HPV odds and ends

A few of the relevant items from the media that have crossed our desks this week...

• "How a vaccine search ended in triumph" (New York Times, 8/29) -- Tells the very interesting backstory of attempts throughout the 20th century (and even into the 19th) to understand the true cause of cervical cancer. Even after HPV was confirmed to be that cause, the road to a vaccine was by no means an easy one, including taking researchers to a convent in upstate New York, of all places. For any medical historian, this story is a book waiting to be written.

• "Parents want HPV shots, but can't find them" (MSNBC, from AP, 8/29) -- In many respects, this is a great sign -- reflecting early enthusiasm for the vaccine which may translate to significant vaccination rates long before mandates enter the discussion. That the vaccine is hard to find is no fault of Merck, it appears, but rather the result of the typical bureaucratic maneuvers that follow licensure and ACIP recommendations, including the publication of 'official' recommendations in MMWR, action required by third-party payers to cover the cost of the vaccine, and reluctance by doctors to stock it until the payment landscape becomes clearer.
  

How to explain HPV vaccination's purpose to teens?

Among the many questions regarding the implementation of Gardasil on a large scale is how the purpose of the vaccine should be explained to children as young as 9 years old (but mostly 11-12) receiving it...

• What level of detail regarding HPV, its sexual transmission, and cervical cancer is appropriate?
  
• Should the physician handle these discussions alone, should they be left to parents to deliver, or should a team effort be employed?
  
• Should parents be permitted to instruct the doctor to give an 'abridged' version of the vaccine's purpose and function vs. the 'full' version they might otherwise deliver?
  
• In general, it's obvious that a discussion of Gardasil with a nine or ten year old would be dramatically different than one with a 13 or 14-year old (with added individual differences even within a specific age group). However, there's no clear guide to help physicians (or the other health care providers who will administer HPV vaccinations) tailor their discussions of the vaccine to children of varying ages, particularly in cases where there isn't an established physician/patient relationship to provide guidance as to a child's maturity, etc.
• What if a parent and child/patient have different opinions regarding whether to vaccinate? Is there a place for child assent to vaccination in these circumstances (particularly among older teenagers)?
  

With all that in mind, an AP story posted this weekend considers some of these questions. Titled "HPV vaccine creates parental challenge," the story follows a 14-year old girl and her mother as they learn about HPV vaccination from the girl's doctor. It's a useful way to begin thinking about these issues less on the national policy level and more from the perspective of individual patients and families. (Thanks to Dom Sisti for the heads-up.)

Gardasil provisional ACIP recommendations posted

As shown by the series of announcements in the past six months regarding Merck's rotavirus vaccine, there's a pattern for how ACIP recommendations become official -- first a vote at one of the committee's thrice-annual meetings, then the online posting of recommendations on the ACIP website a few months later, and, finally, publication in MMWR a few months after that. Only then are the recommendations truly 'official', for what that's worth. In the case of RotaTeq, the ACIP vote came on February 21, provisional recommendations were posted in May, and final publication occurred on August 10 (as we noted here).

Using this timetable for comparison, all signs point to Merck's HPV vaccine, Gardasil, being on a faster track. Recall that the ACIP vote took place on June 29 (as we discussed then), but the provisional recommendations are already posted here at the ACIP website, where they've been available for over a week. The only real news from the document is that publication of the official version of the recommendations in MMWR is tentatively slated for November. (Thanks to the Immunization Action Coalition for the heads-up.)

Bird flu mutation impacting vaccine planning

As always, CIDRAP News is on top of all things avian flu-related. This story from Friday covers the WHO announcement of the most recent data on avian flu mutation and the specific strains that are recommended targets of future vaccine development. Here's the WHO document.

The CIDRAP story offers a nice analysis of the relevant policy and planning ramifications of the science-laden WHO document. Here's an excerpt, featuring comments from Dr. Michael Osterholm:

"Many experts who follow the ongoing analysis of the H5N1 virus sequences are alarmed at how fast the virus is evolving into an increasingly more complex network of clades and subclades, Osterholm said. The evolving nature of the virus complicates vaccine planning. He said if an avian influenza pandemic emerges, a strain-specific vaccine will need to be developed to treat the disease."

That the virus will continue to evolve has long been known, as has the fact that vaccines developed in advance of a pandemic are likely to be increasingly less effective as time passes. For those hoping that a vaccine currently in development would be the vaccine, this news confirms that such hopes are unrealistic. The vaccines in the pipeline today are based on clade 1 strains of the virus, while most recent human cases have been caused by clade 2 strains, according to the WHO report. While it remains unclear how effective "older" vaccines will be against the eventual pandemic strain (if one develops at all), nearly all continue to agree that the most effective vaccine can only be developed after a human pandemic begins.

The WHO document cited here provides our most specific knowledge to date of the virus' pattern of mutation, information needed to develop effective vaccines. It also makes mention of the potential to develop region-specific vaccines if the virus' mutation proceeds in such a way in the months and years ahead.

ACOG issues HPV vaccine recommendations

The American College of Obstetricians and Gynecologists announced their recommendations to ob/gyns for HPV vaccination in women age 9 to 26. Not exactly a surprise that the group supports routine vaccination, but it's an important action, as ob/gyns see the vast majority of women in the 'catch-up' immunization group -- age 13 and above. Coupled with efforts by primary care providers, encouragement for vaccination by ob/gyns increases the likelihood of high vaccination rates overall among the large catch-up population. There's ample evidence that official recommendations from professional groups such as this do influence physician practices.

