Childhood Vaccine: Ensuring an Adequate Supply Poses Continuing Challenges
The federal government plays a variety of roles in immunization programs, one of the leading public health achievements of the 20th century, including ensuring the adequacy of the nation's vaccine supply -- a matter of increasing concern in recent years. In late 2001, the CDC reported shortages in 5 of the 8 recommended childhood vaccines. Concerned about the increasing frequency of these shortages, this report examines: (1) to what extent have recent childhood vaccine shortages affected immunization policies & programs?; (2) what factors have contributed to the recent shortages, & have they been resolved?; & (3) what strategies are federal agencies considering to help mitigate disruptions in the vaccine supply? Tables.
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Page 37 - General (OIG) is transmitting the Department's response to this draft report in our capacity as the Department's designated focal point and coordinator for General Accounting Office reports. The OIG hae not conducted an independent assessment of these comments and therefore expresses no opinion on them.
Page 36 - The Honorable Tom Davis Chairman The Honorable Henry A. Waxman Ranking Minority Member Committee on Government Reform House of Representatives The Honorable Susan M.
Page 22 - IN GENERAL.— The Secretary shall, at the request of the sponsor of a new drug, facilitate the development and expedite the review of such drug if it is intended for the treatment of a serious or life-threatening condition and it demonstrates the potential to address unmet medical needs for such a condition.
Page 49 - Practices, the American Academy of Pediatrics, and the American Academy of Family Physicians.
Page 22 - The biological drug, if approved, must be a significant improvement in the safety or effectiveness of the treatment diagnosis or prevention of a serious or life-threatening disease).
Page 30 - ... private providers. With such information, CDC could set priorities for or resize states' orders and determine how much stockpiled vaccine to release and when to release it. Timely information is important, because releasing vaccine from a stockpile can take up to 30 days. Some of this information may already be available within HHS, but other information is available only from manufacturers or state immunization programs. Information from FDA: FDA has important information about manufacturers...
Page 20 - Supply three manufacturers (see table 5). Consequently, if there are interruptions in supply or if a manufacturer ceases production, there may be few or no alternative sources of vaccine. Table 5: Number of Manufacturers Producing Routine Childhood Vaccines in the United States...
Page 17 - FDA, the Environmental Protection Agency (EPA), and the Agency for Toxic Substances and Disease Registry (ATSDR) have developed guidelines for safe exposure to methyl mercury.
Page 25 - In response to the work group's finding that streamlining the regulatory process needed further study, FDA recently announced that it is examining regulations governing manufacturing processes in both drugs and vaccine products to determine if reform is needed. However, FDA officials told us it is too early to define the scope and time frame for this reexamination. The NVAC work group expressed little support for constructing government-owned production facilities to produce routine childhood vaccines....