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1.
《Vaccine》2019,37(35):4840-4847
BackgroundGavi, the Vaccine Alliance, delivers life-saving vaccines to children in the world’s poorest countries and encourages countries to assume increasing ownership of their immunization programs as their economies grow. Vaccination legislation may promote country ownership and immunization program sustainability. However, despite establishment of vaccination laws as an indicator of national commitment to immunization through the Global Vaccine Action Plan, little is known about the content of vaccination legislation in low- and middle-income countries and the processes by which countries strengthen their legal frameworks. We describe the experiences of three countries supported by Gavi through its partnership with the Sabin Vaccine Institute— Armenia, Georgia, and Moldova—in strengthening their legal frameworks for vaccination as they transition from Gavi support.MethodsInformation presented comes from national legal documents and the 2017 European Regional Workshop on Immunization Legislation, in which legislators and health officials from Armenia, Georgia, and Moldova shared approaches to making immunization a national priority by strengthening legal frameworks. We outline each country’s legislative framework, describe progress in modifying vaccination legislation, and present strategies developed by countries to continue strengthening the legal basis of their immunization programs.ResultsArmenia, Georgia, and Moldova have legal frameworks that guarantee immunization as a public good, define immunization calendars, and establish regulations for vaccine procurement and administration. Legislative priorities include modifications of regulations to optimize procurement (Armenia and Moldova), potential provisions to increase vaccination through incentives (Georgia) or requirements (Moldova, possibly Armenia), and new mechanisms to finance routine program costs (all three countries). Each country is employing a distinct approach to strengthen its legal framework.ConclusionThese country experiences suggest that while legal approaches can promote country ownership, there is no standardized approach to vaccination legislation. A better understanding of the complex legal frameworks and their impact on supporting and sustaining progress in vaccination is needed.  相似文献   

2.
《Vaccine》2016,34(26):2880-2886
Enterotoxigenic Escherichia coli (ETEC) is one of the most common bacterial causes of diarrhea-associated morbidity and mortality, particularly among infants and young children in developing countries. Still, the true impact on child and traveler health is likely underestimated. There are currently no licensed vaccines for ETEC, but studies indicate high public health impact, cost-effectiveness, and feasibility of immune protection through vaccination. ETEC vaccine development remains a World Health Organization priority. Traditionally, ETEC vaccine development efforts have focused on inducing antitoxin and anticolonization antigen immunity, as studies indicate that antibodies against both antigen types can contribute to protection and thus have potential for vaccines. Leading cellular vaccine candidates are ETVAX (a mixture of four inactivated strains) and ACE527 (a mixture of three live attenuated strains), both of which have been found to be safe and immunogenic in Phase 1/2 trials. ETVAX is the furthest along in development with descending-age studies already underway in Bangladesh. Other ETEC vaccine candidates based on protein subunits, toxoids (both LT and ST), or novel, more broadly conserved ETEC antigens are also under development. Of these, a protein adhesin-based subunit approach is the most advanced. Impact and economic models suggest favorable vaccine cost-effectiveness, which may help expand market interest in ETEC vaccines. Combination vaccine formulations may help improve the economic case for development and use, and better point-of-care diagnostics will help to raise awareness of the true health burden of ETEC and highlight the potential public health benefit of ETEC vaccine introduction. Better diagnostics and vaccine demand forecasting will also improve vaccine development financing and support accelerated uptake once a licensed vaccine becomes available.  相似文献   

