Oct 11, 2011
Quebec study affirms single-dose adjuvanted H1N1 vaccine strategy for kids
A study to evaluate Quebec's decision to recommend a single pediatric dose of adjuvanted 2009 H1N1 vaccine in younger children during the fall vaccination campaign suggests that the vaccine helped prevent lab-confirmed pandemic flu hospitalizations, researchers reported yesterday in Pediatrics. Their case-control study of children hospitalized during the fall wave of the pandemic was mandated by the province's health ministry. It included 221 hospitalized children 6 months to 9 years old and 663 matched controls. The vaccine used in Quebec contained the AS03 adjuvant along with the 2009 H1N1 antigen. Quebec officials made the one-dose decision based on higher rates of adverse reactions after the second dose of the vaccine and limited vaccine availability for all target groups. The study included children with lab-confirmed hospitalizations between Nov 12 and Dec 19, 2009. Controls were selected from a provincial health insurance registry. Kids were considered immunized if they were vaccinated 14 or more days earlier, with a secondary analysis interval set at 10 or more days. Researchers found that the single dose conferred 81% effectiveness as early as 10 or more days after vaccination (95% confidence interval [CI], 60%-91%), a level that rose to 85% 14 or more days following vaccination (95% CI, 61%-94%). Both these figures are adjusted for underlying conditions and other factors. The team noted that their estimates were slightly lower than in earlier studies in Canada and the United Kingdom that used a different outcome: medically attended lab-confirmed 2009 H1N1 infections. However, they said their results were slightly higher than a UK study of a single dose of the vaccine in kids with underlying chronic conditions. Study limitations included controls not testing negative for H1N1 and limited statistical power, especially in children 5 to 9 years old, due to small sample size and the fact that most H1N1 cases had occurred earlier in the season.
Oct 10 Pediatrics abstract
School-based education, clinics raise flu vaccine rates in rural Georgia
Providing information about flu vaccination and offering school-based vaccine clinics increased vaccination rates in rural Georgia among predominantly African-American middle school and high school populations, according to a study published yesterday in Pediatrics. Researchers conducted a 2-year education campaign in two counties that included a mailed brochure and school presentations. In one county school-based flu immunization was provided, while in the other it was provider-based. A third county received no intervention. The counties were chosen because of their similar demographics and sizes: Each has only one middle school and one high school. The education campaigns were conducted in October and November 2008 and 2009, with vaccinations following each campaign. Vaccination rates for the 2008-09 flu season were 70 of 370 students (19%) in the school-based county, 110 of 736 (15%) in the provider-based county, and 71 of 889 (8%) in the no-intervention county. In 2009-10, rates rose to 114 of 375 (30.4%), 122 of 663 (16.9%), and 131 of 861 (15.2%), respectively. Risk ratios for the school-based county for the 2 years were 2.4 and 2.3, respectively, and for the provider-based county were 1.9 and 1.2.[Jim: I suggest dropping the preceding sentence, as it's not real clear what the risk ratio refers to.] The authors conclude, "Study findings demonstrate potential implications for improving coverage of other vaccines recommended for adolescents."
Oct 10 Pediatrics abstract
NIH awards up to $45 million for broad-spectrum antiviral development
United Therapeutics Corporation of Silver Spring, Md., announced yesterday that it has been awarded a contract for up to $45 million over 5 years from the National Institutes of Health (NIH) for advancing a broad-spectrum antiviral drug for dengue and flu based on its "glycobiology" antiviral platform. Martine Rothblatt, PhD, United Therapeutics' chairman and CEO, said in a company release, "The overall objective for this partnership with NIH is to develop a safe and orally available broad-spectrum antiviral drug to treat viruses such as dengue and influenza." The award provides $10.6 million over the first three and a half years of the project, with the remaining funds to be allocated as eight milestones are met. The funds will support developing a candidate compound through preclinical safety and efficacy studies toward potential clinical trials against dengue, as well as preclinical studies to develop additional data against flu.
Oct 10 United Therapeutics press release
GAO report addresses Vibrio illness related to oysters
The US Government Accountability Office (GAO) said today that the Food and Drug Administration (FDA) and the Interstate Shellfish Sanitation Conference (ISSC) must work together to develop illness-reduction goals and actions regarding Vibrio vulnificus in raw or undercooked oysters from the Gulf of Mexico. In October 2009, the FDA announced its plan to change its goal from reducing V vulnificus illnesses by 60% to largely eliminating them through a process called low-temperature pasteurization of raw oysters. The ISSC followed with a letter to the FDA expressing disappointment with the decision and reminding the agency of a 1984 memorandum of understanding that called for the FDA to consult with the ISSC on such matters. The ISSC set the 60%-reduction goal in 2001. The GAO asked the two organizations to cooperatively decide on a reduction goal. It also said the FDA's plan to implement low-temperature pasteurization in 2 to 3 years may be unrealistic and its model for illness reduction flawed, and that the method used by the ISSC to measure progress is not scientifically sound. The GAO said the FDA and ISSC "generally agreed with our recommendations." The report was released today but is dated Sep 8.
Oct 11 GAO report landing page
Oct 11 GAO report highlights
Study: RT-PCR for respiratory infections has little effect on treatment
Using real-time polymerase chain reaction (RT-PCR) testing to quickly diagnose acute respiratory infections (ARIs) did not lead to decreased hospital admissions, hospital stays, or antibiotic use for children under 12, according to a study by Dutch scientists. They performed RT-PCR on nasal-wash specimens from 298 children who had suspected ARIs and conveyed results to clinicians in 12 to 36 hours. In the control group, 285 children with similar symptoms had RT-PCR test results conveyed 4 weeks later. The researchers found that 82% of specimens tested positive for at least one pathogen, with respiratory syncytial virus the most common, in 55% of samples. They found no significant between-group differences in hospital admissions (223 intervention, 211 control), hospital stay (3.68 + 2.68 days vs 3.96 + 2.67 days), or antibiotic use (mean + standard deviation: 6.52 + 2.15 days vs 6.97 + 2.86 days). The researchers write, "Logistic arguments and balancing of costs should help determine whether to adopt RT-PCR testing as the new standard for viral testing for children with ARIs."
Oct 10 Pediatrics abstract