FLU NEWS SCAN: Obama signs preparedness law, H1N1 vaccine and GBS, intradermal flu vaccine trial

Mar 13, 2013

Obama signs off on preparedness law
President Barack Obama today signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, which reauthorizes appropriations through fiscal year 2018, according to a White House press release. The law gives public health new authorities to address health and bioterror emergencies, streamlines processes at the Department of Health and Human Services (HHS), and helps the Food and Drug Administration (FDA) bring new countermeasures to market. Assistant Secretary for Preparedness and Response Nicole Lurie, MD, said in an HHS press release, "I commend Congress on its bipartisan leadership in reauthorizing PAHPRA. The reauthorization is a recognition of the importance of investing in innovation and supporting communities in public health preparedness." She said it builds on such work at the HHS as, for example, boosting the capacity of hospitals and communities to respond to disasters. Lurie also said the law gives states new authorities to temporarily deploy federally funded state personnel to meet urgent needs. The law increases flexibility for Project BioShield in advancing the development of medical countermeasures and enhances the FDA's authority to declare an emergency use authorization in emergency situations.
Mar 13 White House press release
Mar 13 HHS press release
Mar 5 CIDRAP News scan "House sends preparedness law to Obama's desk"

Meta-analysis finds small increased GBS risk for 2009 H1N1 vaccine
The largest US study so far to explore the safety of the 2009 H1N1 vaccine found a small increased risk of Guillain-Barre syndrome (GBS), similar to previous estimates for the seasonal flu vaccine, researchers reported today in The Lancet. GBS is an autoimmune disorder that causes neurologic symptoms. In 1976 GBS was linked to a pandemic vaccine in the United States, and officials put several systems in place to monitor the safety of the most recent pandemic vaccine. The Lancet group based their meta-analysis on data from six adverse monitoring systems that included about 23 million vaccinated people. Investigators calculated the risk ratios and risks of excess GBS cases per million vaccinations. They found that the vaccine was associated with about 1.6 excess GBS cases per million people vaccinated, which was consistent across different surveillance systems and other factors such as receipt of the seasonal flu vaccine. They said the findings provide reassurance that the vaccine benefits greatly outweigh the risks.
Mar 13 Lancet abstract

Study: Intradermal flu vaccine immune response similar to shot
A large comparison trial of intradermal (ID) flu vaccine and the intramuscular (IM) version found that immune responses were similar, and though patients often reported injection-site reactions with the ID vaccine, many preferred the route and would receive it again. The phase 3 study of Sanofi Pasteur's ID vaccine appeared today in Vaccine. The study began in October 2008, enrolling 4,292 adults ages 18 to 64 from 47 US centers. Those in the 2,581-subject ID group received one of three vaccine lots. Patients recorded their temperature, along with injection-site and systemic reaction, for 7 days after vaccination. The three ID vaccine lots induced similar antibody levels based on hemagglutination inhibition testing, and the ID vaccine was as immunogenic as the IM version for all three strains. At 28 days postvaccination, seroconversion rates between the two vaccines were similar for H1N1 and H3N2 strains. Researchers wrote that the lower seroconversion rate to the B strain may not be clinically important, because the postvaccination rates for the two vaccines were similar. Local reactions were more frequent after the ID vaccine, but pain did not differ and most reactions were minor and resolved within 3 to 7 days. On a questionnaire, most patients who received the ID vaccine said they would prefer it for the next season.
Mar 13 Vaccine abstract

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