Establishment of vaccination clinics; user fees for investigational new drug (IND) influenza vaccine services and vaccines. Interim final rule and request for comments

We are amending 42 CFR part 70 to establish vaccination clinics and a user fee in connection with the administration of vaccination services and vaccine. On December 7, 2004, HHS Secretary Tommy G. Thompson announced the purchase of 1.2 million doses of GlaxoSmithKline (GSK) influenza vaccine, Fluarix, for distribution to areas most in need as determined by State public health authorities. The Fluarix vaccine has been approved in seventy-eight foreign countries, and FDA has recently reviewed extensive manufacturing and summary clinical information and conducted an inspection of the GSK manufacturing facility in Germany to determine that this vaccine, although not licensed in the United States, is suitable for use under an Investigational New Drug application (IND). The Food and Drug Administration (FDA) reviewed GSK's IND application as well as the clinical protocol and manufacturing data. CDC and CDC's Institutional Review Board approved the GSK flu vaccine response protocol including the informed consent document. To ensure that the vaccine is properly administered to individuals identified to be most at risk and facilitate compliance with IND requirements, CDC is establishing vaccination clinics. CDC is proceeding without delay because of the unprecedented nature of this season's influenza vaccine shortage caused by contamination problems with Chiron Corporation's production facility in the United Kingdom, which effectively cut in half the expected United States supply of inactivated influenza vaccine. A user fee is being established in order to recoup the costs associated with administering the vaccine and for the vaccine itself. All individuals, other than those who are enrolled in Medicare Part B, will be required to pay the user fee.     

Vaccine trial results generate debate and calls for further research

The first large-scale human trial of an HIV vaccine produces disappointing results overall, but finds that the vaccine may have been effective among some of the minority populations participating in the trial. Whatever the significance of this finding (the debate continues), there was a consensus: (a) that the trial provided very useful information on how to conduct large-scale HIV vaccine trials; (b) that further research needs to be conducted; (c) that governments need to contribute more to vaccine research and development; and (d) that existing prevention efforts must be maintained or expanded.     

Assessing mandatory HPV vaccination: who should call the shots?

In 2007, many legislatures considered, and two enacted, bills mandating HPV vaccination for young girls as a condition of school attendance. Such mandates raise significant legal, ethical, and social concerns. This paper argues that mandating HPV vaccination for minor females is premature since long-term safety and effectiveness of the vaccine has not been established, HPV does not pose imminent and significant risk of harm to others, a sex specific mandate raises constitutional concerns, and a mandate will burden financially existing government health programs and private physicians. Absent careful consideration and public conversation, HPV mandates may undermine coverage rates for other vaccines.     

Smallpox Vaccine Injury Compensation Program: Smallpox (Vaccinia) Vaccine Injury Table. Interim final rule

The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), Public Law 108-20, 117 Stat. 638, authorized the Secretary of Health and Human Services (the Secretary), through the establishment of the Smallpox Vaccine Injury Compensation Program (the Program), to provide benefits and/or compensation to certain persons who have sustained injuries as a result of the administration of smallpox covered countermeasures (including the smallpox vaccine) or as a result of vaccinia contracted through accidental vaccinia inoculations. The SEPPA directed the Secretary to establish, by interim final rule, a table identifying adverse effects (including injuries, disabilities, conditions, and deaths) that shall be presumed to result from the administration of or exposure to the smallpox vaccine, and the time interval in which the first symptom or manifestation of each listed injury must manifest in order for such presumption to apply. As mandated by law, the Secretary is establishing such a Smallpox (Vaccinia) Vaccine Injury Table (the Table) through this interim final rule. The Secretary is also establishing a set of Table Definitions and Requirements, which define the terms and conditions included on the Table and are to be read in conjunction with the Table. The Secretary is seeking public comment on the Table established through this interim final rule. At a later date, the Secretary will publish a companion final rule setting forth the administrative implementation of the Program. The public will then be afforded an additional opportunity to comment on the procedures set forth therein.     

Sudden death caused by parasites: postmortem cerebral malaria discoveries in the african endemic zone

This survey presents several cases of sudden deaths in Africa, specifically in Cote d'Ivoire, where the postmortem diagnosis of human cerebral malaria was determined after autopsy followed by pathologic examination of the brain. It is thought that cerebral malaria may be the primary cause of sudden death in nonimmunized persons during or after traveling in such endemic areas of Africa. The target population is composed of tourists, business travelers, and sailors. Because death caused by cerebral malaria occurs so suddenly, it can lead to forensic issues. Therefore, in any cases involving sudden death, it is very important for the forensic scientist to do a systematic evaluation, including pathologic examination of brain tissue, to rule in or exclude cerebral malaria. This practice will reinforce and aid research in progress directed at developing a vaccine and elucidating the role of tumor necrosis factor in this disease. Furthermore, this study will alert the physician to the importance of an effective and well-followed prophylaxis.     

