FDA Approves Vaccines for 2009 H1N1 Influenza Virus

Vaccines should be available nationally in about four weeks

Published on: Sep 16, 2009

Four vaccines for the H1N1 virus have been granted approval by the Food and Drug Administration.

 

"Today's approval is good news for our nation's response to the 2009 H1N1 influenza virus," said Commissioner of Food and Drugs Margaret A. Hamburg. "This vaccine will help protect individuals from serious illness and death from influenza."

 

Four different firms that have long records of making safe seasonal influenza vaccines produced these vaccines. Preliminary data from clinical studies shows immune response to the vaccine in eight to 10 days in healthy adults. Dosing for children is still being determined by clinical studies that are underway, with results expected soon.

 

"The H1N1 vaccines approved undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines," said Jesse Goodman, FDA acting chief scientist.

 

In the ongoing clinical studies, the vaccines have been well tolerated. Potential side effects of the H1N1 vaccines are expected to be similar to those of seasonal flu vaccines.