National Meningitis Association Statement on Advisory Committee on Immunization Practices Vote

/PRNewswire/ -- On October 27, 2010, the CDC's Advisory Committee on Immunization Practices (ACIP) voted to expand the adolescent meningococcal vaccination recommendation to include a booster. Routine vaccination at age 11-12 years continues to be recommended with a booster dose at age 16. For adolescents who are first vaccinated between 13 and 15 years of age, a booster dose is recommended 5 years after the first dose through age 21.

NMA Statement:

The National Meningitis Association supports ACIP's decision to maintain meningococcal immunization at age 11-12 and to add a booster dose to provide increased prevention of disease among adolescents throughout their high-risk years. This is a good public health decision that will protect our children from meningococcal disease.

We looked forward to supporting this recommendation as well as the adolescent immunization platform through our education and outreach programs.

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Vaccine-Delivery Patch with Dissolving Microneedles Boosts Protection

A new vaccine-delivery patch based on hundreds of microscopic needles that dissolve into the skin could allow persons without medical training to painlessly administer vaccines -- while providing improved immunization against diseases such as influenza.

Patches containing micron-scale needles that carry vaccine with them as they dissolve into the skin could simplify immunization programs by eliminating the use of hypodermic needles -- and their "sharps" disposal and re-use concerns. Applied easily to the skin, the microneedle patches could allow self-administration of vaccine during pandemics and simplify large-scale immunization programs in developing nations.

Details of the dissolving microneedle patches and immunization benefits observed in experimental mice were reported July 18th in the advance online publication of the journal Nature Medicine. Conducted by researchers from Emory University and the Georgia Institute of Technology, the study is believed to be the first to evaluate the immunization benefits of dissolving microneedles. The research was supported by the National Institutes of Health (NIH).

"In this study, we have shown that a dissolving microneedle patch can vaccinate against influenza at least as well, and probably better than, a traditional hypodermic needle," said Mark Prausnitz, a professor in the Georgia Tech School of Chemical and Biomolecular Engineering.

Just 650 microns in length and assembled into an array of 100 needles for the mouse study, the dissolving microneedles penetrate the outer layers of skin. Beyond their other advantages, the dissolving microneedles appear to provide improved immunity to influenza when compared to vaccination with hypodermic needles.

"The skin is a particularly attractive site for immunization because it contains an abundance of the types of cells that are important in generating immune responses to vaccines," said Richard Compans, professor of microbiology and immunology at Emory University School of Medicine.

In the study, one group of mice received the influenza vaccine using traditional hypodermic needles injecting into muscle; another group received the vaccine through dissolving microneedles applied to the skin, while a control group had microneedle patches containing no vaccine applied to their skin. When infected with influenza virus 30 days later, both groups that had received the vaccine remained healthy while mice in the control group contracted the disease and died.

Three months after vaccination, the researchers also exposed a different group of immunized mice to flu virus and found that animals vaccinated with microneedles appeared to have a better "recall" response to the virus and thus were able to clear the virus from their lungs more effectively than those that received vaccine with hypodermic needles.

"Another advantage of these microneedles is that the vaccine is present as a dry formulation, which will enhance its stability during distribution and storage," said Ioanna Skountzou, an Emory University assistant professor.

Pressed into the skin, the microneedles quickly dissolve in bodily fluids, leaving only the water-soluble backing. The backing can be discarded because it no longer contains any sharps.

"We envision people getting the patch in the mail or at a pharmacy and then self administering it at home," said Sean Sullivan, the study’s lead author from Georgia Tech. "Because the microneedles on the patch dissolve away into the skin, there would be no dangerous sharp needles left over."

The microneedle arrays were made from a polymer material, poly-vinyl pyrrolidone, that has been shown to be safe for use in the body. Freeze-dried vaccine was mixed with the vinyl-pyrrolidone monomer before being placed into microneedle molds and polymerized at room temperature using ultraviolet light.

In many parts of the world, poor medical infrastructure leads to the re-use of hypodermic needles, contributing to the spread of diseases such as HIV and hepatitis B. Dissolving microneedle patches would eliminate re-use while allowing vaccination to be done by personnel with minimal training.

