Streptococci and E. coli Continue to Put Newborns at Risk for Sepsis

Bloodstream infections in newborns can lead to serious complications with substantial morbidity and mortality. What’s more, the pathogens responsible for neonatal infections have changed over time. In recent years, however, antibiotic prophylaxis given to at-risk mothers has reduced the incidence of early-onset group B streptococcal infections among their babies.

A new nationwide, multi-site study aimed at determining current early-onset sepsis rates among newborns, the pathogens involved, and associated morbidity and mortality demonstrates that the most frequent pathogens associated with sepsis are group B streptococci (GBS) in full-term infants and Escherichia coli in preterm infants.

The study, which included nearly 400,000 newborns, also found that infection rates in newborns increased with decreasing gestational age and birth weight. The overall rate of infection was 0.98 per 1,000 live births; 0.41 per 1,000 live births involving GBS and 0.28 per 1,000 live births involving E. coli.

The study appears online April 25 and in the May 2011 issue of Pediatrics.

GBS emerged as the leading cause of early-onset sepsis and meningitis in newborns in the 1970s. In 2002, the Centers for Disease Control and Prevention recommended universal screening of women at 35 to 37 weeks of pregnancy followed by chemoprophylaxis for women with GBS colonization.

Sepsis occurs when pathogenic bacteria enter the blood stream, causing systemic infection. In infants less than 72 hours old, sepsis is considered of early onset.

“Infections occur in almost one case per thousand live births,” says Barbara Stoll, MD, lead investigator for the study. Stoll is the George W. Brumley, Jr., Professor and Chair, Department of Pediatrics in Emory University School of Medicine. “With approximately 4 million births a year in the United States, this equates to a substantial burden of disease. We estimate that approximately 3,000 infants a year develop early-onset sepsis. With current mortality rates, approximately 300 to 350 deaths per year are associated with neonatal sepsis. So, it’s not inconsequential.”

The study also shows that opportunities for prevention of neonatal GBS infections continue to be missed. “Missed opportunities for prevention of GBS include failure to screen all women who deliver at term, failure to provide antibiotics to all colonized women or to those who delivered preterm with unknown colonization status and false negative GBS screens among women who deliver with GBS infection,” says Stoll.

“Our findings suggest that accurate point-of-care diagnostic tests at the time a woman comes in for delivery would enhance our ability to identify at-risk women.”

In addition, the gap in linking electronic medical records between a woman’s obstetrician and the hospital where she delivers can also impede prevention. “A community health record that links the medical record in a physician’s office with the hospital where the woman gets care could enhance identification and therapy for at-risk women,” says Stoll. “If a woman has been screened for GBS and is known to be colonized, that information should be available to the health care team taking care of her at the time she is in labor.”

The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the Centers for Disease Control and Prevention.

By Robin Tricoles

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FDA approves the first vaccine to prevent meningococcal disease in infants and toddlers

The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop meningococcal disease die from the infection. Another 10 percent to 20 percent suffer complications such as brain damage or loss of limb or hearing.

Although the rates of meningococcal disease are low in the United States, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.

“The highest rate of meningococcal disease occurs in children under one year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease,” said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which over 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability. Occurrence of fever was comparable to other vaccines routinely recommended for young children.

Menactra is given as a two-dose series beginning at 9-months, three months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur Inc. of Swiftwater, Pa.

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New Low-Cost Method to Deliver Vaccine Shows Promise

/PRNewswire/ -- Researchers have developed a promising new approach to vaccination for rotavirus, a common cause of severe diarrheal disease that is responsible for approximately 500,000 deaths among children in the developing world every year. In a study published in the November issue of Clinical and Vaccine Immunology, a vaccine delivered as nasal drops effectively induced an immune response in mice and protected them from rotavirus infection. The new vaccine delivery system has also been tested successfully and found to be heat stable with tetanus and is currently being tested with diphtheria and pertussis.

The team from the Cummings School of Veterinary Medicine at Tufts University and Tufts University School of Medicine collaborated with researchers from Boston and Tulane Universities to test the effectiveness of immunization with harmless bacteria that were engineered to display rotavirus protein.

"The new vaccine, in conjunction with an agent that enhances immunity, induced sufficient antibody formation against rotavirus to protect mice against infection when the mice were exposed to rotavirus three weeks after their third immunization," explained John E. Herrmann, Ph.D., research professor in the infectious diseases division of the department of biomedical sciences at the Cummings School of Veterinary Medicine at Tufts University and the senior author of the published study.

"We created the rotavirus vaccine using a harmless bacterium called Bacillus subtilis (B. subtilis), which we can modify to display on its surface or in its cytoplasm proteins from infectious bacteria and viruses. When people are exposed to these proteins, they develop antibodies against them and therefore become immune to the bacteria and viruses," said the study's first author Sangun Lee, Ph.D., DVM, research associate at the Cummings School. "The B. subtilis bacteria are so harmless that they are part of the normal diet in several Asian countries."

"The vaccine with the Bacillus bacteria is very inexpensive to produce in large quantities and, unlike most traditional vaccines, requires no special purification steps before use. As a result, the cost of vaccine production is unusually low," explained Saul Tzipori, BVSc (DVM), DSc, Ph.D., Agnes Varis University Chair in Science and Society, distinguished professor of microbiology and infectious diseases, and director of the infectious diseases division of the department of biomedical sciences at the Cummings School. These findings are consistent with the team's previous studies in which they demonstrated that B. subtilis bacteria displaying a fragment of tetanus toxin protein completely protect mice from tetanus. Tetanus vaccines have been stored for more than a year at 113(o)F without any loss of potency, a property that may be common to all B. subtilis vaccines.

Vaccines currently available have to be stored in refrigerators or freezers until the moment they are administered. This cold chain is difficult and costly to maintain. In many parts of the world, there is insufficient refrigeration or electricity to keep vaccines cold. The lack of refrigeration combined with the lack of trained personnel, especially in rural areas in developing countries, make it impossible for many children and adults to be vaccinated against standard infections, such as tetanus, rotavirus, diphtheria, pertussis (whooping cough) and other diseases.

"In addition to being heat-stable and low-cost, the B. subtilis vaccines are given in the form of nasal drops or spray. A needle-free approach to vaccination is particularly advantageous in developing countries where clean needles and syringes and trained personnel are not always available," said team leader Abraham L. (Linc) Sonenshein, Ph.D., professor and acting chair of molecular biology and microbiology at TUSM and member of the genetics and microbiology program faculties at the Sackler School of Graduate Biomedical Sciences at Tufts.