Smallpox Vaccine Injury Compensation Program: administrative implementation. Interim final rule

The Smallpox Emergency Personnel Protection Act of 2003 (SEPPA), authorizes the Secretary of Health and Human Services (the Secretary), to establish the Smallpox Vaccine Injury Compensation Program ("the Program"). This program is designed to provide benefits and/or compensation to certain persons harmed as a direct result of receiving smallpox covered countermeasures, including the smallpox vaccine, or as a direct result of contracting vaccinia through certain accidental exposures. In addition, the Secretary may provide death benefits to certain survivors of individuals who died as the direct result of these injuries. On August 27, 2003, the Secretary published an interim final rule that set out a Smallpox (Vaccinia) Vaccine Injury Table ("the Table"). The table includes adverse effects (including injuries, disabilities, conditions, and deaths) within specific time periods that shall be presumed to result from the receipt of, or exposure to, the smallpox vaccine. The Secretary will use this table, as well as the procedures set out in this regulation, in deciding whether persons are eligible to receive benefits under the program. In this interim final rule, the Secretary is setting out the administrative policies, procedures, and requirements governing the program, as authorized by the SEPPA. The Secretary is seeking public comment on this interim final rule.     

Proposed vaccine information materials for hepatitis B, Haemophilus influenzae type b (Hib), Varicella (chickenpox), and measles, mumps, rubella (MMR) vaccines--CDC. Notice with comment period

Under the National Childhood Vaccine Injury Act (42 U.S.C. section 300aa-26), CDC must develop vaccine information materials that health care providers are required to give to patients/parents prior to administration of specific vaccines. CDC seeks written comment on proposed new vaccine information materials for hepatitis B, Haemophilus influenzae type b, and Varicella vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines.     

Resolving legal, ethical, and human rights challenges in HIV vaccine research

In the absence of a cure for AIDS, attention has turned to the possibility of developing a preventive vaccine for HIV infection. Yet many scientific, ethical, legal, and economic obstacles remain. At the current rate, the development and production of an effective vaccine could take 15 to 20 years or longer. If tens of millions more HIV infections and deaths are to be avoided in the coming decades, vaccine research needs to be greatly expedited. Furthermore, it must be undertaken ethically, and the products of this research must benefit people in developing countries. This article, an edited and updated version of a paper presented at "Putting Third First," addresses challenges arising in HIV preventive vaccine research in developing countries. It does not address clinical research in developing countries relating to treatments or therapeutic vaccines. Nor does it address legal and ethical issues relating to HIV vaccine research in industrialized countries, although similar issues arise in both contexts. The article concludes that while ethical codes are silent on the obligation to undertake research and development, international law provides strong legal obligations--particularly with regard to industrialized states--that should be invoked to accelerate HIV vaccine development, and distribution.     

Finding the proper balance between freedom and justice: why we should not eliminate personal belief exemptions to vaccine mandates

Lantos and colleagues (this issue) propose to eliminate personal belief exemptions from school vaccine mandates, particularly for those vaccines that target deadly contagious childhood disease. They argue that not doing so would be unjust. In this counterpoint, we argue that, for reasons grounded in both health policy and morality, a just vaccine policy need not prohibit parents from claiming personal belief exemptions.     

New vaccine information materials for hepatitis B, Haemophilus influenzae type b (Hib), and varicella (chickenpox) vaccines, and revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice

Under the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-26), the CDC must develop vaccine information materials that all health care providers, whether public or private, are required to distribute to patients/parents prior to administration of each dose of specific vaccines. On September 3, 1998, CDC published a notice in the Federal Register (63 FR 47026) seeking public comment on proposed vaccine information materials for the newly covered vaccines hepatitis B, Haemophilus influenzae type b, and varicella vaccines, and also seeking comment on proposed revised vaccine information materials for measles, mumps, rubella (MMR) vaccines. The 60 day comment period ended on November 2, 1998. Following review of the comments submitted and consultation as required under the law, CDC has finalized these vaccine information materials. The final materials are contained in this notice.     

Revised diphtheria, tetanus, and pertussis (DTP/DTaP/DT) vaccine information materials--CDC. Notice

Under the National Childhood Vaccine Injury Act (42 U.S.C section 300aa-26), the CDC must develop vaccine information materials that health care providers, either public or private, are required to distribute to patients/parents prior to administration of each dose of specific vaccines. On September 13, 1996, CDC published a notice in the Federal Register (61 FR 48597) seeking public comment on proposed revision of the diphtheria, tetanus, and pertussis vaccine information materials to reflect Food and Drug Administration (FDA) licensure of acellular pertussis vaccine combined with diphtheria and tetanus toxoids (DTaP) for administration to infants as young as two months of age. The 60-day comment period ended on November 12, 1996. Following review of the comments submitted and consultation as required under the law, CDC has finalized the revised diphtheria, tetanus, and pertussis vaccine information materials. Those final materials are contained in this notice.     

