This article is more than 5 years old. Information may no longer be current.

FDA approves seasonal influenza vaccine

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA has approved a seasonal influenza vaccine (Agriflu, Novartis Vaccines and Diagnostics) for people ages 18 years and older to prevent disease caused by subtypes A and B.

FDA officials said in a press release that the single injection vaccine induced levels of antibodies in the blood likely to be effective in preventing seasonal influenza. It is not intended to protect against the 2009 H1N1 influenza.

“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, MD, acting director of the FDA’s Center for Biologics Evaluation and Research.

Common adverse events in clinical studies included pain, swelling and redness at the injection site, headache, muscle aches and malaise.

As part of the FDA's accelerated approval process, Novartis officials are required to conduct further studies to verify that the vaccine induces levels of antibodies in the blood that are effective in preventing seasonal influenza.