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Briefing and Perspective: The Flu Vaccine Crisis Cayce Utley Outline: On October 5th, flu vaccine manufacturer Chiron announced that there would be a halt to vaccine production this year. The Medicines and Healthcare Products Regulatory Agency (MHRA), the United Kingdom’s version of the FDA, decided to suspend the company’s license for 3 months due to the discovery of a contaminated vaccine supply. Forty million doses of the company’s Fluvarin were contaminated, cutting the number of available immunizations in half. Still, all was not lost. Aventis Pasteur, the only other company that produces the killed flu vaccine for the U.S., had 58 million doses ready for distribution. In addition to Aventis Pasteur’s supply, MedImmune offers a live attenuated vaccine called FluMist in a nasal spray that is available to less vulnerable populations. So if these supplies are still in place, why the media frenzy? Why the long lines at health clinics? Simply put, the Chiron problems have put a huge dent in the number of people who can get immunizations that protect them from this year’s strain of the flu. As the New England Journal of Medicine reports, it takes over one full year to manufacture successful influenza vaccines. Dr. John Treanor writes that flu vaccinations are unique because they have to be reformulated every year. This can be a costly process, since leftover vaccines cannot be stored for the next year’s round of the flu. It is also a time-sensitive process and the three-month suspension of production shut the proverbial window of time on Chiron’s development of this year’s vaccines. The flu vaccine comes in two basic forms: killed virus and live virus. The killed virus vaccines like Fluvarin and Aventis Pasteur’s Fluzone, are injections typically used in the elderly, pregnant women, and children. The live vaccine, or LAIV, is a nasal spray and is given to healthy people between the ages of 5 to 49 years of age and those with chronic medical conditions. This year, the loss of the Chiron's vaccines may not meet the demands of the most vulnerable populations that receive the injected killed virus. The Government’s Response
Since the announcement came from Chiron, government agencies like the Department of Health and Human Services and the Centers for Disease Control have implemented policies to control the distribution of the flu shots. The first definitive measure came from the CDC that immediately issued “Interim Influenza Vaccination Recommendations.” The focus of the recommendations is the establishment of priority groups who should be given primacy in receiving the vaccines. The groups are as follows:
The CDC is currently working to identify long-term care facilities that ordered their vaccines directly from Chiron to make sure that those who were expecting the vaccine are immunized this season. On October 19th, Dr. Tommy Thompson, Secretary of the Department of Health and Human Services, announced that in addition to these measures, HHS is creating a task force on influenza to address future problems and plan for coming flu seasons. Though the federal government is taking action, the CDC emphasizes the importance of local access to the vaccines and subsequent state policies have been put in place to support that recommendation. The state of Indiana has followed this suggestion by creating a website through the State Health Department that providers can use to submit vaccine requests. The State Health Commissioner, Dr. Greg Wilson, said last Thursday (Oct. 28) that information collected on the website will be sent to the CDC so that it can better estimate the need in Indiana. Other states have been working to redistribute supplies to county health agencies that are experiencing shortages. Maryland has implemented redistribution policies to help seven counties that were hit hardest by the Chiron losses. Maryland has also been home to unique countywide initiatives like the one seen in Montgomery County where a flu shot lottery was held in late October- 800 doses were randomly assigned to the "winners". Other counties have strictly adhered to the priority groups listed by the CDC and still others are immunizing on a first-come, first-serve basis. According to the Kaiser Daily Health Policy Report, several states have decided to declare a public health emergency or to enforce requirements concerning the immunization of priority groups. Still other states, like Illinois have chosen to appeal to the federal government for help. Illinois is part of a growing number of states considering importation of the flu vaccine from companies in England and Germany. The FDA is currently considering vaccine importation, but the agency’s response to such requests has been “guarded.” Real Problems and Campaign Promises
In his address on October 19, Secretary of Health and Human Services Dr. Tommy Thompson said “we have been planning for an event such as this literally since we walked through the doors of HHS.” He went on to discuss the Department’s “Pandemic Influenza Response and Preparedness Plan” that was produced in August. What the Secretary failed to mention in his briefing was that in September, the GAO released a report stating that "The draft plan is comprehensive in scope, but it leaves
Ironically, the study points out that the HHS plan did not establish a system for setting vaccination priorities should a shortage occur. It seems that time itself remedied that particular problem since this year's shortage was announced just weeks after the GAO released the results of its study. Still, to its credit, this administration has been working on these issues, particularly with respect to coordinating a response to acts of bioterrorism and preventing shortages and incidents like the one we are experiencing now. But these efforts did not come soon enough for this year's flu crisis. Perhaps now policymakers will be motivated to begin working on long-term solutions to the problems in the production and distribution of influenza vaccines.
Perhaps the biggest obstacle to vaccine production is its cost. Manufacturers lack the motivation to produce vaccines because once they are made, they are only good for that flu season. Flu vaccines must be modified every year to combat newer, stronger strains of influenza. Though policymakers are aware of the need for production incentives, the fact that this year's flu season happens to coincide with such a virulent election season has clouded the discussion. Both presidential candidates have reframed the policy discussion in terms that coincide with their campaign platforms. Senator Kerry has asserted that the vaccine shortage illuminates the unpreparedness of the administration in the event of a large scale bioterrorist attack. Democrats are also using this incident as further rationale for legalizing prescription drug importation.
The Bush campaign points to trial lawyers and the threat of malpractice suits as the culprit causing potential manufacturers to shy away from flu vaccine production. Recent statements on the conservative side seem to suggest that this problem was created, at least in part, by government attempts to control the price of flu vaccines. Both sides are spouting political rhetoric and are ignoring the need for real changes, like those called for by the CDC, HHS, and medical professionals around the country. Once the election is over, we may see some genuine interest in reviewing some of the policies that HHS and the CDC have been trying to push through Congress.
In his article entitled "Weathering the Influenza Crisis," Dr. John Treanor describes changes that could be made in the production of vaccines to be sure that there is flexibility in the process. He suggests expanding vaccine development and reallocating funds that were diverted to bioterrorism research back into "predictable" threats like influenza. Treanor also says that "we should take sensible steps to encourage manufacturers to make influenza vaccines and to facilitate the licensure and marketing of such vaccines in the United States."
CDC has recently created a permanent ethics panel to "help the agency navigate the life-and-death questions" it faces in situations like these. In addition, Health and Human Services continues to reevaluate its "Pandemic Influenza Response and Preparedness Plan" in light of the current crisis and the suggestions made in September by the GAO report. Dr. Thompson has also announced the formulation of a federal task force on the flu. However, vigilance will not fully remedy the problem. Policymakers need to identify practical ways to provide incentives and simplify vaccine production so that breaks in the supply chain will not produce the devastating panic situation that we see in the news today.
Treanor, John, MD. "Weathering the Influenza Vaccine Crisis." New England Journal of Medicine. (may require registration) |
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