Shingles vaccine recommended for adults 60+

We'd be remiss not to mention the biggest development out of this week's ACIP meeting, namely, the recommendation that all adults age 60 and over receive a single dose of Merck's new shingles vaccine, Zostavax. Here's the CDC press release, the Merck press release, and an AP story (courtesy of the Washington Post).

Also useful is this site assembled by the NIP with numerous resources about the painful condition formally known as herpes zoster and the new vaccine against it. Zostavax was licensed by the FDA in May and is the latest in a series of new vaccines introduced by Merck during the past year, though it's safe to say that this news hasn't received a hundredth of the attention that went to Gardasil in June.

WHO and state reports on ethics and pandemic flu planning

The folks at CIDRAP News report in this story that the WHO plans to issue a report in January on ethical issues associated with pandemic flu planning. Among the topics to be explored: access, the ethics of quarantine and related actions, health-care worker responsibilities, and international collaboration. All are important topics will ethical aspects that merit attention alongside the relevant science and public health considerations.

Speaking of WHO, yesterday's New York Times included an editorial, "Preparations for a Flu Pandemic," that questions the current pace of pandemic planning, particularly vaccine development and supply issues that are certain to complicate mass vaccination efforts.

Thinking about limited vaccine supply and the ethics of allocating those doses, a number of scholars and organizations have offered ethical perspectives on how best to do so. (The most notable: the Emanuel/Wertheimer essay in Science back in May, which we wrote about here.) This week, the Minnesota Center for Health Care Ethics released a very interesting report titled "Allocating Pandemic Influenza Vaccines in Minnesota." Growing out of a multi-disciplinary working group of state-wide stakeholders, the report offers a different model for prioritizing specifics groups than the current HHS plan. While the report is written for Minnesotans in particular, the discussion of ethical concerns and priorities is relevant everywhere. The report is well worth reading for anyone interested in the ethical priorities that will influence these difficult decisions.

The Minneapolis Star-Tribune wrote a story ("A Tough Call Awaits if a Killer Flu Breaks Out," October 23) on the report that includes a few quotes from us, among others.

From MMWR: childhood & 65+ vaccination rates, 2006-07 adult schedule, and Menactra safety update

A great deal of news on vaccines and vaccination efforts has appeared in recent issues of the CDC's Morbidity and Mortality Weekly Report. Here are some items of note:

• "Childhood Influenza Vaccination Coverage -- United States, 2004-05 Influenza Season" and "Influenza and Pneumococcal Vaccination Coverage Among Persons >65 Years -- United States, 2004-05." With flu cases starting (very slowly) to appear, these two pieces offer some data on the effectiveness of efforts to vaccinate two populations at higher risk of influenza-related complications. For children, the headline is that young children (19-35 months) had a substantially higher vaccination rate in the 04-05 season than for the previous year -- likely attributable to stronger ACIP recommendations. However, the overall percentage of fully vaccinated children in this age group was still very low (17.8%). For 65+ adults, the reverse phenomenon is true: both flu and pneumococcal vaccination rates are over 60%, but flu vaccination rates in 2005 were 4% lower than a year earlier. (The MMWR story notes that all of these numbers are well below the goal of 90% included in Healthy People 2010.)

• Better news can be found in this report, "Vaccination Coverage Among Children Entering School, 2005-2006 School Year." Compiling the latest data available, a editorial note accompanying the report explains, "More than half of reporting states indicate that they have already reached the Healthy People 2010 goal of >95% coverage for each of the vaccines recommended by the Advisory Committee on Immunization Practices (ACIP); the remaining states are making progress toward this goal."

• The 2006-2007 Recommended Adult Immunization Schedule, approved by the ACIP at their June meeting, has been published. Particularly because of efforts made at simplifying the schedule's design, the document is a great source for a general overview of recommended vaccinations in the 18+ population.