"This vaccine project is still in the developmental stage," he continued. "The next major step for these vaccines is to show that they are safe and work well in humans, and then to extend the rotavirus and tetanus vaccine technology to include diphtheria, pertussis and other infectious diseases. Those diseases cause tens of thousands of deaths, particularly in newborns and in South-East Asia. We are actively looking for partners in the U.S. and around the world to help us pursue our goal of reaching the point where many childhood and adult vaccines can be manufactured in a way that avoids the need for injection or refrigeration. Jerry Keusch of Boston University School of Public Health and I started this project 15 years ago, and it has taken a long time to reach the stage where we now have effective needle-free vaccines. The technology has now advanced enough that we can expect to be successful with many other vaccines in a short time frame."

Additional authors include Boris R. Belitsky, Ph.D., assistant research professor in the department of molecular biology and microbiology at TUSM; James P. Brinker, M.P.H, in the department of biomedical sciences at the Cummings School; Kathryn O. Kerstein, MS, senior research associate in the department of molecular biology and microbiology at TUSM; David W. Brown, Ph.D., DVM, clinical assistant professor in the infectious diseases division of the department of biomedical sciences at the Cummings School; Gerald T. Keusch, MD, professor in the department of international health at Boston University School of Public Health, professor of medicine at Boston University School of Medicine and U.S. chairman of the Indo-U.S. Vaccine Action Program at the National Institutes of Health; and John D. Clements, Ph.D., professor and chair of the department of microbiology and immunology at Tulane University Health Sciences Center.

This study was supported by a grant from the Grand Challenges in Global Health program of the Bill and Melinda Gates Foundation, and this grant was administered by the Foundation for the National Institutes of Health. Patent applications related to the discoveries reported in these studies have been filed by Tufts University.

Lee S, Belitsky BR, Brinker JP, Kerstein KO, Brown DW, Clements JD, Keusch GT, Tzipori S, Sonenshein AL, Herrmann JE. Clinical and Vaccine Immunology.. 2010 (November); 17 (11): 1647-1655. "Development of a Bacillus subtilis-based rotavirus vaccine." DOI: 10.1128/CVI/00135-10.

Lee S, Belitsky BR, Brown DW, Brinker JP, Kerstein KO, Herrmann JE, Keusch GT, Sonenshein AL, Tzipori S. Vaccine. 2010 (September 24); 28 (41), 6658-6665. "Efficacy, heat stability and safety of intranasally administered Bacillus subtilis spore or vegetative cell vaccines expressing tetanus toxin fragment C." DOI:10.1016/j.vaccine.2010.08.016.

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Substantial Consumption of Fluoride Increases Chance of Mild Fluorosis

/PRNewswire/ -- Young children who consume substantial amounts of fluoride through infant formula and other beverages mixed with fluoridated water or by swallowing fluoride toothpaste have an increased chance of developing mild enamel fluorosis, according to research published in the October issue of The Journal of the American Dental Association and supported by the National Institute of Dental and Craniofacial Research. Children can continue using fluoridated water and fluoride toothpaste because fluoride has been proven to prevent tooth decay, and mild fluorosis does not negatively affect dental health or quality of life.

"Nearly all of the fluorosis in our study participants was mild. A recent review of the effects of mild dental fluorosis on oral health-related quality of life concluded that the effect of mild fluorosis was not adverse and could even be favorable," according to the study. "This suggests that concerns about mild dental fluorosis may be exaggerated. Therefore, no general recommendations to avoid use of fluoridated water in reconstituting infant formula are warranted."

According to the American Dental Association, mild enamel fluorosis appears as barely noticeable faint white lines or streaks on tooth enamel that may occur when children ingest excess fluoride while their teeth are developing.

Researchers concluded that substantial fluoride consumption from beverages with fluoridated water, including infant formula, by children between the ages of 3 to 9 months, elevates a child's prospect of developing mild enamel fluorosis. Substantial fluoride consumption from beverages with fluoridated water and from fluoride toothpaste by children between the ages of 16 to 36 months also elevates a child's probability of developing mild enamel fluorosis.

The American Academy of Pediatrics recommends breastfeeding for infants. If parents are concerned about reducing the chances of their infants developing mild fluorosis through consuming substantial amounts of infant formula mixed with fluoridated water, the researchers suggest that they consult with their family dentist or physician. The researchers also encourage parents to follow recommendations to use small (smear or pea-sized) amounts of fluoridated toothpaste and ensure proper supervision of the child's tooth brushing.

Researchers recruited mothers of newborn infants from eight Iowa hospital postpartum wards between 1992 and 1995 for their children's participation in what would become known as the Iowa Fluoride Study, an investigation of dietary and non-dietary fluoride exposures, dental fluorosis and dental cavities. Researchers sent questionnaires to the parents at regular intervals and 630 children underwent visual dental examinations using standardized techniques and portable equipment. The leader of the research team was Steven M. Levy, D.D.S., M.P.H., the Wright-Bush-Shreves Endowed Professor of Research in the Department of Preventive and Community Dentistry at the University of Iowa's College of Dentistry and Professor of Epidemiology at the College of Public Health.

Note: Although this study appears in The Journal of the American Dental Association, it does not necessarily reflect the policies or opinions of the American Dental Association.

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Georgia Southern University Researchers to Study Role of Prenatal Exercise and Nutrition in Childhood Obesity

Georgia Southern University researchers are looking for ways to prevent and reduce childhood obesity by connecting pregnant women with an online health education course. The research is geared towards promoting preventative measures in the earliest stages of prenatal development by offering the course and promoting physical activity among pregnant women.

Researchers from Georgia Southern’s College of Health and Human Sciences have been awarded $24,844 by the University System of Georgia to study women in their first trimester of pregnancy. They have teamed up with faculty colleagues from the University of Georgia, the Medical College of Georgia and East Georgia Regional Medical Center for the study.

“The state of Georgia ranks the third highest in the nation for childhood obesity with one in three children who are overweight or obese,” said Bridget Melton, Ed.D., coordinator of the study and director of the University’s Physical Activity Healthful Living Program, “and this study will help people understand the risks of childhood obesity.”

Melton says nationwide studies have revealed a critical link between childhood obesity and a mother’s health behavior and weight gain during pregnancy.

“Some women feel that it is unsafe to start an exercise routine or maintain one during pregnancy, and we are going to dispel the myths of unsafe exercise,” said Melton. “Hopefully, if women understand the benefits and the safety concerns of exercise during pregnancy they will be more likely to continue being physically active throughout their pregnancy,” she said.

