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1.
BMJ Glob Health ; 8(6)2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37277196

RESUMO

Through the experiences gained by accelerating new vaccines for both Ebola virus infection and COVID-19 in a public health emergency, vaccine development has benefited from a 'multiple shots on goal' approach to new vaccine targets. This approach embraces simultaneous development of candidates with differing technologies, including, when feasible, vesicular stomatitis virus or adenovirus vectors, messenger RNA (mRNA), whole inactivated virus, nanoparticle and recombinant protein technologies, which led to multiple effective COVID-19 vaccines. The challenge of COVID-19 vaccine inequity, as COVID-19 spread globally, created a situation where cutting-edge mRNA technologies were preferentially supplied by multinational pharmaceutical companies to high-income countries while low and middle-income countries (LMICs) were pushed to the back of the queue and relied more heavily on adenoviral vector, inactivated virus and recombinant protein vaccines. To prevent this from occurring in future pandemics, it is essential to expand the scale-up capacity for both traditional and new vaccine technologies at individual or simultaneous hubs in LMICs. In parallel, a process of tech transfer of new technologies to LMIC producers needs to be facilitated and funded, while building LMIC national regulatory capacity, with the aim of several reaching 'stringent regulator' status. Access to doses is an essential start but is not sufficient, as healthcare infrastructure for vaccination and combating dangerous antivaccine programmes both require support. Finally, there is urgency to establish an international framework through a United Nations Pandemic Treaty to promote, support and harmonise a more robust, coordinated and effective global response.


Assuntos
COVID-19 , Doença pelo Vírus Ebola , Vacinas contra Influenza , Influenza Humana , Humanos , Vacinas contra COVID-19 , Influenza Humana/epidemiologia , Pandemias/prevenção & controle , COVID-19/prevenção & controle , Doenças Negligenciadas
2.
BMJ Glob Health ; 8(6)2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37277195

RESUMO

The COVID-19 pandemic triggered a sense of vulnerability and urgency that led to concerted actions by governments, funders, regulators and industry to overcome traditional challenges for the development of vaccine candidates and to reach authorisation. Unprecedented financial investments, massive demand, accelerated clinical development and regulatory reviews were among the key factors that contributed to accelerating the development and approval of COVID-19 vaccines. The rapid development of COVID-19 vaccines benefited of previous scientific innovations such as mRNA and recombinant vectors and proteins. This has created a new era of vaccinology, with powerful platform technologies and a new model for vaccine development. These lessons learnt highlight the need of strong leadership, to bring together governments, global health organisations, manufacturers, scientists, private sector, civil society and philanthropy, to generate innovative, fair and equitable access mechanisms to COVID-19 vaccines for populations worldwide and to build a more efficient and effective vaccine ecosystem to prepare for other pandemics that may emerge. With a longer-term view, new vaccines must be developed with incentives to build expertise for manufacturing that can be leveraged for low/middle-income countries and other markets to ensure equity in innovation, access and delivery. The creation of vaccine manufacturing hubs with appropriate and sustained training, in particular in Africa, is certainly the way of the future to a new public health era to safeguard the health and economic security of the continent and guarantee vaccine security and access, with however the need for such capacity to be sustained in the interpandemic period.


Assuntos
COVID-19 , Vacinas , Humanos , Vacinas contra COVID-19 , Pandemias/prevenção & controle , COVID-19/prevenção & controle , Ecossistema
3.
Vaccine ; 41(13): 2101-2112, 2023 03 24.
Artigo em Inglês | MEDLINE | ID: mdl-36870874

