Updates: H1N1 vaccine supply and NY health care worker mandates

There's more coverage of the H1N1 vaccination program than we or anyone else can digest. However, this story from yesterday's Washington Post, "Why such a shortage of swine flu vaccine?" does a very good job examining the most common topic of late, the recent shortfall in H1N1 vaccine supply compared to government and manufacturer predictions. (Whether this technically qualifies as a 'shortage' is up for debate.)

According to this Associated Press report late yesterday, the vaccine supply situation seems to be improving. Hopefully, interest in the vaccine will remain high until adequate vaccine doses become available. Otherwise, it's quite possible that later this winter, health officials will find themselves with the opposite problem -- millions more doses of H1N1 vaccine than citizens making an effort to receive it.

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In related news, we wrote several posts earlier this month on mandatory vaccination policies for health care workers, particularly the statewide program in New York. Citing inadequate supplies of both H1N1 and seasonal flu vaccines, Gov. David Paterson announced late last week a suspension of the requirement for the current flu season. Here is coverage from the New York Times.

Notwithstanding the New York decision, many health systems are proceeding with influenza vaccination requirements this fall. The Immunization Action Coalition has compiled an "Honor Roll" of health care facilities with vaccination requirements for health care workers.

CDC and Emory launch smallpox eradication history website

The seemingly wall-to-wall coverage of the H1N1 vaccination program has included frequent comparisons to the 1976 swine flu outbreak and the much-maligned national vaccination effort that followed. During that same period, another massive vaccination program was underway, as the worldwide effort to eradicate smallpox through vaccination was nearing completion. By 1977, the last known case of naturally-occurring smallpox was identified, marking the conclusion of what is widely regarded as one of the most significant achievements in the history of public health.

To document this history, CDC and Emory University recently launched a website, The Global Health Chronicles, that begins with a section on the smallpox eradication campaign. The site includes dozens of oral histories from individuals involved in the vaccination effort, photographs, videos, government documents, and much more. It's a remarkable repository of materials documenting the contributions of CDC staff in this global effort to eliminate smallpox.

Future installments of "The Global Health Chronicles" will examine the history of guinea worm and malaria prevention and control activities.

ACIP: No HPV vaccine preference for females, no recommendation for Gardasil in males

News from the meeting of the Advisory Committee on Immunization Practices underway today in Atlanta:

In their morning session, the committee voted to expand its recommendation for HPV vaccination to include the newly-licensed Cervarix, making minor modifications reflecting technical differences regarding the administration of each vaccine.

More importantly, the ACIP expressed no preference between the two vaccines, instead simply noting that both Cervarix and Gardasil are recommended for cervical cancer prevention, while only Gardasil is recommended for prevention of both cervical cancer and genital warts.

By ACIP standards, in which most decisions are largely resolved by working groups prior to public meetings of the full committee, the decision not to express a preference generated significant discussion. Several members questioned the decision not to express preference for Gardasil, with one suggesting it may be perceived as suggesting that the ACIP did not view genital warts as important.

The majority opinion, voiced by ACIP chair Carol Baker, held that cervical cancer prevention was the primary goal of HPV vaccination. This goal would be best served by having two vaccines available, particularly in case of shortages, a common occurrence for vaccines with a single manufacturer. (The implication being that a preferential recommendation could jeopardize the market for and viability of the non-preferred vaccine.) In the end, only one member voted against the recommendation expressing no preference, an action that followed ACIP precedent when two similar vaccines are available against the same disease.

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Later this morning, the ACIP approved only a 'permissive statement' regarding vaccination of males against HPV with Gardasil, essentially stating that males may be vaccinated but stopping far short of the routine, universal recommendation common for most vaccines (including HPV vaccination in females). Despite endorsements for a routine recommendation from several liaison groups participating in the meeting, cost effectiveness data for male vaccination and concerns over the use of limited public health resources appeared to steer the committee away from a broad endorsement of male HPV vaccination.

The 'permissive statement' means that private insurers will be less likely to provide coverage of HPV vaccination for males, according to a representative from America's Health Insurance Plans (AHIP) in attendance at the meeting. Male vaccination will still be included in the Vaccines for Children program for uninsured and underinsured children, however. Historically, vaccines lacking a routine recommendation from the ACIP -- as is now the case for Gardasil in boys and men -- have had significant difficulty gaining widespread use.

We'll add links to coverage of today's developments as they're posted online.

