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Manganello J.A.,University at Albany | Carter T.C.,PATH Malaria Vaccine Initiative | Stokley S.,Centers for Disease Control and Prevention
Pediatrics | Year: 2011

OBJECTIVE: To identify and describe vaccine safety in US newspaper articles. METHODS: Articles (1147) from 44 states and Washington, DC, between January 1, 1995, and July 15, 2005, were identified by using the search terms "immunize or vaccine" and "adverse events or safety or exemption or danger or risk or damage or injury or side effect" and were coded by using a standardized data-collection instrument. RESULTS: The mean number of vaccine-safety articles per state was 26. Six (not mutually exclusive) topics were identified: vaccine-safety concerns (46%); vaccine policy (44%); vaccines are safe (20%); immunizations are required (10%); immunizations are not required (8%); and state/school exemption (8%). Three spikes in the number of newspaper articles about vaccine-safety issues were observed: in 1999 regarding rotavirus vaccine and in 2002 and 2003 regarding smallpox vaccine. Excluding articles that referred to rotavirus and smallpox vaccines, 37% of the articles had a negative take-home message. CONCLUSION: Ongoing monitoring of news on vaccine safety may help the content and framing of vaccine-safety messages. Copyright © 2011 by the American Academy of Pediatrics.


News Article | February 15, 2017
Site: www.eurekalert.org

The acid test for a vaccine is: "Does it protect people from infection?" Emory Vaccine Center researchers have analyzed this issue for a leading malaria vaccine called RTS,S, and their results have identified candidate signatures, or biomarkers, in the blood of vaccinated subjects which predict the likelihood of success from vaccination. Bali Pulendran, PhD, and colleagues, identified molecular signatures - sets of genes that are turned on and off in immune cells in the blood - that can discern whether volunteers in a malaria vaccine study were protected when they were exposed to mosquitoes carrying the Plasmodium falciparum parasite. The results are scheduled for publication in PNAS. The research could inform decisions on how RTS,S or other malaria vaccines are deployed or modified. RTS,S was developed by GlaxoSmithKline, and has been tested in Phase 3 clinical trials with support from the PATH Malaria Vaccine Initiative. The vaccine was shown to provide partial protection against malaria and is scheduled for roll-out through pilot projects in three African countries next year, according to the World Health Organization. Pulendran is Charles Howard Candler professor of pathology and laboratory medicine at Emory University School of Medicine and a researcher at Yerkes National Primate Research Center. He and his team have pioneered the use of systems biology approaches to identify signatures to define molecular signatures or biomarkers, induced within a few days of vaccination, that can be used to accurately predict the strength of the immune response weeks later. A major challenge in vaccinology has been whether such signatures could be used to predict, not merely the strength of the immune response, but the efficacy of vaccination - that is the extent to which vaccination protected against infection. The present study addressed this issue by vaccinating human subjects with the RTS,S malaria vaccine, and then deliberately challenging them with Plasmodium falciparum in a controlled experimental human infection model. This provides proof of concept of the utility of systems based approaches in identifying signatures that can be used to predict vaccine efficacy. "Many of the genes contained in the predictive signatures are known to be expressed in natural killer cells, which mediate critical immune functions against viruses," Pulendran says. "It was a surprise to see such a robust 'NK cell signature' in predicting success of vaccination against the malaria parasite, and raises the hypothesis that such cells may be playing a vital role in orchestrating immunity against malaria." Pulendran says that other elements such as the signatures of antibody-producing plasma cells in the blood, and activation of antiviral interferon pathways, were conserved with vaccines such as yellow fever and flu. "The extent to which these candidate signatures of protection can successfully predict vaccine efficacy in other field trials remain to be determined," he adds. The underlying malaria vaccine study was performed at Walter Reed Army Institute of Research from 2011 to 2012, and involved 46 volunteers who received two vaccine regimens, one with RTS,S only and another adding an adenovirus-based vector. About 50 percent of the participants were protected after exposure to parasite-carrying mosquitos for both regimens. After analyzing the immune responses, the researchers propose that the two vaccine regimens may be conferring protection against malaria by distinct mechanisms, with the RTS,S-only regimen relying on high levels of antibodies, and the other recruiting more T cells. The same signatures that predicted protection from infection were confirmed using data from an independent study that was also testing the RTS,S vaccine. The co-first authors of the paper are bioinformatics analyst Dmitri Kazmin and former Emory postdoc Helder Nakaya, now at University of Sao Paulo. Co-authors include Ripley Ballou, Robbert van der Most, Robert van den Berg and Erik Jongert from GlaxoSmithKline, Eva Lee from Georgia Tech, Daniel Zak and Alan Aderem at the Center for Infectious Disease Research, Jerald Sadoff at Crucell, and Ulli Wille Reece and Christian Ockenhouse at the PATH Malaria Vaccine Initiative. Emory co-authors include Rafi Ahmed and Jens Wrammert. The research was supported by the PATH Malaria Vaccine Initiative, the National Institute of Allergy and Infectious Diseases (U19AI090023 and U19AI057266), and the Office of Research Infrastructure Programs (Primate centers: P51OD11132).