Interim polio vaccine information materials. Centers for Disease Control and Prevention (CDC), Department of Health and Human Services. Notice

The Centers for Disease Control and Prevention has modified its recommendation for use of the two polio vaccines to discourage use of oral poliovirus vaccine (OPV) for the first two doses administered, except in limited circumstances. This revised recommendation necessitates a revision of the vaccine information statement entitled, "Polio Vaccines: What You Need to Know" (dated February 6, 1997), which was developed by the CDC as required by the National Childhood Vaccine Injury Act of 1986 (NCVIA). To ensure that up-to-date information is available regarding this revised recommendation, CDC is distributing the following interim polio vaccine information statement for use pending completion of the formal revision process mandated by the NCVIA.     

Prizes and Parasites: Incentive Models for Addressing Chagas Disease

Recent advances in immunology have provided a foundation of knowledge to understand many of the intricacies involved in manipulating the human response to fight parasitic infections, and a great deal has been learned from malaria vaccine efforts regarding strategies for developing parasite vaccines. There has been some encouraging progress in the development of a Chagas vaccine in animal models. A prize fund for Chagas could be instrumental in ensuring that these efforts are translated into products that benefit patients.     

RECENT STUDIES ON THE HPV VACCINE GARDASIL: ADDENDUM TO OCTOBER 2008 NOTE

This Note advocates that states require all females entering the sixth grade to be vaccinated with the HPV vaccine Gardasil, as a means of preventing cervical cancer deaths in the United States. States that do pass such a mandate would receive federal funding to help disperse the cost of the expensive three-dose vaccine, especially to those females most in need. Subject to each individual state's mandate, parents would be allowed to opt their children out of such a mandate for either, religious, medical, and/or philosophical reasons.     

CERVICAL CANCER PREVENTION: MANDATING THE HPV VACCINE AS A CONDITION OF SCHOOL ATTENDANCE

This Note advocates that states require all females entering the sixth grade to be vaccinated with the HPV vaccine Gardasil, as a means of preventing cervical cancer deaths in the United States. States that do pass such a mandate would receive federal funding to help disperse the cost of the expensive three‐dose vaccine, especially to those females most in need. Subject to each individual state's mandate, parents would be allowed to opt their children out of such a mandate for religious, medical, and/or philosophical reasons.     

Beta-tryptase and quantitative mast-cell increase in a sudden infant death following hexavalent immunization

The association between sudden infant death syndrome and immunization is frequently discussed. Serious adverse events following vaccination have generally been defined as those adverse events that result in permanent disability, hospitalization or prolongation of hospitalization, life threatening illness, congenital anomaly or death. They are generally referred to the inherent properties of the vaccine (vaccine reaction) or some error in the immunization process (programme error). The event could also be totally unrelated but only temporally linked to immunization (coincidental event). A fatal case of a 3-month-old female infant, who died within 24 h of vaccination with hexavalent vaccine is presented. Clinical data, post-mortem findings (acute pulmonary oedema, acute pulmonary emphysema), quali-quantitative data collected from immunohistochemical staining (degranulating mast cells) and laboratory analysis with a high level of beta-tryptase in serum, 43.3 microg/l, allows us to conclude that acute respiratory failure likely due to post hexavalent immunization-related shock was the cause of death.     

从人权保障视角看我国《疫苗管理法》的制度设计

2019年12月1日,由第十三届全国人大常委会第十一次会议表决通过的《中华人民共和国疫苗管理法》正式实施。该法是基于近些年来发生的多起假劣疫苗事件为社会背景,回应社会关切而制定的旨在加强疫苗监管,保证疫苗质量,保护接种对象特别是婴幼儿的生命健康,维护社会公共卫生安全的一部专门性法律。该法设计了严密的制度体系,设置了一系列的制度规则,体现了"四个最严",是我国药品领域最严的管理法。从人权角度看,它不仅是一部《疫苗管理法》,更是一部人权保障法。     

HIV vaccines: current challenges and future directions

Volume seven of the Review will mark the tenth anniversary of the Canadian HIV/AIDS Legal Network with a series of articles that describe past developments and future directions in several areas of policy and law related to HIV/AIDS. The following article is the first of these, discussing current challenges and future directions in the development of and access to HIV vaccines. It argues that governments are under public health, ethical, and legal obligations to develop and provide access to HIV vaccines. It further explains what is required for governments to fulfill their obligations: additional commitment and resources for HIV vaccine development in the context of increased global research and development regarding diseases of the poor; increased support and advocacy for partnerships to develop HIV vaccines; enhanced regulatory capacity in every country to review, approve, and monitor HIV vaccines; and assurance of global supply of, procurement of, delivery of, and access to vaccines in the context of efforts to increase global access to public health measures and technologies.     

Managing Dissonance and Dissent: Bureaucratic Professionalism and Political Risk in Policy Implementation

This article examines the implementation of a Michigan rule requiring vaccine‐critical parents to attend an education session at a local health department prior to receiving an immunization waiver. During interviews (N = 35), public health professionals recognized that providing waivers deviated from their professional mission. Yet, they chose to prioritize client service in their interactions, thereby managing and absorbing conflict at the parent level. Politically, vaccine critics have succeeded in proposing bills to undo this rule. This suggests that conflict management and absorption is a vital policy function because conflict can turn into political action, endangering the future of a promising rule.