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| |  Ongoing A(H1N1) Vaccination Trials Show No Safety Problems By Denise Baez NEW YORK -- August 21, 2009 -- No red flags regarding safety have been detected by the Safety Data and Monitoring Board in the ongoing influenza A(H1N1) adult vaccination trials, according to a media briefing held by the Centers for Disease Control and Prevention (CDC). “This is good news,” said Anthony S. Fauci, MD, National Institute of Allergy and Infectious Diseases, National Institutes of Health (NIH), Bethesda, Maryland. He added that because no new safety issues have been observed, the NIH is moving ahead with the paediatric trials. The NIH is sponsoring 5 fundamental vaccination trials that are ongoing or will begin shortly. Two adult studies began in August 7 and are almost fully enrolled, one of which will assess 15 versus 30 mcg in healthy adults and the other assessing 1 dose versus 2 doses in healthy adults. First-dose data is expected in mid-September and second-dose data is expected in mid-October. Two paediatric trials, similar in design to the adult trials, began on August 19 and on August 20 in children aged 6 months to 17 years. First-dose data is expected in late September and second-dose data in late October. In addition, there are trials that will assess sequential administration questions in adults and elders. Researchers are aiming to determine whether to vaccinate prior to, simultaneously, or after administration of the seasonal influenza vaccine. In addition, 3 separate trials testing 3 different products in pregnant women are expected to begin in early September. Each trial will assess 1 versus 2 doses of 15 mcg versus 30 mcg of the vaccine in 120 pregnant women (360 total). A mix-and-match trial will also begin in September where researchers will take an antigen of 1 vaccine manufacturer and use the adjuvant of another vaccine manufacturer. In all, about 4,500 to 4,600 individuals are expected to participate in these trials Jeffrey Goodman, MD, US Food and Drug Administration (FDA), Rockville, Maryland, said that the FDA is conducting continuous quality and safety surveillance of the vaccine being produced. According to Jay C. Butler, MD, of the CDC, Atlanta, Georgia, 45 to 52 million doses of the vaccine will be available by mid-October and up to 195 million doses will become available by the end of the year. Five manufacturers are working to produce as much vaccine as possible. Initially, vaccine doses to each state in the United States will be based on the state’s population. There are no new estimates for reported cases of A(H1N1). “The last estimate was over 1 million,” said Dr. Butler. He added that A(H1N1) continues to disproportionally affect young people and that most hospitalisations and deaths are among adults aged younger than 49 years. “Flu is unpredictable and it is hard to say what our influenza season will look like,” said Dr. Butler, adding that we must prepare for heavy influenza activity, both seasonal and A(H1N1). Surveillance data has not seen any changes in the epidemiology of the virus, and based on projection, no changes have been made on the recommendations for the vaccine target groups. On July 29, 2009, the CDC announced that the target vaccination groups pregnant women; household contacts of children aged younger than 6 months of age; children and adults aged 6 months to 24 years; healthcare and emergency workers; and individuals aged 25 to 64 years who have underlying conditions that put them at risk for complications and/or hospitalisation from the A(H1N1) flu. SOURCE: Centers for Disease Control and Prevention
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