While clinical results of some 2009 pandemic influenza A(H1N1) vaccine trials won't be known until late September at the earliest, planning a vaccination program for the virus is well underway.
Officials from the National Vaccine Advisory Committee provided a wide-ranging update on activities related to 2009-H1N1 vaccine development and implementation planning during a recent teleconference.
Dr. Anne Schuchat, director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, noted that there have been “disruptive clusters and outbreaks” of H1N1 influenza at summer camps in the United States with “remarkable heterogeneity,” with some people disproportionately affected. “We are continuing to see illness here in the U.S. at a lower frequency than in the spring, but a very high frequency compared to a usual summer.”
Robin Robinson, Ph.D., director of BARDA (Biomedical Advanced Research and Development Authority), an agency of the Health and Human Services department, noted that the HHS has contracted with five manufacturers to develop 2009 H1N1 vaccine: Four are producing an inactivated form of the vaccine, which will be available in prefilled syringes and multidose vials, and one is producing a live attenuated form. Clinical vaccine trials will be carried out in adults first, and then proceed to pediatric populations. Dr. Robinson estimated that about 20% of the entire clinical trial population will include children. Results from the first clinical trials—which began in mid-July—are expected by late September or early October.
The CDC's H1N1 Vaccine Task Force recommends that vaccine administration planning should take into account certain at-risk groups, including children and staff in day care centers and in schools serving grades K-12; pregnant women; young children; persons with household contact of children younger than 6 months of age; persons with underlying medical conditions; health care workers; and then—when enough vaccine is available—everyone else. Dr. Jay C. Butler, director of the task force, noted that uncertainties about a vaccine roll-out persist, including the amount of vaccine required and when it will be available; its formulation; specific recommendations for use; and demand for the vaccine.
Dr. Marie McCormick, a member of NVAC who is also a professor of maternal and child health at Harvard School of Public Health, presented draft recommendations of the H1N1 Vaccine Safety Subgroup. It calls for a federal plan to monitor 2009 H1N1 influenza vaccine safety, “both for proper planning purposes and to provide information to the public and stakeholders (including states) about important vaccine activities.”
One key recommendation says that the need “to actively monitor vaccine recipients for vaccine adverse events is critical given that the vaccine candidates will all contain a new antigen and may be combined with adjuvants that are not part of licensed vaccines in the United States.” Another recommendation calls for “transparent and independent review of vaccine safety data as it accumulates.”
The NVAC voted to adopt these recommendations, which will be passed along to National Vaccine Program Director Dr. Bruce G. Gellin for consideration.
Dr. Anne Bailowitz, medical director of environmental health and emergency programs for the National Association of County and City Health Officials, expressed concern about the implementation of a 2009 H1N1 vaccine program in light of financial challenges faced by many local health departments. In 2008, she said, 27% of local health departments had budget cuts and 53% had layoffs. This year, she said, 44% of local departments have had budget cuts and 32% have had layoffs. Establishing local partnerships, such as encouraging large business to immunize their own employees, will be key to successful implementation, she said. Volunteer H1N1 vaccination providers could also include student nurses, medical school students, dental students, veterinarians, EMTs, and pharmacy chain personnel.