Though the study examined only the administration of flu vaccine with the dissolving microneedles, the technique should be useful for other immunizations. If mass-produced, the microneedle patches are expected to cost about the same as conventional needle-and-syringe techniques, and may lower the overall cost of immunization programs by reducing personnel costs and waste disposal requirements, Prausnitz said.

Before dissolving microneedles can be made widely available, however, clinical studies will have to be done to assure safety and effectiveness. Other vaccine formulation techniques may also be studied, and researchers will want to better understand why vaccine delivery with dissolving microneedles has been shown to provide better protection.

Beyond those already mentioned, the study involved Jeong-Woo Lee, Vladimir Zarnitsyn, Seong-O Choi and Niren Murthy from Georgia Tech, and Dimitrios Koutsonanos and Maria del Pilar Martin from Emory University.

"The dissolving microneedle patch could open up many new doors for immunization programs by eliminating the need for trained personnel to carry out the vaccination," Prausnitz said. "This approach could make a significant impact because it could enable self-administration as well as simplify vaccination programs in schools and assisted living facilities."

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Immunization Rates Remain Stable at High Levels Among the Nation′s 19- Through 35-Month-Old Children

Childhood immunization rates in the United States remain stable at high levels, according to data from CDC′s 2008 National Immunization Survey (NIS) published in this week′s Morbidity and Mortality Weekly Report (MMWR).

“Vaccination is one of the most important things parents can do to protect their children′s health,” said Dr. Melinda Wharton, Deputy Director, National Center for Immunization and Respiratory Diseases. “Thanks to the hard work of doctors and nurses and other immunization providers and the commitment of parents, rates are still high, but we must all continue to work hard to reach those children who are not fully vaccinated.”

The 2008 NIS included children aged 19–35 months and born during January 2005–June 2007.

Among these children, coverage was 76.1 percent with the 4:3:1:3:3:1 series of vaccines, not a statistically significant difference from the 2007 estimate of 77.4 percent. The national goal for coverage with the 4:3:1:3:3:1 series is 80 percent.

Vaccines in the series are:

* Four or more doses of diphtheria, tetanus and pertussis vaccine (DTaP)
* Three or more doses of polio vaccine
* One or more doses of measles, mumps and rubella vaccine (MMR)
* Three or more doses of Haemophilus influenzae type b vaccine (Hib)
* Three or more doses of hepatitis B vaccine
* One or more doses of varicella (chickenpox) vaccine

For each vaccine in the series, the goal is 90 percent and this was met, except for four doses of DTaP vaccine, which was 84.6 percent.

The 2008 NIS data showed a small but statistically significant decrease nationally for coverage with the Hib vaccine. In 2007, coverage with three or more doses of Hib was 92.6 percent and in 2008 coverage was 90.9 percent. This decrease is likely due to a shortage of the vaccine that began in December 2007 and a temporary recommendation to defer the booster dose. At least 8 percent of the children in the survey were likely impacted by this recommendation. More vaccine became available this summer, and the booster dose is now being recommended again for children at age 12–15 months.

In 2008, coverage with three or more doses of doses of pneumococcal conjugate vaccine (PCV7) increased from 90.0 percent to 92.8 percent and coverage with four or more doses increased from 75.3 percent to 80.1 percent.

As in previous years, estimated vaccination coverage levels varied substantially among states and local areas. 4:3:1:3:3:1 state coverage ranged from 59.2 percent in Montana to 82.3 percent in Massachusetts. Coverage also varied among the 17 local areas surveyed, from 68.5 percent in Northern California to 80.9 percent Santa Clara County, Calif.

This is the first NIS report to include coverage for two or more doses of hepatitis A vaccine, which was 40.4 percent. This report also includes coverage among newborns with the first dose of the hepatitis B vaccine, which was 55.3 percent, an increase from 53.2 percent in 2007.

The proportion of children who had received no vaccine doses remained at 0.06 percent.

Among racial/ethnic groups, little variation in coverage was observed. Coverage for most vaccines remained lower for children living below poverty than children living at or above poverty. Sustaining high coverage levels and finding effective methods of reducing disparities across states/local areas and income groups remains a priority to fully protect children and limit the incidence of vaccine-preventable diseases in the United States.

