine may have had in the reported condition.

Numerous other outlets have raised questions about Gardasil's safety in the past few days, most notably this CBS News story by Sharyl Attkinson, the media member who is increasingly at the forefront of reporting on alleged vaccine risks. Other media outlets examining the topic include CNN and WebMD.

In the meantime, officials from CDC and FDA have assured the public that the vaccine remains safe and effective and that reports of possible adverse events will continue to be investigated. Merck responded similarly yesterday, noting the limitations of reports made to VAERS.

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Meanwhile, it appears that the U.S. head-to-head battle between Gardasil and GSK's Cervarix will most likely be delayed until late 2009. Last week, the Wall Street Journal and Reuters, among others, reported the GSK announcement of its timetable for submitting additional trial data requested by FDA. Here is the GSK press release. It notes that Cervarix is already approved in 67 countries, including the E.U., but it's no secret that the U.S. market is by far the most lucrative, as Merck's sales figures from earlier this year illustrated.

From a business standpoint, this is decidedly good news for Merck, as it extends its head start in the U.S. (The news has not all been good, however, as it was announced late last month that Merck's application to expand the indication for Gardasil for women through age 45 will face additional scrutiny and delays. Here's a story from Reuters and the Merck press release.)

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In other news, two papers have recently been published in academic journals on HPV mandates (joining a growing literature on this topic -- including papers by Schwartz, et al., Colgrove, and Zimmerman.) One paper, "Assessing Mandatory HPV Vaccination: Who Should Call the Shots?" (Javitt, et al.) appears in the Summer 2008 issue of the Journal of Law, Medicine & Ethics (subscription required). In short, the authors conclude, "...Mandating HPV vaccination at the present time would be premature and ill-advised."

Also, the May 2008 Harvard Law Review published a paper titled "Toward a 21st Century Jacobson v. Massachusetts (pdf), alluding to the 1905 case that is widely seen as the foundation for state public health powers. The authors argue that a distinction should be drawn between vaccines that are 'medically necessary' (such as smallpox) and those that are 'practically necessary' (such as hepatitis B and HPV, for which other preventive measures are available but not widely used). The paper suggests that current law and policy fail to acknowledge the implications of this distinction.

"Protecting public trust in immunization"

That's the title of an article in the current issue of Pediatrics (Vol. 122, No. 1, 149-153), a timely one given the ever-increasing rate of public attention to confirmed or alleged vaccine-related safety concerns. The authors present a persuasive account of the factors that are driving contemporary controversies as well as why they seem to have commanded greater attention in recent years.

The authors offer a set of policy recommendations aimed at preserving (and, in some cases, improving) public trust, suggesting improvements in public information and public engagement regarding new vaccines and vaccination programs. In particular, the authors call for increased attention and funding to the science of immunization safety, particularly by strengthening coordination efforts at the top levels of the Department of Health & Human Services.

It's a very interesting paper that offers an even-handed assessment of the successes, challenges, and present shortcomings of national vaccination efforts.

Impressive data on likely RotaTeq impact; Rotarix ACIP recommendation added

A good amount of news about rotavirus vaccination in the U.S. came out of Atlanta yesterday. First, a CDC report issued as an MMWR Early Release detailed encouraging data on trends regarding the impact of rotavirus. Titled "Delayed onset and diminished magnitude of rotavirus activity -- United States, November 2007-May 2008," the report examines data from clinical laboratories as to the frequency and timing of confirmed rotavirus samples during the rotavirus season currently underway.

In addition to seeing a delay of 2-4 months in the start of this year's rotavirus season, the report states that the number of positive tests for rotavirus was "substantially lower during the 2007-08 rotavirus season than during any of the prevaccine seasons." These trends coincide with increasing use of RotaTeq, Merck's rotavirus vaccine, approved in 2006. (Despite being the most likely explanation, both the report and an accompanying CDC press release acknowledge that the role of the vaccine cannot be stated definitively from these data alone.)

If these changes are, in fact, attributable to RotaTeq, there are also early signs that the benefit of vaccination may extend beyond those vaccinated to the community-at-large. The MMWR piece explains:

"Because the changes in rotavirus activity appear more pronounced than might be attributed to direct protective effects of vaccination alone, the results of this analysis suggest that vaccination of a proportion of the population might offer indirect benefits to unvaccinated children (i.e., herd immunity) by reducing transmission of rotavirus in the community. "

Needless to say, more data will be needed to see whether this positive trend continues in future years, as well as whether the declines in positive tests for rotavirus correspond with decreases in rotavirus-induced hospitalizations and deaths as vaccination programs proceed.

Here's coverage from the Los Angeles Times and the Washington Post, and a press release by Merck touting the positive news.

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In other rotavirus vaccine news, GSK's Rotarix, approved by FDA in April (as we noted previously), was added yesterday by the Advisory Committee on Immunization Practices to its universal recommendation for infants. No preference was stated between the two vaccines by ACIP. Here's a story on the recommendation (technically not official until published in MMWR) by the Associated Press.