3.
Klaus Cichutek 《Vaccine》1994,12(16):1520-1525
Nucleic acid (NA) vaccines may offer the safety of subunit or inactivated vaccines and, at the same time, provide the advantages of live recombinant vaccines, such as induction of a protective cellular immune response. In Germany, the so-called ‘Gene Law’ regulates the genetic modification of organism such as prokaryotic or eukaryotic cells for the construction of recombinant NAs intended for use as NA vaccines. Neither NAs nor human being treated with NAs are subject to Gene Law regulations but preclinical laboratory experiments are regulated by the Gene Law. Gene therapy, as defined in a recent draft of a European guideline for the production of gene therapeutics, includes the genetic modification of human somatic cells via transfer of NAs and thus includes NA vaccines. The guideline provides recommendations for the production of NA vaccine for human use and for preclinical safety testing. NA vaccines are products derived by biotechnological processes, as defined in part A of the annex of Council Regulation (EEC) No. 2309/93 of 22 July 1993. Applications for marketing authorization in Member States of the European Union will thus be reviewed by the European Agency for the Evaluation of Medicinal Products starting from 1 January 1995. Inoculation NAs encompassing a full-length but int/nef-defective simian immunodeficiency provirus allowing limited replication of viruses released is being investigated at the Paul-Ehrlich-Institute as a model for a NA vaccine against AIDS. The system may offer a promising way towards a vaccine and will also be used to study safety requirements for future human use of NA vaccines.  相似文献   

4.
BackgroundCOVID-19 vaccines are in short supply worldwide. China was among the first countries to pledge supplies of the COVID-19 vaccine as a global public product, and to date, the country has provided more than 600 million vaccines to more than 200 countries and regions with low COVID-19 vaccination rates. Understanding the public’s attitude in China toward the global distribution of COVID-19 vaccines could inform global and national decisions, policies, and debates.ObjectiveThe aim of this study was to determine the attitudes of adults living in China regarding the global allocation of COVID-19 vaccines developed in China and how these attitudes vary across provinces and by sociodemographic characteristics.MethodsWe conducted a cross-sectional online survey among adults registered with the survey company KuRunData. The survey asked participants 31 questions about their attitudes regarding the global allocation of COVID-19 vaccines developed in China. We disaggregated responses by province and sociodemographic characteristics. All analyses used survey sampling weights.ResultsA total of 10,000 participants completed the questionnaire. Participants generally favored providing COVID-19 vaccines to foreign countries before fulfilling domestic needs (75.6%, 95% CI 74.6%-76.5%). Women (3778/4921, 76.8%; odds ratio 1.18, 95% CI 1.07-1.32; P=.002) and those living in rural areas (3123/4065, 76.8%; odds ratio 1.13, 95% CI 1.01-1.27; P=.03) were especially likely to hold this opinion. Most respondents preferred providing financial support through international platforms rather than directly offering support to individual countries (72.1%, 95% CI 71%-73.1%), while for vaccine products they preferred direct provision to relevant countries instead of via a delivery platform such as COVAX (77.3%, 95% CI 76.3%-78.2%).ConclusionsAmong our survey sample, we found that adults are generally supportive of the international distribution of COVID-19 vaccines, which may encourage policy makers to support and implement the distribution of COVID-19 vaccines developed in China worldwide. Conducting similar surveys in other countries could help align policy makers’ actions on COVID-19 vaccine distribution with the preferences of their constituencies.  相似文献   

5.
Tick-borne encephalitis virus (TBEV) is a flavivirus of wide geographic distribution and the causative agent of tick-borne encephalitis (TBE), an infection of the central nervous system. TBE has the highest incidence rate in Russia, where locally produced as well as Western European vaccines for the prevention of TBE are available. The Western European vaccines are based on TBE viruses that belong to the European subtype, while the Russian vaccines are based on Far Eastern subtype viruses. The question of to which extent vaccination with a vaccine based on the European subtype is effective in protecting against the heterologous Far Eastern virus subtype - and vice versa - has not been answered conclusively. Here we immunized mice with TBE vaccines based on European and Far Eastern subtype viruses, and used an unbiased hybrid virus test system to determine cross-neutralizing antibody titers and cross-protective efficacy. All vaccines tested elicited cross-protective responses against the heterologous strains, similar to those induced against the respective homologous vaccine strains. These data, therefore, fully support the use of TBE vaccines in geographic regions where virus subtypes heterologous to the vaccine strains are prevalent.  相似文献   