On religion, ethics, and swine flu vaccination

The Washington Post's "On Faith" section has been hosting an online discussion on H1N1 vaccination and whether there are valid ethical or religious arguments to refuse vaccination. The conversation, "The Swine Flu Vaccine: Option or Moral Duty?" includes contributions from clergy of various faiths, theologians, scholars, and others with backgrounds in religion or ethics. It's a very interesting set of perspectives from individuals not usually heard from in public discussions of vaccine ethics and policy.

So far, there's been little support for individuals refusing vaccines for religious reasons. Here's a sample, a post from David Wolpe, a well-known Los Angeles-area Rabbi, titled "Not to Vaccinate is a Sin":

"We do not raise children for ourselves alone, or for themselves alone. We raise them for the world. Educating a child is not so that she can live well, or not only so that she can live well. It is to enable her to make a genuine contribution to society.

When we refuse a child a vaccination we are violating the rationale for having children. We are unnecessarily endangering others. Not only is one's own child at risk. Vaccinations are a barrier against contagion. In unvaccinated populations everyone is at risk.

...Can there be a more urgent religious imperative than to prevent harm to one's own child, and to others?"

Fuller results from HIV vaccine trial suggest marginal benefit

That's the bottom line coming out of the AIDS Vaccine 2009 conference in Paris this morning, where detailed information was released on the results of the HIV vaccine trial in the news earlier this month. The announcement was timed with the online release of a paper and accompanying editorial in the New England Journal of Medicine.

Two stories written about today's news present sharply different perspectives about how to interpret the trial results. Marilynn Marchione of the Associated Press describes the findings at "exciting to scientists," and her story is peppered with quotes from the researchers and boosters of HIV vaccine research touting the study as a "landmark" in the long road toward a viable HIV vaccine.

A much more cautious tone is seen in a story by Gautam Naik of the Wall Street Journal. Naik writes:

"Now, two other analyses of the trial data suggests that the results could have been due to pure chance, and therefore the vaccine may not have conferred protection to people after all."

Naik's story looks closely at the various statistical analyses used to assess the benefit (if any) of the vaccine candidate being tested and the seemingly conflicting results that emerge from them. While digging into the finer points of study design and biostatistics, the story reveals the frequent difficulty in distinguishing meaningful research results from statistical flukes, a boundary that is often criticized as arbitrary. The research group involved in this study has been criticized by some for glossing over this ambiguity while initially publicizing their positive results earlier this month.

Two stories currently on the website of the BBC underscore the difficulty of interpreting scientific research results and conveying them to the public in an accessible way. One headline says, "HIV vaccine trial was significant," while another is titled "HIV vaccine: Doubts over trial." Despite seemingly contradicting themselves, both offer reasonable summaries of today's news and the reactions from experts.

In his New England Journal editorial, Raphael Dolin strikes a measured tone about what to take from the research results and its implications for future work toward an HIV vaccine:

"The clinical trial reported here represents an enormous effort by investigators, sponsoring institutions, and participants in the community. The findings raise a number of questions that have important implications for future directions in vaccine research. The answers to these and related questions will require the application of a balanced and coordinated research approach to the complex and difficult problem of the development of an HIV vaccine. This balanced approach includes fundamental laboratory and experimental-model studies, as well as rigorously designed and conducted clinical trials, such as the one reported on here."

Opposing views from ethicists on health care worker flu vaccine mandates

Two bioethicists have weighed in via op-eds on the debate over mandating seasonal and swine flu vaccination for health care workers.

On the 'pro' side, our colleague Art Caplan minces no words in his column, "Health Workers: Get Flu Shots or Get a New Job," on MSNBC.com this morning. He writes:

"Look, there are legitimate issues that ought to be debated whenever someone says you must do something to benefit others ranging from taxation to restrictions on driving under the influence. But health care workers' own code of ethics dictates that they put the interests of others — their patients — first. Getting a flu shot is the least those who claim to be bound by professional ethics ought to do."

Taking the other side is George Annas, professor of health law at Boston University and a strong critic of mandates in medicine and public health. In an op-ed published in Newsday, "Don't Force Medical Pros to Get H1N1 Vaccine," Annas writes:

"The ultimate measure of success or failure of a swine flu vaccination program will be in lives saved and lives lost. The most effective way to maximize the numbers of the public being vaccinated is to send the message that physicians and nurses believe this is the most reasonable approach to take to prevent wide-scale death and disease from the swine flu. Legal threats and mandates undercut that public health message and will backfire."

