When a vaccine for the pandemic influenza A(H1N1) virus is cleared for use, expect the distribution process to resemble the Vaccines for Children program.
The vaccine will be allocated to states based on their populations, Dr. Jay C. Butler said during a teleconference of the National Vaccine Advisory Committee (NVAC) last month. McKesson Specialty will receive vaccine from the five manufacturers and ship it to providers under the direction of state health departments.
“Providers may include physician's offices, hospitals, occupational health clinics, pharmacies, anyone the state designates as an appropriate recipient of vaccines to administer,” said Dr. Butler, director of the H1N1 Vaccine Task Force at the Centers for Disease Control and Prevention, Atlanta.
To date, the federal government has purchased 195 million doses of the vaccine. All orders will be filled in increments of 100 doses. For federal employees, Dr. Butler noted, the CDC will play role of “state health department,” receiving and submitting orders from federal agencies.
The overall process “was developed in collaboration with state and local health officials,” he said. “Distribution of vaccine can be achieved without rebuilding infrastructure for in-state distribution, which has mostly been lost within the last couple of years.”
The Countermeasure and Response Administration, a Web-based aggregate reporting by age group, will track the number of doses being given. “This system may underestimate the number of doses that are administered,” Dr. Butler said. “There will be a certain amount of work involved in the data entry, and it's possible that vaccinators may not enter all the data.”
As for coverage assessment, the National Immunization Survey can begin collecting data as early as the week of Oct. 10, and provide weekly coverage estimates, he said. The Behavioral Risk Factor Surveillance System “will provide a more complete picture of vaccine coverage by state and in specific risk groups.”
Dr. Butler emphasized that the current distribution plan is a “dynamic situation. There are a number of things that we don't yet have a good handle on, including the proportion of vaccine that will be delivered in the private sector and the willingness of clinicians to provide H1N1 vaccine.”
While some of the clinical trials of pandemic H1N1 vaccine have been underway since mid-July, Robin Robinson, Ph.D., said that no adverse events have been reported to date. “That is very encouraging,” said Dr. Robinson, director of the Biomedical Advanced Research and Development Authority.
During the 2-hour meeting, NVAC members approved two recommendations that will be passed along to the assistant secretary for health for review. One advises that the Department of Health and Human Services “develop, and where possible test in advance, a strong and organized response to scientific and public concerns about vaccine safety that may emerge during the 2009 H1N1 vaccination campaign. The challenge will be to communicate effectively and to differentiate rapidly between adverse events that may be causally related to the vaccine and those which would be expected by chance alone.”
Such a response, the recommendations continue, could involve “organizing drills or practice scenarios for how the government will respond to concerns about adverse events temporally related to H1N1 vaccination, including identifying data resources and strategies for communications messages.”