6.
In Canada, several new vaccines were recently approved for clinical use or are expected to be soon. Decision-makers are faced with the choice whether or not to include these vaccines in publicly funded vaccination programs. The aim of this study was to assess Canadian pediatricians' and family physicians' opinions regarding 7 new vaccines, and perceived priority for the introduction of new programs. A self-administered, anonymous, mail-based questionnaire was sent during fall 2009 to a random sample of 1182 family physicians and to all 1852 Canadian pediatricians. Responses to 8 statements regarding frequency and severity of the diseases, efficacy and safety of the vaccines as well as feasibility of immunization programs were used to calculate priority scores to rank the 7 potential new vaccination programs (calculated scores ranging from 0 to 100). Overall response rate was 43%. The majority of respondents perceived the health and economic burden of diseases prevented by the seven new vaccines as important and considered new vaccines to be safe and effective. More than 90% of physicians strongly agreed or agreed that the new vaccines would be or are currently well accepted by the public and by the health professionals who administer vaccines, except for the HPV and rotavirus vaccines (respectively 30% and 29% strongly agreed or agreed). Mean priority scores were: 77.4 out of 100 for the measles, mumps, rubella and varicella (MMRV) combined vaccine; 75.6 for the hexavalent (DTaP-IPV-Hib-HBV) vaccine; 73.1 for the new pneumococcal conjugate vaccines; 69.8 for the meningococcal ACYW135; 68.9 for the combined hepatitis A and B; 63.5 for the human papillomavirus vaccine and 56.9 for the rotavirus vaccine. Health professionals' opinion is an important element to consider in the decision-making process regarding implementation of new immunization programs. Without health professional support, the introduction of a new vaccination program may be unsuccessful. In this study, the MMRV and the hexavalent (DTaP-IPV-Hib-HBV) vaccines received the highest ratings.  相似文献   

7.
Haemophilus influenzae type b (Hib) disease is estimated to cause 3 million cases of meningitis and severe pneumonia and approximately 386,000 deaths worldwide per year in children aged <5 years. Safe and effective Hib conjugate vaccines have been widely used in industrialized countries for nearly 20 years. However, primarily because of financial constraints and lack of awareness among both public health officials and the public regarding Hib disease burden and benefits of the vaccine, use of these vaccines has been low in developing countries, where most Hib disease and deaths occur. In 2000, the GAVI Alliance (formerly known as the Global Alliance for Vaccines and Immunizations) began providing financial support for Hib vaccine in 72 countries that had a gross national income of < or =$1,000 (USD) per capita. Despite this support, before 2005, adoption of Hib vaccine by these countries remained low. In response, in June 2005, the GAVI Alliance established the Hib Initiative to accelerate evidence-informed decision making regarding use of Hib vaccine in GAVI-eligible countries. During 2004-2007, the number of GAVI-eligible countries using Hib vaccine or approved to use the vaccine increased from 13 (18%) to 47 (65%).  相似文献   

8.
《Vaccine》2015,33(4):512-518
Eradication of bluetongue virus is possible, as has been shown in several European countries. New serotypes have emerged, however, for which there are no specific commercial vaccines. This study addressed whether heterologous vaccines would help protect against 2 serotypes. Thirty-seven sheep were randomly allocated to 7 groups of 5 or 6 animals. Four groups were vaccinated with commercial vaccines against BTV strains 2, 4, and 9. A fifth positive control group was given a vaccine against BTV-8. The other 2 groups were unvaccinated controls. Sheep were then challenged by subcutaneous injection of either BTV-16 (2 groups) or BTV-8 (5 groups). Taken together, 24/25 sheep from the 4 experimental groups developed detectable antibodies against the vaccinated viruses. Furthermore, sheep that received heterologous vaccines showed significantly reduced viraemia and clinical scores for BTV-16 when compared to unvaccinated controls. Reductions in clinical signs and viraemia among heterologously vaccinated sheep were not as common after challenge with BTV-8. This study shows that heterologous protection can occur, but that it is difficult to predict if partial or complete protection will be achieved following inactivated-BTV vaccination.  相似文献   