The NIS is an ongoing random-digit dialed survey of households with children aged 19-35 months. It also includes a mail survey of the children′s vaccination providers to collect vaccination information. During 2008, 18,430 children with provider-reported vaccination records were included in this report.

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Nation's Teen Vaccination Coverage Increasing, But Below 2010 Goals

The nation's immunization coverage rates for preteens and teens are increasing for routinely recommended vaccines, but most still do not have all of the recommended immunizations, according to 2007 estimates released today by the Centers for Disease Control and Prevention (CDC).

"The overall trends are good news," said Dr. Lance Rodewald, director of the Division of Immunization Services at the CDC's National Center for Immunization and Respiratory Diseases. "We are seeing more preteens and teenagers being protected against serious, sometimes deadly diseases. But we remain short of our goals -- for almost all of these vaccines we want at least 90 percent of adolescents to be fully immunized. As such, we have much work to do to get many more adolescents protected."

The survey provides estimates for three vaccines recommended at 11 or 12 years of age: the tetanus-diphtheria-acellular pertussis (Tdap) vaccine, the meningococcal conjugate vaccine (MCV4), and the human papillomavirus (HPV4) vaccine for girls and young women. It also includes estimates of the percentage of 13- through 17-year-old teens who should have received the recommended immunizations for measles, mumps and rubella vaccine (MMR), hepatitis B (HepB) vaccine, and varicella vaccine (VAR) earlier in life.

According to Rodewald, the nation's Healthy People 2010 goals for preteens and teens ages 13-15 years are not being met for any of the vaccines for which goals were set. The Healthy People 2010 goals are for 90 percent coverage for preteens and teens 13 to 15 years of age with three doses of hepatitis B vaccine, two doses of measles, mumps and rubella vaccine, one dose of either tetanus-diphtheria or tetanus, diphtheria and acellular pertussis vaccine, and one dose of varicella vaccine for those who have not previously had chickenpox. There is not a Healthy People 2010 goal for HPV vaccination, which was first licensed and recommended in 2006.

The survey found that, compared to 2006, there was a substantial increase in the percentage of preteens and teens who had received the recommended vaccinations. Specific findings included:

-- Vaccination coverage levels for three or more doses of hepatitis B
(HepB) and two or more doses of measles, mumps and rubella vaccine
(MMR) were over 80 percent;
-- Coverage with one dose of varicella vaccine (VAR) was high at 75.7
percent but coverage with two doses was low at 18.8 percent among
preteens and teens without a previous history of disease;
-- 32.4 percent of preteens and teens surveyed had received MCV4
vaccination, up from 11.7 percent in 2006 (a 20.7 percentage point
increase);
-- 30.4 percent had received Tdap vaccination, up from 10.8 percent in
2006 (a 19.6 percentage point increase);
-- 25.1 percent of adolescent females had received at least one dose of
HPV vaccine

Rodewald encourages parents to take their preteens and teenagers for routine medical checkups as a way to ensure they receive the recommended vaccinations.

Additional Background Information

The meningococcal conjugate vaccine (MCV4) vaccine protects against meningococcal meningitis, the tetanus-diphtheria-acellular pertussis (Tdap) vaccine protects against pertussis, also known as whooping cough, and the human papillomavirus (HPV) vaccine protects girls against cervical cancer. The recommended series consists of one dose of Tdap vaccine, one dose of the MCV4 vaccine, and three doses of the HPV4 vaccine.

CDC has conducted the National Immunization Survey for teens since 2006. It is similar to the standard NIS which began in 1994, that collects immunization information among children 19 through 35 months old. It is a random digit-dialed telephone survey.

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Hopkins Experts: Most Vaccine-Allergic Children Can Still Be Safely Vaccinated

With close monitoring and a few standard precautions, nearly all children with known or suspected vaccine allergies can be safely immunized, according to a team of vaccine safety experts led by the Johns Hopkins Children’s Center. Writing in the September issue of Pediatrics, the multicenter research team offers pediatricians a step-by-step tool for quickly identifying children with allergic reactions to vaccines, and a much-needed guide, they say, to safely immunize those who are allergic.

