FDA Grants Fast Approval for Novartis Seasonal Flu Vaccine
Agriflu, a seasonal flu vaccine manufactured by Novartis Vaccines and Diagnostics has been approved by the U.S. Food and Drug Administration (FDA), however, it offers no protection against the H1N1 virus, commonly known as swine flu.
As demonstrated by Novartis, the vaccine induces anti-body levels in the blood effective enough to prevent seasonal influenza, though further studies are still required for Agriflu, available in single dose, pre-filled syringes that do not contain preservatives, for 18-plus adults and administered as a single injection in the upper arm.
Fluvirin, another licensed seasonal influenza vaccine produced by Novartis has also been approved for children who are four and older.
According to FDA, while no vaccine offers 100% effectiveness in preventing the disease, the only way to prevent the flu from spreading is by vaccinating as many of the population as one can.
Eric Althoff, a spokesman for Novartis informs that Agriflu, which is available in Europe under the brand name Aggripal, is manufactured with eggs in Siena, Italy. The Swiss drug manufacturer has also opened a vaccine-manufacturing plant in North Carolina for making flu vaccines, without relying on decades-old technology that employs millions of chicken eggs to grow viruses.
The approval ‘is an important step in adding to the production capacity to enhance the supply of vaccine for the United States for future influenza seasons,’ said Karen Midthun, Acting Director of the FDA’s Center for Biologics Evaluation and Research.