RESUMO

Broadly protective coronavirus vaccines are an important tool for protecting against future SARS-CoV-2 variants and could play a critical role in mitigating the impact of future outbreaks or pandemics caused by novel coronaviruses. The Coronavirus Vaccines Research and Development (R&D) Roadmap (CVR) is aimed at promoting the development of such vaccines. The CVR, funded by the Bill & Melinda Gates Foundation and The Rockefeller Foundation, was generated through a collaborative and iterative process, which was led by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and involved 50 international subject matter experts and recognized leaders in the field. This report summarizes the major issues and areas of research outlined in the CVR and identifies high-priority milestones. The CVR covers a 6-year timeframe and is organized into five topic areas: virology, immunology, vaccinology, animal and human infection models, and policy and finance. Included in each topic area are key barriers, gaps, strategic goals, milestones, and additional R&D priorities. The roadmap includes 20 goals and 86 R&D milestones, 26 of which are ranked as high priority. By identifying key issues, and milestones for addressing them, the CVR provides a framework to guide funding and research campaigns that promote the development of broadly protective coronavirus vaccines.


Assuntos
COVID-19 , Vacinas , Animais , Humanos , SARS-CoV-2 , COVID-19/prevenção & controle , Vacinas contra COVID-19 , Pandemias/prevenção & controle , Pesquisa
5.
Vaccine ; 39(51): 7357-7362, 2021 12 17.
Artigo em Inglês | MEDLINE | ID: mdl-34799142

RESUMO

Infectious diseases may cause serious morbidity and mortality in pregnant women, their foetuses, and infants; the risk associated with any newly emerging infectious disease (EID) is likely unknown at the time of its emergence. While the ongoing SARS-CoV-2 pandemic shows that the development of vaccines against new pathogens can be considerably accelerated, the immunization of pregnant women generally lags behind the general population. Guided by the priority pathogen list for WHO's R&D Blueprint for Action to Prevent Epidemics, this workshop sought to define the evidence needed for use of vaccines against EIDs in pregnant and lactating women, using Lassa fever as a model. Close to 60 maternal immunization (MI) and vaccine safety experts, regulators, vaccine developers, Lassa fever experts, and investigators from Lassa-affected countries examined the critical steps for vaccine development and immunization decisions for pregnant and lactating women. This paper reports on key themes and recommendations from the workshop. Current practice still assumes the exclusion of pregnant women from early vaccine trials. A shift in paradigm is needed to progress towards initial inclusion of pregnant women in Phase 2 and 3 trials. Several practical avenues were delineated. Participants agreed that vaccine platforms should be assessed early for their suitability for maternal immunization. It was noted that, in some cases, nonclinical data derived from assessing a given platform using other antigens may be adequate evidence to proceed to a first clinical evaluation and that concurrence from regulators may be sought with supporting rationale. For clinical trials, essential prerequisites such as documenting the disease burden in pregnant women, study site infrastructure, capabilities, and staff experience were noted. Early and sustained communication with the local community was considered paramount in any program for the conduct of MI trials and planned vaccine introduction.


Assuntos
COVID-19 , Doenças Transmissíveis Emergentes , Vacinas , Doenças Transmissíveis Emergentes/epidemiologia , Doenças Transmissíveis Emergentes/prevenção & controle , Feminino , Humanos , Lactação , Londres , Gravidez , Encaminhamento e Consulta , SARS-CoV-2 , Desenvolvimento de Vacinas
7.
Biologicals ; 71: 55-60, 2021 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33966960

RESUMO

The International Alliance for Biological Standardization and the Coalition for Epidemic Preparedness Innovations organized a joint webinar on the use of platform technologies for vaccine development. To tackle new emerging infectious diseases, including SARS-CoV-2, rapid response platforms, using the same basic components as a backbone, yet adaptable for use against different pathogens by inserting new genetic or protein sequences, are essential. Furthermore, it is evident that development of platform technologies needs to continue, due to the emerging variants of SARS-CoV-2. The objective of the meeting was to discuss techniques for platform manufacturing that have been used for COVID-19 vaccine development, with input from regulatory authorities on their experiences with, and expectations of, the platforms. Industry and regulators have been very successful in cooperating, having completed the whole process from development to licensing at an unprecedented speed. However, we should learn from the experiences, to be able to be even faster when a next pandemic of disease X occurs.