9.
《Vaccine》2016,34(50):6436-6448
The global vaccine market is diverse while facing a plethora of novel developments. Genetic modification (GM) techniques facilitate the design of ’smarter’ vaccines. For many of the major infectious diseases of humans, like AIDS and malaria, but also for most human neoplastic disorders, still no vaccines are available. It may be speculated that novel GM technologies will significantly contribute to their development. While a promising number of studies is conducted on GM vaccines and GM vaccine technologies, the contribution of GM technology to newly introduced vaccines on the market is disappointingly limited.In this study, the field of vector-based GM vaccines is explored. Data on currently available, actually applied, and newly developed vectors is retrieved from various sources, synthesised and analysed, in order to provide an overview on the use of vector-based technology in the field of GM vaccine development. While still there are only two vector-based vaccines on the human vaccine market, there is ample activity in the fields of patenting, preclinical research, and different stages of clinical research. Results of this study revealed that vector-based vaccines comprise a significant part of all GM vaccines in the pipeline. This study further highlights that poxviruses and adenoviruses are among the most prominent vectors in GM vaccine development.After the approval of the first vectored human vaccine, based on a flavivirus vector, vaccine vector technology, especially based on poxviruses and adenoviruses, holds great promise for future vaccine development. It may lead to cheaper methods for the production of safe vaccines against diseases for which no or less perfect vaccines exist today, thus catering for an unmet medical need. After the introduction of Jenner’s vaccinia virus as the first vaccine more than two centuries ago, which eventually led to the recent eradication of smallpox, this and other viruses may now be the basis for constructing vectors that may help us control other major scourges of mankind.  相似文献   

10.
Regulatory considerations for nucleic acid vaccines   总被引:3,自引:0,他引:3  
Herbert A. Smith 《Vaccine》1994,12(16):1515-1519
For regulatory purposes nucleic acid vaccines are considered biological products and will be regulated by the Center for Biologics Evaluation and Research (CBER). Vaccines derived through the use of this technology may ultimately find broad application as preventive vaccines for infectious disease or as therapeutic vaccines for treatment of disease. The regulations that govern the use of biological products as well as other guidance documents available from CBER are applicable to the regulation of nucleic acid vaccines. The regulatory concerns associated with the manufacture, preclinical evaluation and clinical studies for these vaccines are similar to those for other biological products. The following discussion will provide an overview of the organization of CBER and how nucleic acid vaccines will be reviewed within this organization. This discussion will also describe the regulations encoded in the US Code of Federal Regulations which govern the use of biological products and additional guidance provided in Points to Consider Documents and in specific Guidelines. In addition, this discussion will note specific concerns regarding the manufacture, lot release and preclinical evaluation to assess the safety of polynucleotide vaccines. Finally, the process for submission of an Investigational New Drug application and the design of protocols for clinical studies will be described.  相似文献   

11.
《Vaccine》2018,36(17):2346-2355
BackgroundThe dengue vaccination era began when Dengvaxia (CYD-TDV) became available in 2016. In addition, several second-generation vaccine candidates are currently in phase 3 trials, suggesting that a broader availability of dengue vaccines may be possible in the near future. Advancing on the recent WHO-SAGE recommendations for the safe and effective use of CYD-TDV at the regional level on average, this study investigates the vaccination impacts and cost-effectiveness of CYD-TDV and of a hypothetical new vaccine candidate (NVC) in a country-specific manner for three endemic countries: Vietnam, Thailand, and Colombia.MethodsThe vaccination impacts of CYD-TDV and NVC were derived by fitting the empirical seroprevalence rates of 9 year olds into an individual-based meta-population transmission model, previously used for the WHO-SAGE working group. The disability-adjusted life years were estimated by applying country-specific parametric values. The cost-effectiveness analyses of four intervention strategies in combination with routine and catch-up campaigns were compared for both vaccines to inform decision makers regarding the most suitable immunization program in each of the three countries.Results and conclusionBoth CYD-TDV and NVC could be cost-effective at the DALY threshold cost of $2000 depending upon vaccination costs. With CYD-TDV, targeting 9 year olds in routine vaccination programs and 10–29 year olds as a one-off catch-up campaign was the most cost-effective strategy in all three countries. With NVC, while the most cost-effective strategy was to vaccinate 9–29 and 9–18 year olds in Vietnam and Thailand respectively, vaccinating younger age cohorts between 1 and 5 years old in Colombia was more cost-effective than other strategies. Given that three countries will soon face decisions regarding whether and how to incorporate CYD-TDV or future dengue vaccines into their budget-constrained national immunization programs, the current study outcomes can be used to help decision makers understand the expected impacts and cost-effectiveness of such vaccines.  相似文献   

