AAP-Vaccine Shortages: Why They Occur and What Needs to Be Done to Strengthen Vaccine Supply

[Guest guest]

This seems to be an interesting regurgitation..and timed so well. http://tinyurl.com/qjzdl Vaccine Shortages: Why They Occur and What Needs to Be Done to Strengthen Vaccine Supply By Klein, Jerome O; Myers, G Abbreviations: TIV, trivalent inactivated influenza virus vaccine; NVAC, National Vaccine Advisory Committee; IOM, Institute of Medicine; DTaP, diphtheria-tetanus-acellular pertussis; MMR, measles, mumps, rubella; FDA, Food and Drug Administration; CDC, Centers for Disease Control and Prevention; VFC, Vaccines for Children; cGMP, current good manufacturing practices; VICP, Vaccine Injury Compensation Program; SEC, Securities and Exchange Commission VACCINE SHORTAGES HAVE been a frequent problem during the past 50 years, but most shortages have been associated with a single product and were of short duration with minimal disruption

to national immunization programs. In 2001 attention was directed to the vulnerability of the vaccine supply when, for various reasons, 8 of the 11 vaccines recommended for universal immunization of infants and children were unavailable or in short supply. In addition, tetanus toxoid was in short supply and needed to be prioritized for emergency use only. Although most of these shortages resolved in the following year, periodic shortages of pneumococcal conjugate vaccine (Prevnar; Wyeth Vaccines, Collegeville, PA) continued into 2004. The shortage of trivalent inactivated influenza virus vaccine (TIV) in the fall of 2004 was reported each night on national and local news and was the subject of Congressional inquiries. The legislators wanted to know why this country with vast resources and huge manufacturing capability was unable to provide a reliable supply of routinely recommended vaccines. The immediate answer to the Congressional inquiry about influenza

vaccine shortage was the contamination problem at the Chiron plant in Liverpool, England. However, there are substantive problems with domestic vaccine- manufacturing capacity; shortages will likely continue to occur until core problems are addressed. Since 2002, concern about the vulnerability of vaccine production and supply has been the subject of workshops convened by the National Vaccine Advisory Committee (NVAC) of the Department of Health and Human Services,1,2 the focus of a Congressional accounting office report,3 was discussed at a colloquium of the Sabin Institute,4 has been considered by the Institute of Medicine (IOM),5 and is extensively reviewed in a series of articles about development, financing, and implementation of vaccine programs.6 Pediatricians are called on to modify vaccine schedules when shortages occur, to provide catch-up immunizations when shortages are alleviated, and to explain to parents why the vaccine schedules

need to be altered. Although there are specific reasons for each shortage, there are generic issues that are complex and not readily solved. In this commentary we outline the problems of vaccine supply and the proposed solutions to achieve a constant and reliable supply of routinely administered vaccines. PROBLEMS IN VACCINE SUPPLY Financial Issues The United States Has Lost Domestic Vaccine Capability In 1967 there were 26 licensed vaccine manufacturers in the United States; in 2005 there were only 6 manufacturers with products licensed in the United States (Wyeth Vaccines, Merck Vaccines, Sanofi Pasteur, Medlmmune, Chiron, and GlaxoKline Biologies). All are multinational corporations, and not all US-licensed vaccines are produced in the United States. The reasons for the reduced number of manufactures includes mergers and acquisitions (eg, purchase of Lederle Laboratories by Wyeth Vaccines) and discontinuation of

production of biologicals (eg, Eli Lilly). There is only 1 vaccine manufacturer for many products in the United States (eg, inactivated poliovirus, measles, mumps, rubella [MMR], varicella vaccine and pneumococcal polysaccharide, and pneumococcal and meningococcal conjugate vaccines). Even when there are 2 or 3 manufacturers, there may be insufficient manufacturing reserve to sustain the number of doses needed when there is a disruption in supply from 1 manufacturer (eg, withdrawal of the Chiron influenza vaccine in the fall of 2004). A decrease in vaccine supply can be exaggerated when 1 of several manufacturers ceases production of vaccine without previous notification, leading to an unexpected shortfall in supply (eg, withdrawal of Wyeth Vaccines from the production of tetanus toxoid-containing vaccines in 2001). Vaccines Are Complex and Expensive to Develop and Manufacture The manufacturer of a proposed vaccine has to

