Sanofi Pasteur, the vaccines division of Sanofi-Aventis (SNY), yesterday provided an interim analysis of clinical data on the company’s U.S. licensed Influenza A (H1N1) 2009 Monovalent Vaccine. The study is being conducted in infants and children 6 months through 9 years of age.
Although the analysis showed that the vaccine is immunogenic and a single dose may protect many children, results indicated that two doses of the vaccine will be required for optimal protection of children under the age of 10 years. This is in-line with the recommendations for seasonal influenza immunization in children belonging to this age group.
No serious adverse events were reported. The company will monitor the occurrence of adverse events for six months after the second dose of the vaccine. Information regarding the optimal dosage, number of doses and schedule should be available once final data from the ongoing trials are released.
These results are the first data to be presented on children under the age of 10 years. Earlier, Sanofi-Aventis reported that 98% of adults in the age group of 18 years to 64 years had an immune response considered protective after receiving a 15 mcg dose of vaccine.
The swine flu pandemic should prove to be a major revenue earner for pharmaceutical companies. According to the Centers for Disease Control and Prevention, young children are among those who have top priority for immunization with the swine flu vaccine due to the relatively high incidence of the disease and potential for transmission in this population.
Several companies are looking to tap the highly lucrative swine flu vaccine market. Earlier in September, four companies received approval from the U.S. Food and Drug Administration (FDA) for their swine flu vaccines. These include names like Sanofi-Aventis, Novartis Vaccines and Diagnostics Limited, the vaccine and diagnostics arm of Novartis (NVS), MedImmune LLC, a subsidiary of AstraZeneca (AZN) and CSL Limited of Australia.
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