Annas makes a strong point about the potentially troublesome message sent to the public about the importance of flu vaccination, if even health care professionals have to be compelled to receive it. Why enthusiasm for vaccination among health care workers is so low continues to puzzle public health experts. In the meantime, requiring vaccination in this community may be a necessary evil to prevent avoidable disease and death among patients.

Looking at one hospital's health care worker flu vaccine mandate

Earlier this week we wrote about the opposition in some quarters to the growing number of health care workers being required to receive flu vaccinations. In the past few days, media coverage of this issue has continued to grow, much of it centered on the state-wide policy recently introduced in New York and a recent protest against it.

Far more common, however, are policies created by individual hospitals or health systems. Shortly after our last post on this topic, we learned that our own institution, the University of Pennsylvania, had recently announced an influenza vaccination requirement for all personnel working in one of Penn's hospitals or other patient care facilities. This includes physicians, students, staff, and volunteers, regardless of whether they have direct patient contact. The requirement is for both seasonal flu vaccination annually and (depending on availability) the H1N1 vaccine this fall.

The policy -- available here -- is a useful case study for how one of the nation's most prominent health systems is implementing and enforcing the annual requirement, described as "a condition of employment or access to Penn Medicine facilities." The vaccines will be administered at no cost to employees. Exemptions are available for medical or religious reasons, supported by a letter from an employee's physician or clergy, respectively. Exemptions will be evaluated on a case-by-case basis; those employees for whom exemptions are granted will be required to wear face masks at work for the duration of flu season.

After a warning, those failing to receive the vaccine or an approved exemption "will be subject to further disciplinary action up to termination of employment." More information is available in this Q&A document distributed with the new policy.

Policies will surely differ slightly among health care institutions, but the Penn policy provides a good example of the evidence and arguments cited by disease control specialists in support of health care worker flu vaccination requirements.

Again, it's worth repeating that this and every other flu vaccine mandate in the news lately involves only health care workers, part of an initiative launched long before the current H1N1 situation. Public health officials remain unequivocal that there are no plans to require H1N1 vaccination for the general public, a message at risk of getting lost amid coverage of this related, but distinct policy debate.

Putting the HIV vaccine trial news in context

We'd be remiss not to acknowledge Friday's news about positive results from an HIV vaccine trial in Thailand, a story that received tremendous attention from the print and broadcast media. (Here's more coverage from the Associated Press, Washington Post, Philadelphia Inquirer, and Reuters, and press releases from the International AIDS Vaccine Initiative and the NIH.)

The title of the NIH press release notably refers to the "modest" preventive effect of the vaccine, a clear indication that everyone ought to take a deep breath before even considering headlines about the "End of AIDS." This message evidently was received by the media (with one exception). Coverage of the trial results largely avoided the breathless optimism that often appears in stories about vaccine research against a novel target -- we've written at length on this topic. Even after Friday's news, all agree that a vaccine against HIV is, at best, many years away, and there are still prominent voices in the scientific community who doubt whether one will ever be developed.

As the stories above explain, the vaccine tested in Thailand -- a combination of two previously-unsuccessful vaccine components -- seems to have provided some additional protection against HIV infection. Experts are for now at a loss to explain the mechanism by which this could happen. The level of protection is far less than what most associate with an effective vaccine, even less than the reduced target set for a potential HIV vaccine. However, as we've documented over the years, HIV vaccine research has endured decades of setbacks and disappointments, making Friday's news a welcome departure from the norm.

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In yesterday's New York Times, Donald McNeil took a break from the H1N1 flu beat to imagine the potential implications of an AIDS vaccine. His excellent story, "If AIDS Went the Way of Smallpox," balances a look at the potential implications of a safe and effective vaccine with the reality of the limitations of the current news and the many scientific challenges that remain.

Hospitals facing resistance to health care worker flu vaccine mandate

A brief respite from all-things-H1N1 to mention a related topic in vaccine ethics and policy: the growing number of hospitals requiring employees to be vaccinated against seasonal influenza this fall and the resistance they are reportedly encountering.

As readers of this site know, public health and disease control experts have long been discouraged by the shockingly low rates of influenza vaccination among health care workers, despite the potential benefits to patients in reducing the likelihood of hospital-borne infections (not to mention the personal protection the vaccine provides). Strategies to boost vaccination rates among hospital staff -- educational campaigns, pleas to professional duty, monetary incentives like prize raffles -- have had only modest results.