Women will receive a nutrition education packet and personal pedometer.  The women will be given a pre and post 30 minute survey and their physical activity patterns will be analyzed during each trimester.  The women will also take part in an online course that will explore the benefits and precautions of exercise during pregnancy. The course will include information about the importance of physical activity, safe exercise programs, nutrition, improving pregnancy outcomes and childhood obesity. Additionally, participants will have the opportunity to join online discussions, complete quizzes and question/answer sessions for reinforcement and feedback. “The discussions and blogs offer a great platform for social networking with peers and the women will develop a strong bond online,” said Melton. Upon successful completion of the study, all participants will receive a total of $50 in gift cards from Wal-Mart.

Recruitment for the 50 participants is now underway for the year-long study. Those who would like to participate must be Bulloch County area residents who are at least 18 years old and in their first trimester of pregnancy. For more information, or to participate in the study, call 912-478-1976 or e-mail jn00964@georgiasouthern.edu.

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'Legacy of Katrina' Report Details Impact of Stalled Recovery on Mental Health Status of Children

/PRNewswire/ -- Five years ago Hurricane Katrina and the flooding of New Orleans caused the evacuation of 1.5 million Gulf Coast residents. After a year, 500,000 people remained displaced, many residing in highly transitional shelters, including the notorious FEMA trailer parks. Now at the five-year mark, substantial consequences from this prolonged displacement have resulted in widespread mental health issues in children living in the region, according to a new study by the National Center for Disaster Preparedness (NCDP) at Columbia University's Mailman School of Public Health and a related white paper from the Children's Health Fund (CHF). Together, these documents indicate that although considerable progress has been made in rebuilding the local economy and infrastructure, there is still an alarming level of psychological distress and housing instability. Investigators believe that housing and community instability and the uncertainty of recovery undermine family resilience and the emotional health of children. These factors characterize what researchers are calling a failed recovery for the Gulf region's most vulnerable population: economically disadvantaged children whose families remain displaced.

The CHF report, "Legacy of Katrina: The Impact of a Flawed Recovery on Vulnerable Children of the Gulf Coast," expands upon on a study by NCDP researchers, who have followed a cohort of more than 1,000 families affected by Katrina and the ensuing disruption. According to the Gulf Coast Child & Family Health Study, funded by the Children's Health Fund and published in the current issue of American Medical Association's Journal of Disaster Management and Public Health Preparedness, the widespread mental health problems still experienced by Gulf Coast children serve as a barometer for the failed recovery of their families and their communities. Over one-third of the children in displaced families have been clinically diagnosed with at least one mental health problem since Katrina -- with behavioral and conduct disorders the most common of these problems. Yet fewer than 50% of parents seeking needed mental health counseling for their children were able to access professional services. Furthermore, nearly half of the households in the study were still living in unstable conditions and, five years later, 60% of respondents still report their situation as being unstable or worse than it was before Katrina.

"This study points to a major crisis facing the children of the post-Katrina Gulf Region," says Irwin Redlener, M.D., director of the National Center for Disaster Preparedness at Columbia's Mailman School of Public Health and president of the Children's Health Fund. "From the perspective of the Gulf's most vulnerable children and families, the recovery from Katrina and the flooding of New Orleans has been a dismal failure."

"Previous studies have demonstrated a significant increase in the prevalence of anxiety, depression, and post-traumatic stress disorder, following Hurricane Katrina, as well as a rise in violence and suicide," said Italo Subbarao D.O., MBA, deputy editor of AMA's Disaster Medicine and Public Health Preparedness Journal. "This study adds further credence to widely accepted views that adults and children affected by catastrophic emergencies can experience up to a 40% increase in mental and behavioral illness."

According to David M. Abramson, Ph.D., MPH, director of research at the NCDP and senior author of the study which looked at the roles of parents and communities in children's recovery, "Children are completely dependent upon others in their lives to provide the security and stability that will help them recover. This suggests that the many support systems in children's lives - their parents, their communities, and their schools - are not yet functioning properly. The slow recovery of children's mental health in Gulf Coast populations is a bellwether indicator of how well the region is recovering."

Additional key findings:

-- Even as long as four and a half years after the event, about 45% of
parents report that their children are experiencing emotional or
psychological problems that they hadn't experienced prior to Katrina.

-- Children post-Katrina are 4.5 times more likely to have serious
emotional disturbance than pre-Katrina. For the purposes of this
study, such disturbances were defined as emotional issues,
hyperactivity, conduct and problems relating to peers.

-- Nearly half of people who had been displaced for over a year by
Katrina are still living in unstable conditions.


The study findings are supported by clinical data from the Children's Health Fund, which provides mobile clinics that travel to underserved areas in the Gulf Coast to provide care for families and children. In the period of June 2009 through June 2010, despite improvement in housing conditions in Louisiana, psychiatric, developmental or learning-related disorders in children were diagnosed as frequently as respiratory illness. And in New Orleans alone, approximately 30,000 school children were not able to return to public school. However, data also shows that children who were relocated sooner did better in school than students with longer periods of displacement and those who were enrolled in higher performing schools did the best, thus highlighting the importance of social systems in a child's post-disaster recovery.

Both the study and the clinical reports from the Children's Health Fund's Gulf Coast pediatric programs paint a clear picture of how insufficient government response and recovery efforts continue to take a toll on children's welfare, especially those who are the most underserved. Dr. Redlener, a pediatrician and professor at Columbia University's Mailman School of Public Health, outlined a number of implications for policymakers and others: "Affected families need urgent assistance to return to a state of 'normalcy' characterized by safe communities and stable housing. Nearly two out of three children affected by Katrina continue to experience serious mental and behavioral problems or the stress of unstable housing or both, with children living in poverty over two times as susceptible to serious emotional disorders. We believe that this represents at least 20,000 children affected by Katrina--and perhaps considerably more. Immediate action needs to be taken to increase mental health services in the region."

Dr. Redlener continues, "And it's not just clinical services that are needed by these marginalized families. Every effort must be made to rapidly bring back a 'state of normalcy', that is, stable safe housing for every family in communities with appropriate access to essential services and economic stability."

The Gulf Coast Child & Family Health Study has collected mental health data in the Gulf Coast since January 2006 and covers a random sample of 1,079 households in Louisiana and Mississippi, including 427 children. Face-to-face interviews were conducted by trained interviewers, and the key outcome variable was Serious Emotional Disturbance, based upon the Strengths and Difficulties Questionnaire (SDQ), a widely validated diagnostic screener. The data were collected in four waves over the course of four years with the majority of data for this analysis drawn from the fourth round of data, collected through March 2010.

