CDC Announces Distribution Plan for Remaining Flu Vaccine Doses
CDC officials on Tuesday announced a flu vaccine distribution plan that directs states to allocate the nation's remaining 10.3 million doses based on states' populations of high-risk residents and the number of doses states have received amid a nationwide vaccine shortage, the Washington Post reports (Connolly, Washington Post, 11/10).
California-based Chiron on Oct. 6 announced that the British Medicines and Healthcare Products Regulatory Agency suspended the manufacturing license of the company's facility in Liverpool, England, that produces all of the flu vaccine Chiron manufactures for the United States. As a result, Chiron will not send any flu vaccine doses to the United States for the current season. U.S. officials had expected to have about 100 million flu vaccine doses for the current flu season. France-based Aventis Pasteur will provide the United States with 56 million flu vaccine doses, and Maryland-based MedImmune will provide about three million doses of the nasal-spray flu vaccine FluMist (California Healthline, 11/8).
Under the plan -- which is a collaboration among CDC, Aventis and the Association of State and Territorial Health Officials -- 7.2 million doses of vaccine will be sent to states under a formula that takes into account the number of high-risk individuals in each state, based on census data; the number of doses a state already has received; and the number of high-risk residents who have not received a vaccination. State health officials then will distribute the doses.
In addition, about 3.1 million doses of vaccine will be sent to state health departments to be directed to public health clinics. According to the Atlanta Journal-Constitution, that shipment "will guarantee that the clinics, which serve mostly low-income patients, get 100% of what they ordered from either Chiron or Aventis." CDC will reserve the remaining 1.3 million doses of flu vaccine until redistribution is complete "in case problems arise once flu season intensifies," according to the Journal-Constitution (McKenna, Atlanta Journal-Constitution, 11/10). CDC Director Julie Gerberding said that the agency would try to place the 29 states that already have reported flu activity at the "top of the shipping line" (Howard Price, Washington Times, 11/10). Vaccine will be shipped over the next two months "as it becomes available," according to the Post. Gerberding declined to say how many doses each state would receive. However, she acknowledged that several million high-risk U.S. residents will not be immunized. Gerberding "discouraged" states, such as Illinois and New Mexico, from trying to buy vaccine from other countries as they have requested, the Post reports (Washington Post, 11/10). Gerberding said that no state is reporting widespread flu activity but noted that the influenza virus is "unpredictable" (Washington Times, 11/10).
Under the plan, California received 315,000 additional doses of flu vaccine. The Department of Health Services will distribute the doses to county health departments, which will administer distribution among nursing homes, public health clinics and physicians in private practices who treat low-income and high-risk patients.
In addition, California expects to receive another 844,000 doses of flu vaccine, possibly in as soon as two weeks, DHS spokesperson Lea Brooks said. Brooks said the state is "working on" a distribution plan for the next shipment of doses (Russell, San Francisco Chronicle, 11/10).
The redistribution plan "represents the first time the federal agency has used its clout to effectively commandeer and reallocate a precious commodity for public health purposes," according to the Post. Gerberding said the plan attempts to "make sure the remaining doses of vaccine are distributed in the fairest way we can" (Washington Post, 11/10). She said, "The CDC has been working very hard to get doses out as quickly as they are produced, and the cooperation we've had (from state and local health departments) has been unprecedented." She added, "Once a state gets its allocation, it will allocate vaccine to individuals and agencies where the need is greatest," directing the doses to private physicians or nursing homes, for example (Washington Times, 11/10).
Several state health officials "applauded" the CDC plan as "equitable," according to the Post (Washington Post, 11/10). Mary Selecky, secretary of health for Washington state and former ASTHO director -- who announced the plan with Gerberding -- said it is appropriate for state officials to distribute the vaccines because they "know where [the] high-priority residents are" (Atlanta Journal-Constitution, 11/10). She added, "The shortage can't be fixed at this point. This will ensure available vaccine is allocated in the fairest way possible" (Washington Post, 11/10).
Some state health department officials said the plan could create problems if the departments are required to purchase the vaccine before they can allocate it, according to Georgia Division of Public Health spokesperson Richard Quartarone.
Under a previous arrangement, public and private health care providers paid directly for vaccine redirected by Aventis and CDC. If states are required to pay, they could become "middlemen" forced to find unbudgeted funding and also could be burdened with the cost of unused vaccine, according to the Journal-Constitution (Atlanta Journal-Constitution, 11/10).
FDA officials have released to Congress "an array of materials" on the agency's regulatory actions regarding Chiron's Liverpool plant, the Los Angeles Times reports (Peterson, Los Angeles Times, 11/10). House Committee on Government Reform ranking member Henry Waxman (D-Calif.) and Committee Chair Tom Davis (R-Va.) requested that FDA officials by Oct. 20 produce, among other materials, the results of a June 2003 FDA inspection that showed evidence of contamination at the Liverpool plant, along with communications between Chiron and FDA officials and British health authorities.
FDA did not meet the deadline; FDA Acting Commissioner Lester Crawford said FDA officials needed additional time, citing the agency's obligations to distribute the nation's existing flu vaccine. Waxman then requested that Davis issue a subpoena for the documents, but Davis declined to do so (California Healthline, 10/27).
The documents contain some proprietary business information that will not be made available to the public. However, much of the material could be publicly released by next week, at a committee hearing on the shortage. Davis and four members of the committee staff on Tuesday met with British regulators and Chiron officials to discuss problems at the plant. Crawford in an interview Tuesday said he is "[a]bsolutely" satisfied with the agency's actions as regulator of the Chiron plant, the Los Angeles Times reports. A Chiron official said the company "welcomed attention from Congress in improving the environment for manufacturing and supplying vaccines," according to the Los Angeles Times (Peterson, Los Angeles Times, 11/10).
Aventis will begin to take measures to produce flu vaccine year-round under a $10 million HHS contract announced Tuesday. The contract will increase the company's supply of chicken eggs, which are necessary to manufacture the vaccine. The contract also will provide stockpiles of other vaccine-making supplies. HHS officials could increase the contract to $41 million by 2008 (Manning, USA Today, 11/10). The new contract is not expected to have any effect on the current flu vaccine shortage (AP/St. Petersburg Times, 11/10). According to USA Today, the agreement is "aimed at providing a hedge against future flu vaccine shortages or a global flu pandemic." It was negotiated prior to Chiron's announcement of its Liverpool factory license suspension (USA Today, 11/10).
Under a separate HHS contract, Aventis will manufacture a potential pandemic vaccine once a year from a virus identified by health officials. The vaccine would be held in reserve in the event of a pandemic. The company has produced 8,000 doses of an experimental avian flu vaccine that will be tested in humans early next year. About two million doses of the vaccine will be held in case outbreaks in Asia become more widespread (AP/St. Petersburg Times, 11/10). Aventis spokesperson Len Lavenda said, "We will start immediately. However, it takes time to get this set up, so eggs won't be available until September (2005)" (USA Today, 11/10).