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    <recommendedItem id="20100101_19_432"
                     title="Short Needle May Short HBV Protection for Obese (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/Pediatrics/Vaccines/tb/18348?impressionId=1265779562092"
                     
      &lt;p&gt;Obese adolescents and young adults may not generate an adequate immune response to hepatitis B (HBV) vaccine because the needles used to vaccinate them are too short, a randomized study suggests.&lt;/p&gt;
&lt;p&gt;Immunization with a 1.5-inch needle was associated with 80% higher anti-HBV titers than a 1.0-inch needle, researchers reported online in &lt;em&gt;Pediatrics.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;The difference persisted in analyses performed to correct for imbalances in the study population.&lt;/p&gt;
&lt;p&gt;&quot;This supports the hypothesis that inadequate muscle penetration is responsible, at least in part, for lower immune response to HBV vaccine among obese adolescent and adult vaccine recipients,&quot; Amy Middleman, MD, of Baylor College of Medicine in Houston, and colleagues concluded.&lt;/p&gt;
&lt;p&gt;Several studies have shown that adolescents and adults with a higher body mass index (BMI) have lower antibody titers after HBV vaccination. The observations have taken on new significance, given that an increasing number of vaccines target a population that has a rising BMI, the authors wrote.&lt;/p&gt;
&lt;p&gt;Researchers hypothesize that standard-length needles do not penetrate through the deltoid fat and into the muscle of obese adolescents and adults. Because of its less abundant blood supply, adipose tissue may delay antigen presentation to B and T cells responsible for immune response, the authors continued.&lt;/p&gt;
&lt;p&gt;To test the hypothesis, Middleman and colleagues conducted a randomized, clinical trial involving adolescents and adults ages 14 to 24 with no prior exposure to HBV vaccine. Eligibility criteria included weight &amp;gt;90 kg for female patients and &amp;gt;120 kg for male patients.&lt;/p&gt;
&lt;p&gt;Patients were randomized to receive the HBV vaccine series with a standard one-inch needle or a 1.5-inch needle. Patients younger than 19 received 0.5-mL injections, and older patients received 1.0-mL injections.&lt;/p&gt;
&lt;p&gt;Investigators used a standardized injection procedure: insertion of the needle at a 90&amp;#176; angle to the deltoid muscle, leaving 2 to 3 mm of needle visible between the skin and the hub.&lt;/p&gt;
&lt;p&gt;Patients received three doses of vaccine at baseline, one month, and four months. Blood samples were obtained at baseline and two months after the final injection.&lt;/p&gt;
&lt;p&gt;The two groups did not differ significantly with respect to median age (21), BMI (~40), deltoid skinfold (41 mm), triceps skinfold (~40 mm), days between vaccine doses one and three (~135), and days from third vaccine dose to titer assessment (65).&lt;/p&gt;
&lt;p&gt;At the end of the study, 24 patients had completed the immunization protocol, 10 in the one-inch group and 14 in the 1.5-inch group.&lt;/p&gt;
&lt;p&gt;Patients vaccinated with a one-inch needle had a median antibody titer of 189.8 mIU/mL compared with 345.4 mIU/mL for patients vaccinated with the 1.5-inch needle (&lt;em&gt;P&lt;/em&gt;=0.03).&lt;/p&gt;
&lt;p&gt;The between-group difference remained significant in analyses that excluded an outlier from the 1.5-inch group (&lt;em&gt;P&lt;/em&gt;=0.047) and that excluded the only two male patients in the study (&lt;em&gt;P&lt;/em&gt;=0.035).&lt;/p&gt;
&lt;p&gt;&quot;As we continue to experience high rates of obesity in the U.S. and throughout the world, additional evidence-based research on optimizing the effective delivery of immunizations to adolescents and young adults will be critical,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;&quot;Following updated needle length recommendations will be a first step toward improving the health of our youth and young adults by preventing vaccine-preventable diseases.&quot;&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by federal grants and awards. GlaxoSmithKline provided the vaccine.&lt;/p&gt;&lt;p&gt;The authors had no disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_343"
                     title="U.S. Marshals Seize Unapproved Ozone Generators"
                     score="0.009"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/EnvironmentalHealth/tb/18228?impressionId=1265779562092"
                     