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Robots to Help Children With Autism

/PRNewswire/ -- Interbots, Inc., a high-tech spin-off company associated with the Carnegie Mellon University Entertainment Technology Center has teamed up with the Autism Center of Pittsburgh to provide innovative robot-based therapy for children with autism.

The program, "Character Therapy," through the use of the Interbot robot "Popchilla" will test the ability of children with autism with limited or no verbal skills.

According to Seema Patel, CEO and co-founder of Interbots, "We've had numerous individuals tell us our robots could be tremendous tools for Autism therapy. We're excited to be working with the Autism Center of Pittsburgh and the Sprout Foundation to take this first step. We're going to learn a lot from the next few months."

"The premise behind the program is that children with autism are sometimes more likely to communicate with a non-human entity," said Cindy Waeltermann, Founder and Director of the Autism Centers of Pittsburgh. "When you have a child with autism, you use whatever interests them to gain access into their world. The idea is to bridge the gap between their word and ours.

Popchilla will be used in the first phase of the program with a trained therapist. Programmers and developers at Interbots have created an iPad application that will allow the therapist to direct sessions, which will eventually be transitioned to allow the child to control the robot through an iPad application to identify emotions.

According to Waeltermann, "By using Popchilla as an intermediary, we hope to increase the understanding of the child's internal feelings, thus reducing behavioral frustrations. If they are able to identify that they are 'angry' and what 'angry' means, it can significantly help them understand what they are feeling, reducing behavioral ramifications."

The program is funded by Spark. Spark is an initiative of The Sprout Fund catalyzing projects and programs that engage children ages birth to eight through the creative use of technology and media. Spark challenges individuals, organizations, and communities to generate inventive technology-based solutions to the issues and opportunities facing today's young child. Through its funding opportunities and extensive network of support, Spark is unleashing the innovative potential of Southwestern Pennsylvania and transforming our region into one of the best places on earth to be a kid.

"Our emphasis has always been making the use and control of our robots as simple and flexible as possible. You don't need to have a technical background to control our characters. You can control them with a variety of other familiar devices. So that opens a lot of interesting applications - like having a therapist or a parent use our robots as a tool to interact with children - even the possibility of kids using the robot to express themselves and explore emotions on their own," according to Sabrina Haskell, Interbots, Designer & Co-Founder.

The iPad application is currently in production and the program is slated to begin this fall.

"Nobody is more excited than the parents of the children with autism who have the potential to gain great strides from this program," said Cindy Waeltermann. "That's what this is all about -- thinking outside the box to reach these kids."

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FDA Approves Drug for Chronic Drooling in Children

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Cuvposa (glycopyrrolate) Oral Solution to treat chronic severe drooling caused by neurologic disorders in children ages 3 years to 16 years.

Drooling is normal in infants. But a significant proportion of the developmentally disabled population experiences drooling caused primarily by neuromuscular dysfunction that makes it hard to swallow. Cuvposa reduces drooling by lowering the volume of saliva produced.

Glycopyrrolate was approved decades ago to treat peptic ulcers and reduce salivation in patients under anesthesia. Until now, glycopyrrolate has been used on an off-label basis to treat drooling in the developmentally disabled population, but in a different dosage form than the approved product. A drug is said to be used off-label when a physician prescribes its use in a different way than described in the FDA-approved drug label.

In 2001, the FDA held an advisory committee meeting to discuss how best to develop products for drooling with ethically and scientifically sound trials in children who have neurological disorders. Utilizing the advice provided, the FDA has been able to move forward in addressing the needs of this population.

"Cuvposa provides an important therapy for controlling salivation in patients with neurologic disease," said John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "FDA approval not only ensures that the product meets modern standards for safety, effectiveness, quality and labeling; but, also results in a more suitable dose form for this patient population."

The FDA drug approval process provides a review of product-specific information that is critical to ensuring the safety and efficacy of a finished drug product. For instance, the applicant must demonstrate that its manufacturing processes can reliably produce drug products of expected identity, strength, quality, and purity. FDA's review of the applicant's labeling ensures that health care professionals and patients have the information necessary to understand a drug product's risks and its safe and effective use.

When used off label, oral tablets of glycopyrrolate had to be crushed to treat drooling in children with neurological disorders. Cuvposa is a flavored oral solution that is easier to administer and provides the optimal dose for each patient.

In clinical trials of Cuvposa glycopyrrolate oral solution, 78 percent of the children on the drug reached clinical improvement in drooling compared with 19 percent of those given an inactive substance (placebo).

Common adverse reactions reported with glycopyrrolate are dry mouth, constipation, flushing, and urinary retention.

Cuvposa (glycopyrrolate) Oral Solution is marketed by Shionogi Pharma Inc. of Osaka, Japan.

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A Better Genetic Test for Autism

/PRNewswire/ -- A large study from Children's Hospital Boston and the Boston-based Autism Consortium finds that a genetic test that samples the entire genome, known as chromosomal microarray analysis, has about three times the detection rate for genetic changes related to autism spectrum disorders (ASDs) than standard tests. Publishing in the April issue of Pediatrics (and online March 15), the authors urge that CMA become part of the first-line genetic work-up for ASDs.

Expectant parents who have family members with ASDs, as well as families who already have an affected child, often request genetic testing. However, there is still only limited knowledge about actual causative genes. The currently recommended tests (karyotyping to look for chromosomal abnormalities and testing for Fragile X, the single largest known genetic cause of ASDs) often come up negative. Chromosomal microarray analysis (CMA) is a genome-wide assay that examines the chromosomes for tiny, sub-microscopic deletions or duplications of DNA sequences, known as copy-number variants.

CMA offers about 100-fold greater resolution than standard karyotyping. However, since it is new, it is often considered a second-tier test. Depending on where a person lives, or what insurance they have, CMA may not be covered by health insurance. "Based on our findings, CMA should be considered as part of the initial clinical diagnostic evaluation of patients with ASDs," says Bai-Lin Wu, PhD, Director of Children's DNA Diagnostic Lab in the Department of Laboratory Medicine, which has offered CMA to families since 2006.

The research team, led by co-senior authors Wu (heading the Children's team), and David Miller, MD, PhD, of Children's Division of Genetics and Department of Laboratory Medicine (heading the Autism Consortium team), assessed the diagnostic value of CMA in the largest cohort to date - 933 patients with a clinical diagnosis of ASD (by DSM-IV-TR criteria) who received clinical genetic testing in 2006, 2007 and 2008.

