2007 Pediatric & adolescent immunization schedules released

Yesterday, the American Academy of Pediatrics released the 2007 recommended immunization schedules for children, adolescents and catch-up immunization. (As always, the schedules are a joint production of the ACIP, AAP, and American Academy of Family Physicians, but it appears that the AAP website is first to release it publicly.) The new schedule includes, among other changes, the new recommendations for rotavirus and HPV vaccination, as announced in 2006.

The traditional one-page schedule covering all vaccine doses from birth to 18 years had grown increasingly complex and crowded in recent years, a multi-colored sea of bars, shaded boxes, dotted lines, abbreviations, and minuscule print. The chief solution to this problem is the expansion of the single-page schedule to three pages, one for birth-6 years, another for ages 7-18, and a third for catch-up immunization spacing. Many of the more confusing design elements from years past have been eliminated and the fine-print footnotes are now bullet points.

While this update is marked improvement over previous versions with respect to comprehensibility, most parents will still be far better served consulting their physician to understand clearly which vaccines are recommended for their children and when.

Update, 1/5/06 -- The latest issue of CDC's MMWR also announces the newly revised schedules.

CDC releases updated "General Recommendations on Immunization"

Every few years, the Advisory Committee on Immunization Practices releases an updated version of its "General Recommendations on Immunization." The new document released Friday is an update to the previous version released in 2002.

As the title suggests, it is a series of recommendations that are not specific to a particular vaccine, addressing issues such as vaccine handling, administration, spacing, contraindications, and vaccination of specific populations (such as pregnant women or those with altered immune systems). Coupled with 200+ references to the medical literature, it's an excellent resource for those looking for a synopsis of a particular topic and directions for further study.

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.)

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.

Gardasil receives ACIP recommendation for girls 11-26

We're in Atlanta for the summer ACIP meeting, where the biggest news coming out of the CDC is the (not unexpected) action on Gardasil. In short, the ACIP unanimously recommended that all 11-12 year old girls receive the 3-dose series, although vaccination can begin as young as 9, at the physician's discretion. Additionally, a 'catch-up' immunization program was recommended for girls and women through age 26.

Here's the coverage from the New York Times, Associated Press, Los Angeles Times, and Reuters, as well as the press releases from Merck and the CDC. Also of interest is this transcript of a CDC media briefing held this afternoon shortly after the recommendation.

In many respects, today's proceedings were rather anti-climactic, despite a standing-room-only crowd in the meeting auditorium. Coming after four hours of presentations and discussion on HPV vaccines at the February ACIP meeting, there was very little new information presented this morning. The pre-vote discussion was equally subdued, as Gardasil's trial data and FDA indications provided few alternatives beyond the recommendation as approved. That's probably a good thing, as decisions made amid uncertainty or a significant division in opinion would likely mean that things hadn't been thoroughly explored prior to the meeting. Clearly, the committee was well prepared and ready to act.

Personally, we were curious to see whether any of the groups opposing state mandates for HPV vaccination would use the "public comment" time to continue making themselves heard (as the Family Research Council did at the February meeting). Once again, however, no fireworks to report, as all nine public commenters strongly supported the vaccine. Commenters included representatives from the National Coalition for Cancer Survivorship, the Planned Parenthood Federation of America, AmeriChoice, The Balm in Gilead, the American Social Health Association, the Celebrate Life Foundation, Women in Government, and the International RRP ISA Center. Also commenting was Dr. Otis Brawley, a professor at Emory University. While unanimously praising the ACIP's recommendation, several commenters advocated broadening the vaccine's target groups in the future to include boys as well, an action that will surely occur in the not-too-distant future.

It should be noted that several opponents of state mandates, while not vocal at today's meeting, are quoted in some of the news stories linked above.

With licensure and a recommendation secured this month, the fate of Gardasil now depends on a variety of financing programs to make the vaccine available and affordable to all who should receive it, a comprehensive education program for parents and physicians alike, and the actions of all 50 state departments of health, whose decisions regarding school-entry mandates will impact greatly the degree of vaccine uptake and, thus, the overall benefit of the vaccine for society. Stay tuned.