      &lt;p&gt;WASHINGTON  --  U.S. Marshals have seized 77 unapproved ozone generators, valued at almost $76,000 from a California device manufacturer, the FDA announced.&lt;/p&gt;
&lt;p&gt;The devices were advertised as treatments for various conditions, including cancer, AIDS, hepatitis, herpes, and other diseases, but lacked approval or efficacy data to support the claims made on their behalf, an FDA release said.&lt;/p&gt;
&lt;p&gt;The raid came after the company, Applied Ozone Systems (AOS) of Auburn, Calif., failed to respond to a voluntary recall request last December, the agency said.&lt;/p&gt;
&lt;p&gt;The FDA raised concerns that patients using AOS-IM and AOS-IMD devices will consider it an appropriate treatment for an affliction and delay or stop FDA-approved and proven medical treatments. Patients using the devices may risk infection from contamination of the applicator or catheter, the release said.&lt;/p&gt;
&lt;p&gt;The FDA recommended that healthcare professionals and consumers cease use of the devices.&lt;/p&gt;
&lt;p&gt;The agency said it obtained an inspection warrant for the company&apos;s manufacturing facilities after the owner refused to admit FDA inspectors. It said the inspection revealed several breaches of the FDA&apos;s good manufacturing practice requirements for medical devices, which had never been approved in the first place.&lt;/p&gt;
&lt;p&gt;Ozone is an unstable allotrope of oxygen with three atoms, instead of the normal two. Ozone generators produce ozone from oxygen and have consumer and industrial applications, but ozone itself is harmful to the respiratory system, even at relatively low concentrations.&lt;/p&gt;
&lt;p&gt;Instructions with the Applied Ozone Systems devices suggest blowing ozoned air into the rectal and vaginal areas.&lt;/p&gt;
&lt;p&gt;Friday&apos;s seizure was part of a joint effort of the FDA and the California Department of Public Health to remove or prevent unapproved or unsafe medical devices from entering the market.&lt;/p&gt;
&lt;p&gt;A statement on the company&apos;s Web site said the two ozone generator models, which sold for $750 and $1,200 respectively, were no longer available by order of the FDA and California authorities.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_310"
                     title="Rotavirus Vaccine Effective in Third World Nations (CME/CE)"
                     score="0.005"
                     href="http://www.medpagetoday.com/Pediatrics/Vaccines/tb/18174?impressionId=1265779562092"
                     
      &lt;p&gt;Vaccination against rotavirus appears to be highly effective in reducing death and serious gastrointestinal disease among young children in developing countries, according to two&lt;strong&gt; &lt;/strong&gt;publications in the Jan. 28 &lt;em&gt;New England Journal of Medicine.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;In Malawi and South Africa, a vaccination program significantly reduced infantile gastroenteritis associated with the pathogen, researchers said.&lt;/p&gt;
&lt;p&gt;In a companion paper, investigators reported that a rotavirus vaccination program in Mexico appears to have been the cause of a marked reduction in deaths from diarrhea among young children.&lt;/p&gt;
&lt;p&gt;Taken together, the two studies suggest that physicians have &quot;another powerful weapon&quot; to help prevent death from diarrhea among young children, according to Mathuram Santosham, MD, of the Johns Hopkins Bloomberg School of Public Health, who was not involved in the research.&lt;/p&gt;
&lt;p&gt;&quot;It is time to act to combat the 1.8 million unnecessary deaths from diarrhea that continue to occur each year,&quot; Santosham wrote in an accompanying editorial.&lt;/p&gt;
&lt;p&gt;Two oral, live attenuated vaccines against rotavirus have been shown to prevent the associated gastroenteritis  --  GlaxoSmithKline&apos;s Rotarix and Merck&apos;s RotaTeq, according to Nigel Cunliffe, MBChB, PhD, of the University of Liverpool in England, and colleagues.&lt;/p&gt;
&lt;p&gt;But trials of those drugs mainly occurred in more developed countries, the researchers noted, so the World Health Organization  --  fearing they might not work as well among the very poor  --  suggested additional trials in the Third World.&lt;/p&gt;
&lt;p&gt;To fill the knowledge gap, Cunliffe and colleagues conducted a randomized, placebo-controlled trial in Malawi and South Africa, enrolling 4,939 healthy infants.&lt;/p&gt;
