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.
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. 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.
Although no vaccine is 100 percent effective in preventing disease, vaccination is the key to flu prevention, according to the FDA. Novartis spokesman Eric Althoff said Agriflu is made in Siena, Italy, with eggs, and it has been available in Europe under the brand name Aggripal. This approval, he said, will add to future seasonal vaccine supplies.
