FDA Expands Approved Use of H1N1 Vaccines to Include Infants and Children

The U.S. Food and Drug Administration has approved the use of the CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.

“Because children are among those most vulnerable to the 2009 H1N1 virus, having a broader range of children’s vaccines available is an important step in responding to the H1N1 outbreak,” said Margaret A. Hamburg, M.D., commissioner of food and drugs.

The company’s 2009 H1N1 vaccine is manufactured and tested using the same well-established licensing processes that have been in place for many years for the company’s seasonal flu vaccine. The expanded approval also covers the company’s seasonal flu vaccine.

The approval was based on a study of the company’s seasonal flu vaccine in children showing the vaccine's safety and efficacy in inducing antibodies to protect against influenza. These efficacy findings supported approval under FDA's accelerated approval regulation, which helps safe and effective medical products for serious or life-threatening diseases to become available sooner to the public.

Common adverse events experienced by children after administration of seasonal and H1N1 vaccines typically include pain, redness and swelling at the injection site as well as, in some cases, irritability, loss of appetite and drowsiness.

As with any medical product, unexpected or rare serious adverse events may occur. FDA is collaborating with the U.S. Department of Health and Human Services, including the Centers for Disease Control and Prevention, and other government agencies to enhance the capacity for adverse event safety monitoring during and after the 2009 H1N1 vaccination program.

Because CSL’s seasonal and H1N1 monovalent vaccines contain a small amount of egg protein, they should not be administered to anyone allergic to eggs or egg products.

The vaccines will be available in single-dose, preservative-free, pre-filled syringes and in multi-dose vials that contain thimerosal, a mercury derivative, as a preservative.

Both vaccines are manufactured by CSL Ltd. of Australia.

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Vaccinations of Volunteers Start in First H1N1 Clinical Trial

Emory University researchers began vaccinating volunteer participants Aug. 10 in the first of several planned clinical trials of a new H1N1 vaccine.

The clinical trials are being conducted by the eight Vaccine and Treatment Evaluation Units (VTEUs), supported by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).

Emory began signing up several hundred interested volunteers about two weeks ago and has been screening the volunteers to make sure they fit certain criteria. Volunteers will receive their first vaccinations over the first week of the trial and will return several times over the course of nine weeks to receive additional vaccinations and blood tests.

The Emory clinical trial will evaluate the safety and immune response to an H1N1 vaccine and also help determine how the pandemic flu shot should be given along with the seasonal flu shot to make it most effective. Participants will receive two H1N1 vaccinations concurrent with, before, or after, the seasonal flu shot.

The trials are being conducted in a compressed timeframe because of the possible fall resurgence of pandemic H1N1 flu infections that may coincide with the circulation of seasonal flu strains in the Northern Hemisphere.

The trials are expected to gather critical information that will allow the NIH to quickly evaluate the new vaccines to determine whether they are safe and effective in inducing protective immune responses. The results will help determine how to begin a fall 2009 pandemic flu vaccination program.

The U. S. government declared the H1N1 outbreak a public health emergency in April and two months later, the World Health Organization classified the outbreak a pandemic, reflecting its widespread nature.

“We have had a tremendous response from volunteers wanting to participate in the clinical trials,” says Mark Mulligan, MD, principal investigator of the Emory VTEU and executive director of the Hope Clinic of the Emory Vaccine Center. “Hopefully this will make it much easier to have a vaccine available for the fall flu season. We are very appreciative of the efforts of our volunteers.”

This first adult clinical trial as well as subsequent pandemic vaccine clinical trials will be conducted at the Emory Vaccine Center’s Hope Clinic in nearby Decatur. Pediatric clinical trials will be initiated one week after the first adult trial and will be conducted at the Emory-Children’s Center on Emory University’s campus. Harry Keyserling, MD, and Paul Spearman, MD, co-directors of the Emory VTEU, lead the pediatric studies at Emory-Children’s Center.

The VTEUs were established in 1962 as a vital research component of the NIAID. The units conduct clinical trials for all infectious diseases other than HIV/AIDS. They have conducted hundreds of clinical studies over the past four decades. Emory was designated a VTEU site in 2007 and received a seven-year contract of approximately $23.7 million.

An important strength of the VTEUs is their ability to rapidly enroll large numbers of volunteers into trials and to immunize the volunteers in a safe, effective and efficient manner. This rapid-response capability is especially important for testing vaccines designed to combat pandemic influenza. Results are expected to be available weeks after the trials begin.

In addition to Emory, VTEU sites are Baylor College of Medicine, Houston; Children’s Hospital Medical Center, Cincinnati; Group Health Cooperative, Seattle; Saint Louis University, St. Louis; University of Iowa, Iowa City; University of Maryland School of Medicine, Baltimore; and Vanderbilt University, Nashville. They will be joined for these studies by Children’s Mercy Hospital in Kansas City and Duke University Medical Center.

For more information about the Emory flu clinical trials, call 877-424-HOPE (4673) for the adult and senior studies, or 404-727-4044 for the pediatric studies, or e-mail for further information about the upcoming trials.

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