Bird Flu Vaccine Approved

H5N1 bird flu vaccine approved for use by FDA and will be added to National Stockpile

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Talk of bird flu may make people a little nervous. So many will likely be relieved to hear that the US government has approved a vaccine to protect against one strain of the virus.

Though the H5N1 strain of bird flu has not been discovered as the source of any illness in the US, it has caused illness and death abroad.

The US Food and Drug Administration (FDA) recently approved a vaccine to protect against H5N1. Health officials would distribute the vaccine as needed to those at risk.

"Cough into a tissue or your elbow to avoid spreading germs."

The FDA has approved the first adjuvanted vaccine to prevent H5N1 avian influenza for use in adults who are at risk for exposure to the virus.

H5N1 is a strain of bird flu that has caused over 600 illnesses in 15 countries since November 2003, the Centers for Disease Control and Prevention (CDC) reported. The virus can cause severe respiratory illness and has lead to death in about 60 percent of reported cases.

"H5N1 is an influenza virus with pandemic potential because it continues to infect wild birds with occasional outbreaks of influenza disease in poultry populations, and most humans have no immunity to it," FDA reported.

The newly approved vaccine is produced by a subsidiary of GlaxoSmithKline Biologicals called ID Biomedical Corporation, located in Quebec, Canada.

According to the FDA, the vaccine is produced using eggs, a process common in some seasonal influenza vaccines. The vaccine is delivered via injection in two doses, 21 days apart.

The vaccine is adjuvanted, meaning it contains a substance, or adjuvant, used to help increase the body's immune system response to the vaccine.

"The adjuvant makes it possible to use a small amount of influenza protein per dose of vaccine to elicit the desired immune response in an individual to prevent influenza disease," explained the FDA.

Safety tests for the vaccine involved the examination of around 3,400 adults over the age of 18 who received the vaccine and around 1,100 adults who received a placebo (or inactive replacement), the FDA reported.

The most common reported side effect was pain at the injection site. Some participants experienced other side effects like muscle aches, headache, fatigue and redness or swelling at the injection site.

The immune response created by the vaccine was examined in around 2,000 of the vaccinated participants in order to measure the vaccine's success.

"The results showed that 91 percent of individuals between the ages of 18 and 64 years and 74 percent of individuals 65 years and older who received the two-dose regimen developed antibodies at a level that is expected to reduce the risk of getting influenza," the FDA reported.

According to the FDA, the vaccine is not intended to be sold commercially. Rather, the US Department of Health and Human Services will add the newly approved vaccine to the National Stockpile for distribution as needed.

Review Date: 
December 2, 2013
Last Updated:
December 3, 2013