Assuntos
Vacinas contra COVID-19/imunologia , COVID-19/imunologia , COVID-19/prevenção & controle , Desenvolvimento de Medicamentos , SARS-CoV-2/imunologia , Vacinas contra COVID-19/uso terapêutico , Congressos como Assunto , Humanos
8.
Nat Med ; 27(4): 591-600, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33846611

RESUMO

Examination of the vaccine strategies and technical platforms used for the COVID-19 pandemic in the context of those used for previous emerging and reemerging infectious diseases and pandemics may offer some mutually beneficial lessons. The unprecedented scale and rapidity of dissemination of recent emerging infectious diseases pose new challenges for vaccine developers, regulators, health authorities and political constituencies. Vaccine manufacturing and distribution are complex and challenging. While speed is essential, clinical development to emergency use authorization and licensure, pharmacovigilance of vaccine safety and surveillance of virus variants are also critical. Access to vaccines and vaccination needs to be prioritized in low- and middle-income countries. The combination of these factors will weigh heavily on the ultimate success of efforts to bring the current and any future emerging infectious disease pandemics to a close.


Assuntos
Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , Doenças Transmissíveis Emergentes/prevenção & controle , SARS-CoV-2/imunologia , Vacinas/imunologia , Vacinas contra Cólera/imunologia , Doenças Transmissíveis Emergentes/epidemiologia , Vacinas contra Dengue/imunologia , Acessibilidade aos Serviços de Saúde , Humanos , Farmacovigilância , Vacinas Tíficas-Paratíficas/imunologia , Vacina contra Febre Amarela/imunologia
9.
Biologicals ; 69: 76-82, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33234420

RESUMO

This International Alliance for Biological Standardization COVID-19 webinar was organized to provide an update on the virology, epidemiology and immunology of, and the vaccine development for SARS-CoV-2, none months after COVID-19 was declared a public health emergency of international concern. It brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable delegation from low- and middle-income countries.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Pandemias , SARS-CoV-2 , Anticorpos Neutralizantes/biossíntese , Anticorpos Antivirais/biossíntese , Produtos Biológicos/isolamento & purificação , COVID-19/epidemiologia , COVID-19/etiologia , COVID-19/terapia , Vacinas contra COVID-19/administração & dosagem , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/isolamento & purificação , Ensaios Clínicos como Assunto , Desenvolvimento de Medicamentos/tendências , Europa (Continente)/epidemiologia , Humanos , Imunidade Celular , SARS-CoV-2/genética , SARS-CoV-2/imunologia , SARS-CoV-2/patogenicidade , Segurança , Organização Mundial da Saúde
11.
mSphere ; 5(4)2020 07 08.
Artigo em Inglês | MEDLINE | ID: mdl-32641430

RESUMO

Nipah disease is listed as one of the WHO priority diseases that pose the greatest public health risk due to their epidemic potential. More than 200 experts from around the world convened in Singapore last year to mark the 20th anniversary of the first Nipah virus outbreaks in Malaysia and Singapore. Most of these experts are now involved in responding to the coronavirus disease 2019 (COVID-19) pandemic. Here, members of the Organizing Committee of the 2019 Nipah Virus International Conference review highlights from the Nipah@20 Conference and reflect on key lessons learned from Nipah that could be applied to the understanding of the COVID-19 pandemic and to preparedness against future emerging infectious diseases (EIDs) of pandemic potential.