Birkett A.J.,PATH Malaria Vaccine Initiative | Moorthy V.S.,World Health Organization | Loucq C.,Korean International Vaccine Institute | Chitnis C.E.,International Center for Genetic Engineering and Biotechnology | Kaslow D.C.,PATH Malaria Vaccine Initiative
Vaccine | Year: 2013

While recent progress has been made in reducing malaria mortality with other interventions, vaccines are still urgently needed to further reduce the incidence of clinical disease, including during pregnancy, and to provide " herd protection" by blocking parasite transmission. The most clinically advanced candidate, RTS,S, is presently undergoing Phase 3 evaluation in young African children across 13 clinical sites in eight African countries. In the 12-month period following vaccination, RTS,S conferred approximately 50% protection from clinical Plasmodium falciparum disease in children aged 5-17 months, and approximately 30% protection in children aged 6-12 weeks when administered in conjunction with Expanded Program for Immunization (EPI) vaccines. The development of more highly efficacious vaccines to prevent clinical disease caused by both P. falciparum and Plasmodium vivax, as well as vaccines to support elimination efforts by inducing immunity that blocks malaria parasite transmission, are priorities. Some key barriers to malaria vaccine development include: a paucity of well-characterized target immunogens and an absence of clear correlates of protection to enable vaccine development targeting all stages of the P. falciparum and P. vivax lifecycles; a limited number of safe and effective delivery systems, including adjuvants, that induce potent, long-lived protective immunity, be it by antibody, CD4+, and/or CD8+ T cell responses; and, for vaccines designed to provide " herd protection" by targeting sexual stage and/or mosquito antigens, the lack of a clear clinical and regulatory pathway to licensure using non-traditional endpoints. Recommendations to overcome these, and other key challenges, are suggested in this document. © 2013 Elsevier Ltd.


