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    <recommendedItem id="20100101_19_414"
                     title="H1N1 Vaccination Still a Good Idea, CDC Says"
                     score="0.011"
                     href="http://www.medpagetoday.com/InfectiousDisease/SwineFlu/tb/18325?impressionId=1265819816718"
                     
      &lt;p&gt;Although pandemic H1N1 influenza activity appears to have leveled off, the CDC remains wary of what the future may hold.&lt;/p&gt;
&lt;p&gt;No states were reporting widespread influenza activity, and only six  --  Alabama, Georgia, Maine, New Jersey, New Mexico, and Virginia  --  were reporting regional activity, Anne Schuchat, MD, director of the CDC&apos;s National Center for Immunization and Respiratory Diseases, told reporters on a conference call today.&lt;/p&gt;
&lt;p&gt;Influenza-like activity remained below the baseline level for this time of year for the third straight week, Schuchat said.&lt;/p&gt;
&lt;p&gt;&quot;That&apos;s fairly similar to what we would normally see at this time of year with seasonal flu,&quot; she said.&lt;/p&gt;
&lt;p&gt;However, she said that the H1N1 virus continues to circulate, causing severe disease and death in some cases.&lt;/p&gt;
&lt;p&gt;Although total activity is down, Schuchat noted that the proportion of deaths attributed to either flu or pneumonia is higher than the epidemic threshold, and has been for the past three weeks. The reasons were unclear, but she said there are no indications that the virus has become more virulent.&lt;/p&gt;
&lt;p&gt;But, she said, &quot;H1N1 vaccination remains a good idea.&quot;&lt;/p&gt;
&lt;p&gt;The most recent results of the CDC&apos;s National H1N1 Flu Survey revealed that about 70 million people, or 23.4% of Americans, have been vaccinated so far. About 76 million doses of the vaccine have been used because of the requirement that children younger than 10 get two.&lt;/p&gt;
&lt;p&gt;About 37% of children up to age 18 have been vaccinated. For those younger than 10, 37% have received their second dose.&lt;/p&gt;
&lt;p&gt;Vaccine supply remains ample, Schuchat said, with about 124 million doses shipped around the country up to this point.&lt;/p&gt;
&lt;p&gt;Citing an &quot;unprecedented&quot; effort to monitor safety, she said there have not been any major safety concerns identified.&lt;/p&gt;
&lt;p&gt;&quot;So if safety was the reason that you were waiting, I think you can be reassured on that front.&quot;&lt;/p&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=1265819816718"
                     
      &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="20090101_19_2294"
                     title="FDA Lays Framework for Expedited H1N1 Vaccine Approvals"
                     score="-0.005"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/15170?impressionId=1265819816718"
                     
      WASHINGTON, July 21 -- The FDA will be extraordinarily flexible in evaluating vaccines for pandemic H1N1 influenza, suggested an agency briefing document issued for an upcoming advisory committee meeting.
              &lt;p&gt; 
              &lt;p&gt;On Thursday, the Vaccines and Related Biological Products Advisory Committee will hear about the status of H1N1 vaccine production, as well as the FDA&apos;s plans for evaluating vaccines in time for the fall flu season, when public health officials expect to see resurgent H1N1 infections. 
              &lt;p&gt; 
              &lt;p&gt;It&apos;s expected that at least one vaccine will be available for clinical test by late summer. The National Institutes of Health has said it would like to begin vaccinating certain high-risk groups, such as healthcare workers, by mid-October, which doesn&apos;t leave much time for the FDA to approve a vaccine. (See &lt;a href=&quot;http://www.medpagetoday.com/Washington-Watch/Washington-Watch/15021&quot; target=&quot;blank&quot;&gt;H1N1 Summit: October Target Date for H1N1 Vaccine Distribution&lt;/a&gt; and &lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/SwineFlu/15053&quot; target=&quot;blank&quot;&gt;WHO Says Healthcare Workers Are H1N1 Vaccine Priority&lt;/a&gt;) 
              &lt;p&gt; 
              &lt;p&gt;Normally, clinical trials are completed before the FDA would even accept an application for a drug or vaccine. But given the perceived urgency of the H1N1 situation, the agency might approve a vaccine based on incomplete or very small studies, according to a briefing document from the FDA&apos;s Center for Biologics Evaluation and Research Office of Vaccines Research and Review.
              &lt;p&gt; 
              &lt;p&gt;In fact, the document suggested, the agency might even waive its customary demands for compelling safety and immunogenicity data.
              &lt;p&gt; 
              &lt;p&gt;The government expects Novartis, Sanofi Pasteur, CSL, and GlaxoSmithKline to supply inactivated H1N1 vaccines to the U.S. market, while MedImmune will produce a live attenuated H1N1 vaccine, according to the document. 
              &lt;p&gt; 
              &lt;p&gt;The FDA said it would like the sponsors of the study to perform double-blind or observer-blinded studies in which patients are administered two doses of the vaccine, 21 days apart. 
              &lt;p&gt; 
              &lt;p&gt;Manufacturers should stratify their patients into four age groups: infants and toddlers, ages 3 to 9, 18- to 64-year-olds, and older than 65. 
              &lt;p&gt; 
              &lt;p&gt;The FDA did not request an adolescent group because those data can be interpolated from the other age groups, the document said.
              &lt;p&gt; 
              &lt;p&gt;It also didn&apos;t specify a study protocol for babies less than six months, because such studies will have to be designed to evaluate the entire series of infant vaccinations.
              &lt;p&gt; 
              &lt;p&gt;The FDA said that 100 patients in each arm of the trials &quot;is sufficient to provide a description assessment of immunogenicity with a reasonable degree of confidence in that estimate.&quot; If a control arm is used, it should contain at least 25 patients.
              &lt;p&gt; 
              &lt;p&gt;The FDA recommended that patients should be followed for six months after the second vaccination to monitor for serious adverse events, and for one year if the second vaccine contains an adjuvant, the FDA said. 
              &lt;p&gt; 
              &lt;p&gt;The vaccine will be considered as having an immunogenic response if: 
              &lt;ul&gt; 
              &lt;li&gt; The lower bound of the two-sided 95% confidence interval for the percentage of subjects achieving seroconversion for H1 antibody should meet or exceed 40%, or 30% for those over 65.  
              &lt;li&gt; The lower bound of the two-sided 95% CI for the percentage of subjects achieving an H1 antibody titer more than or equal to 1:40 should meet or exceed 70%, or 60% for those over 65. 
              &lt;/ul&gt; 
              &lt;p&gt;The FDA will be working with manufacturers and government agencies to coordinate surveillance plans, according to the briefing document. 
              &lt;p&gt; 
              &lt;p&gt;It is expected that the National Institutes of Health will also sponsor some H1N1 vaccine studies, and the agency will present its plan to the advisory panel on Thursday. 
              &lt;p&gt; 
              &lt;p&gt;According to the briefing document, the FDA is considering vaccines from Novartis and GlaxoSmithKline that use dose-sparing, oil-in-water adjuvants to stretch the quantity of the antigen farther. 
              &lt;p&gt; 
              &lt;p&gt;There are currently no licensed influenza vaccines that contain an adjuvant, and if the FDA decides to approve a vaccine with an adjuvant, it would have to issue &quot;emergency use authorization,&quot; which would allows emergency use of products that &quot;may be effective&quot; in preventing serious or life threatening disease.  
              &lt;p&gt; 
              &lt;p&gt;Normally, emergency use authorization is issued when the FDA commissioner determines there are no available alternatives, but in this case, the commissioner could issue the emergency use authorization if there are insufficient supplies to meet the emergency need, according to the briefing document. 
              &lt;p&gt; 
              &lt;p&gt;The advisory panel is not being asked to vote formally on specific questions. It will hear an update from the FDA, an update from the five vaccine manufacturers, and it will discuss the FDA&apos;s trial protocol recommendations. 
             