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Unrelated to rotavirus, the ACIP also voted to add recommendations for two combination vaccines as options for parents and physicians: Sanofi Aventis' Pentacel (DTaP, polio, Hib) and GSK's Kinrix (DTap, polio), both of which would reduce the total number of injections needed to complete the recommended vaccination series. This Reuters story has more.

Fundraising drive marks latest polio eradication effort

Rotary International, an organization that has been one of the leaders in supporting global polio eradication efforts since the 1980s, announced the start of a $100 million fundraising drive aimed at funding the 'final push' toward eradication. Once complete, the Gates Foundation will match the total, as this Rotary International press release describes. Rotary also launched this website with more information.

Developing-world polio vaccination efforts have been quite successful, as this summary on the website of the Global Polio Eradication Initiative details, but eliminating the final few thousand worldwide cases each year has proven extraordinarly difficult. As we've written about, 2007 saw 1313 confirmed cases of polio, nearly 90% of which in two countries, India and Nigeria. (Some have argued that the current state of tight control of the virus and its spread is sufficient, given the challenges and cost of eradication efforts aimed at the final few thousand global cases.)

Here's coverage of the announcement from CIDRAP News and The Canadian Press.

Perspectives on vaccine safety, exemptions, and autism links

Tuesday's Washington Post included a story about religious and other non-medical exemptions to state vaccine requirements. The article, "Faith lets some kids skip shots," examines the increase in personal belief exemptions by parents to forgo vaccination and its implications on disease rates as seen by the medical community. Interviewed for the story were Paul Offit, Saad Omer, and Barbara Loe Fisher.

This piece appears a few weeks after the cover story of Time magazine titled "The Truth about Vaccines." The story detailed the ongoing worries about alleged links between MMR or other vaccines with increases in autism rates and the response of the medical community to these concerns. Of particular note is the reporter's discussion of research using genetics and genomics to understand individual responses to vaccination. The story included a useful diagram (.pdf) tracing the recent increase in measles cases in the U.S., an increase suspected of being linked to trends in exemptions.

The Time cover story was likely motivated -- at least in part -- by the case of Hannah Poling which received significant attention this spring. In March, CDC acknowledged that vaccines Poling had received had exacerbated an underlying genetic condition related to mitochondria (a cellular component) leading to symptoms resembling those of autism. The case has been viewed by proponents of the vaccine-autism link as a 'smoking gun,' but CDC officials and others have noted that Poling's diagnosis and condition are exceptional and do not speak to a more general connection between vaccines and autism. The case was the subject of a commentary in the New England Journal of Medicine last month by Paul Offit that focused on the confusion surrounding many aspects of the decision.

Finally, returning to exemptions and their consequences, the New York Times' Ethicist column -- an often light-hearted Q&A on ethical dilemmas -- featured this question last weekend:

"My daughter’s play group consists of children ranging in age from infancy to 4 years old. One mother revealed that she does not vaccinate her son. After much frank but cordial discussion and opinions from pediatricians — some thought she endangered our vaccinated kids; others did not — she felt pressured to leave the group. Did the group behave ethically?"

Based on pediatricians' opinions that the unvaccinated child did not pose a significant threat to her vaccinated playmates (a view that is not held by all in the medical community), 'The Ethicist' concludes that the other parents were wrong to exclude the unvaccinated child.

Discussing HPV with teens; Overlooking genital warts; New data on South Asian HPV prevalence

A potpourri of recent publications on various aspects of HPV vaccination:

• "Genital warts: Mountains or molehills?" (Lancet Infectious Diseases, Vol. 8, No. 5, 277-278 -- free abstract) -- Co-authored by Sarah Hull and our own Art Caplan, this commentary focuses on genital warts, protection for which is included Merck's Gardasil but not in GSK's Cervarix. The authors discuss how the additional benefit provided by Gardasil may factor in to debates over pricing and the market battle between the two products sure to occur in the U.S. in the years ahead.

• "Informing adolescents about human papillomavirus vaccination: What will parents allow?" (Vaccine, Vol. 26, No. 18, 2203-2210) -- A study by British researchers Vallely, et al., this paper reports on a study using an informational film to improve adolescents' knowledge about HPV, cervical cancer, and HPV vaccinations. The key messages of the film were: 1) HPV causes cervical cancer, 2) HPV is sexually transmitted, 3) Condoms may not fully protect against HPV, and 4) HPV vaccination protects against cervical cancer. A post-screening test revealed improved knowledge regarding the information presented in the film. The adolescents' parents found the messages of the film acceptable.

• "A meta-analysis of human papillomavirus-type distribution in women from South Asia: Implications for vaccination" (Vaccine, Vol. 26, No. 23, 2811-2817) -- One of the unanswered questions regarding the use of HPV vaccines in the developing world is the extent of protection provided by the cervical cancer-causing HPV strains (16 and 18) included in the vaccine. In the U.S., these strains account for approximately 70% of cervical cancer cases. Studies examining the prevalence of these strains in other parts of the world have generally found them to be less common by as much as 10%. This paper, by Bhatla et al, examines nine previously published studies from India. The researchers conclude that HPV 16/18 vaccines could provide over 75% protection against invasive cervical cancer. While an encouraging finding, it is important to note that this data is largely the product of a mathematical estimate, and it does not speak to the challenges of implementing a large-scale vaccination program in India or elsewhere.
  