&lt;p&gt;They were assigned to get either three doses of placebo (at six, 10, and 14 weeks of age), two doses of the Rotarix vaccine and one of placebo to maintain blinding, or three doses of the vaccine.&lt;/p&gt;
&lt;p&gt;The researchers found: &lt;ul&gt; &lt;li&gt;Severe gastroenteritis caused by rotavirus occurred in 4.9% of the placebo group and in 1.9% of the pooled vaccine group, yielding a vaccine efficacy of 61.2%, which was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001. &lt;/li&gt; &lt;li&gt;Vaccine efficacy was lower in Malawi than in South Africa  --  49.4% versus 76.9%. But the vaccine prevented more cases of severe rotavirus gastroenteritis in Malawi  --  6.7 cases prevented per 100 infants vaccinated yearly versus 4.2.&lt;/li&gt; &lt;li&gt;Efficacy against all-cause severe gastroenteritis was 30.2%.&lt;/li&gt; &lt;li&gt;At least one serious adverse event was reported in 9.7% of the vaccinated infants and 11.5% of the placebo group, but only three were judged to be related to the vaccine.&lt;/li&gt; &lt;li&gt;There was a single case of intussusception -- a 6-month-old child in the three-dose vaccine group, who recovered after bowel resection.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The findings have led WHO to recommend that rotavirus vaccination be included in all national immunization programs, Cunliffe and colleagues noted.&lt;/p&gt;
&lt;p&gt;Mexico phased in rotavirus vaccination over slightly more than a year, from February 2006 through May 2007, according to Manish Patel, MD, of the CDC, and colleagues.&lt;/p&gt;
&lt;p&gt;To estimate the effect of the program, Patel and colleagues compared annual deaths from diarrhea before and after the immunization program began.&lt;/p&gt;
&lt;p&gt;Over the four years before the program started, the median annual number of diarrhea-related deaths among children younger than five was 1,793, the researchers found, for a mortality rate of 18.1 deaths per 100,000.&lt;/p&gt;
&lt;p&gt;In 2008, by contrast, there were 1,118 deaths, a reduction of 765, which yielded a mortality rate of 11.8 per 100,000 children, they reported in the journal.&lt;/p&gt;
&lt;p&gt;The rate reduction of 35% was significant at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001, Patel and colleagues said.&lt;/p&gt;
&lt;p&gt;The findings come with some caveats, the researchers said. Among them: &lt;ul&gt; &lt;li&gt;It was not possible to pin down the reduction in deaths attributable to vaccination because precise vaccine coverage information is lacking. &lt;/li&gt; &lt;li&gt;Other changes, such as hygiene improvements, might also have affected the trend.&lt;/li&gt; &lt;li&gt;Because of difficulty obtaining fecal specimens, it wasn&apos;t possible to study trends in rotavirus deaths specifically.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;While the studies suggests that rotavirus vaccination would prevent much disease and many deaths, there are obstacles to introducing the vaccine to poorer countries, Santosham noted in the editorial.&lt;/p&gt;
&lt;p&gt;A key obstacle, he said, is that the vaccine requires more refrigeration  --  so-called &quot;cold-chain&quot; storage  --  than typical childhood vaccines.&lt;/p&gt;
&lt;p&gt;Also problematic, he said, is the current recommendation that the vaccines be given early in life to avoid age-dependent occurrence of intussusception, which led to an earlier vaccine being taken off the market.&lt;/p&gt;
&lt;p&gt;In many of the poorest countries, on-time vaccination is rare, which may impede the use of a rotavirus vaccine unless the time window for administration can be opened wider, he said.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The African study was supported by GlaxoSmithKline and the PATH Rotavirus Vaccine Program, a collaboration with the World Health Organization and the CDC with support from the Global Alliance for Vaccines and Immunization (GAVI). Cunliffe reported financial links with Sanofi Pasteur and GlaxoSmithKline.&lt;/p&gt;&lt;p&gt;For the Mexican study, the researchers did not report any external support or any conflicts.&lt;/p&gt;&lt;p&gt;Santosham reported financial links with GlaxoSmithKline and Merck, both of which make rotavirus vaccines.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_1_721"
                     title="IDSA: Pneumonia Shot Succeeds With Five-Vaccine Combo for Kids"
                     score="-0.005"
                     href="