Notably, health care workers who decline vaccination typically explain their decision by pointing to the same inaccuracies that vaccination proponents are continually trying to correct among the general public. (Included in this list: the possibility of getting the flu from the vaccine itself, something about one's personal constitution that means they "never get the flu," and unproven concerns about the vaccine's safety.)

In the past few years, a handful of hospitals and other health care facilities experimented with mandating seasonal flu vaccination as a condition of employment. This fall, the number of institutions implementing such a policy appears to have surged. Opponents of the requirements -- including many of the usual voices in the vaccine safety and policy debate joined here by labor organizations representing hospital workers -- are already lining up to voice their concerns, as stories in last week's Washington Post and New York Times report.

Left unclear in both of these stories is how H1N1 vaccination fits into programs that had been developed with the annual seasonal influenza vaccination in mind. The Post story implies that at least some of the hospitals mentioned are implementing requirements that include both types of flu vaccine, a difficult task given the uncertainties surrounding the timing of the H1N1 vaccine's arrival in large quantities.

That ambiguity underscores the confusion sure to surround the enforcement of health care worker seasonal flu vaccination mandates amid the tremendous attention surrounding H1N1 flu this fall. In fact, the nation's leading voice in public health, CDC director Thomas Frieden, suggested in the Times that waiting to introduce these mandates would have preferable. He says, "This is just not the right flu season to take this on."

It's hard to argue that vaccination of health care workers against flu doesn't protect patients, reduce hospital infections, and set a good example for the importance of annual vaccination. For health officials already confronting the overwhelming communication and logistical challenges related to H1N1 vaccination, introducing health care worker vaccine requirements (and responding to resistance and resulting media coverage) adds to the unprecedented challenges facing our public health infrastructure and leaders in the coming months.

H1N1 roundup: international vaccine supply, nasal vaccine first in US, and more

Several H1N1 vaccine-related items in the news over the past few days:

• President Obama announced Thursday that the US would share 10 percent of its H1N1 vaccine globally, working with WHO. As this Associated Press story reports, the announcement is part of a joint effort by several western countries to improve access to H1N1 vaccine in the developing world. Here is the press statement from the White House, as well as a statement from WHO praising the announcement. This Washington Post story has more.

• Speaking of WHO, this Associated Press story published Friday reports that recent WHO projections of H1N1 vaccine production are "substantially less" than previous forecasts. Supply shortages further complicate the already-enormous challenge of large-scale vaccination against H1N1 influenza in the developing world. (A UN report leaked to the UK newspaper The Guardian presents a particularly ominous forecast of the impact of H1N1 flu in developing countries without a coordinated global assistance effort.)

• Here in the U.S., CDC announced Friday afternoon that 3.4 million doses of MedImmune's nasal spray vaccine (known as FluMist in its seasonal flu variety) will be the first H1N1 vaccine available. These doses should be available by early October, followed by the other (injected) vaccines throughout the month and beyond.
  

• Finally, Flu.gov, the U.S. government website launched several years ago as PandemicFlu.gov, completed a redesign and expansion on Friday. Billed as a 'one stop' for information on both seasonal and H1N1 influenza, the site summarizes its newly added features here.
  

H1N1 vaccines approved by FDA, to be available by mid-October

Today, FDA licensed four vaccines against H1N1 influenza (swine flu). Distribution of the initial doses is likely to begin within the next four weeks, according to HHS secretary Kathleen Sebelius. Here is coverage of today's announcement from the Associated Press and Wall Street Journal.

The vaccines approved today include MedImmune's nasal spray vaccine and injectable vaccines from SanofiPasteur, Novartis, and CSL Limited. Each of these manufacturers produces seasonal flu vaccines in the United States, as does GSK, whose H1N1 vaccine was not included in today's announcement. None of the vaccines contain adjuvants, a recent focus of concern among vaccine safety critics, and thimerosal-free vaccine will be available for those preferring it.

With respect to supply, CIDRAP News reports:

"The Department of Health and Human Services (HHS) has ordered about 195 million doses of H1N1 vaccine. According to a recent federal report, Novartis is expected to contribute 45.7% of that, Sanofi 26.4%, CSL 18.7%, MedImmune 5.8%, and GSK 3.4%."

