One-shot H1N1 vaccine on the way
The U.S. Food and Drug Administration has approved four vaccines against the 2009 H1N1 influenza virus, with the first lots expected to be distributed by mid-October.
Early data from trials indicate that 2009 H1N1 influenza vaccines are well tolerated and induce a strong immune response in most healthy adults when administered in a single unadjuvanted 15 µg dose, the National Institute of Allergy and Infectious Diseases (NIAID) reports.
NIAID conducted clinical trials of 2009 H1N1 influenza vaccines, produced by Sanofi Pasteur and CSL Limited. The NIAID trials tested two different dosages (15 µg vs. 30 µg) and evaluated the immune response to one and two doses of these vaccines. More than 2,800 people are participating in ongoing NIAID trials of these vaccines.
"We are pleased to note that preliminary analyses of early data from the NIAID trials align with the recently announced findings and those to be announced imminently by other companies in that both vaccines studied induced what is likely to be a protective immune response in most adults following a single dose in the same amount (15 µg) used in seasonal flu vaccines. Specifically, in blood samples obtained eight to 10 days after vaccination," NIAD announced on its web site.
Among healthy adults who received a single 15 µg dose of the Sanofi Pasteur vaccine, a robust immune response was measured in 96% of adults aged 18 to 64 and in 56% of adults aged 65 and older. Similarly, among healthy adults who received a single 15 µg dose of the CSL Limited vaccine, a robust immune response was measured in 80% of adults ages 18 to 64 and in 60% of adults ages 65 and older.
"On the basis of these strong early data, our results are consonant with other reports that a single 15 µg dose of unadjuvanted 2009 H1N1 influenza vaccine is well tolerated and induces a robust immune response in healthy adults between the ages of 18 and 64," NIAID states. "For adults aged 65 and older, the immune response to 2009 H1N1 influenza vaccine is somewhat less robust, as is the case with seasonal influenza vaccines."
The U.S. Food and Drug Administration has approved four vaccines against the 2009 H1N1 influenza virus, with the first lots expected to be distributed by mid-October.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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