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Tuesday, September 15, 2009

H1N1 vaccine data shows no side effects

Early data on the H1N1 vaccines show the vaccines to be highly effective with no adverse effects. Two peer-reviewed articles now published in the online first addition of new England Journal of medicine, which has the preliminary data of the monovalent H1N1 vaccine, have shown that the vaccines are working in a large number of healthy adults.

The two rivals, Greenberg et al and Clark et al, describe preliminary data on the immunogenicity of the influenza A (H1N1) 2009 monovalent vaccine. This data has been awaited, as governments, public health officials, and other stakeholders respond to the first influenza pandemic in over 40 years.

The study by Greenberg et al. shows that a single dose of nonadjuvanted vaccine containing the usual 15 �g of hemagglutinin (HA) antigen is immunogenic, or creates immunity, in a high proportion of healthy young and middle-aged adults. The study was conducted in Australia during a time when the virus was circulating, and one participant had laboratory-confirmed infection with the 2009 H1N1 virus.

The report evaluates immunogenicity and safety of the vaccine 21 days after the first of two scheduled doses is given. A total of 240 subjects, equally divided into two age groups, less than and over 50 years of age, underwent randomisation to receive either 15 �g or 30 �g of hemagglutinin antigen by intramuscular injection. No deaths or serious adverse events were reported, but mild discomfort like headaches were reported in a few cases.

The study by Clark et al, involving 175 adults between 18 to 50 years of age, to test the monovalent influenza A/California/2009 (H1N1) surface-antigen vaccine, concluded that the vaccine generates antibody responses within 14 days after a single dose is administered. The antibody tier protection was higher in those who had received two doses of the same vaccine.

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