Half were Children's patients who had their samples submitted to the hospital's DNA Diagnostic Laboratory, and the others were recruited through the Autism Consortium, a research and clinical collaboration of five Boston-area medical centers. Nearly half of the patients were diagnosed with autistic disorder, nearly half with PDD-NOS (pervasive developmental disorder - not otherwise specified) and about 3 percent with Asperger disorder. Ages ranged from 13 months to 22 years.

Testing included the two currently used tests (G-banded karyotype and fragile X), as well as CMA. When the researchers compared the tests' diagnostic yield, they found:

-- Karyotyping yielded abnormal results in 2.23 percent of patients
-- Fragile X testing was abnormal in 0.46 percent
-- CMA results were judged to be abnormal in 7.3 percent of patients when
the entire length of the chromosomes (the whole genome) was sampled.


Extrapolating from these results, the researchers estimate that without CMA, genetic diagnosis will be missed in at least 5 percent of ASD cases. CMA performed best in certain subgroups, such as girls with autistic disorder, and past studies indicate that it also has a higher yield in patients with intellectual disability (who constituted only 12 percent of this sample).

"CMA clearly detects more abnormalities than other genetic tests that have been the standard of care for many years," says Miller. "We're hoping this evidence will convince insurance companies to cover this testing universally."

In all, roughly 15 percent of people with autism have a known genetic cause. Establishing a clear genetic diagnosis helps families obtain early intervention and services for autism, and helps parents predict the possibility of having another child with autism.

In addition, by pinpointing bits of chromosomes that are deleted or duplicated, CMA can help researchers zero in on specific causative genes within that stretch of DNA. They can also begin to classify patients according to the type of deletion or duplication they have, and try to find specific treatment approaches for each sub-type of autism.

"Just in the last two years, a number of studies have revealed the clinical importance of ever smaller chromosome deletions and duplications found with advanced microarray technology," says Wu. "These new, highly-efficient tests can help in the evaluation or confirmation of autism spectrum disorders and other developmental disorders, leading to early diagnosis and intervention and a significantly improved developmental outcome."

Two known chromosome locations - on chromosome 16 (16p11.2) and chromosome 15 (15q13.2q13.3) accounted for 17 percent of abnormal CMA findings. Both chromosome abnormalities were initially linked with ASDs by Children's Hospital Boston and collaborators in The New England Journal of Medicine and the Journal of Medical Genetics, respectively, in 2008. Children's now offers specific tests targeting both of these "hot spots."

However, the researchers note that most copy-number changes were unique or identified in only a small number of patients, so their implications need further study. Many of them are presumed to be related to ASDs because they involve important genes, cover a large region of the chromosome, or because the child is the first person in that family to have the change.

"Some deletions and duplications are rare and specific to one individual or one family," says Miller. "Learning about them is going to be an evolving process. There won't be one single test that finds all genetic changes related to autism, until we completely understand the entire genome."

The paper's co-first authors were Autism Consortium members Yiping Shen, PhD, of Children's Department of Laboratory Medicine and the Center for Human Genetic Research at Massachusetts General Hospital, and Kira Dies, ScM, LGC, of the Family Research Network of the Autism Consortium and Children's Multi-Disciplinary Tuberous Sclerosis Program. A number of specialists from Children's Departments of Neurology, Developmental Medicine and Clinical Genetics and physicians from other medical centers in greater Boston were also authors on the study. The research was supported by the Nancy Lurie Marks Family Foundation, the Simons Foundation, Autism Speaks and the National Institutes of Health.

Families interested in scheduling an appointment at Children's may call the Developmental Medicine Center (617-355-7025) or the Department of Neurology (617-355-2711).

Citation: Shen Y; et al. Clinical genetic testing for patients with autism spectrum disorders. Pediatrics 2010 Apr; 125(4):e1-e17. (Published online March 15)

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FDA Approves Pneumococcal Disease Vaccine with Broader Protection

The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

Prevnar 13 is approved for the prevention of invasive disease caused by 13 different serotypes of the bacterium Streptococcus pneumoniae. It also is approved for the prevention of otitis media caused by the seven serotypes shared with Prevnar. The bacterium can cause infections of the blood, middle ear, and the covering of the brain and spinal cord, as well as pneumonia.

“Although the rates of invasive pneumococcal disease have declined dramatically, there are still children in the United States who are suffering with this serious illness,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “The availability of Prevnar 13 will help prevent pneumococcal disease caused by the six additional serotypes.”

The seven Streptococcus pneumoniae serotypes against which Prevnar is directed accounted for about 80 percent of IPD in young children in North America at the time that the vaccine was licensed. With the use of Prevnar, by 2007 the overall rate of IPD caused by these seven serotypes in children less than 5 years old was reduced by 99 percent. However, at that time, it was also shown that of the remaining invasive pneumococcal disease in this age group, 62 percent are caused by the six additional serotypes that will be included in Prevnar 13.

Safety was evaluated in 5,084 infants and young children who received Prevnar 13, compared with 2,760 who received Prevnar, the control vaccine. Common adverse reactions reported after administration of Prevnar 13 were pain, redness and swelling at the injection site, irritability, decreased appetite and fever. These reactions were similar to what has been observed with Prevnar, which has a good safety record in the United States.

Vaccine effectiveness was assessed in a randomized U.S. multi-center immunogenicity study. Prevnar 13 post-vaccination antibody response comparisons to Prevnar were evaluated by several immunological measures. An evaluation of all these measures showed that Prevnar 13 induced antibodies that were comparable to those shown to be protective in Prevnar.

Post marketing studies will include continued monitoring for reduction in IPD and otitis media, as well as continued evaluation of safety.

The vaccine is administered in a four-dose schedule given at 2, 4, 6 and 12-15 months of age. The vaccine is available in single-dose, pre-filled syringes.

Prevnar 13 is manufactured by Wyeth Pharmaceuticals Inc. of Collegeville, Pa., a wholly owned subsidiary of Pfizer Inc.

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Type 2 Diabetes Gene Predisposes Children to Obesity

/PRNewswire/ -- Pediatric researchers have found that a gene already implicated in the development of type 2 diabetes in adults also raises the risk of being overweight during childhood. The finding sheds light on the genetic origins of diabetes and may present an avenue for developing drugs to counteract the disease, which has been on the upswing in childhood and adolescence.

Researchers from The Children's Hospital of Philadelphia and the University of Pennsylvania School of Medicine published the study Nov. 23 in the online version of the journal Diabetes.