Serious allergic reactions to vaccines are extremely rare — one or two per million vaccinations, according to some estimates — but when they happen, such episodes can be serious, even life-threatening, making it critical for pediatricians to instantly spot true allergic reactions and differentiate them from more benign nonallergic responses, investigators say. It is also crucial that pediatricians design a safe immunization plan for children with confirmed vaccine allergies. Children who have had one allergic reaction are believed to be at a higher risk for future reactions, typically more serious than the first.

“We cannot reiterate enough that the vaccines used today are extremely safe, but in a handful of children certain vaccine ingredients can trigger serious allergic reactions,” says Robert Wood, M.D., lead author on the paper and chief of pediatric Allergy and Immunology at Hopkins Children’s. “For the most part, even children with known allergies can be safely vaccinated.”

Given recent outbreaks of vaccine-preventable infections like measles, mumps and whooping cough in the United States, and measles and polio overseas, it is essential to safely vaccinate as many children as possible, investigators say.

Combing through available evidence on vaccine safety and allergies, the Hopkins-led team developed a sequence of instructions – an algorithm – that prompts physicians one step at a time on how to evaluate and immunize children with known or suspected vaccine allergies.

The guidelines are intended for doctors and parents who are uncertain about vaccine safety in children who have already had or are at high risk for having allergic reactions to vaccines.

In such cases, the Hopkins-led group advises a workup by an allergist, including skin prick testing—a prick on the skin or an injection under the skin with a small dose of vaccine or the suspected allergen from the vaccine—or blood tests that would detect the presence of characteristic antibodies that patients develop to allergens, such as antibodies to gelatin or egg proteins used in several common vaccines.

In many cases, allergic children can be vaccinated using alternative forms of a vaccine that are free of the allergen. Even if allergen-free formulations are unavailable, many children can still be vaccinated and remain under physician supervision for several hours after vaccination. Another option is testing the child to check for immunity. If blood tests show the child has already developed protective antibodies, it may be OK, at least temporarily, to withhold further doses of the vaccine, researchers write.

“Vaccines save lives, and parents should know that children who have had allergic reactions after a vaccine are likely to have developed protection against infection as a result of the vaccination,” says investigator Neal Halsey, M.D., an infectious disease specialist at Hopkins Children’s, and professor of International Health at the Johns Hopkins University Bloomberg School of Public Health.

“Most children who have had an allergic reaction after a vaccine can still be vaccinated against other diseases safely and some can receive additional doses of vaccines they might have reacted to,” Halsey adds.

Many children with known vaccine allergies who have low levels of protective antibodies and require more doses can be vaccinated safely under the guidelines. In some cases, children with known allergies can be given antiallergy medications, such as antihistamines and corticosteroids, before vaccination to help ward off or lessen the allergic reaction. For a step-by-step guide to vaccine administration in children with known or suspected vaccine allergy, see the full text of the article at http://pediatrics.aappublications.org/future/122.3.shtml.

Immunizations of children with known vaccine allergies should always be administered under medical supervision in a clinic equipped to treat life-threatening allergic reactions or in a hospital intensive-care unit. Patients can usually go home after an hour or two if they have no adverse reactions.

True allergies typically cause immediate reactions, involving the immune system as a whole that occur within a few minutes to a few hours of vaccination. By contrast, delayed reactions, which occur within days, even weeks after vaccination, are generally benign and are rarely, if ever, dangerous.

Symptoms of immediate allergic reactions include hives, swelling, wheezing, coughing, low blood pressure, vomiting, diarrhea, and can lead to full-blown anaphylaxis, a life-threatening allergic reaction.

The research was funded by the Centers for Disease Control and Prevention.

Co-investigators on the research: Melvin Berger, M.D. Ph.D., University Hospitals of Cleveland; Stephen Dreskin, M.D. Ph.D., University of Colorado; Rosanna Setse, M.D. M.P.H., Johns Hopkins University Bloomberg School of Public Health; Renata Engler, M.D., Walter Reed Army Medical Institute; Cornelia Dekker, M.D., Stanford University School of Medicine. The Clinical Immunization Safety Assessment Network, consisting of six medical research centers with expertise in immunization safety, was part of the study.

Conflict of interest disclosure for Hopkins investigators: Halsey has received research support from vaccine manufacturer Wyeth and is a consultant for vaccine manufacturers GlaxoSmithKline and Merck.

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