• One final item provides an update on reports of cases of Guillain-Barre Syndrome (GBS) among recipients of Menactra, Sanofi Pasteur's meningococcal vaccine. (We've written previously about this story in April.) A total of 17 cases have been reported with a suspected link to Menactra vaccination. As the report explains, analysis of these cases suggests a slightly increased risk of GBS among Menactra recipients, but the risk of meningococcus itself is among the reasons why no change in the current recommendation is being made at this time.
  

CDC Weekly Flu Update

We've added a link at the right to the CDC's Weekly Influenza Update. For those interested in tracking the flu season, the page includes week-by-week updates on the number of seasonal flu cases identified, the specific flu strains isolated, geographical variation, mortality, and more.

The Lancet calls for mandatory HPV vaccination

An editorial in the current issue of the The Lancet is making news. (Free registration required.) It says, in part:

"For effective and long-term eradication of HPV, all adolescents must be immunised. Data from the vaccine trials in boys are urgently needed; in the mean time, EU member states should lead by making the vaccinations mandatory for all girls aged 11-12."

Here's coverage of the editorial from Forbes.com, the BBC, and the Telegraph. The Lancet is a bit imprecise about the status of the Michigan bill that would mandate vaccination -- while it did pass the Michigan Senate last month, House consideration of the bill will not begin until after next month's election, and its passage is by no means assured.

The biggest question is what the editorial means, precisely, when referring to making vaccination mandatory in the E.U. The term implies some program of enforcement and consequences for those who refuse vaccination. (In the U.S., of course, that takes the form of being prohibited from school or day-care.) These mechanisms don't exist in the E.U.; their establishment would represent a major policy change and an equally large philosophical shift regarding European vaccination efforts.

Fifth vaccine approved for upcoming flu season

Yesterday, the FDA approved FluLaval, a seasonal flu vaccine developed by ID Biomedical, a subsidiary of GSK. Here are the FDA press release and news items from Time and CIDRAP News.

FluLaval joins the four vaccines approved by the FDA in early August for the upcoming flu season, as we wrote about here. It's an injected vaccine (like three of the other four -- the exception being the nasally-administered FluMist) and is licensed for use in adults 18 and older. Among the five products, this year's supply is expected to set a record, with estimates of 115 doses being available in the U.S. Today's New York Times has a related story about the surge in flu vaccine supply.

The challenge for health care providers and public health officials will be to see that most or all of these doses are administered to patients, as the current record for vaccinations in a single flu season is 83 million, as we wrote last month. However, compared to the much-publicized shortages of years past, this is a far better 'problem' to face.

Perspectives on HPV vaccination, Michigan mandate bill

Yesterday's Lexington Herald-Leader included a pair of items about HPV vaccines with comments from a host of vaccine experts (and not-quite-experts). One story, "Is Prevention Worth a Shot?," offers general advice to parents. The other is a sidebar, "Feedback about Michigan Law," with comments on the bill under consideration that would mandate vaccination for girls in sixth grade. I was asked by the Herald-Leader for comments on the ethical merits of such a mandate. From the story, here are my remarks:

"Ethically, electing to mandate a vaccine for children requires weighing the societywide benefits of vaccination versus the infringement, however minor, on the decision-making authority of parents. Among the factors that influence this ethical analysis are the risk of infection, the severity of disease without vaccination, and, very importantly, the likelihood that a vaccination program can succeed without state mandates. Unfortunately, history tells us that vaccines in the U.S. have great difficulty achieving high levels of support without the power of mandates.

"The points above are true for any vaccine, but the HPV vaccine has unique considerations that point in favor of a mandate. We know that groups with reduced access to medical care, and particularly regular Pap screenings, are more likely to develop cervical cancer than the general population. They are also more likely to die as a result of it than cervical cancer patients overall. Without a mandate, there remains a great risk that those not getting Pap screens or other care will similarly not be reached by HPV vaccination efforts. Without a mandate, we may miss exactly the same people who stand to benefit most from HPV vaccination. Ethically, this is of great concern.

"While a mandate is not a silver-bullet solution to these potential problems, it would signify the importance of HPV vaccination and very likely lead to novel strategies by local health departments and school districts to deliver the vaccine to all girls in the target age group. A mandate puts the vaccine in the best position to save the most lives, while still allowing parents with philosophical or religious objections to opt out by means of the generally straightforward exemption policies."

