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By Herb Newborg

Oops! National Institutes of Health to Test Safety of H1N1 Vaccine AFTER Vaccination is Underway
NIH has decided to test the safety of the H1N1 vaccine in people with asthma and the dose needed.

The US Centers for Disease Control and Prevention (CDC) has been advising those with asthma be vaccinated with the new H1N1 vaccine. In fact, the CDC has recommended that individuals with underlying chronic medical conditions, including asthma, receive the new H1N1 vaccine as a PRIORITY before the general population.

As early as September 2, 2009, CDC advised those with asthma: get a seasonal flu vaccine now and the new H1N1 vaccine as soon as it becomes available. The following advisory is posted on the CDC website:

“Everyone with asthma who is aged 6 months through 64 years should get the 2009 H1N1 flu shot when it becomes available. The 2009 H1N1 flu shot is not the same as the shot for seasonal flu. If the H1N1 flu vaccine is in short supply, some persons may not be able to get the shot right away.”

The only problem is there have been NO SAFETY OR EFFICACY STUDIES conducted for the new H1N1 vaccine among those with asthma.

It seems that this glaring oversight is now going to be addressed.

In a recent press release, Wake Forest University School of Medicine announced that it is one of seven sites that are taking part in a study by the National Institutes of Health to determine “the safety of the H1N1 vaccine in people with asthma and the dose needed to protect them from the flu virus.”

The other sites that will be conducting these after-the-fact trials (those with asthma have been getting the vaccine despite the complete lack of safety and efficacy testing since the vaccines began shipping on September 29th) are as follows:

• Cleveland Clinic, Ohio
• Emory University, Atlanta
• University of Pittsburgh Asthma Institute
• University of Virginia, Charlottesville
• University of Wisconsin, Madison
• Washington University School of Medicine, St. Louis

Dr. Wendy Moore of Wake Forest says that while they will have some preliminary results from the study this winter, that won't be too late.

Not too late? How is a study conducted AFTER the massive distribution of a new drug not too late?

When the National Institutes of Health (NIH) announced on October 9th that it was PREPARING to conduct these after the fact safety tests, it noted that the study plan has been submitted to the Food and Drug Administration for review and that despite the fact that the REVIEW HAS NOT YET BEEN COMPLETED, the FDA is allowing it to proceed with the clinical trials.

According to the NIH press release:

“The study will enroll approximately 350 people with mild, moderate and severe asthma. Participants will be organized into two groups: those with mild or moderate asthma and those with severe asthma. Half of the participants in each group will receive a 15-microgram dose of vaccine, and the other half a 30-microgram dose. Three weeks later, each participant will receive a second dose of the same amount. The strength of the immune response induced by the vaccine will be determined in blood samples by measuring the level of antibodies against 2009 H1N1 flu virus.

Safety data will be collected and examined throughout the course of the study by trial investigators and by an independent safety monitoring committee. Participants will be monitored for any side effects they may experience because of the vaccine, as well as asthma attacks that occur during the study period.”

This is the best our top government health organizations can offer, safety and efficacy testing data months after the wide scale distribution of a new, unproven drug. This is truly a sad state of affairs and the public is rightfully distrustful of those promoting the H1N1 vaccine agenda.