News Article | December 12, 2016
Site: marketersmedia.com

SAN DIEGO, CA / ACCESSWIRE / December 12, 2016 / Each year, 1.7 billion citizens of developing countries need treatment for neglected diseases, according to the World Health Organization's (WHO) 2016 World Health Statistics. In a dynamic global environment, pharmaceutical companies face myriad obstacles in supplying poverty stricken communities with necessary medicines and vaccines. Shareholders often question such pursuits, as the cost-benefit matrix of developing drugs for countries with political or economic instability provides limited financial gain, at best. Dr. Najib Babul, an accomplished pharmaceutical scientist, drug developer and biotech entrepreneur, explains a new model of partnership between the public and private sectors that can successfully advance global health initiatives. Public-private partnerships have already helped address some of the world's largest public health challenges, noted Dr. Babul. Following the declaration of smallpox’s eradication in 1980, Merck, the WHO, the World Bank, the United Nations Children's Fund, the National Ministries of Health, and the Task Force for Global Health joined forces to launch a global initiative to distribute and administer treatment for river blindness. This campaign demonstrated that companies could successfully collaborate with government and non-profit partners, providing critical expertise in the areas of R&D, manufacturing, and distribution. In another example, pharmaceutical giant GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative collectively developed malaria candidate vaccine RTS,S (Mosquirix™), with grant monies from the Bill & Melinda Gates Foundation to PATH and support from a network of African research centers that performed the studies. Mosquirix recently received a positive scientific opinion from the European Medicines Agency for the prevention of malaria in young children in sub-Saharan Africa. The WHO has announced that the Mosquirix vaccine will first be rolled out in pilot projects in 3 countries in sub-Saharan Africa. The pilot program will assess whether the vaccine’s protective effects in Phase 3 clinical trials can be replicated in real-life settings. Effective research remains the basis and most vital component of developing promising medicines, and again, it is partnership, rather than the competitive model, which has shown most promise in accelerating solutions. For example, Dr. Babul cites the Pool for Open Innovation Against Neglected Tropical Diseases, administered by the non-governmental organization Bio Ventures for Global Health, which is embracing data sharing by partnering with companies who agree to grant access to their compound "libraries", and creating a singular, comprehensive collection of molecular entities. The initiative began with GSK's efforts to create a "Patent Pool" for new therapeutics to treat neglected tropical diseases. Pharmaceutical companies, academia and non-governmental organizations are encouraged to donate drug compounds for neglected tropical diseases. GSK has donated over 800 patents and patent applications to the collaboration. The Patent Pool is targeting sixteen diseases that the U.S FDA has identified in its neglected tropical diseases initiative. To date, approximately 150,000 compounds have been screened for efficacy against diseases including African sleeping sickness, visceral leishmaniasis and Chagas disease, potentially allowing for results to be achieved efficiently and with greater accuracy. A graduate of the University of British Columbia, the State University of New York in Buffalo and the California Institute of Advanced Management, Dr. Najib Babul is presently a drug development consultant to pharmaceutical companies and investment banks with over two decades of experience in bringing new drugs to market. Dr. Babul is the author of over 170 abstracts and manuscripts published by leading medical journals and scientific proceedings, including the Lancet, the Journal of American Medical Association (JAMA), the Journal of Clinical Pharmacology, the Journal of Clinical Oncology, Cancer, Anesthesiology, Clinical Pharmacology & Therapeutics, and Anesthesia & Analgesia. Najib Babul - Discusses the Benefits and Limitations of Opioids for Neuropathic Pain: https://www.yahoo.com/news/najib-babul-discusses-benefits-limitations-233500333.html Najib Babul - Explains Why Treatment Advances in Fibromyalgia Have Been Slow: http://sports.yahoo.com/news/najib-babul-explains-why-treatment-130500043.html