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Nasal Vaccine Is Efficacious, But More Safety Data Needed.(Brief Article)
2001 AUG 22 - (NewsRx.com & NewsRx.net) --
The U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that there are adequate data to support the efficacy of FluMist(TM) (Influenza Virus Vaccine, Trivalent, Types A & B Live, Cold Adapted) for the prevention of influenza in healthy children and healthy adults ages one to 64 years.
The committee also recommended that the data analysis completed to date is not sufficient to support the safety of the vaccine at this time. In closing this discussion, Dr. Robert S. Daum, VRBPAC, indicated that the committee would welcome the opportunity to evaluate the safety data when the analyses are complete. Aviron (AVIR) is continuing to work with the FDA as they complete the analysis of the safety data supporting the license application.
The Biologics License Application for FluMist is currently under review by the FDA. If licensed by the FDA, FluMist would be the first influenza vaccine delivered as a nasal mist to be commercially available in the United States. Delivered as a nasal mist, FluMist ...
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Source: HighBeam Research, Nasal Vaccine Is Efficacious, But More Safety Data Needed.(Brief...