take a calculated gamble that the vaccine will have a sufficient market to be worthy of the investment of hundreds of millions of dollars for development, including the costs of clinical trials and new plant construction. It can cost more than $700 million to bring a new vaccine from concept to market.5 Costs of successful products must include the costs of development of failed products and opportunities lost to invest in other, potentially successful products. The complexity of vaccine manufacture is illustrated by the production of the pneumococcal conjugate vaccine. Large-scale fermentation and purification of the 7 separate capsular polysaccharides is followed by each polysaccharide separately activated and conjugated to the carrier protein, CRM 197, followed by combination of the separate conjugates to formulate the final vaccine. Three hundred separate quality-control tests are performed during production, and 1 lot of vaccine takes ~1 year to produce.7 Even after Food and Drug Administration (PDA) approval and introduction of a vaccine, there is no guarantee of profitability. The tetravalent rotavirus vaccine, Rotashield (Wyeth Vaccines), was approved by the PDA in August 1998 and was included in the American Academy of Pediatrics and Advisory Committee on Immunization Practices immunization schedule for 1999, but the manufacturer ceased production of the vaccine in October 1999 after recognition of an association of recent immunization with intussusception. The Lyme disease vaccine (LYMErix; GlaxoKline Biologies, Rixensart, Belgium) was approved in 1998 but withdrawn in 2002 because of poor sales and unproven concerns of vaccine-associated arthritis. Vaccine Manufacturers Must Achieve Optimal Return on Invested Capital The vaccine business is no different from other for-profit industries; capital is available only for products that provide optimal

return on invested capital. The leaders of publicly held corporations have a fiduciary responsibility to their stockholders to maximize profit. Products that are marginal or unprofitable are withdrawn from the marketplace. Within a large pharmaceutical manufacturer, vaccines are in competition for funding with other products in the company portfolio (eg, over-the-counter medications, consumer products, and therapeutic drugs), and vaccines lose support for funding within the company if they are not profitable. A successful vaccine manufacturer is one that achieves sustained profitability from old and new products. New products command higher prices and are more profitable. For example, the new meningococcal conjugate vaccine costs approximately $80 per dose (as does the previously introduced meningococcal polysaccharide vaccine). The conjugate pneumococcal vaccine, Prevnar, has proven to be an important profit center for Wyeth Vaccines; sales in

2004 were in excess of 1 billion dollars, and sales during the second quarter of 2005 were $323 million.8 In contrast to new vaccines, most mature vaccines are more like commodities: the older vaccines are unable to command a high price per dose and have limited profitability. Even with recent price increases, diptheriatetanus-acellular pertussis (DTaP) and MMR vaccine prices are less than $20 per dose. Over the past several years, manufacturers have increased the price for TIV, whereas the Centers for Disease Control and Prevention (CDC) has recommended influenza immunization for many more people, creating both demand and incentive for the industry. CDC Vaccine-Purchasing Practices The government is the largest purchaser of childhood vaccines in the United States. The CDC purchases >50% of routinely administered vaccines through the Vaccination Assistance Act (section 317 of the Public Health Service Act, 1963) and the

Vaccines for Children (VFC) program (established in 1994). The VFC program is a mandated entitlement program contained in the Medicaid law funded by the federal government, whereas the section 317 program is funded by annual discretionary appropriation by Congress.9 In 2002, 41% of childhood vaccines were purchased through the VFC program, 11% through section 317 funds, 5% through state and local governments, and 43% through the private sector.9 The federal government negotiates vaccine prices at significant savings compared with costs for the private sector because of the large volume of the purchase, limited number of distribution sites, and a no-return policy. For example, the 2003 cost to the CDC of 4 inactivated polio virus vaccine doses is $39.84, whereas the catalog price is $87.20; the cost of 4 doses of the pneumococcal conjugate vaccine to the CDC is $193, whereas the catalog price is $246.9 The government purchase program creates an

inherent conflict of interest\: the need of the purchasing group at the CDC to negotiate the lowest price possible while maintaining the goal of a healthy, vigorous, and profitable vaccine industry. Inadequate Compensation for Administration of Vaccines Limited administration fees paid by Medicare (and Medicaid and insurance companies, which base their reimbursements on those set by Medicare) have been disincentives to successful immunization programs. Physicians and health care workers need to be champions of recommended vaccines, but enthusiasm to develop office- or clinic- based immunization programs is dampened if the administrative costs are not met by reimbursement schedules. The investment in an office or clinic immunization program is substantive; it requires an infrastructure and dedicated personnel. Until recently the compensation for administration has been less than $5 per vaccine administered. Some primary care physicians