SAN DIEGO, CA / ACCESSWIRE / December 12, 2016 / Each year, 1.7 billion citizens of developing countries need treatment for neglected diseases, according to the World Health Organization's (WHO) 2016 World Health Statistics. In a dynamic global environment, pharmaceutical companies face myriad obstacles in supplying poverty stricken communities with necessary medicines and vaccines. Shareholders often question such pursuits, as the cost-benefit matrix of developing drugs for countries with political or economic instability provides limited financial gain, at best. Dr. Najib Babul, an accomplished pharmaceutical scientist, drug developer and biotech entrepreneur, explains a new model of partnership between the public and private sectors that can successfully advance global health initiatives. Public-private partnerships have already helped address some of the world's largest public health challenges, noted Dr. Babul. Following the declaration of smallpox’s eradication in 1980, Merck, the WHO, the World Bank, the United Nations Children's Fund, the National Ministries of Health, and the Task Force for Global Health joined forces to launch a global initiative to distribute and administer treatment for river blindness. This campaign demonstrated that companies could successfully collaborate with government and non-profit partners, providing critical expertise in the areas of R&D, manufacturing, and distribution. In another example, pharmaceutical giant GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative collectively developed malaria candidate vaccine RTS,S (Mosquirix™), with grant monies from the Bill & Melinda Gates Foundation to PATH and support from a network of African research centers that performed the studies. Mosquirix recently received a positive scientific opinion from the European Medicines Agency for the prevention of malaria in young children in sub-Saharan Africa. The WHO has announced that the Mosquirix vaccine will first be rolled out in pilot projects in 3 countries in sub-Saharan Africa. The pilot program will assess whether the vaccine’s protective effects in Phase 3 clinical trials can be replicated in real-life settings. Effective research remains the basis and most vital component of developing promising medicines, and again, it is partnership, rather than the competitive model, which has shown most promise in accelerating solutions. For example, Dr. Babul cites the Pool for Open Innovation Against Neglected Tropical Diseases, administered by the non-governmental organization Bio Ventures for Global Health, which is embracing data sharing by partnering with companies who agree to grant access to their compound "libraries", and creating a singular, comprehensive collection of molecular entities. The initiative began with GSK's efforts to create a "Patent Pool" for new therapeutics to treat neglected tropical diseases. Pharmaceutical companies, academia and non-governmental organizations are encouraged to donate drug compounds for neglected tropical diseases. GSK has donated over 800 patents and patent applications to the collaboration. The Patent Pool is targeting sixteen diseases that the U.S FDA has identified in its neglected tropical diseases initiative. To date, approximately 150,000 compounds have been screened for efficacy against diseases including African sleeping sickness, visceral leishmaniasis and Chagas disease, potentially allowing for results to be achieved efficiently and with greater accuracy. A graduate of the University of British Columbia, the State University of New York in Buffalo and the California Institute of Advanced Management, Dr. Najib Babul is presently a drug development consultant to pharmaceutical companies and investment banks with over two decades of experience in bringing new drugs to market. Dr. Babul is the author of over 170 abstracts and manuscripts published by leading medical journals and scientific proceedings, including the Lancet, the Journal of American Medical Association (JAMA), the Journal of Clinical Pharmacology, the Journal of Clinical Oncology, Cancer, Anesthesiology, Clinical Pharmacology & Therapeutics, and Anesthesia & Analgesia. Najib Babul - Discusses the Benefits and Limitations of Opioids for Neuropathic Pain: https://www.yahoo.com/news/najib-babul-discusses-benefits-limitations-233500333.html Najib Babul - Explains Why Treatment Advances in Fibromyalgia Have Been Slow: http://sports.yahoo.com/news/najib-babul-explains-why-treatment-130500043.html


