FDA Approves Agriflu Seasonal Influenza Vaccine

Main Category: Respiratory / Asthma
Also Included In: Infectious Diseases / Bacteria / Viruses;  Immune System / Vaccines;  Regulatory Affairs / Drug Approvals
Article Date: 28 Nov 2009 - 1:00 PDT

email icon email to a friend   printer icon printer friendly   write icon opinions  

Current Article Ratings:

Patient / Public:not yet rated

Healthcare Prof:1 star

1 (1 votes)


The U.S. Food and Drug Administration approved Agriflu for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.

Agriflu, manufactured by Novartis Vaccines and Diagnostics in Siena, Italy, was approved using the FDA's accelerated approval pathway, which helps safe and effective medical products for serious or life-threatening diseases become available sooner. In this case, Novartis demonstrated that the vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza.

Agriflu is administered as a single injection in the upper arm and is available in single dose, pre-filled syringes that do not contain preservatives.

"The approval of the new seasonal influenza vaccine, Agriflu, 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, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.

Common side effects in clinical studies included pain, swelling and redness at the injection site, headache, muscle aches and malaise. People with severe or life-threatening allergies to chicken eggs, or to any other substance in the vaccine, should not be vaccinated.

As part of the accelerated approval process, Novartis is required to conduct further studies to verify that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza. The company also manufactures another licensed seasonal influenza vaccine, Fluvirin, for use in the United States. Fluvirin is approved for people ages 4 years and older. Agriflu is not intended to protect against the 2009 H1N1 influenza.

Source: U.S. Food and Drug Administration

Article adapted by Medical News Today from original press release.
Visit our respiratory / asthma section for the latest news on this subject.
There are no references listed for this article.
Please use one of the following formats to cite this article in your essay, paper or report:

MLA
U.S. Food and Drug Administration. "FDA Approves Agriflu Seasonal Influenza Vaccine." Medical News Today. MediLexicon, Intl., 28 Nov. 2009. Web.
8 Feb. 2012. <http://www.medicalnewstoday.com/releases/172405.php>

APA
U.S. Food and Drug Administration. (2009, November 28). "FDA Approves Agriflu Seasonal Influenza Vaccine." Medical News Today. Retrieved from
http://www.medicalnewstoday.com/releases/172405.php.

Please note: If no author information is provided, the source is cited instead.


Respiratory / Asthma

What is Asthma?

Asthma is a disease affecting the airways that carry air to and from your lungs. People who suffer from this chronic condition (long-lasting or recurrent) are said to be asthmatic. Read more...

Most Popular Articles



Follow Our Respiratory News On Twitter

Follow Us On Twitter
Get the latest news for this category delivered straight to your Twitter account. Simply visit our Respiratory / Asthma Twitter account and select the 'follow' option.



View list of all 'What Is...' articles »