FDA approves H5N1 avian influenza vaccine

FDA approves H5N1 avian influenza vaccine

(HealthDay)—The U.S. Food and Drug Administration has approved the first adjuvanted vaccine for the prevention of H5N1 influenza in adults at greater-than-average risk of exposure.

While most strains of avian influenza don't infect people, the H5N1 virus has caused "serious illness and death in people outside of the United States, mostly among people who have been in close contact with infected and ill poultry," the agency said in a news release announcing the approval.

The shot, called the Influenza A (H5N1) Virus Monovalent Vaccine, has been developed "in the event that the H5N1 virus develops the capability to spread efficiently from human to human, resulting in the rapid spread of the disease across the globe," the FDA added.

The vaccine, produced by a Canadian subsidiary of GlaxoSmithKline, is not intended for commercial distribution, the FDA said. It's designed to be administered in two doses given three weeks apart.

In clinical testing involving some 3,400 adults, the most common side effects included injection-site pain and swelling, muscle aches, headache, and fatigue.

More information: More Information

Related Stories

FDA approves first 4-in-1 flu vaccine

date Feb 29, 2012

Federal health officials have approved the first vaccine that protects against four strains of the common flu, offering one additional layer of protection against the influenza virus that affects millions each year.

Recommended for you

Rising antibiotic shortages raise concerns about patient care

date Apr 23, 2015

Shortages of key antibiotics, including gold-standard therapies and drugs used to treat highly resistant infections, are on the rise, according to a new study of shortages from 2001 to 2013 published in Clinical Infectious Di ...

Study supports HPV vaccination guidelines

date Apr 21, 2015

(HealthDay)—New research finds that young women who get the HPV vaccine gain significant protection against infection in three parts of the body if they haven't already been exposed to the human papillomavirus.

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.