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

add to favorites email to friend print save as pdf

Related Stories

FDA approves first 4-in-1 flu vaccine

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

FDA OKs Cubist antibiotic for serious infections

23 hours ago

The Food and Drug Administration has approved a new medicine to fight complex infections in the abdomen and urinary tract, the fourth antibiotic the agency has approved since May.

Xtoro approved for swimmer's ear

Dec 18, 2014

(HealthDay)—Xtoro (finafloxacin otic suspension) eardrops have been approved by the U.S. Food and Drug Administration to treat swimmer's ear, clinically known as acute otitis externa.

Drug interaction identified for ondansetron, tramadol

Dec 18, 2014

(HealthDay)—In the early postoperative period, ondansetron is associated with increased requirements for tramadol consumption, according to a review and meta-analysis published online Dec. 10 in Anaesthesia.

New system targets germs in donated blood plasma

Dec 17, 2014

(HealthDay)—A new system designed to eliminate germs in donated blood plasma and reduce the risk of transmitting a plasma-borne infection has been approved by the U.S. Food and Drug Administration.

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.