AP and NEJM on potential hay fever vaccine

As regular visitors are aware, we're more than a bit reluctant to join the hype over whatever the next breakthrough vaccine is said to be. As the newly licensed vaccines over the past year have shown, getting a product from the lab to the doctor's office takes a few decades and, while not necessarily a good thing, fewer than a half dozen companies are capable of guiding vaccines through the large Phase III clinical trials. So when a story appears that refers to a vaccine trial with fewer than 100 research participants for a product made by a company you've never heard of, it's a safe bet that the vaccine in question has a long road to travel.

However, we've seen that news about nicotine vaccines and the like are of interest to many. So with that disclaimer in mind, here's a story from the Associated Press (where 'dummy pills' is apparently now an acceptable synonym for 'placebo') about a vaccine in development to lessen the symptoms of hay fever. The story piggybacks on a report in this week's New England Journal of Medicine of a 25-subject clinical trial (free abstract, subscription required for full access).

Ethics of potential 'behavioral' vaccines

No newspaper headline would seem to be more relevant to our work than this one from yesterday's Chicago Tribune: "New breed of vaccines raises new ethical questions". The story in question is actually a sidebar accompanying a lengthier examination of research underway hoping, hoping, to lead to safe and effective vaccines that would target nicotine addiction, obesity, and drug addiction. Here's the opening of the larger story, "Can vaccines cure our bad habits?":

"Vaccines, the most potent medical weapon ever devised to vanquish deadly germs, are now being called on to do something totally different and culturally revolutionary--inoculate people against bad habits like overeating, cigarette smoking and drug use. Whether this new era of vaccine research can actually subdue many of the poor lifestyle choices that are today's biggest threats to health--causing obesity, cancer, heart disease and other problems--has yet to be proved."

The story is a fair account of the early-stage research underway looking at these strategies. (Back in July, the New York Times looked specifically at NicVAX, a product designed to reduce the pleasurable and addictive aspects of smoking. We wrote about that story here.)

As for the ethical issues piece, it's little more than conjecture regarding the use of products years away from arriving in doctors' offices, if ever. While it may be an interesting question to ponder whether it would be appropriate to vaccinate our children 'against' obesity, it seems that vaccines face far more pressing and immediate ethical issues on a variety of fronts that would be a much more productive use of everyone's time.

ACIP: June minutes and October agenda

The folks at the Immunization Action Coalition pointed out that the full minutes from the June 2006 meeting of the CDC Advisory Committee on Immunization Practices are now available here. The 96-page PDF is the next best thing to attending the meeting yourself, as it provides comprehensive coverage of everything that took place. In June, of course, the major news was the recommendation vote for Merck's HPV vaccine, Gardasil. For those interested in the data that informed the ACIP's recommendation, the report is invaluable.

Also on the ACIP website is a draft agenda for the group's next meeting, scheduled for October 25-26. The most notable item is a scheduled vote on a recommendation for Merck's shingles vaccine, Zostavax, for use in adults.

NY Times on Project Bioshield and VaxGen anthrax vaccine

As we catch up on our inbox, a story on Project Bioshield in the New York Times in late September caught our eye. It's worth noting, albeit late, for those who haven't yet seen it. (Recall that Project Bioshield is the $5.6 billion series of programs which is largely the result of the 2001 anthrax attack, intended to develop drugs and vaccines to respond to probable agents of bioterrorism.)

The road to developing safe and effective products has been more than a bit bumpy, to put it mildly, and every few months a major publication offers a rather gloomy assessment of where the work stands, particularly with regard to VaxGen's next-generation anthrax vaccine, the keystone of the project. Back in March, the Washington Post weighed in, as we wrote about here.

The New York Times story linked above explores the struggle between Emergent Biosolutions (the maker of the old anthrax vaccine) and VaxGen (the small company awarded the major contract to develop the new product). For those few who didn't already recognize how entangled politics, science, and public health are (is there anyone?), the story makes that point, and others, quite clear.