How the Delayed Distribution: DISCUSSION AND POSSIBLE NEXT STEPS
Several points related to the recent influenza vaccine delays and the influenza vaccine process are worth emphasizing. First, the overall process has worked well for decades despite its many complexities and “fragilities.” Although the recent delays highlight the need to take certain actions to strengthen the system, such major disruptions have been exceptional and the potential benefits of any fundamental changes should be considered carefully against the potential drawbacks.
Second, disruptions to the influenza vaccine supply can never be fully anticipated. The information needed to select the new vaccine viruses each year depends in part on when influenza activity starts relative to the strain selection meetings and upon a vast voluntary network of surveillance laboratories that in many areas is poorly supported. In addition, the development and production of influenza vaccine involves the processing of new biologic agents each year. In some years, important growth and processing issues occur that cannot be fully predicted until production begins. Similarly, the emergence of regulatory issues, such as those related to current GMP, cannot always be anticipated. order levitra
Third, a fundamental concern is the decline in the number of manufacturers producing influenza vaccine for the U.S. Although the remaining three influenza vaccine manufacturers have increased their production capacity substantially and plan further expansion, the small number of remaining manufacturers is of major concern because it leaves the U.S. with a minimal safety net if unanticipated problems affect the production capabilities of any of the remaining manufacturers. This situation will become worse if any of the remaining companies decide to stop selling inactivated influenza vaccine. The small number of manufacturers and the lack of new companies entering the field is directly related to the economics of influenza vaccine manufacture and the profitability of this product. From the perspective of individual recipients and providers, increases in the price of vaccination can be alarming, especially if the levels of reimbursement lag behind vaccination prices. Nonetheless, the long-term viability of the influenza vaccine supply process in the U.S. depends on the attractiveness of influenza vaccine as a product for manufacturers and their perception that its production will provide adequate levels of profit.
Fourth, despite the perception by many that there was a “shortage” of vaccines in 2000 and 2001, the overall pattern was more of a shifting mismatch during the fall and winter months between the levels of demand and supply for influenza vaccine. One of the striking aspects about both of the 2000 and 2001 influenza seasons was that several millions of doses of vaccine remained unused at the end of each season. The demand for vaccine decreased substantially by December, even though influenza activity had not yet peaked in either season; consequently, many people for whom vaccine was recommended remained unvaccinated. canadian antibiotics
Although the optimal timeframe for influenza vaccine administration is October through the end of November, the continued vaccination of unvaccinated persons after November is highly desirable, especially for improving the protection of groups at high risk for complications from influenza. Traditionally, many vaccine providers, including physicians, stop administering vaccine after mid-November because they believe it is no longer indicated or it is too late. However, 15 out of the 25 influenza seasons between 1976 and 2001 peaked in February or later, indicating that continued vaccination clearly has the potential to benefit substantial numbers of people. The continuation of vaccination activities after November would also help to ensure that available influenza vaccine supplies are not wasted. Implementing this approach will require extensive educational efforts over years to change the vaccination behaviors of many vaccine providers and recipients; nonetheless, this critical change is needed.
The recent delays also demonstrated that the current system encounters difficulties in responding rapidly to unanticipated vaccine supply disruptions. For example, with the exception of the small amounts of vaccine purchased by the federal government and some state governments, the existing system for purchasing, distributing, and administering influenza vaccine is a private-sector enterprise involving a complicated and noncentralized network in which manufacturers sell and distribute vaccine to large and small distributors and to providers directly. Both the distributors and providers comprise large numbers of heterogeneous enterprises. Providers, for example, range from small solo physician office practices to large vaccination campaigns conducted at work sites or at commercial enterprises, such as grocery or pharmacy store chains. During years in which the supply of vaccine is adequate, this system has worked well. However, this system was very difficult to coordinate under the rapidly changing conditions of the recent vaccine delays. buy antibiotics in canada
Although a more centralized distribution system could, theoretically, respond more rapidly to meet urgent supply shortfalls, an overly centralized system would also run the risk of being unnecessarily cumbersome and bureaucratic during years of normal vaccine supply. An intermediate approach would be to strengthen the federal government’s role in adult immunization activities, similar to the magnitude of its role in pediatric vaccination efforts. This approach could retain the benefits of the current distribution system, while providing the foundation for a more coordinated response if future influenza vaccine supply disruptions occur. It could also allow for more focused efforts to attain national vaccination coverage objectives.