have chosen to refer the patient to a public health clinic rather than invest in the structure necessary for a successful immunization program. Because administration of vaccines is compensated by the shot, the introduction of combination vaccines will further diminish the compensation provided to the office or clinic. Regulatory Issues The PDA has the responsibility to ensure the safety and effectiveness of biological products intended for use in humans, which includes the regulation of vaccine development, testing, and licensure. After licensure, the PDA monitors the product and the production facilities, including periodic facility inspections, and may request that the manufacturer conduct postmarketing surveillance of safety and efficacy. Current Good Manufacturing Practices PDA oversight of vaccine facilities and production requires manufacturers to adhere to evolving standards of manufacture in the

industry, termed current good manufacturing practices (cGMPs). Vaccine manufacturers undergo frequent PDA inspections of their production facilities, batches of vaccine require separate approval for release, and modifications to manufacturing processes require product reviews. Evolving cGMP may increase costs for vaccine manufacture by requiring more extensive record-keeping or revision of the production process or facilities. In recent years, the PDA has used more drug-like standards for the manufacture of biological products. The new inspection process, termed Team Biologics, uses new record-keeping and administrative requirements. It is possible that a vaccine produced for decades without safety problems would be manufactured in a plant that would no longer meet cGMP. The manufacturer then would need to choose to invest in renovation or new plant construction or cease production; in many cases, the manufacturer has chosen to close the vaccine facility.

Wyeth Vaccines ceased production of DTaP, TIV, and pneumococcal polysaccharide vaccine because significant new investment in facilities required by cGMP could not be justified by market potential ( Paradiso, PhD, verbal communication, 2005). Lack of Uniformity of National Regulation of Vaccines Each country regulates drugs and biologicals for use by its citizens. Manufacturers producing and selling vaccines in the United States and overseas face the challenge of meeting the requirements of multiple national regulatory authorities and must decide in which countries to seek licensure. As a consequence, in the fall of 2004 with limited supplies of TIV in the United States, there were supplies of vaccine in other countries that could not be imported, because those products had not been presented for review to the PDA. Vaccine Liability Many manufacturers ceased production of diphtheriatetanus toxoids- pertussis

and other childhood vaccines in the 1970s and 1980s because of the high costs of litigation resulting from purported adverse events associated with immunizations. A coalition of interested parties including the American Academy of Pediatrics and parent advocacy groups was successful in developing legislation that resulted in a no-fault compensation program for adverse events associated with vaccines. The result of these efforts was passage of the National Childhood Vaccine Injury Act of 1986, which established nofault compensation for victims of serious adverse events associated with vaccines through the Vaccine Injury Compensation Program (VICP). The VICP is funded by a tax of $0.75 placed on each dose (or disease prevented) of designated childhood vaccine. For example, the tax for the 7-valent pneumococcal conjugate vaccine is $0.75 per dose, whereas tax on the MMR vaccine is $2.25 per dose. The VICP recognized the need to compensate those who were injured

by an approved vaccine, removed the financial threat of liability from manufacturers and health care workers who administered vaccines, and effectively stabilized the vaccine market in the 1980s. The VICP is managed by the Department of Health and Human Services and the Justice Department with adjudication by a group of special masters. Vaccines covered by VICP include those recommended by the CDC for routine administration to children. For example, TIV was not covered by the VICP until the recommendation was made by the Advisory Committee on Immunization Practices for universal immunization of infants 6 to 23 months of age. Once a vaccine is covered by VICP, claims of an adverse event must first be filed through this system for all age groups. If the outcome for the claim under VICP is unacceptable, the claimant retains the option of independently filing a lawsuit. Another important aspect of the VICP is that the court determines appropriate

attorney fees. Thus, there is no contingency incentive for claimant attorneys. Trial lawyers have and are trying various stratagems to circumvent the VICP. At present, multiple class-action suits have been filed in a number of jurisdictions on the basis of the claim that cases of autism were caused by inclusion of the preservative thimerosal in vaccines. The claim is that thimerosal is an adulterant and not covered by the VICP definition of "vaccine." Litigation against manufacturers for inclusion of thimerosal is proceeding, although the argument that the preservative is not part of the vaccine has been rejected in federal courts. Vaccine Adverse Events Hypotheses Establishing causality between an adverse event and a vaccine is difficult. Because vaccines are administered to children at ages when an underlying problem may first be recognized, there may be a temporal association of immunization and conditions with causes