"It has been a bit of a mystery to scientists how or even if these adult diabetes genes function during childhood," said study leader Struan F.A. Grant, Ph.D., a researcher and associate director of the Center for Applied Genomics of The Children's Hospital of Philadelphia. "This finding suggests that there may be genetic activity during childhood that lays the foundation for the later development of type 2 diabetes."

Type 2 diabetes occurs either when the pancreas produces too little insulin, or when the body cannot efficiently use the insulin that is produced because the cells have become resistant. Formerly called adult-onset diabetes and still most common in adults, type 2 diabetes has been increasing sharply among children and teenagers.

Grant and study co-leader Hakon Hakonarson, M.D., Ph.D., director of the Center for Applied Genomics at Children's Hospital, investigated 20 gene variants, known as single nucleotide polymorphisms (SNPs), previously reported to be associated with type 2 diabetes. The researchers drew on a cohort of nearly 7,200 Caucasian children, aged 2 to 18 years, in an ongoing genome-wide association study of childhood obesity at Children's Hospital. Dividing the cohort randomly in half allowed the team to follow their discovery study with a replication study.

Researchers continue to unravel the complicated role of different diabetes-related genes in influencing body weight toward both lower and higher ends of the scale. The risk of developing type 2 diabetes in adulthood is often influenced by factors in the first year of life, including lower birth weight, as well as by higher body mass index (BMI) during childhood. Obesity is a well-known risk factor for type 2 diabetes.

A previous study earlier this year by the same study team found that another type 2 diabetes gene, CDKAL1, affects fetal growth and increases the likelihood that a baby will be underweight at birth.

The current study found that the gene HHEX-IDE does not affect birth weight, but makes it more likely that a child will become obese during childhood. The gene does not appear to predispose to obesity in adults, although by contributing to childhood obesity, it may set the stage for type 2 diabetes in adulthood.

Grant cautioned that HHEX-IDE accounts for only a small proportion of the genetic contribution to the risk of type 2 diabetes, so many other gene variants remain to be discovered. However, he adds, HHEX-IDE may represent an important underpinning of the disease. "Previously we thought that this gene affects insulin production during adulthood, but we now see that it may play an early role in influencing insulin resistance through its impact on body size during childhood," said Grant. "One implication is that if we can develop medicines to target specific biological pathways in childhood, we may be able to prevent diabetes from developing later in life."

The National Institutes of Health, the Cotswold Foundation and The Children's Hospital of Philadelphia supported this study.

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$10 Million in Grants Aimed at Enrolling American Indian, Alaska Native Kids in Health Care to be Awarded

HHS Secretary Kathleen Sebelius today announced the availability of up to $10 million in grants to help reach American Indian and Alaska Native (AI/AN) children who qualify for, but are not yet enrolled, in Medicaid and the Children's Health Insurance Program (CHIP).

These new grants are part of a broader effort to find and enroll uninsured children who are eligible for Medicaid or CHIP but not enrolled. The Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) set aside $100 million for fiscal years 2009-2013
expressly to help find and enroll eligible uninsured children, including $10 million specifically for Indian health providers.

As called for in CHIPRA, grants will be awarded by the Centers for Medicare & Medicaid Services (CMS) to applicants whose outreach, enrollment and retention efforts will target geographic areas with high rates of eligible but uninsured American Indian and Alaska Native
children, who often live in isolated areas and are uninsured at higher-than-average rates.

"American Indian children are often uninsured, although many are eligible for Medicaid and CHIP," Secretary Sebelius said. "These grants will help Tribes and Indian health providers reach out to children and families to ensure more children get the health care they need."

Grants will be awarded to applicants that will be able to demonstrate increases in enrollment and improved retention of children already in Medicaid and CHIP. Grantees will report to CMS the number of new enrollees and those who retained coverage that are directly attributable
to the grant activities. Grantees will also report activities they believe were the most effective in finding, enrolling and maintaining coverage for eligible children.

"States have been effective in enrolling over 28 million children in Medicaid and more than 7 million children in CHIP, but there are still millions of uninsured, low-income children who are not enrolled in these programs even though they are eligible" said Cindy Mann, the director of
the CMS Center for Medicaid and State Operations. "We are looking forward to innovative grant proposals that will put new outreach, enrollment and renewal systems in place to ensure that uninsured Indian children get enrolled and stay enrolled for as long as they are eligible."

Applications are due by Jan. 15, 2010, and the grants will be awarded on April 15. Grants will be available to:

* The Indian Health Service;
* Tribes and Tribal organizations operating a health program; and,
* Urban Indian organizations operating a health program.

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FDA Expands Use of CSL Limited’s Seasonal and H1N1 Vaccines to Infants and Children

The U.S. Food and Drug Administration has approved the use of the CSL Limited’s seasonal and 2009 H1N1 influenza vaccines to include children ages 6 months and older. These vaccine were previously approved for use in adults, ages 18 years and older

“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of vaccines available for use in children is an important step in responding to the H1N1 outbreak,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

The company’s 2009 H1N1 vaccine is manufactured and tested using the same well-established licensing processes that have been in place for many years for the company’s seasonal flu vaccine.

The approval was based on a study of the company’s seasonal flu vaccine in children, showing both the vaccine's safety and its ability to induce antibodies expected to protect against influenza. These findings supported approval under FDA's accelerated approval regulations, which help safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.

Common adverse events experienced by children after administration of seasonal and H1N1 vaccines typically include pain, redness and swelling at the injection site as well as, in some cases, irritability, loss of appetite and drowsiness.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Because CSL’s seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products.

The vaccines will be available both in single-dose, preservative-free, pre-filled syringes and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative.

Both vaccines are manufactured by CSL Ltd. of Australia.

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FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children

The U.S. Food and Drug Administration has approved the use of the CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.

“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children’s vaccines available is an important step in responding to the H1N1 outbreak,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

The company’s 2009 H1N1 vaccine is manufactured and tested using the same well-established licensing processes that have been in place for many years for the company’s seasonal flu vaccine. The expanded approval also covers the company’s seasonal flu vaccine.

The approval was based on a study of the company’s seasonal flu vaccine in children showing the vaccine's safety and efficacy in inducing antibodies to protect against influenza. These efficacy findings supported approval under FDA's accelerated approval regulation, which helps safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.

Common adverse events experienced by children after administration of seasonal and H1N1 vaccines typically include pain, redness and swelling at the injection site as well as, in some cases, irritability, loss of appetite and drowsiness.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Because CSL’s seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products.

The vaccines will be available in single-dose, preservative-free, pre-filled syringes and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative.