Here's the ACOG press release as well as excerpts from the full recommendations posted yesterday on the ACOG website. The full recommendations will be published in the September issue of Obstetrics and Gynecology.

Rotavirus vaccine recommendations published in MMWR

Back in February, the ACIP recommended Merck's rotavirus vaccine, RotaTeq, for universal administration to infants. While provisional recommendations were posted on the ACIP's website in May (as we discussed here), just yesterday did the recommendations become official upon their publication in MMWR. Here are the full recommendations.

The publication means a few things: 1) The process of insurance companies adding RotaTeq to their list of covered vaccines will likely accelerate over the coming months, and 2) professional groups and individual pediatricians will increasingly recommend vaccination to parents as it becomes a standard part of pediatric care.

Medical groups point to importance of vaccines in pandemic planning

This story from CIDRAP News called our attention to a joint statement released yesterday by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. In response to the government's pandemic flu national strategy released in May, the two groups urge that vaccines be the primary focus of pandemic planning and response efforts. The statement explains:

"Although the federal government’s pandemic plan addresses vaccination, IDSA and SHEA believe a more comprehensive, international approach is needed for vaccine development, production, and delivery throughout the world. 'The United States must take a leading role in fostering an international effort to develop vaccines against likely and eventual pandemic strains,' said Martin J. Blaser, MD, president of IDSA. 'We must do the legwork now so that we can produce and deploy those vaccines where we need them when a pandemic hits.'"

The statement appears as a result of formal comments and recommendations sent by the two organizations to the White House. The full document is available here as a PDF.

Follow-up: NY Times editorial on '05 measles outbreak

Following up on the report in last week's NEJM about a measles outbreak in Indiana -- the subject of our last post -- today's New York Times includes an editorial that takes a strong stand against parents declining vaccination. Titled "The Measles Vaccine Follies," the editorial points to 'irrational fears of vaccination' as being responsible for the outbreak that sickened 34. Noting that many of those exposed were home schooled, and thus unaffected by school vaccination requirements, the Times ends this way:

"Families that evade vaccination put themselves and their neighbors at risk. All young children, not just those attending school, should be required to get immunized."

(By the way, this is our 100th post and comes -- coincidentally -- on the 5-month anniversary of our launch back in March. Many thanks for your visits to the site; they have made this experiment far more successful than even our most optimistic expectations.)

NEJM on measles in the U.S.

This week's issue of the New England Journal of Medicine includes two pieces that explore the status of measles in the U.S., particularly in relation to a 2005 outbreak in Indiana. That outbreak -- the largest in a decade -- was triggered by the return of a 17-year old unvaccinated girl who traveled to an orphanage in Romania as part of a church group.

One paper is a report tracing the spread of the virus from that individual through everyone she exposed. Titled "Implications of a 2005 Measles Outbreak in Indiana for Sustained Elimination of Measles in the United States" (available free), it concludes, in part:

"Measles was eliminated in the United States through high rates of routine childhood vaccination coverage. The outbreak in Indiana shows that states, localities, and health care organizations need to implement more effective policies to protect persons traveling abroad, home-schooled children, and health care workers against measles and other vaccine-preventable diseases. In addition, to preclude the experience of those countries where vaccine-preventable diseases have become epidemic through the refusal of vaccination, better communication strategies are needed concerning the adverse events associated with vaccines."

The second is a perspective essay by E. Kim Mulholland, M.D., from the London School of Hygiene and Tropical Medicine. Titled "Measles in the United States, 2006," Dr. Mulholland's conclusion is sure to raise the ire of critics of vaccine policy and safety. Putting the blame for outbreaks such as that in Indiana on those alleging vaccine safety issues, Mulholland writes:

"And as long as some groups within a given community respond to spurious claims about the risks of the vaccine by refusing to vaccinate their infants, further outbreaks will occur even in industrialized countries."

FDA approves 2006-2007 flu vaccines

News from Washington yesterday that the FDA approved the vaccines to be used for the upcoming flu season. Here's the FDA press release and AP story regarding the announcement.

These approvals are an annual occurrence, as manufacturers produce flu vaccines including the specific strains of the virus recommended by WHO and FDA. There are four vaccines available:

• Fluvirin (Novartis Vaccines, formerly Chiron)
• Fluarix (GSK)
• Fluzone (Sanofi Pasteur)
• FluMist (Medimmune)

FluMist is the increasingly popular nasally-administered vaccine, the other three are injected (and few patients know which of the three they receive). In total, the FDA estimates a supply of approximately 100 million doses in the U.S. for the season.

June ACIP presentations available online

We neglected to mention that the slides from speakers at June's ACIP meeting were posted online in the last few weeks. For those looking for details, data, references, and scientific sophistication well beyond anything available in the media (for understandable reasons), these are great resources, particularly regarding Merck's HPV vaccine, the main item on the June agenda.

The files available include several presentations on Gardasil (safety and efficacy data from Merck, cost-effectiveness analyses, recommendation details, etc.), as well as the many other topics the committee considered, including a new recommendation for varicella vaccination, updates on influenza, mumps, rotavirus, avian flu, and much more.