By Joy Pierce Mathews for Summit Medical Group

With increasing availability of the H1N1 vaccination, people are understandably eager to know more about its safety and effectiveness. To clarify misinformation about the vaccine, Centers for Disease Control and Prevention (CDC) Director, Thomas R. Frieden, MD, MPH, said “there is every reason to believe this [H1N1] vaccine will be safe.” Dr. Frieden emphasized that the H1N1 vaccine has undergone the same production, research, testing, and monitoring processes required for all vaccines. He added that the same manufacturers in the same factories have made the H1N1 vaccine, “with the same mechanisms and safety precautions as every year’s seasonal flu vaccine.”

H1N1 vaccine safety data from the CDC show:

• Only 1,922 adverse events have been reported for the 33.7 million vaccine doses delivered to US health care providers since November 10, 2009
• Of the 1,922 adverse events, 96% have not been serious
• The figure for serious events, which total 84 (4%), is comparable to serious events reported for the seasonal flu vaccine
• Preliminary research shows no common cause or pattern in age, gender, geographic location, other illnesses, or underlying conditions that suggests an association with the vaccine

The CDC notes that the Vaccine Adverse Event Reporting System (VAERS), Food and Drug Administration, and Vaccine Safety Datalink Project will continue to monitor H1N1 vaccination safety. The CDC also partners with other federal and state agencies, professional organizations, and academic institutions to monitor and evaluate adverse events so that “the H1N1 vaccine is held to a very high standard of safety.”

Dr. Frieden said, “the bottom line is that vaccination is our best tool to prevent flu.” He added that clinical trial data “give us every reason to be confident that [the H1N1 vaccine] will be effective this year.” He suggests that both the nasal spray and injectable vaccine will be effective because the vaccine is so closely matched to the H1N1 virus.

Reference
Centers for Disease Control and Prevention. Weekly 2009 H1N1 flu media briefing.
www.cdc.gov. Accessed October 28, 2009.