12.

Background  

Although there is rapid progress in vaccine research regarding influenza pandemic vaccines it is expected that pandemic influenza vaccine production can only start once the pandemic virus has been recognized. Therefore, pandemic vaccine capacity will be limited at least during the first phase of an influenza pandemic, requiring vaccine prioritization strategies. WHO recommends developing preliminary priorities for pandemic vaccine use. The goal of this review is to provide a thorough overview of pandemic vaccine prioritization concepts in the 27 European Union (EU) member states and the four non-EU countries of the Global Health Security Action Group.  相似文献   

13.
《Vaccine》2022,40(13):1987-1995
National immunisation programmes require an adequate supply of vaccines to function properly but many countries, globally and in Europe, have reported vaccine shortages. A comprehensive view of vaccine shortages and stockouts in the EU/EEA is missing in the published literature.This study was conducted in the framework of the European Joint Action on Vaccination (EU-JAV). Twenty-eight countries, including 20 EU-JAV consortium member states and an additional 8 EU/EEA countries, were invited to participate in a survey aimed at collecting information on vaccine shortages and stock-outs experienced from 2016 to 2019, their main causes, actions taken, and other aspects of vaccine supply. Twenty-one countries completed the survey (response rate 75%), of which 19 reported at least one shortage/stock-out event. Overall, 115 events were reported, 28 of which led to a change in the national immunisation programme. The most frequently involved vaccines were DT- and dT-containing combination vaccines, hepatitis B, hepatitis A, and BCG vaccines. The median duration of shortages/stock-outs was five months (range <1 month–39 months). Interruption in supply and global shortage were the most frequently indicated causes. Only about half of countries reported having an immunization supply chain improvement plan. Similarly, only about half of countries had recommendations or procedures in place to address shortages/stockouts. The survey also identified the occurrence of shortages/stockouts of other biological products (e.g. diphtheria antitoxin in 12 countries). Public health strategies to assure a stable and adequate vaccine supply for immunization programmes require coordinated actions from all stakeholders, harmonized definitions, strengthening of reporting and monitoring systems, the presence of an immunization supply chain improvement plan in all countries, and procedures or recommendations in place regarding the use of alternative vaccines or vaccination schedules in case of shortages/stockouts.  相似文献   

14.
Oura CA  Edwards L  Batten CA 《Vaccine》2012,30(2):112-115
Despite the widespread use of bluetongue serotype 8 (BTV-8) inactivated vaccines across Europe from 2008 to 2011, two very practical questions remain unanswered about the length of persistence of group-specific antibodies in milk and serum post-vaccination and the duration of protection beyond one year post-vaccination. This study has firstly revealed that group-specific antibodies persist at high levels in milk and serum in the majority of cattle for at least 3 years post-vaccination, thus removing the option of using these animals in ELISA-based surveillance programmes. Secondly neutralising antibodies have been shown to persist in the majority of cattle for at least 3 years post-vaccination, indicating that the cattle are likely to be protected for this time period. This extended duration of protection may have contributed towards the rapid and efficient eradication of BTV-8 from many European countries, despite reducing levels of vaccine coverage.  相似文献   