Today's news is not at all surprising, especially following the favorable clinical trial results announced last week by NIH and published on the website of the New England Journal of Medicine. (Particularly encouraging were findings that only one dose of the vaccine was needed to produce immunity. This means that vaccine supply should be much larger and mass vaccination relatively less challenging than if two doses were required, as had been the expectation until last week's results.)

Over the past few days, the CDC H1N1 vaccination website has added increased information on vaccine safety, focusing particularly on concerns related to thimerosal and Guillain-Barre syndrome.

It bears repeating that the H1N1 vaccination program in the United States will be completely voluntary. (Vaccination will be required, however, for uniformed personnel in the U.S. military, according to this Department of Defense statement.)

FDA advisors support Gardasil for males, Cervarix for females

Yesterday was the busiest day in months for news on HPV vaccines, as the FDA Vaccines and Related Biological Products Advisory Committee met to consider applications by GSK for initial U.S. licensure of its HPV vaccine, Cervarix, for girls and women ages 10 to 25, and by Merck for an expanded licensed indication for its vaccine, Gardasil, for males (ages 9 to 26 -- the same age range for which it has been approved for use in females since 2006). Information and extensive materials related to the meeting are available here and here.

The committee found both vaccines to be safe and effective in their target populations, actions likely to mean FDA approval in the coming months for Cervarix (already available in over 100 countries) for women and Gardasil for both sexes. (The usual caveat: agencies such as FDA are not obligated to follow the recommendations of their advisory committees, but they almost always do in these circumstances.)

Here is coverage of the meeting from the New York Times, Philadelphia Inquirer, and Associated Press. Also of note are press releases from GSK and Merck on yesterday's news.

Assuming FDA follows the recommendations voted on yesterday, we are likely to see in 2010 a spirited advertising campaign by each manufacturer asserting superiority of its product over the competition. (This is an easier case for Merck to make, given the additional protection Gardasil provides against genital warts in both sexes. Early indications are that GSK will argue that Cervarix provides better protection against cervical cancer-causing HPV strains, including 'cross-protection' against additional strains not included in either vaccine.)

Also on the horizon is a decision by CDC (namely, the Advisory Committee on Immunization Practices) in the coming months regarding its recommendation for HPV vaccination. The history of the ACIP suggests that it is highly unlikely that the group will preferentially recommend one vaccine over the other for use in females. Instead, the current recommendation will probably be reworded to reflect the availability of both products and the slight differences between them with respect to administration.

More interesting will be its recommendation (or lack thereof) regarding male vaccination with Gardasil. Merck will no doubt be pushing for a universal recommendation that all males within the target age group receive the vaccine, and it will certainly have support from some corners of the medical and public health communities. However, the cost of the vaccine and the non-life-threatening nature of genital warts may make justifying universal vaccination of males difficult. (Another argument sure to surface is the indirect benefits for women resulting from male vaccination -- targeting a potential reservoir of cervical cancer-causing HPV. Despite its logical appeal, this strategy has not fared well in cost-effectiveness and other economic studies of HPV vaccination.)

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Speaking of male vaccination, our colleague Arthur Caplan co-authored (with Sarah Hull) a paper in the latest issue of Public Health Genomics titled, "The Case for Vaccinating Boys against Human Papillomavirus," (free abstract, subscription required for full text). As the title suggests, the authors argue for universal male vaccination against HPV, paying special attention to ethical arguments for such a policy.

CDC cautions against White House H1N1 death forecast

Yesterday, we wrote about the report issued by the President's Council of Advisors on Science and Technology (PCAST) on H1N1 (swine) flu preparedness. We argued that the daily stream of reports, recommendations, and announcements from an ever-changing cast of government bodies ought to be replaced (or at least supplemented) by a single source and spokesperson for H1N1 information and guidance from the federal government.

It took only a day for the potential hazards of offering so much information from so many different government sources to become clear. In today's New York Times, Donald McNeil's story, "Agency Urges Caution on Estimates of Swine Flu," details efforts by CDC officials yesterday to ever-so-politely distance themselves from the rather alarming estimates of H1N1 impact included in the White House advisors' report.

The PCAST report wrote that in a 'plausible scenario,' H1N1 influenza could infect up to half the American population, causing 1.8 million hospitalizations, and as many as 90,000 deaths. In today's Times, CDC staff respond:

“We don’t necessarily see this as a likely scenario,” said Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases.