Examining future lessons of HIV vaccine trials

A recent issue of Vaccine included a paper that asked this question: "What can HIV vaccine trials teach us about future HIV vaccine dissemination?" (Newman, et al. Vaccine 26 (2008), 2528-2536 -- free abstract).

Based on focus groups conducted in the Los Angeles area, the researchers map the common barriers between participants' willingness to participate in vaccine trials and the acceptability of a hypothetical vaccine. In both cases, common themes emerged, including fear of vaccine-induced infection, false positives to HIV tests and associated consequences, side effects, partial vaccine efficacy, AIDS stigma, and mistrust of government, among others.

The authors conclude that these parallels provide a valuable opportunity to use HIV vaccine clinical trials to study issues related to acceptability of an approved vaccine. They write:

"...Rigorous sociobehavioral research conducted in conjunction with HIV vaccine trials, in addition to facilitating informed enrollment in safe and ethically conducted trials, may provide an empirical basis for targeted sociobehavioral interventions to ensure the effectiveness of future HIV vaccines in controlling the epidemic."

From CDC: Zoster recommendations, measles outbreak, post-vaccine fainting, and more

Several items of note have been released by CDC in recent weeks, including:

• "Prevention of Herpes Zoster: Recommendations of the Advisory Committee on Immunization Practices" -- The publication making official the recommendations regarding the use of Merck's zoster vaccine, Zostavax. In short, routine vaccination of all persons age 60 and older is advised, except for those with specific contraindications.

• "Measles--United States, January 1-April 25, 2008" -- A report on the unexpectedly large number of measles cases confirmed in the U.S. in the early months of the 2008. Of the 64 cases, 63 occurred in people who were unvaccinated or were of undocumented vaccination status. The report notes that a large number of the cases occurred in children whose parents had received philosophical exemptions from vaccine requirements.

• "Syncope After Vaccination--United States, January 2005-July 2007" -- The arrival of newly recommended adolescent vaccines has led to an increase in fainting, particularly among 11-18 year old females, CDC reports. One fatality has been confirmed as a result of a head injury caused by a fainting-induced fall. The report reiterates a previous recommendation to observe patients for 15 minutes following vaccination to reduce the risk of falls and injuries caused by fainting.

• NCIRD Annual Report -- The 2008 annual report of the National Center for Immunization and Respiratory Diseases -- the administrative home of most of CDC's vaccination-related activities -- was released last month. Of interest to those interested in the breadth of CDC's immunization activities, it its own words.
  

No evidence of RotaTeq-intussusception link observed

Students of contemporary vaccine history are likely familiar with the story of RotaShield, a vaccine against rotavirus licensed in 1998 but withdrawn a year later following the apparent correlation between it and intussusception, a potential life-threatening bowel obstruction.

The clinical testing of RotaTeq, the Merck vaccine licensed in 2006, showed no such link, yet alarms were raised by a 'public health notification' titled "Information on RotaTeq and Intussusception" issued by FDA in February 2007. Despite its title, the announcement did not suggest that intussusception rates among vaccinees were any greater than what could be expected in the general population.

This month's issue of Pediatrics examines the topic in much greater detail, in a paper from CDC and FDA researchers titled, "Postlicensure Monitoring of Intussusception After RotaTeq Vaccination in the United States, February 1, 2006, to September 25, 2007". Based primarily on VAERS reports, the study concludes that there is no association between RotaTeq and intussusception.

Information about general trends in intussusception rates -- independent of a connection to vaccines -- appeared in a paper in the May issue of Pediatrics: "Trends in Intussusception Hospitalizations Among US Infants, 1993–2004: Implications for Monitoring the Safety of the New Rotavirus Vaccination Program".

"Science Progress" on Vaccine Policy

Our colleague Jonathan Moreno, also a Senior Fellow at the Center for American Progress, directs a project there on science and technology policy called "Science Progress." The project, consisting thus far of a web magazine and blog, celebrates its inaugural print edition this Friday. Last month, it published an interview with Dr. Saad Omer of Johns Hopkins, best known for his work on non-medical exemptions to vaccine requirements.

An excerpt from the interview:

SP: What do you think is most important for people who are both working in the public health community, people who are policymakers, people who might be hearing about this issue, and for parents to take away from this whole conversation in the public sphere at the moment?

Omer: One thing that people should realize is that we know that vaccines have some side effects. And we should acknowledge that, everyone who is involved. However, the risk and benefit calculus for all vaccines that are out there, based on our current knowledge, heavily favors not only getting your child vaccinated, but also getting them vaccinated according to the specified schedule.

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.