that are poorly understood. Thus, some parents believed that the first signs of autism occurred after the administration of MMR vaccine in the second year of life. When the IOM examined the data concerning vaccines and autism, it concluded that the preponderance of evidence favored rejection of a causal relationship between MMR vaccine10 and thimerosal-containing vaccines and autism.11 These IOM reports and the reports of other IOM vaccinesafety issues are available on the IOM project Web page (www.iom.edu/imsafety). When a vaccine is licensed, the PDA may require specific postlicensure vaccine-safety studies, but other than the FDA directive, there are few incentives for the manufacturer to invest in large-scale surveillance studies subsequent to introduction of a vaccine. Postlicensure vaccine-safety studies have historically not been supported by the National Institutes of Health or other government agencies. As a consequence, when a hypothesis

is raised that there might be a causal relationship between a vaccine and an adverse event, such as autism, there are limited resources available to test these hypotheses. Because large-scale epidemiologic studies of the purported association of an adverse event with a vaccine often requires years, misinformation may become widely disseminated and affect immunization coverage. Vaccine Stockpiles The stockpile program was initiated in 1986 with the intent of creating an inventory for a 6-month supply of selected vaccines. Vaccine was to be purchased and paid for by the CDC, stored, and available if there should be a surge demand or a shortage. If the stockpiled vaccine was unused, it was rotated out of the stockpile in sufficient time to be used in the private and public sectors. The stockpile program has been successful in providing a reserve for short-term shortages and has been made available on at least 12 occasions. In 2003 the

NVAC recommended extension of the program as one of the most effective solutions to short-term vaccine shortages; subsequently, Congress approved additional funds to increase the number of vaccines to be stockpiled. However, in the 2 years since these funds became available, no new vaccines have been added to the stockpile because of a securities and Exchange Commission (sec) ruling that inhibited the manufacturers from participating in the expanded stockpile program. The sec ruled that the stockpile program fell under regulations of "bill and hold arrangements" in which manufacturers could not count stockpile payments as revenue until the vaccine was taken out of the stockpile. The manufacturer received cash payment on delivery of the vaccine into the stockpile program but the payment needed to be recorded as "cash" and not "revenue." Manufacturers objected to this accounting rule, because the delay in declaring revenue would decrease current

reported earnings; most vaccine manufacturers chose not to participate in the stockpile program. Although many legislators and representatives of the manufacturers and CDC continue to negotiate resolution of the sec ruling, the barrier to expansion of the stockpile remains as of November 2005.* Vaccines Are Undervalued Because most young parents are unaware of the serious morbidity and mortality of vaccine-preventable diseases, they have less appreciation for the benefits of the array of vacc\ines now available. Even health care workers (physicians, nurses, public health officials) are of a generation that has seen few of the vaccine-preventable diseases and, therefore, they are unfamiliar with them. The public and its representatives have short attention spans: the demand for influenza vaccine in the fall of each year is often fueled by vaccine shortage; the demand is usually limited to a few months, and there is little carry-over to

the next respiratory season. Parents are alarmed by claims of harm from vaccines raised in the media and on Web sites of various antivaccine groups. ADDRESSING THE PROBLEMS OF VACCINE SUPPLY Financial Issues Financial Incentives for Manufacturers Developing financial incentives for manufacturers to continue in the vaccine business and encouraging new manufacturers to enter the market have been the subject of extensive discussions and reviews.1- 6 One of the results of the NVAC-convened vaccine-supply workshops was a series of principles aimed at sustaining the present vaccine industry and encouraging new manufacturers to enter the vaccine market1,2: 1. Manufacturers should be able to obtain an appropriate profit for research, development, and production of vaccines. 2. Financial incentives may be made by means other than increased price, such as tax relief for new facilities or reconstruction