News Article | December 14, 2016
Site: marketersmedia.com

— According to the World Health Organization’s (WHO) 2016 World Health Statistics, 1.7 billion citizens of developing countries need treatment for neglected diseases each year. In a dynamic global environment, pharmaceutical companies face myriad obstacles in supplying poverty stricken communities with necessary medicines and vaccines. Shareholders often question such pursuits, as the cost-benefit matrix of developing drugs for countries with political or economic instability provides limited financial gain, at best. Dr. Najib Babul, an accomplished pharmaceutical scientist, drug developer and biotech entrepreneur, explains a new model of partnership between the public and private sectors that can successfully advance global health initiatives. Public-private partnerships have already helped address some of the world’s largest public health challenges, noted Dr. Babul. Following the declaration of smallpox’s eradication in 1980, Merck, the WHO, the World Bank, the United Nations Children’s Fund, the National Ministries of Health, and the Task Force for Global Health joined forces to launch a global initiative to distribute and administer treatment for river blindness. This campaign demonstrated that companies could successfully collaborate with government and non-profit partners, providing critical expertise in the areas of R&D, manufacturing, and distribution. In another example, pharmaceutical giant GlaxoSmithKline (GSK) and the PATH Malaria Vaccine Initiative collectively developed malaria candidate vaccine RTS,S (Mosquirix™), with grant monies from the Bill & Melinda Gates Foundation to PATH and support from a network of African research centers that performed the studies. Mosquirix recently received a positive scientific opinion from the European Medicines Agency for the prevention of malaria in young children in sub-Saharan Africa. The WHO has announced that the Mosquirix vaccine will first be rolled out in pilot projects in 3 countries in sub-Saharan Africa. The pilot program will assess whether the vaccine’s protective effects in Phase 3 clinical trials can be replicated in real-life settings. Effective research remains the basis and most vital component of developing promising medicines, and again, it is partnership, rather than the competitive model, which has shown most promise in accelerating solutions. For example, Dr. Babul cites the Pool for Open Innovation Against Neglected Tropical Diseases, administered by the non-governmental organization Bio Ventures for Global Health, which is embracing data sharing by partnering with companies who agree to grant access to their compound “libraries”, and creating a singular, comprehensive collection of molecular entities. The initiative began with GSK's efforts to create a “Patent Pool” for new therapeutics to treat neglected tropical diseases. Pharmaceutical companies, academia and non-governmental organizations are encouraged to donate drug compounds for neglected tropical diseases. GSK has donated over 800 patents and patent applications to the collaboration. The Patent Pool is targeting sixteen diseases that the U.S FDA has identified in its neglected tropical diseases initiative. To date, approximately 150,000 compounds have been screened for efficacy against diseases including African sleeping sickness, visceral leishmaniasis and Chagas disease, potentially allowing for results to be achieved efficiently and with greater accuracy. A graduate of the University of British Columbia, the State University of New York in Buffalo and the California Institute of Advanced Management, Dr. Najib Babul is presently a drug development consultant to pharmaceutical companies and investment banks with over two decades of experience in bringing new drugs to market. Dr. Babul is the author of over 170 abstracts and manuscripts published by leading medical journals and scientific proceedings, including the Lancet, the Journal of American Medical Association (JAMA), the Journal of Clinical Pharmacology, the Journal of Clinical Oncology, Cancer, Anesthesiology, Clinical Pharmacology & Therapeutics, and Anesthesia & Analgesia. Najib Babul - Discusses the Benefits and Limitations of Opioids for Neuropathic Pain: https://www.yahoo.com/news/najib-babul-discusses-benefits-limitations-233500333.html Najib Babul - Explains Why Treatment Advances in Fibromyalgia Have Been Slow: http://sports.yahoo.com/news/najib-babul-explains-why-treatment-130500043.html For more information, please visit http://www.NajibBabulNews.com


Brooks A.,Voltaire | Brooks A.,Swiss Tropical and Public Health Institute | Ba-Nguz A.,PATH Malaria Vaccine Initiative
Health Policy and Planning | Year: 2012

Traditionally it has taken years or decades for new public health interventions targeting diseases found in developing countries to be accessible to those most in need. One reason for the delay has been insufficient anticipation of the eventual processes and evidence required for decision making by countries. This paper describes research into the anticipated processes and data needed to inform decision making on malaria vaccines, the most advanced of which is still in phase 3 trials. From 2006 to 2008, a series of country consultations in Africa led to the development of a guide to assist countries in preparing their malaria vaccine decision-making frameworks. The guide builds upon the World Health Organization's Vaccine Introduction Guidelines. It identifies the processes and data for decisions, when they would be needed relative to the development timelines of the intervention, and where they will come from. Policy development will be supported by data (e.g. malaria disease burden; roles of other malaria interventions; malaria vaccine impact; economic and financial issues; malaria vaccine efficacy, quality and safety) as will implementation decisions (e.g. programmatic issues and socio-cultural environment). This generic guide can now be applied to any future malaria vaccine. The paper discusses the opportunities and challenges to early planning for country decision-making - from the potential for timely, evidence-informed decisions to the risks of over-promising around an intervention still under development. Careful and well-structured planning by countries is an important way to ensure that new interventions do not remain unused for years or decades after they become available. © World Health Organization 2012. All rights reserved.