Both vaccines are manufactured by CSL Ltd. of Australia.

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Emory, Georgia Tech, Children's Healthcare of Atlanta Team Up on Kidney Replacement Devices for Kids

When children need kidney dialysis because of disease or congenital defects, doctors are forced to adapt adult-size dialysis equipment. No FDA-approved kidney replacement devices exist that are specifically designed for children.

To address this problem, physicians and researchers from Emory University, Children’s Healthcare of Atlanta and the Georgia Institute of Technology have teamed up to develop a kidney replacement device capable of treating children.

Over the past five years, the three institutions have further solidified a cohesive relationship aimed at medical discovery, quality-care improvement and health care innovation.

The team has been awarded a Challenge grant of $1 million from the National Institutes of Health (NIH) to refine a prototype device. The grant is part of the American Recovery and Reinvestment Act (ARRA) funding. Challenge grants are part of a new NIH program to stimulate rapid advances in focused disease areas.

Matthew Paden, MD, assistant professor of pediatrics (critical care) at Emory University School of Medicine and a physician at Children’s Healthcare of Atlanta, is the grant’s principal investigator. Ajit P. Yoganathan, PhD, Regents’ Professor of biomedical engineering in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, is the grant’s co-investigator.

“The adaptations doctors are forced to perform make adult kidney replacement devices inaccurate and potentially dangerous when used with kids,” Paden says. “We have invented a new continuous renal replacement therapy device that is designed specifically with kids in mind. It can be used accurately on a six-pound child, all the way up to a football linebacker.”

In the United States, it is estimated that at least 5,000 children per year, or 1 percent of the 500,000 children admitted to intensive care units, require some form of renal replacement therapy. Children may need kidney replacement therapy because of severe infections that lead to the kidney-damaging inflammatory condition called sepsis, or because of congenital defects, which can only be permanently remedied by a kidney transplant.

Paden says adult dialysis equipment can have a tendency to withdraw too much fluid from a pediatric patient, leading to dehydration and loss of blood pressure. Other possible problems resulting from inaccurate dialysis equipment include clotting or internal bleeding. Part of the problem is that the volume of blood required to fill up the tubes leading to and from the apparatus is too large, Paden says. As the child gets smaller, the proportion of blood outside the body gets larger.

Existing dialysis equipment for adults takes up space comparable to a refrigerator, while Paden says the team’s goal is to have a pediatric device the size of a shoebox.

The inventors:

Lakshmi Prasad Dasi, PhD, former research engineer at Georgia Tech, now assistant professor of mechanical engineering at Colorado State University.
James Fortenberry, MD, pediatrician in chief and medical director of critical care for Children’s Healthcare of Atlanta, and clinical associate professor of pediatrics (critical care) at Emory School of Medicine
Matthew Paden
Ajit Yoganathan

The team’s plan is to test their prototype in the laboratory and prepare for live experiments over the next two years, with the goal of being ready for clinical trials in five years.

“This is a project where we are taking technology from the laboratory bench to the basinet,” Yoganathan says. “First, we have to build a machine capable of reliably performing these tasks without damaging blood cells in the process.”

The team’s prototype device is also designed to work in tandem with equipment that replaces the function of the heart and lungs for severely ill patients. Extracorporeal membrane oxygenation (ECMO) equipment is commonly used in neonatal intensive care units for newborns whose lungs can’t work properly. Children requiring ECMO often have fluid overload and swelling. The demand for ECMO has been rising because of H1N1 influenza, which in severe cases leads to respiratory failure.

Emory, Georgia Tech and Children’s Healthcare of Atlanta are in the process of patenting the kidney replacement device. As the technology is developed further, it could be licensed to an existing company or a new start-up company.

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FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use

The U.S. Food and Drug Administration today approved use of the seasonal influenza vaccine Fluarix for children ages 3 years to 17 years. Previously, this vaccine, which contains inactivated (killed) influenza A and B viruses, had been approved for use in adults, ages 18 years and older.

The safety and effectiveness of Fluarix for use in children ages 3 years and older is documented by a U.S. study comparing 2,115 children who received Fluarix with 1,210 children who received Fluzone, a different influenza vaccine already licensed by the FDA for use in children ages 6 months and older. Study results showed that children 3 years and older vaccinated with Fluarix and Fluzone produced similar amounts of antibodies in the blood at levels considered likely to be protective against seasonal influenza.

Fluarix is a seasonal influenza vaccine not intended to protect against the 2009 H1N1 influenza virus.

"This approval of an additional seasonal influenza vaccine for children provides help in protecting them against influenza,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research. “Children are very vulnerable to the influenza virus and are more likely to be hospitalized for associated problems.”

With today’s approval, there are now four companies approved by the FDA to manufacture seasonal influenza vaccine for use in children.

Influenza is far more dangerous than the common cold for children, who often require medical care, especially if they are younger than 5 years. It is best to vaccinate children each fall, but vaccination also can occur in the winter months when influenza season often peaks.

Common adverse events experienced after administration of Fluarix are typical of those for flu shots and include pain, redness, and swelling at the injection site as well as irritability, loss of appetite, and drowsiness.

Because Fluarix contains a small amount of egg protein, it should not be administered to anyone allergic to eggs or egg products.

Fluarix is manufactured by GlaxoSmithKline Biologicals of Dresden, Germany.

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Secretary Sebelius Awards $40 Million to States to Find, Enroll Children in CHIP, Medicaid

Georgia grantees are West End Medical Centers Inc and Medical College of Georgia Research Institute.

HHS Secretary Kathleen Sebelius today announced $40 million in grants to 69 grantees in 41 states and the District of Columbia to help them find and enroll children who are uninsured but eligible for either Medicaid or the Children's Health Insurance Program (CHIP).

"Today's awards will help fulfill President Obama's pledge to assure the health and well-being of our nation's children," said Secretary Sebelius. "With millions of Americans either out of work or otherwise struggling to make ends meet during this recession, there is an even greater urgency to bring steady, reliable health care to children in these families who may have lost their coverage."

Recognizing that millions of children are eligible for Medicaid or CHIP, but are therefore needlessly uninsured, the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) set aside $100 million for fiscal years 2009-2013 expressly to help find and enroll eligible children. Of the total outreach amount, $80 million will be given to states and other organizations, $10 million to Tribal organizations and $10 million for a national outreach effort. Today's awards are for a two year period ending Dec. 31, 2011, which will then be followed by a
second round of $40 million in new grants.