of old facilities. 3. Increasing market size for selected vaccines, such as recommending universal immunization of infants with TIV, would likely lead to increased profitability. 4. Previous notification should be required if a manufacturer plans to cease production of a routinely administered vaccine. The notification should be sufficient to permit the CDC to provide incentives to other manufacturers to expand production to make up for the shortfall and avoid disruption of supply of routinely administered vaccines. Developing action steps based on these principles will require a sustained effort by the various vaccine constituencies. All parties recognize the vulnerability of the national vaccine program and risk additional constriction in the number of manufacturers if the financial issues are not addressed quickly. Appropriate Compensation for Those Who Administer Vaccines Fees for administration

of vaccines must be commensurate to the effort and responsibility assumed. Medicare has increased compensation in recent years, and insurance programs have followed with higher fees, but in many locales the cost of administering childhood vaccinations in office practices remains greater than the reimbursement provided by the various agencies. A recent study of pediatrie practices in Colorado compared costs per shot and reimbursement and identified a loss of $2.40 per shot.12 The fee schedule needs to be reconsidered to ensure that costs are met and appropriate compensation is provided so that health care workers can continue to provide complete vaccine services. CDC Vaccine Purchase Manufacturers need to be able to increase the price for older "commodity" vaccines as their production costs rise and profit margins decline. Regulatory Issues Streamlining PDA Regulations There is an inherent tension

between the PDA and manufacturers because the FDA has the regulatory responsibility to ensure safety, efficacy, and uniformity of product. The cGMP, however, should be a dynamic process that incorporates needed technical advances without resulting in inappropriate manufacturing expenses or disruption of the distribution of vaccine. Harmonization of International Regulatory Requirements The FDA is an active participant in the International Committee on Harmonization, the goal of which is to achieve common regulatory procedures. The pace of these efforts has been slow because of the complexity of the issues and the many parties that need to agree on common protocols. Nevertheless, the FDA needs to accelerate the effort to agree on criteria for approval of vaccines in the United States and elsewhere. Harmonization of regulatory requirements across countries and regions would reduce the complexity and expense of bringing vaccines to

international markets. Such agreements between the United States and other countries to introduce vaccines manufactured and licensed in another country that had met equivalent FDA standards would permit importation of vaccines in times of shortages. Thus, the availability of TIV in Canada and Europe during the vaccine shortage in the United States in the fall of 2004 indicated that there was need for FDA emergency regulatory procedures to permit expedited temporary licensure of products that have undergone similar regulatory review by local authorities. Liability Issues The VICP program needs to be strengthened by legislative initiative that ensures that the program remains the primary mechanism for resolution of vaccine injury claims. The definition of "vaccine" needs clarification so that the term includes all constituents of the product including excipients, preservatives, stabilizers, and diluents. The VICP trust fund made available by the vaccine tax is now sufficiently funded, so a portion of the money received in the future could be designated for vaccinesafety research. Weaknesses in the VICP program should be addressed through other legislative initiatives including coverage of the unborn child of a pregnant woman (eg, a potential vaccine for group B streptococcal infection) and coverage of vaccines that are not routinely recommended (eg, may have prevented the demise of the Lyme vaccine). Expanding the Stockpile Program It is incomprehensible why a program such as the expanded stockpile program, which has been funded by executive and legislative action and agreed on as necessary for protection of the public, can be impeded by an accounting ruling of the sec. One would expect that the administration could provide a solution to resolve the impasse and satisfy the manufacturers and the accountants. Changing Public Perception of the

Value of Vaccines All vaccine advocates including manufacturers, physicians, and advocacy groups need to do a better job in presenting the morbidity of vaccine-preventable diseases, the benefits of immunization, and the risk of being unimmunized for the individual and the community. At the NVAC workshops,1,2 recommendation for a national campaign to emphasize vaccines as the most effective measure against infectious diseases was made. Decades ago, because thousands of children and adults contracted vaccine-preventable diseases, people were more concerned about the disease than rare adverse events associated with vaccines. Today, most parents and many health care providers have never encountered these once-dreaded diseases. A lack of information or erroneous information about vaccine safety and effectiveness can create confusion among parents considering immunization of their children. The NVAC workshops1,2 emphasized the importance of

making up-to- date, complete, and scientifically valid information about vaccine widely available so that parents understand the value of (and also the small but actual risks that accompany) vaccine administration. Two thirds of adults in the United States use the Internet, and most have searched for health information. Trustworthy, nontechnical, written information may be found at various Web sites including the National Network for Immunization Information (www. immunizationinfo.org), the National Immunization Program (www.cdc.gov/nip), the World Health Organization (www.who.int/ immunization_safety), and a number of vaccine-advocacy sites such as Children's Hospital of Philadelphia (www.vaccine.chop.edu) and the Immunization Action Coalition (www.immunize. org). Legislative Initiatives Over the years there have been legislative efforts to address vaccine shortages. The following are a few examples of interest that