A press officer for the disease centers, speaking carefully to avoid a feud with the White House press office, said, “Look, if the virus keeps behaving the way it is now, I don’t think anyone here expects anything like 90,000 deaths.”

The story later quotes Harold Varmus, the Nobel Prize-winning former NIH director and co-chairman of PCAST. Varmus defended his group's report but expressed displeasure over the way it was released.

These types of intra-governmental squabbles are all but inevitable given the number of agencies involved in some aspect of H1N1 planning, many such groups having little in-house experience or expertise regarding public health or disease control and prevention. (PCAST, with its illustrious roster of members from fields in science and technology, has not traditionally addressed clinical medicine or public health in its work. Its reports dating back to 1995 have focused on R&D issues, biotechnology, and energy policy.)

So while disagreements such as this CDC/PCAST debate over H1N1 forecasts may be inevitable, it is greatly preferable that they occur somewhere other than the pages of the New York Times. While the diversity of opinions on the severity of the H1N1 threat reflects, to some degree, the uncertainty that continues to abound, this public back-and-forth is unhelpful. To an American population already seemingly unconcerned by the threat of H1N1 flu, the lack of a single, coherent voice from government makes the challenge of educating and preparing the public in the coming months that much more difficult.

Vaccination programs rely foremost on public trust in the importance of vaccines and confidence in the individuals crafting policy. H1N1 influenza vaccination will be no exception. Implementing a mass vaccination program so quickly is already a staggering logistical challenge, saying nothing of addressing the ethical and safety debates sure to emerge. A federal government seemingly at odds with itself regarding its messages to the public only adds to the difficulty of building support for the programs it eventually hopes to implement.

Presidential and HHS advisors on H1N1 mortality scenarios and vaccine plans

Observers of American vaccine policy (and readers of this site) are well aware of the veritable alphabet soup of government offices and advisory bodies with responsibilities for aspects of vaccination in the U.S., including ACIP, NCIRD, VRBPAC, CBER, NVAC, NVPO, NVICP, NIAID, and their parent agencies, CDC, FDA, and NIH, all part of HHS. Despite the potential for overlapping jurisdiction and regulatory gridlock, each of these groups has a clearly defined set of duties and, in normal circumstances, outward appearances suggest a relatively well-functioning bureaucracy.

The situation surrounding H1N1 (aka swine) influenza has meant even more executive branch interest in planning a possible vaccination program, most notably within DHS (Department of Homeland Security) and ED (Department of Education).

Lately, rarely a day passes without an executive branch department, agency, or committee offering a new report on some aspect of the planning efforts. Yesterday, PCAST became the latest addition to the H1N1 'initialese' lexicon, as the President's Council of Advisors on Science and Technology (part of OSTP in the EOP, for those keeping score), issued an 86-page report to the president on H1N1 preparations.

The report, discussed today by the Washington Post, the Associated Press, and the New York Daily News, among others, has generated most attention for its estimates of potentially 90,000 deaths and 1.8 million hospitalizations caused by H1N1 influenza in a 'plausible scenario,' according to the council. Among its recommendations were to accelerate availability of vaccine, increase communication efforts and disease surveillance capabilities, and appoint a point-person in the White House to coordinate planning and response. The White House released a document accompanying the report that details progress made toward these recommendations.

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Also yesterday, the previously mentioned NVAC (National Vaccine Advisory Committee) met via teleconference to discuss H1N1 preparations. The meeting, covered only by the indispensable CIDRAP News, focused on communication strategies surrounding vaccine safety concerns (real or alleged) all but certain to emerge once vaccination begins. According to Robert Roos' story, the committee approved a recommendation stating that HHS:

..."develop, and where possible test in advance, a strong and organized response to scientific and pubic concerns about vaccine safety that may emerge during the 2009 H1N1 vaccination campaign."

"The challenge will be to communicate effectively and to differentiate rapidly between adverse events that may be causally related to the vaccine and those which would be expected by chance alone," states the recommendation.

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The takeaway from the latest round of reports, meetings, and recommendations? Both groups in the news yesterday seem to be correct in emphasizing the critical importance of coordination within the federal government (not to mention among state and local governments) and communication to the general public. With so many government hands involved in H1N1 planning and response, many of them unfamiliar with public health and vaccination, the risk of conflicting and confusing policy and public guidance is real.