Provisional rotavirus recommendations expected within a month

This afternoon, the National Immunization Program hosted a live netconference titled "Current Issues in Immunization". Among the topics covered in the one-hour session were revisions to the General Recommendations on Immunization, the document updated every few years that provides general guidance of immunization practices in the U.S. The revisions, addressing particulars of simultaneous administration of multiple vaccines and the impact of altered immunocompetence on vaccination recommendations, were discussed in detail at the February ACIP meeting.

Also presented was an update on the recently licensed and recommended rotavirus vaccine, Merck's RotaTeq. CDC's Dr. Umesh Parashar gave an overview of rotavirus epidemiology worldwide and in the U.S., contrasted RotaTeq with RotaShield (Wyeth's failed vaccine of 1998-99), and offered an update on the current status of the ACIP recommendation approved in February that all infants receive the vaccine at 2, 4, and 6 months.

According to Dr. Parashar, the ACIP recommendation is currently undergoing final clearance from the CDC and HHS. These required approvals are expected within the next month, at which point provisional recommendations will be posted online here. Recommendations do not become official until printed in the Morbidity and Mortality Weekly Report (MMWR), a step expected to occur sometime in fall 2006.

Still, federal government vaccination recommendations remain only recommendations unless individual states act to require the vaccine as a condition of school or day care attendance. These mandates are widely expected for RotaTeq, but require actions by state departments of health or (in some cases) legislatures. Mandates for rotavirus vaccination are not expected to be nearly as contentious as those for HPV vaccines in the months and years ahead.

Society for Adolescent Medicine position on HPV and other teen vaccines

This is a few weeks old, but the March issue of the Journal of Adolescent Health included this position paper on adolescent immunization from the Society for Adolescent Medicine. (free PDF).

The paper addresses several vaccines administered to teenagers and outlines some of the general challenges that adolescent immunization programs face. HPV vaccines receive significant attention, with respect to the science, cost-effectiveness, and behavioral concerns the vaccine raises among many. On the latter, here's what they write...

"Data indicate that parents will support the use of a vaccine to prevent sexually transmitted infections (STIs) including HPV, especially after receiving education and an understanding of the potential outcomes of the disease. In addition, provider acceptability is important to parents and their adolescent children. Thus, health care professionals need to educate themselves, parents and patients with the goal of promoting the health and well-being of patients regardless of the transmission routes of infection and disease. Vaccination does not preclude the use of other methods to prevent disease, including significant educational initiatives. Even with significant educational efforts aimed at behavioral change, adolescents still engage in health-risk behaviors. Just as with any other health prevention strategy, it makes the most sense to protect all youth--including our most vulnerable youth--with all prevention strategies available, including education and vaccination."

GSK rotavirus vaccine approved by EU

Rotarix, the GSK rotavirus vaccine, received EU approval Monday. Forbes, among other places, had the details.

While GSK's vaccine is out in front on the international stage, it's yet to be licensed in the United States. RotaTeq, the rotavirus vaccine from Merck, was licensed by the FDA in December. As was widely reported last week, CDC's Advisory Committee on Immunization recommended routine vaccination with RotaTeq for all newborns at 2, 4, and 6 months. Here's the Washington Post story.

For those confused by news accounts of vaccines in development, similar products from competing manufacturers, and the maze of regulatory steps required in the U.S., the American Academy of Pediatrics has a very useful table on its website that provides the trade name, target, manufacturer, age range, licensure status, and AAP/ACIP recommendations (if any) for vaccines recently approved or currently in the approval process. The page is updated regularly and is a great resource. A link has been added on the right of the page.

NY Times Calls for Further Expansion of Flu Vaccine Recommendations

Responding to ACIP's recommendation earlier this week calling for flu vaccination for 2-5 year olds, the New York Times this weekend suggested expanding the recommendation ever further, increasing the production capacity potentially necessary if or when a pandemic arrives...

"Our only qualm is to wonder whether even more children should be vaccinated to protect us all from the flu bugs circulating in elementary, middle and high schools. The advisory committee seems to have limited its recommendation at least in part because of concerns that the troubled vaccine industry may not be able to meet a much higher demand. But in the long run, it would make sense to ramp up production capacity and vaccinate virtually everyone as a prelude to preparing for mass vaccinations should an influenza pandemic strike."