Assuntos
Infecções por Henipavirus , Vírus Nipah/patogenicidade , Animais , Betacoronavirus/patogenicidade , COVID-19 , Congressos como Assunto , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Infecções por Henipavirus/diagnóstico , Infecções por Henipavirus/prevenção & controle , Infecções por Henipavirus/terapia , Humanos , Pandemias/prevenção & controle , Pneumonia Viral/diagnóstico , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , SARS-CoV-2 , Zoonoses/epidemiologia
15.
Artigo em Inglês | MEDLINE | ID: mdl-31776599

RESUMO

Today's world is characterized by increasing population density, human mobility, urbanization, and climate and ecological change. This global dynamic has various effects, including the increased appearance of emerging infectious diseases (EIDs), which pose a growing threat to global health security.Outbreaks of EIDs, like the 2013-2016 Ebola outbreak in West Africa or the current Ebola outbreak in Democratic Republic of the Congo (DRC), have not only put populations in low- and middle-income countries (LMIC) at risk in terms of morbidity and mortality, but they also have had a significant impact on economic growth in affected regions and beyond.The Coalition for Epidemic Preparedness Innovation (CEPI) is an innovative global partnership between public, private, philanthropic, and civil society organizations that was launched as the result of a consensus that a coordinated, international, and intergovernmental plan was needed to develop and deploy new vaccines to prevent future epidemics.CEPI is focusing on supporting candidate vaccines against the World Health Organization (WHO) Blueprint priority pathogens MERS-CoV, Nipah virus, Lassa fever virus, and Rift Valley fever virus, as well as Chikungunya virus, which is on the WHO watch list. The current vaccine portfolio contains a wide variety of technologies, ranging across recombinant viral vectors, nucleic acids, and recombinant proteins. To support and accelerate vaccine development, CEPI will also support science projects related to the development of biological standards and assays, animal models, epidemiological studies, and diagnostics, as well as build capacities for future clinical trials in risk-prone contexts.


Assuntos
Doenças Transmissíveis Emergentes , Epidemias , Vacinas , África Ocidental , Animais , Surtos de Doenças , Alemanha , Humanos
16.
Vaccine ; 37(43): 6248-6254, 2019 10 08.
Artigo em Inglês | MEDLINE | ID: mdl-31500964

RESUMO

Emerging and re-emerging infectious diseases are an expanding global threat to public health, security, and economies. Increasing populations, urbanization, deforestation, climate change, anti-vaccination movements, war, and international travel are some of the contributing factors to this trend. The recent Ebola, MERS-CoV, and Zika outbreaks demonstrated we are insufficiently prepared to respond with proven safe and effective countermeasures (i.e., vaccines and therapeutics). The State University of New York Upstate Medical University and the Trudeau Institute convened a summit of key opinion and thought leaders in the life sciences and biomedical research and development enterprises to explore global biopreparedness challenges, take an inventory of existing capabilities and capacities related to preparation and response, assess current "gaps," and prospect what could be done to improve our position. Herein we describe the summit proceedings, "Translational Immunology Supporting Biomedical Countermeasure Development for Emerging Vector-borne Viral Diseases," held October 2-3, 2018, at the Trudeau Institute in Saranac Lake, NY.


Assuntos
Doenças Transmissíveis Emergentes , Vetores de Doenças , Vacinas Virais/farmacologia , Viroses/prevenção & controle , Animais , Ensaios Clínicos como Assunto , Doenças Transmissíveis Emergentes/prevenção & controle , Modelos Animais de Doenças , Avaliação Pré-Clínica de Medicamentos , Feminino , Humanos , Influenza Humana/etiologia , Influenza Humana/prevenção & controle , Gravidez , Complicações Infecciosas na Gravidez/etiologia , Pesquisa Translacional Biomédica , Vacinas Virais/uso terapêutico , Infecção por Zika virus/etiologia , Infecção por Zika virus/prevenção & controle
17.
Curr Opin Virol ; 37: 105-111, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31472333

RESUMO

Lassa fever is a zoonotic disease caused by the Lassa virus, a rodent-borne arenavirus endemic to West Africa. Recent steady increase in reported cases of the disease in Nigeria, where 123 deaths occurred in 546 confirmed cases in 2019 has further underlined the need to accelerate the development of vaccines for preventing the disease. Intensified research and development of Lassa fever medical countermeasures have yielded some vaccine candidates with preclinical scientific plausibility using predominantly novel technology. The more advanced candidates are based on recombinant measles, Vesicular Stomatitis Virus or Mopiea and Lassa virus reassortants expressing Lassa virus antigens, and the deoxyribonucleic acid platform. However, the Lassa fever portfolio still lags behind other neglected tropical diseases', and further investments are needed for continued development and additional research, such as the safety and efficacy of these vaccine candidates in special populations.


