Why did FDA decide to OK Novartis Vaccine?
From CNN.com: FDA approves new flu vaccine (CNN) — The U.S. Food and Drug Administration said Friday it has approved a new vaccine to prevent seasonal influenza. Agriflu, made by Novartis Vaccines and Diagnostics, is not intended to protect against the H1N1 virus, commonly known as swine flu. The vaccine was approved using an accelerated approval process, the FDA said. Novartis demonstrated that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza, but it still needs to conduct further studies. Agriflu, for ages 18 and older, is administered as a single injection in the upper arm and is available in single-dose, prefilled syringes, according to the FDA. Read more at the link below. Sources: http://www.cnn.com/2009/HEALTH/11/28/fda.flu.
The US Food and Drug Administration has approved four vaccines for the H1N1 influenza virus, while other companies, including GlaxoSmithKline (GSK, London), have reported promising results from clinical studies with a single-dose vaccine. The approved vaccines are made by CSL (Melbourne, Australia), MedImmune (Gaithersburg, MD), Novartis Vaccine and Diagnostics (Basel) and Sanofi Pasteur (Lyon, France). According a Sept. 15 FDA release, all of the vaccines are manufactured using the same processes, which “have a long record of producing safe seasonal influenza vaccines”. Critically, data have shown that a single dose is enough to ensure immunity. “Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults 8 to 10 days after a single dose,” according to the release. Meanwhile, data from a trial currently being conducted in Germany by GSK have also suggested that a single dose may be enou
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- Why did FDA decide to OK Novartis Vaccine?
