H1N1 Vaccine Ingredients
HHS Secretary Kathleen Sebelius announced today that the department will commit $884 million to purchase additional supplies of two key ingredients for potential H1N1 vaccine to further prepare the nation for a potential resurgence of the 2009 H1N1 virus.
“We recognize that preparedness is shared responsibility between federal, tribal, state, local governments, private organizations and individuals. We are doing our part to be as prepared as possible for the impact that this infectious disease could have on our country,” Secretary Sebelius said. “Vaccines may serve an important role in that preparedness. The action we are taking today will provide flexibility in a future immunization program, if a program is recommended.”
The funds will be used to place additional orders for bulk H1N1 antigen and adjuvant on existing contracts with Sanofi Pasteur, MedImmune, GlaxoSmithKline and Novartis. The vaccine ingredients will become a part of the pandemic stockpile, for use if a vaccination campaign is necessary.
Antigen is the active ingredient in a vaccine that causes the human body’s immune system to develop antibodies that help fight an invading virus. Depending on the results of clinical studies, adjuvant could be added to a vaccine to boost the immune system’s response and potentially reduce the amount of antigen necessary for the body to recognize and fight a virus.
In May, Secretary Sebelius directed approximately $1 billion to be used for the development of a vaccine and for clinical studies to determine dose level and assess the safety and effectiveness of potential vaccines.
The Biomedical Advanced Research and Development Authority (BARDA) in the HHS Office of the Assistant Secretary for Preparedness and Response established the existing contracts with these companies in 2004 as part of the National Strategy for Pandemic Influenza.
Concerns raised about H1N1 vaccine
Concerns raised about H1N1 vaccine. The message that the vaccine appears safe for almost everyone may not be getting across — even as the vaccine arrives in states and cities and mass vaccination programs are set to begin.
A study released Oct. 2 by Harvard School of Public Health researchers found that only 40% of adults were “absolutely certain” they would get the H1N1 vaccine for themselves and 51% of parents were “absolutely certain” they would get the vaccine for their children. Children are among the designated priority groups to receive the vaccine.
But if the flu outbreak is severe in their own communities, those queried told researchers they might be more inclined to get the vaccine for themselves and their children. The survey was conducted Sept. 14-20 by telephone with a sample of 1,042 adults.
Those who were not “absolutely certain” they would get the H1N1 vaccine said they were concerned about possible side effects, did not think they were at risk of getting seriously ill from the virus or thought they could get medication to treat H1N1 if they got sick.
By late September, widespread H1N1 activity had been reported in 27 states, and the virus’ spread showed no signs of slowing, according to the CDC. If the increasing reach of the illness prompts more people to get the vaccine, tracking systems will help determine if anything unusual occurs.
VAERS, which is jointly managed by the CDC and the Food and Drug Administration, is ready to receive reports of events from physicians and others, said Claudia Vellozzi, MD, MPH, deputy director of the CDC’s Immunization Safety Office. Staff is being increased for the upcoming flu season to process reports more rapidly, she said.
But there are limitations to VAERS, Dr. Vellozzi said. The quality of the data varies, and there is no unvaccinated comparison group. There also is a great deal of underreporting, she said.
Some other tracking efforts include the Vaccine Safety Datalink project, a joint effort involving the CDC’s Immunization Safety Office and eight large managed care organizations.
A new tracking system, the Real Time Immunization Monitoring System, will use a Web-based system developed at Johns Hopkins Bloomberg School of Public Health to follow people for up to six weeks postvaccination.
The CDC and six academic medical centers with vaccine safety experts will provide clinical expertise in the evaluation of serious adverse events. The Dept. of Defense is monitoring 1.5 million active duty personnel. Another tracking component is Post-Licensure Rapid Immunization Safety Monitoring, a collaboration involving the National Vaccine Program Office, the FDA and the CDC.
About 600,000 doses of the nasal-spray H1N1 vaccine have been shipped and scheduled to arrive in early October in 25 states and cities, Dr. Schuchat said. Injectable vaccine was expected to be shipped soon after that.