Assuntos
Febre Lassa/prevenção & controle , Vírus Lassa/imunologia , Vacinas Virais/imunologia , Animais , Antígenos Virais/imunologia , Ensaios Clínicos como Assunto , Modelos Animais de Doenças , Humanos , Vírus Lassa/genética , Roedores , Vacinas Virais/classificação , Vacinas Virais/genética
18.
Hum Vaccin Immunother ; 13(9): 2004-2016, 2017 09 02.
Artigo em Inglês | MEDLINE | ID: mdl-28598256

RESUMO

Two large pivotal phase III studies demonstrated the efficacy of the tetravalent dengue vaccine (CYD-TDV; Dengvaxia®, Sanofi Pasteur) against all dengue serotypes. Here we present an unprecedented integrated summary of the immunogenicity of CYD-TDV to identify the parameters driving the neutralizing humoral immune response and evolution over time. We summarized the immunogenicity profiles of a 3-dose schedule of CYD-TDV administered 6 months apart across 10 phase II and 6 phase III trials undertaken in dengue endemic and non-endemic countries. Dengue neutralizing antibody titers in sera were determined at centralized laboratories using the 50% plaque reduction neutralization test (PRNT50) at baseline, 28 d after the third dose, and annually thereafter for up to 4 y after the third dose in some studies. CYD-TDV elicits neutralizing antibody responses against all 4 dengue serotypes; geometric mean titers (GMTs) increased from baseline to post-dose 3. GMTs were influenced by several parameters including age, baseline dengue seropositivity and region. In the 2 pivotal studies, GMTs decreased initially during the first 2 y post-dose 3 but appear to stabilize or slightly increase again in the third year. GMTs persisted 1.2-3.2-fold higher than baseline levels for up to 4 y post-dose 3 in other studies undertaken in dengue endemic countries. Our integrated analysis captures the fullness of the CYD-TDV immunogenicity profile across studies, age groups and regions; by presenting the available data in this way general trends and substantial outliers within each grouping can be easily identified. CYD-TDV elicits neutralizing antibody responses against all dengue serotypes, with differences by age and endemicity, which persist above baseline levels in endemic countries.


Assuntos
Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Vacinas contra Dengue/imunologia , Vírus da Dengue/imunologia , Dengue/prevenção & controle , Imunogenicidade da Vacina , Adolescente , Adulto , Criança , Ensaios Clínicos Fase II como Assunto , Ensaios Clínicos Fase III como Assunto , Vacinas contra Dengue/administração & dosagem , Vírus da Dengue/classificação , Feminino , Seguimentos , Humanos , Imunidade Humoral , Internacionalidade , Masculino , Pessoa de Meia-Idade , Estudos Multicêntricos como Assunto , Testes de Neutralização , Sorogrupo , Vacinação , Adulto Jovem
19.
PLoS Negl Trop Dis ; 10(7): e0004821, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27414655