indicate the types of legislative initiatives that have been considered now and in the recent past. In 2003 Senator Bill Frist introduced an "Improved Vaccine Affordability and Availability Act." The legislation authorized additional appropriations to increase influenza-immunization rates in high-risk populations, directed the secretary of DHHS to maintain a 6-month supply of prioritized vaccines, and improved the VICP program by providing additional compensation and protection for those who experience rare but serious adverse effects from vaccines. A recent effort (August 2005) was the "Vaccine Access and Supply Act of 2005," which was submitted by Representatives Henry Waxman, Sherrod Brown, and Lucille Roybal-Allard. A companion bill was introduced in the Senate by Senators Kennedy and Jack . The bill covers many of the problems cited above for vaccine shortages and additional areas of importance in reaching immunization goals. Some

of the areas of importance included: 1. Buyback of influenza vaccine: The section grants authority to the DHHS secretary to purchase 50% of unsold doses of influenza vaccine for the season. This provision would provide relative security for vaccine manufacturers that a guaranteed market would be available if a reserve of vaccine was unused. 2. Vaccine for Adults program: This program would be modeled on the VFC program. The federal government would purchase vaccines that are recommended for uninsured and underinsured adults and adults who received care in state or local public health departments. The bill would also provide funds to develop and implement a program to promote immunizations among adults. 3. One-year notice for discontinuing vaccine production: This section would require vaccine manufacturers to inform the FDA at least 12 months before discontinuing vaccine production. 4. Vaccine stockpile: This

section requires that within 30 days of enactment, the DHHS secretary, in consultation with Chairman of the sec, shall submit a plan to Congress to ensure the participation of vaccine companies in a stock\pile of pediatrie vaccines. Although the successful passage and enactment of these initiatives are unknown at this time (April 2006), the legislation suggests that some members of the Senate and Congress are aware of the vulnerability of supply of routinely administered vaccines in the United States and are ready to pursue appropriate remedies. The Biopreparedness Acts provide funding to encourage vaccine development and production as well as a vaccine-stockpile program. At this time, the funds are earmarked for medical countermeasures against bioterrorism-threat agents. Among the acquisition programs underway are a large-scale manufacturing capability for an attenuated smallpox vaccine, development of anthrax therapeutics, and a

posting for contracts for botulinum and anthrax vaccines. Although not directed to routinely administered vaccines, there are features of Project BioShield that might be of value for achieving a robust vaccine industry for routine immunizations including market assurance, long-term federal commitment, and funding support throughout the researchand-development pipeline of designated vaccines. Although the recent announcement of an aggressive $7.1 billion national strategy for pandemic influenza includes investments in creating vaccine-production capacity and stockpiles, it is unlikely that the program will address the core issues that are responsible for vaccine supply.13 CONCLUSIONS A robust domestic vaccine-manufacturing capability should be considered a national priority. There are multiple and complex reasons for the vulnerability of vaccine supply in the United States. The solutions that are needed to strengthen vaccine

supply will require sustained effort, political will, and commitment from the various vaccine constituencies. Shortages of routinely administered vaccines will likely continue because of the complexity of vaccine manufacture, but solutions are available to ensure that such shortages will be readily resolved without compromising national immunization programs. Although there may be differences of opinion of the method to ensure a reliable supply of vaccine, most experts agree on the following statements. 1. Vaccines must be profitable for the manufacturer. Financial incentives are needed to ensure that manufacturers stay in business and new manufacturers are attracted to the US marketplace. 2. Those who administer vaccines need to be compensated appropriately. 3. FDA enforcement of cGMP needs to be flexible and take into account vaccine supply, safety, and effectiveness. 4. International harmonization of vaccines

