NIH announces government-sponsored clinical trial of H1N1 vaccine

NEW YORK There still is widespread concern over the safety and efficacy of the new H1N1 influenza vaccine, despite public assurances from executives at the highest levels of the Centers for Disease Control and Prevention — the point agency around the H1N1 pandemic — that the H1N1 vaccines have been subject to the same safety and efficacy protocols as seasonal vaccine, which generally is considered both safe and effective.

And the clinical trials that have been published to date show that the H1N1 vaccine, at the 15-microgram dose, works, even among children. Sanofi Pasteur late last week announced that clinical trials of its H1N1 vaccine in infants and children ages 6 months through 9 years was efficacious and only required one dose.

The NIH trial, though, is specifically exploring whether or not a 15-microgram dose provides adequate protection against asthmatics, or people with other upper respiratory chronic diseases, one of the high-priority groups identified by CDC for H1N1 influenza inoculation and a disease-state that may place sufferers at greater risk of complications from influenza. According to the American Lung Association, 7.6 million people in America have been diagnosed with chronic bronchitis; 3.7 million Americans will develop emphysema over the course of their lifetime; 6.7 million children have been diagnosed with pediatric asthma; and 8.4% of all adults report having adult asthma.

It’s important also because the prevalence of H1N1 influenza remains higher than expected influenza levels for this time of year and continues to be on the rise, even this early into the season.

Two weeks ago, a total of 37 states reported widespread influenza activity (which means that more than half of the counties have reported influenza activity)— only Washington, D.C., Hawaii and Vermont reported less than regional influenza activity (regional activity is more than one, but less than half of all counties have reported influenza activity; less than regional activity means only one county has reported influenza activity).