RESUMO

A recombinant live attenuated tetravalent dengue vaccine (CYD-TDV) has been shown to be efficacious in preventing virologically-confirmed dengue disease, severe dengue disease and dengue hospitalization in children aged 2-16 years in Asia and Latin America. We analyzed pooled safety data from 18 phase I, II and III clinical trials in which the dengue vaccine was administered to participants aged 2-60 years, including long-term safety follow-up in three efficacy trials. The participants were analyzed according to their age at enrollment. The percentage of participants aged 2-60 years reporting ≥1 solicited injection-site or systemic reactions was slightly higher in the CYD-TDV group than in the placebo group. The most common solicited injection-site reactions were pain. Headache and malaise were the most common solicited systemic reactions. In both groups 0.3% of participants discontinued for safety reasons. The most common unsolicited adverse events were injection-site reactions, gastrointestinal disorders, and infections. Reactogenicity did not increase with successive doses of CYD-TDV. The frequency and nature of SAEs occurring within 28 days of any dose were similar in the CYD-TDV and placebo groups and were common medical conditions that could be expected as a function of age. Baseline dengue virus serostatus did not appear to influence the safety profile. No vaccine-related anaphylactic reactions, neurotropic events or viscerotropic events were reported. In year 3 after dose 1, an imbalance for dengue hospitalization, including for severe dengue, observed in participants aged <9 years in the CYD-TDV group compared with the placebo group was not observed for participants aged ≥9 years. In Year 4, this imbalance in participants aged <9 years was less marked, giving an overall lower risk of dengue hospitalization or severe dengue from dose 1 to Year 4 in the CYD-TDV group. These results have contributed to the definition of the target population for vaccination (≥9 years old) for which CYD-TDV has a satisfactory safety profile. Long-term safety will continue to be monitored in the ongoing follow-up of efficacy trials. Safety and effectiveness in real-life settings will be assessed through post-licensure studies.


Assuntos
Vacinas contra Dengue/administração & dosagem , Vírus da Dengue/imunologia , Dengue/prevenção & controle , Vacinas Atenuadas/administração & dosagem , Adolescente , Adulto , Anticorpos Neutralizantes/imunologia , Anticorpos Antivirais/imunologia , Criança , Pré-Escolar , Dengue/imunologia , Dengue/virologia , Vacinas contra Dengue/efeitos adversos , Vacinas contra Dengue/genética , Vacinas contra Dengue/imunologia , Vírus da Dengue/genética , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Vacinação , Vacinas Atenuadas/efeitos adversos , Vacinas Atenuadas/genética , Vacinas Atenuadas/imunologia , Adulto Jovem
20.
PLoS Negl Trop Dis ; 10(7): e0004830, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27459266

RESUMO

BACKGROUND: Two large-scale efficacy studies with the recombinant yellow fever-17D-dengue virus, live-attenuated, tetravalent dengue vaccine (CYD-TDV) candidate undertaken in Asia (NCT01373281) and Latin America (NCT01374516) demonstrated significant protection against dengue disease during two years' active surveillance (active phase). Long-term follow up of participants for breakthrough disease leading to hospitalization is currently ongoing (hospital phase). METHODOLOGY/PRINCIPAL FINDINGS: We assessed the cytokine profile in acute sera from selected participants hospitalized (including during the active phase) up to the beginning of the second year of long-term follow up for both studies. The serum concentrations of 38 cytokines were measured in duplicate using the Milliplex Human Cytokine MAGNETIC BEAD Premixed 38 Plex commercial kit (Millipore, Billerica, MA, USA). Partial least squares discriminant analyses did not reveal any difference in the overall cytokine profile of CYD-TDV and placebo recipients hospitalized for breakthrough dengue regardless of stratification used. In addition, there was no difference in the cytokine profile for breakthrough dengue among those aged <9 years versus those aged ≥ 9 years. CONCLUSIONS/SIGNIFICANCE: These exploratory findings show that CYD-TDV does not induce a particular immune profile versus placebo, corroborating the clinical profile observed.


Assuntos
Citocinas/sangue , Vacinas contra Dengue/administração & dosagem , Vírus da Dengue/isolamento & purificação , Dengue/terapia , Vacinas Atenuadas/administração & dosagem , Adolescente , Anticorpos Antivirais/sangue , Criança , Pré-Escolar , Dengue/sangue , Dengue/imunologia , Dengue/virologia , Vacinas contra Dengue/imunologia , Vírus da Dengue/classificação , Vírus da Dengue/genética , Feminino , Hospitalização/estatística & dados numéricos , Humanos , Lactente , Masculino , Vacinas Atenuadas/imunologia
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