15.
《Vaccine》2019,37(50):7300-7306
Clostridium difficile associated disease is fundamentally associated with dysbiosis of the gut microbiome as a consequence of antibiotic use. This is because this sporulating, obligate anaerobe germinates and proliferates rapidly in the dysbiotic gut, which is an indirect consequence of their use. During its growth, C. difficile produces two toxins, toxin A (TcdA) and toxin B (TcdB), which are responsible for the majority of clinical symptoms associated with the disease. Three parenterally delivered vaccines, based on detoxified or recombinant forms of these toxins, have undergone or are undergoing clinical trials. Each offers the opportunity to generate high titres of toxin neutralising antibodies. Whilst these data suggest these vaccines may reduce primary symptomatic disease, they do not in their current form reduce the capacity of the organism to persist and shed from the vaccinated host. The current progress of vaccine development is considered with advantages and limitations of each highlighted. In addition, several alternative approaches are described that seek to limit C. difficile germination, colonisation and persistence. It may yet prove that the most effective treatments to limit infection, disease and spread of the organism will require a combination of therapeutic approaches. The potential use and efficacy of these vaccines in low and middle income countries will be depend on the development of a cost effective vaccine and greater understanding of the distribution and extent of disease in these countries.  相似文献   

16.
《Vaccine》2018,36(34):5194-5203
The three encephalitic alphaviruses, western, eastern, and Venezuelan equine encephalitis viruses (WEEV, EEEV, and VEEV) are potential biothreat agents due to high infectivity through aerosol exposure, ease of production in large amounts, and relative stability in the environment. Currently, there is no licensed vaccine for human use to these three encephalitic alphaviruses, and efforts to move vaccine candidates forward into clinical trials have not been successful. In this study, the modified vaccinia Ankara-Bavarian Nordic (MVA-BN®) vaccine platform was used to construct and produce three monovalent recombinant MVA-BN-based encephalitic alphavirus vaccines, MVA-BN-W, MVA-BN-E, and MVA-BN-V. Additionally, a MVA-BN-based construct was designed to produce antigens against all three alphaviruses, the trivalent vaccine MVA-BN-WEV. The protective efficacy of these vaccines was evaluated in vivo. Female BALB/c mice were immunized with two doses of each monovalent MVA-BN-based alphavirus vaccine, a mixture of the three monovalent vaccines, MVA-BN-W + E + V, or the trivalent vaccine MVA-BN-WEV at a four-week interval. Two weeks after the booster immunization, the mice were instilled intranasally with 5 × 103 to 1 × 104 plaque forming units of WEEV, EEEV, or VEEV. All mice immunized with monovalent vaccines survived the respective virus challenge without any signs of illness or weight loss, while all the control mice died. The triple mixture of vaccines or the trivalent vaccine also provided 90 to 100% protection to the mice against WEEV and VEEV challenges, and 60% to 90% protection against EEEV challenge. These data suggest that each monovalent MVA-BN-W, MVA-BN-E, and MVA-BN-V is a potential vaccine candidate against respective encephalitic alphavirus and the three monovalent vaccines can be given in a mixture (MVA-BN-W + E + V) or the trivalent vaccine MVA-BN-WEV can serve as a true multivalent vaccine without significantly reducing efficacy against WEEV and VEEV despite slightly reduced efficacy against EEEV challenge.  相似文献   

17.
Since 2000, GAVI provided essential support for an unprecedented increase in the use of hepatitis B (HepB) and Haemophilus influenzae (Hib) containing vaccines in resource poor countries. This increase was supported with significant funding from international donors, intended to be time-limited. To assess the sustainability of this important expansion of the global access to vaccines, we reviewed supply chains, financial resources for procurement and decision-making in countries that introduced hepatitis B or Hib vaccines with GAVI support. During the period studied, the types of vaccine products supplied fluctuated rapidly in relationship with the number of suppliers and availability of more combination products. The price of the cheaper vaccines decreased while that of pentavalent DTwP-HepB-Hib remained stable. In average, vaccine introduction was associated with an increase of national programs budget, with new vaccines representing more than half of that increase, while the part of GAVI contributions to the budget went from 25% to 46%. Less than 20% of the vaccine introductions were decided by a national advisory body. Strengthening supply chains, adjusting funding schemes and increasing national ownership will be key to the sustained use of hepatitis B and Hib vaccines and the eventual addition of other important vaccines where they are the most needed.  相似文献   