As called for in CHIPRA, grants were awarded to applicants whose outreach, enrollment and retention efforts will target geographic areas with high rates of eligible but uninsured children, particularly those with racial and ethnic minority groups who are uninsured at higher than-average rates. For example, 20 percent of the projects to be funded will target Hispanic children, with an emphasis on Hispanic teens, and 11 percent will focus on homeless children and seven percent will be aimed at Native American/Alaska Native children.

The vast majority of grantees will be using multiple, community-based approaches. One grantee in Missouri, for example, will work with a consortium of 35 churches in low-income, minority communities. Those parishioners will go door-to-door to locate potentially eligible children and then help those families apply for CHIP or Medicaid coverage. Another grantee will place self-service kiosks in community centers and Native American Chapter Houses (community halls) where there will also be staff available to help with applications if needed. One state school system will track children who receive free or reduced cost lunches and, with the families' permission, share that information with state health programs, which will, in turn, mail applications for CHIP and Medicaid to those families. The state will also provide one-on-one-assistance with those applications.

The grant awards require that recipients be able to show actual increases in enrollment and retention of children already in the programs. Both CHIP and Medicaid state agencies are to report to the Centers for Medicare & Medicare Services (CMS) the number of new enrollees and those who retained coverage that are directly attributable to the grant activities. Grantees are also to report activities they believe were the most effective in finding, enrolling and maintaining
children in these benefit programs.

"No child in America should go without decent health care," said Cindy Mann, director of the Center for Medicaid and State Operations -- the group within CMS that will administer the grants. "With the funds we are awarding today we hope to reduce the number of children who do."

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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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FDA Approves XYZAL(R) For Use In Children Age Six Months And Older For The Relief Of Perennial Allergic Rhinitis And Chronic Idiopathic Urticaria

/PRNewswire/ -- UCB and sanofi-aventis U.S. announced today that the U.S. Food and Drug Administration (FDA) has approved XYZAL (levocetirizine dihydrochloride) for children age six months and older for the relief of symptoms of perennial allergic rhinitis (indoor allergies) and chronic idiopathic urticaria (chronic hives) and for children age two years and older for symptoms of seasonal allergic rhinitis (outdoor allergies). Until now, XYZAL , a once-daily prescription antihistamine in both tablet and liquid formulations, has been used to treat symptoms of indoor and outdoor nasal allergies, as well as chronic idiopathic urticaria in patients age six years and older.

"There are options for treating nasal allergies in young children, one of which is XYZAL . The availability of a liquid treatment with the established safety and efficacy of XYZAL provides caregivers a new treatment option that can help relieve nasal allergy symptoms in young patients once diagnosed by a physician," said Michael Blaiss, M.D., clinical professor of pediatrics and medicine at the University of Tennessee Health Science Center; past president of the American College of Allergy, Asthma, and Immunology (ACAAI) and co-editor of the Atlas of Allergic Diseases.

Nasal allergies are currently the most common chronic condition found in children, with allergic rhinitis believed to affect as many as 40 percent of U.S. children. Recognizing the symptoms and increased hereditary risk are key elements to ensuring early diagnosis and proper management. A child with one parent living with allergies has a 48 percent chance of developing allergies, while a child with two parents living with allergies has a 70 percent chance of developing allergies.

XYZAL tablets received FDA approval on May 25, 2007 and XYZAL oral solution received FDA approval on February 19, 2008.

In September 2006, UCB and sanofi-aventis U.S. entered into an agreement to launch and co-market XYZAL in the U.S. UCB and sanofi-aventis U.S. have a long history in the nasal allergy treatment arena and are committed to advancing treatment for nasal allergy sufferers and helping meet unmet medical needs for patients with chronic nasal allergy symptoms.

About Allergic Conditions

Many people suffer from the symptoms associated with common allergic conditions. The immune system of nasal allergy sufferers overreacts to something in the environment, leading to symptoms that affect their respiratory system, eyes, or skin. Experts estimate indoor and outdoor nasal allergies affect as many as 40 million people in the U.S.

Seasonal allergic rhinitis (SAR), commonly referred to as "hay fever" or "outdoor allergies," is the most common form of allergic rhinitis. By definition, SAR includes nasal allergies to seasonal pollens like grass, trees, and weeds, as well as mold. Perennial Allergic Rhinitis (PAR) is sometimes referred to as "year round" or "indoor allergies" and is characterized by allergic symptoms that last longer than four weeks. House dust mites, animal dander, and mold most commonly trigger PAR. Chronic Idiopathic Urticaria (CIU) is most commonly known as "chronic hives of unknown origin" and is defined as the occurrence of daily, or almost daily, wheals and itching for at least six weeks with no obvious causes.

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Sabril Approved by FDA to Treat Spasms in Infants and Epileptic Seizures

Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.

Sabril (vigabatrin) Tablets have been approved for adult use in combination with other medications to treat complex partial seizures that have not responded adequately to previous drug therapies.

“Seizures can cause impaired nervous system function and reduced quality of life,” said Russell Katz, M.D., director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research. “Infantile spasms in children this young are very serious and this approval provides these patients and their parents a treatment option.”

Infantile spasms consist primarily of a sudden bending forward of the body with stiffening of the arms and legs; some children arch their backs as they extend their arms and legs. Spasms tend to occur upon awakening or after feeding, and often occur in clusters of up to 100 spasms. Infants may have dozens of clusters and several hundred spasms per day. Many underlying disorders, such as birth injury, metabolic disorders, and genetic disorders can give rise to spasms, making it important to identify the underlying cause. In some children, no cause can be found.

Epilepsy is a neurological condition that produces disturbances in the normal electrical functions of the brain, causing people to have recurring seizures. Seizures happen when nerve cells, or neurons, in the brain send out the wrong signals. People may have strange sensations and emotions or behave strangely. They may have violent muscle jerking, which may be repetitive, or lose consciousness.

Damage to vision is an important safety concern with the use of Sabril. The drug will have a boxed warning to alert health care professionals to this risk of a progressive loss of peripheral vision with potential decrease in visual acuity. The risk of vision damage may increase based on the dosage and duration of use, but even the lowest doses of Sabril can cause vision damage. Periodic vision testing is required for those taking Sabril. Because of the risk of permanent vision damage, the drug will be available only through a restricted distribution program.

Sabril was designated as an orphan drug by the FDA for use in treating infantile spasms. A drug is eligible for orphan drug designation if it is intended to treat a disease or condition that affects less than 200,000 people in the United States. Orphan drug status provides the company with financial incentives to promote the development of a drug to treat a rare disease or condition.

Sabril is made by Lundbeck Inc. of, Deerfield, Ill.

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