Bingham A.,PATH Kenya | Gaspar F.,Traditional Medicine Institute | Lancaster K.,University of North Carolina at Chapel Hill | Conjera J.,M and e | And 2 more authors.
Malaria Journal | Year: 2012

Background: Malaria is a leading cause of mortality and morbidity in Mozambique, with nearly three-quarters of the country's malaria-related deaths occurring in children younger than five years. A malaria vaccine is not yet available, but planning is underway for a possible introduction, as soon as one becomes available. In an effort to inform the planning process, this study explored sociocultural and health communications issues among individuals at the community level who are both responsible for decisions about vaccine use and who are likely to influence decisions about vaccine use. Methods. Researchers conducted a qualitative study in two malaria-endemic districts in southern Mozambique. Using criterion-based sampling, they conducted 23 focus group discussions and 26 in-depth interviews. Implementation was guided by the engagement of community stakeholders. Results: Community members recognize that malaria contributes to high death rates and affects the workforce, school attendance, and the economy. Vaccines are seen as a means to reduce the threat of childhood illnesses and to keep children and the rest of the community healthy. Perceived constraints to accessing vaccine services include long queues, staff shortages, and a lack of resources at health care facilities. Local leaders play a significant role in motivating caregivers to have their children vaccinated. Participants generally felt that a vaccine could help to prevent malaria, although some voiced concern that the focus was only on young children and not on older children, pregnant women, and the elderly. Probed on their understanding of vaccine efficacy, participants voiced various views, including the perception that while some vaccines did not fully prevent disease they still had important benefits. Overall, it would be essential for local leaders to be involved in the design of specific messages for a future malaria vaccine communications strategy, and for those messages to be translated into local languages. Conclusions: Acceptance of routine childhood vaccines bodes well for a future malaria vaccine. Vaccinating children is a well-established routine that is viewed favourably in Mozambique. A communications strategy would need to build on existing immunization efforts and use trusted sources-including current government dissemination arrangements-to deliver health information. © 2012 Bingham et al.; licensee BioMed Central Ltd.


Miura K.,U.S. National Institutes of Health | Deng B.,U.S. National Institutes of Health | Tullo G.,U.S. National Institutes of Health | Diouf A.,U.S. National Institutes of Health | And 5 more authors.
PLoS ONE | Year: 2013

Vaccines that interrupt malaria transmission are of increasing interest and a robust functional assay to measure this activity would promote their development by providing a biologically relevant means of evaluating potential vaccine candidates. Therefore, we aimed to qualify the standard membrane-feeding assay (SMFA). The assay measures the transmission-blocking activity of antibodies by feeding cultured P. falciparum gametocytes to Anopheles mosquitoes in the presence of the test antibodies and measuring subsequent mosquito infection. The International Conference on Harmonisation (ICH) Harmonised Tripartite Guideline Q2(R1) details characteristics considered in assay validation. Of these characteristics, we decided to qualify the SMFA for Precision, Linearity, Range and Specificity. The transmission-blocking 4B7 monoclonal antibody was tested over 6 feeding experiments at several concentrations to determine four suitable concentrations that were tested in triplicate in the qualification experiments (3 additional feeds) to evaluate Precision, Linearity and Range. For Specificity, 4B7 was tested in the presence of normal mouse IgG. We determined intra- and inter-assay variability of % inhibition of mean oocyst intensity at each concentration of 4B7 (lower concentrations showed higher variability). We also showed that % inhibition was dependent on 4B7 concentration and the activity is specific to 4B7. Since obtaining empirical data is time-consuming, we generated a model using data from all 9 feeds and simulated the effects of different parameters on final readouts to improve the assay procedure and analytical methods for future studies. For example, we estimated the effect of number of mosquitoes dissected on variability of % inhibition, and simulated the relationship between % inhibition in oocyst intensity and % inhibition of prevalence of infected mosquitos at different mean oocysts in the control. SMFA is one of the few biological assays used in preclinical and early clinical development of transmission-blocking vaccines, and this study strongly supports its further development and application.


