Was the H1N1 vaccine subjected to the same testing and clinical trials as seasonal flu vaccine?
The FDA. does not require a new round of human clinical trials to study minor changes in the flu vaccine each year. However, clinical trials were conducted on the H1N1 2009 vaccine to determine the adequate dose. In addition, because H1N1 is a pandemic, we now have more information from other countries. Of the first 39,000 H1N1 flu shots given in China, only four people had side effects, including muscle cramps and headaches. “You could argue that this is better tested than seasonal flu vaccine,” said Dr. Paul A. Offit, chief of infectious diseases for Children’s Hospital of Philadelphia.