needs to be accelerated to facilitate a broader availability of vaccines that are manufactured outside the country. 5. The VICP needs to be strengthened to ensure that the intent of the program (to provide rapid and appropriate compensation for those who suffer vaccine injury) is maintained. 6. Implementation of the expanded US stockpile program needs to be addressed immediately. 7. Parents have to receive complete information about vaccine- preventable diseases as well as the safety and efficacy of routinely administered vaccines. Opinions expressed in these commentaries are those of the authors and not necessarily those of the American Academy of Pediatrics or its Committees. www.pediatrics.org/cgi/doi/10.1542/peds.2005-2427 doi:10.1542/peds.2005-2427 * On December 5,2005, the sec said that vaccine manufacturers could recognize revenue on vaccines placed into government

stockpiles instead of waiting to count payment when the vaccine was taken out of the stockpile (sec releases 33-8642,34-52885, and IC- 27178: Commission Guidance Regarding Accounting for Sales of Vaccines and Bioterror Countermeasures to the Federal Government for Placement Into the Pediatric Vaccine Stockpile or the Strategic National Stockpile). REFERENCES 1. Santoli JM, G, Arvin AM, et al. Strengthening the supply of routinely recommended vaccines in the United States: recommendations from the National Vaccine Advisory Committee. JAMA. 2004;290:3122-3128 2. Klein JO, guest ed. Strengthening the supply of routinely administered vaccines in the United States: presentations at workshops convened by the National Vaccine Advisory Committee, Department of Health and Human Services, February 2002 and January 2005. Clin Infect Dis. 2006;42(suppl 3): S97-S150 3. US General Accounting Office. Childhood vaccines:

ensuring an adequate supply poses continuing challenges. September 2002. Available at: www.gao.gov/new.items/d02987.pdf. Accessed March 24, 2006 4. Albert B. Sabin Vaccine Institute. Feasible solutions to global vaccine shortages: proceedings of the Albert B. Sabin Vaccine Institute Tenth Annual Vaccine Colloquium. 2004. Available at: www.sabin.org/PDF/CSH2003final.pdf. Accessed March 24, 2006 5. Institute of Medicine. Financing Vaccines in the 21st Century: Assuring Access and Availability. Washington, DC: The National Academies Press; 2004 6. Iglehart NK, ed. The vaccine enterprise. Health Aff (Millwood). 2005;24(special issue):594-769 7. Paradise PR. A look at pediatrie vaccine development. Contemp Pediatr. 2003:4-6 8. Hensley S, Temoriero H, Greil A. Pfizer, Wyeth report 2nd quarter gains. Wall Street Journal. July 20, 2005:B2 9. Hinman AR, Orenstein WA, Rodewald L. Financing immunizations

in the United States. CUn Infect Dis. 2004;38:1440-1446 10. Stratton K, Gable A, Shetty P, McCormick MC, eds. Immunization Safety Review: Measles, Mumps, Rubella Vaccine and Autism. Washington, DC: National Academy Press; 2001 11. Stratton K, Gable A, McCormick MC, eds. Immunization Safety Review: Thimerosal-Containing Vaccines and Neurodevelopmental Disorders. Washington, DC: National Academy Press; 2001 12. Glazner JE, Beaty BL, Pearson KA, Berman S. The cost of giving childhood vaccinations: differences among provider types. Pediatrics. 2004:113:1582-1587 13. US Department of Health and Human Services. Pandemic planning update. Available at: www.pandemicflu.gov. Accessed April 5, 2006 Jerome O. Klein, MD(a), G. Myers, MD(b-c) a Department of Pediatrics, Boston Medical Center, Boston University School of Medicine, Boston, Massachusetts; b Department of Pediatrics and Preventive

Medicine, University of Texas, Medical Branch, Galveston, Texas; c the National Network for Immunization Information, Galveston, Texas Dr Myers has indicated he has no financial relationships relevant to this article to disclose; Dr Klein is a consultant for Wyeth Vaccines and Merck Vaccines and is the former Chair of the data safety monitoring board for a trial of an 11 -valent pneumococcal conjugate vaccine manufactured by GlaxoKline Biologies. Accepted for publication Dec 1, 2005 Address correspondence to Jerome O. Klein, MD, Pediatrie Infectious Diseases, Finland 5, Boston Medical Center, 774 Albany St, Boston, MA 02118. E-mail: jerome.kleingbmc.org PEDIATRICS (ISSN Numbers: Print, 0031 -4005; Online, 1098-4275). Copyright & 2006 by the American Academy of Pediatrics Copyright American Academy of Pediatrics Jun 2006 © 2006 Pediatrics. Provided by ProQuest Information and

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