    </recommendedItem>
    <recommendedItem id="20090101_19_4090"
                     title="FDA Gives Emergency Approval for New Swine Flu Test"
                     score="-0.005"
                     href="http://www.medpagetoday.com/InfectiousDisease/URItheFlu/tb/17533?impressionId=1265819816718"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has granted emergency use authorization for an H1N1 influenza virus detection test to be used on the portable GeneSTAT platform.&lt;/p&gt;
&lt;p&gt;This GeneSTAT &quot;lab in a box&quot; allows point-of-care testing for novel H1N1 and determines infection status in about 50 minutes without need for a technician or pathologist, according to the manufacturer, DxNA.&lt;/p&gt;
&lt;p&gt;A sample is collected by cheek or nasal swab and put in a closed cartridge that screws into the unit.&lt;/p&gt;
&lt;p&gt;Because the device is portable, fast, easy to use, and comparatively cheaper than PCR testing done in reference labs, it could be especially useful in rural areas and developing nations.&lt;/p&gt;
&lt;p&gt;Real-time reverse transcription PCR is considered the gold standard for testing specimens; rapid test kits have only 40% to 69% accuracy. (See &lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/SwineFlu/15416&quot; mce_href=&quot;http://www.medpagetoday.com/InfectiousDisease/SwineFlu/15416&quot; target=&quot;_blank&quot;&gt;Rapid Tests Miss Mark for Pandemic H1N1 Flu&lt;/a&gt;) But last spring, the FDA authorized the CDC to send out rapid PCR diagnostic test kits to public health and other qualified laboratories. (See &lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/SwineFlu/13928&quot; mce_href=&quot;http://www.medpagetoday.com/InfectiousDisease/SwineFlu/13928&quot; target=&quot;_blank&quot;&gt;FDA Releases Flu Drugs, Test Kits to Combat Swine Flu Outbreak&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;Initially, all samples had to be sent to the CDC in Atlanta for confirmatory testing, but as the pandemic progressed state public health laboratories took over the bulk of testing.&lt;/p&gt;
&lt;p&gt;But in part because of the delay in getting results back, the CDC has recommended starting antiviral treatment for even suspected cases without confirmation.&lt;/p&gt;
&lt;p&gt;Device manufacturer DxNA requested emergency approval for the swine flu test that runs on its GeneSTAT platform in May after reworking the detection system to find H1N1 instead of H5 avian flu. (See &lt;a href=&quot;http://www.medpagetoday.com/InfectiousDisease/SwineFlu/14073&quot; mce_href=&quot;http://www.medpagetoday.com/InfectiousDisease/SwineFlu/14073&quot; target=&quot;_blank&quot;&gt;Mobile H1N1 Test May Offer Fast, Accurate Flu Detection&lt;/a&gt;)&lt;/p&gt;
&lt;p&gt;DxNA is based in St. George, Utah.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_1_70"
                     title="Evidence Mounts for Shelving Two Flu Drugs"
                     score="-0.006"
                     href="