In addition to the PCAST-proposed White House "Flu Czar" (as some have dubbed it) to coordinate policy-making, identifying a single individual to serve as the public face and voice of the federal government on H1N1 influenza this fall seems essential. During the virus' first wave this spring, then-acting CDC director Richard Besser served in this role to overwhelmingly positive reviews. (Dr. Besser is soon leaving CDC for a television position at ABC News.) Such an individual will be vital to translating reports and recommendations from the aforementioned alphabet soup of government bodies into a single, coherent set of messages for the American public.

Assessing public attitudes toward H1N1 vaccination

This month, CDC has been holding 10 public meetings around the country soliciting input on H1N1 vaccination planning. The meetings, organized through a contact with The Keystone Center, a Colorado-based non-profit, continue through this weekend.

This past Saturday's meetings included one in Bucks County, PA, just north of Philadelphia. We attended the meeting, which was covered by The Philadelphia Inquirer, The Intelligencer, and WFMZ-TV. As those stories describe, several attendees were sharply critical of U.S. vaccination policy generally and, in particular, ongoing H1N1 vaccine activities. CDC communications specialist Marsha Vanderford was peppered with questions related to a range of concerns circulating on the internet. These questions/criticisms (and answers from Vanderford) included:

• The presence of thimerosal in multi-dose vials of influenza vaccines (thimerosal-free vaccine will be available for those who prefer it),
  
• The possible use of novel adjuvants (such as squalene) in the final formulation of the vaccine (none are included in the vaccine currently being tested),
  
• The possibility that vaccination will be made mandatory (it will be voluntary),
  
• The adequacy of clinical testing currently underway with respect to determining safety, (the vaccine is subject to the same requirements as any new influenza vaccine, but the timeline is accelerated in light of the urgency of the potential threat), and
  
• The decision by HHS secretary Kathleen Sebelius to grant legal immunity to H1N1 manufacturers and federal officials.

After this somewhat tense start to the day, the majority of the meeting was spent with participants in small groups considering the relative merits of three broad strategies to promote and implement H1N1 vaccination in the coming months. Dubbed "Go Slow," "Moderate Effort," and "Full Throttle," each approach included a set of promotion, funding, safety monitoring, disease surveillance, and other activities reflecting increasing "levels of effort," in the parlance of the meeting organizers.

Most groups favored elements from each strategy rather than supporting one particular approach wholesale. Nevertheless, when polled at the end of the day, a plurality of participants (49%) favored the "Moderate Effort" approach, with 30% preferring "Go Slow" and 21% advocating going "Full Throttle."

Participants also expressed preferences for a vaccination program that is flexible to changing circumstances, avoids safety concerns as much as possible, and prevents the maximum number of deaths and hospitalizations caused by H1N1.

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Speaking of public attitudes regarding H1N1 vaccination, a Washington Post story published late last week reported that more than 60% of those surveyed were not worried that H1N1 flu will affect his or her family this fall. 55% of respondents said they were likely to get the vaccine for themselves or a family member, a number which increases to 65% if recommended by their doctor.

Preparations intensifying for H1N1 mass vaccination program

A front page story in today's Washington Post ("Swine flu campaign waits on vaccine") highlights the increasing likelihood of an unprecedented mass vaccination program this fall against H1N1 influenza. Much is still unknown about the precise size and scope of the vaccination campaign, but, according to NIH's Dr. Anthony Fauci in the Post, "There's little doubt we're going to vaccinate people. Who and when and exactly how -- we have to figure out."

Answers to these questions will be learned in part from the ongoing clinical testing of the vaccine. According to a report in yesterday's New York Times, no serious side effects have been seen in the initial stages of H1N1 vaccine trials. As the Times reports, 4,500 research volunteers will receive the vaccine, making detection of any rare adverse events related to the vaccine impossible to detect during clinical testing.

CIDRAP News also reported this weekend on the status of H1N1 vaccine trials. According to an NIAID teleconference, preliminary data will be available by mid-September. Of particular importance will be data on the quantity of vaccine needed to provide immunity in a person, results that will impact the total number of doses that will be available in the fall.

Finally, the official recommendations from the ACIP regarding H1N1 vaccine priority groups were published electronically on Friday. The priority groups -- pregnant women, those in close contant with infants, health care personnel, children and adults under 24 years old, and older adults at risk of influenza-related complications -- were determined at a special meeting of the ACIP last month. Presentation slides from that meeting are available on the CDC website.

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.