The timely distribution of accurate and helpful information is always critical, during both urgent and normal conditions. However, the recent delays also highlight the fact that such information is often simply not available in a timely manner. For example, during the 2000 vaccine delay, rapidly changing conditions during the summer made it significantly more difficult for CDC, the FDA, and others to predict the eventual degree of the delay or to know whether a substantial shortage would occur. The 2000 delay also highlighted the importance and difficulty of reaching certain groups, especially individual physicians and other private vaccine providers. suhagra
These issues are complicated and will be difficult to address. Nonetheless, the population of the U.S. is aging and the overall number of people at high risk for complications from influenza is increasing. In addition, the demand for influenza vaccine has increased, both among groups targeted for vaccination and among healthy people not specifically targeted for vaccination. Given this situation, the myriad problems raised by the 2000 and 2001 influenza vaccine delays, and the possibility of future delays or shortages, it is clear that these issues must be addressed if the U.S. is to sustain adequate influenza vaccination efforts in the future. Moreover, it is sobering to realize that the more severe 2000 delay took place within the context of one of the mildest influenza seasons recorded in several years. The consequences of a similar delay in a more typical influenza season could have been much graver.
Since the delays, several groups have taken a number of steps to address some of these issues. For example, an investigation of the 2000 delay was conducted by the General Accounting Office, the investigative arm of the U.S. Congress. The report noted that the Department of Health and Human Services undertook several steps in response to the 2000 vaccine delay, but concluded that similar disruptions could be repeated in the future and that additional steps were needed. These include the completion of a national influenza pandemic plan and more meetings between public health officals, vaccine manufacturers, distributors, physicians, and others to develop guidelines.
The ACIP developed new recommendations on the timing of vaccination so that vaccine doses available early in the season would go first to persons in high-risk groups and to health care workers. In recognition of the recent vaccine delays, and continued uncertainty about future seasons, the ACIP recommendations for 2002 continue to recommend the scheduling of influenza vaccination so that vaccination of certain groups (i.e., high-risk groups, close contacts of high-risk groups, health care workers, and children requiring two doses of vaccine) can begin in October and the vaccination of others can begin in November. CDC provided specific guidance to state and local health departments and co-hosted two meetings with the American Medical Association. As recommended by the General Accounting Office report, these meetings brought together a wide range of public and private sector representatives to identify both problems raised by the recent delays and practical solutions, including those related to the Medicare payment for the influenza vaccine and its administration. A third meeting is of Health conducted a study on the immunogenicity of a half dose of influenza vaccine in healthy adults as a possible option for stretching the vaccine supply. The manufacturers have worked extensively to increase their production capacities. Some have also begun to alter their vaccine distribution practices so that all vaccine orders are at least partially filled early in the season, rather than have some orders completely filled and other orders completely unfilled. Many providers have begun to schedule their vaccination efforts to reflect the ACIP recommendations. Several organizations, such as CDC and the FDA, have substantially stepped up their efforts to communicate information about vaccine supplies. silagra tablets
The steps taken to date are encouraging and will continue, along with others, into 2002 and beyond. The discussions between public and private sector groups have led to a better understanding and greater degree of cooperation. Nonetheless, increasing the number of vaccine manufacturers, changing the behavior of vaccine providers and vaccine recipients so that vaccination efforts continue into December and the beginning of the following year, and strengthening the presence of the federal government in adult immunization activities are all essential steps that have yet to be accomplished.