Milstien J.,University of Maryland Baltimore County | Crdenas V.,PATH Malaria Vaccine Initiative | Cheyne J.,Voltaire | Brooks A.,Voltaire
Malaria Journal | Year: 2010

Abstract. Background. Recommendations from the World Health Organization (WHO) are crucial to inform developing country decisions to use, or not, a new intervention. This article analysed the WHO policy development process to predict its course for a malaria vaccine. Methods. The decision-making processes for one malaria intervention and four vaccines were classified through (1) consultations with staff and expert advisors to WHO's Global Malaria Programme (GMP) and Immunization, Vaccines and Biologicals Department (IVB); (2) analysis of the procedures and recommendations of the major policy-making bodies of these groups; (3) interviews with staff of partnerships working toward new vaccine availability; and (4) review and analyses of evidence informing key policy decisions. Case description. WHO policy formulation related to use of intermittent preventive treatment in infancy (IPTi) and the following vaccine interventions: Haemophilus influenzae type b conjugate vaccine (Hib), pneumococcal conjugate vaccine (PCV), rotavirus vaccine (RV), and human papillomavirus vaccine (HPV), five interventions which had relatively recently been through systematic WHO policy development processes as currently constituted, was analysed. Required information was categorized in three areas defined by a recent WHO publication on development of guidelines: safety and efficacy in relevant populations, implications for costs and population health, and localization of data to specific epidemiological situations. Discussion and evaluation. Data needs for a malaria vaccine include safety; the demonstration of efficacy in a range of epidemiological settings in the context of other malaria prevention interventions; and information on potential rebound in which disease increases subsequent to the intervention. In addition, a malaria vaccine would require attention to additional factors, such as costs and cost-effectiveness, supply and demand, impact of use on other interventions, and distribution issues. Conclusions. Although policy issues may be more complex for future vaccines, the lead-time between the date of product regulatory approval and a recommendation for its use in developing countries is decreasing. This study presents approaches to define in advance core data needs to support evidence-based decisions, to further decrease this lead-time, accelerating the availability of a malaria vaccine. Specific policy areas for which information should be collected are defined, including studying its use within the context of other malaria interventions. © 2010 Milstien et al; licensee BioMed Central Ltd.


The new paradigm of elimination and eradication and constrained economic environment - combined with a first decade of experience - have lead the PATH Malaria Vaccine Initiative (MVI) to redefine its vaccine development strategy. This strategy has two targets: the pre-erythrocytic and sexual stages of the parasite, the latter including the parasite's evolution inside the mosquito. It encompasses four components: the selection of new antigens, identification of presenting platforms, adjuvant development and vaccine formulation and evaluation technologies. However, the development of a malaria vaccine cannot occur in isolation from other interventions; rather, it should be carried out in coordination with them. RTS,S is now in a Phase III trial, after demonstrating levels of efficacy from 30 to 50% against clinical malaria. Bringing a partially effective vaccine to licensure and use is a long and complex process that will require efficacy as well as public health impact data. Prime-boost and attenuated sporozoite approaches are, or will be, part of the portfolio required to build on these results, the former including use of adenovirus-based platforms. Current investments in blood-stage approaches are limited to attempting to resolve the challenge of AMA1 polymorphism and to an approach aimed at blocking re-entry of merozoites into red blood cells. MVI has prioritized the development of transmission-blocking vaccines and has identified some promising projects, while also researching their regulatory pathway. Two projects targeting Plasmodium vivax are supported. As part of its strategy, MVI has adopted a new classification of projects into small-scale preclinical feasibility studies, larger translational projects and, finally, vaccine candidates, the latter requiring proof-of-concept to be established in endemic countries. © 2010 Future Medicine Ltd.

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