18.
The 14,543 spontaneous reports of suspected adverse reactions received in EudraVigilance from 1 November 2009 to 30 April 2010 for three centrally authorized Influenza A/H1N1 vaccines marketed in the European Economic Area (Celvapan™, Focetria™ and Pandemrix™) were extracted to evaluate the effectiveness of recommendations to strengthen pharmacovigilance systems during the pandemic and illustrate methods of signal detection used by the European Medicines Agency in this context. The number of vaccinees on 30 April 2010 was estimated to be at least 37,166,000 with a reporting rate of 391 per million vaccinees. 81.4% of reports were received in a period of 2 months ending 31 December 2009. Reports for A/H1N1 vaccines had fewer missing values for date of birth, age, case narrative, vaccination date and reaction onset date than reports involving human papilloma virus vaccines in a pre-pandemic period but more missing batch numbers (46.6%), with earlier notification by health care professionals to national authorities (median of 7 days since reaction onset date) and by national authorities to EudraVigilance (4 days). The network of European pharmacovigilance centers and the Agency was effective for monitoring the safety of A/H1N1 vaccines during the 2009-2010 influenza pandemic and coped with a sudden increase of the number of reports. Areas to be reinforced in order to improve the response to a future pandemic and to strengthen vaccine pharmacovigilance systems in general are highlighted. Observed-to-expected analyses were affected by uncertainties regarding the numbers of vaccinated individuals and age-specific background incidence rates. Imbalance analysis used by the Agency may overcome some of these limitations but needs further development. A multinational vaccine health outcome resource is needed to assess the burden of vaccine preventable diseases and the epidemiology of potential adverse outcomes, and to quickly evaluate safety signals, estimate the utilization, benefits and risks of vaccines and evaluate the effectiveness of public health measures.  相似文献   

19.
Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.  相似文献   

20.
Cholera remains a huge public health problem. Although in 1894, the first cholera vaccination was reported, an ideal vaccine that meets all the requirements of the WHO has not yet been produced. Among the different approaches used for cholera vaccination, attenuated vaccines represent a major category; these vaccines are beneficial in being able to induce a strong protective response after a single administration. However, they have possible negative effects on immunocompromised patient populations. Both the licensed CVD103-HgR and other vaccine approaches under development are detailed in this article, such as the Vibrio cholerae 638 vaccine candidate, Peru-15 or CholeraGarde® and the VA1.3, VA1.4, IEM 108 VCUSM2 and CVD 112 vaccine candidates. In another strategy, killed V. cholerae vaccines have been developed, including Dukoral®, mORCAX® and Sanchol™. The killed vaccines are already sold, and they have successfully demonstrated their potential to protect populations in endemic areas or after natural disasters. However, these vaccines do not fulfill all the requirements of the WHO because they fail to confer long-term protection, are not suitable for children under two years, require more than a single dose and require a distribution chain with cold storage. Lastly, other vaccine strategies under development are summarized in this review. Among these strategies, vaccine candidates based on alternative drug delivery systems that have been reported lately in the literature are discussed, such as microparticles, proteoliposomes, LPS subunits, DNA vaccines and rice seeds containing toxin subunits. Preliminary results reported by many groups working on alternative delivery systems for cholera vaccines demonstrate the importance of new technologies in addressing old problems such as cholera. Although a fully ideal vaccine has not yet been designed, promising steps have been reported in the literature resulting in hope for the fight against cholera.  相似文献   

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