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1.
N Engl J Med ; 386(22): 2097-2111, 2022 06 02.
Artigo em Inglês | MEDLINE | ID: mdl-35507481

RESUMO

BACKGROUND: The ZF2001 vaccine, which contains a dimeric form of the receptor-binding domain of severe acute respiratory syndrome coronavirus 2 and aluminum hydroxide as an adjuvant, was shown to be safe, with an acceptable side-effect profile, and immunogenic in adults in phase 1 and 2 clinical trials. METHODS: We conducted a randomized, double-blind, placebo-controlled, phase 3 trial to investigate the efficacy and confirm the safety of ZF2001. The trial was performed at 31 clinical centers across Uzbekistan, Indonesia, Pakistan, and Ecuador; an additional center in China was included in the safety analysis only. Adult participants (≥18 years of age) were randomly assigned in a 1:1 ratio to receive a total of three 25-µg doses (30 days apart) of ZF2001 or placebo. The primary end point was the occurrence of symptomatic coronavirus disease 2019 (Covid-19), as confirmed on polymerase-chain-reaction assay, at least 7 days after receipt of the third dose. A key secondary efficacy end point was the occurrence of severe-to-critical Covid-19 (including Covid-19-related death) at least 7 days after receipt of the third dose. RESULTS: Between December 12, 2020, and December 15, 2021, a total of 28,873 participants received at least one dose of ZF2001 or placebo and were included in the safety analysis; 25,193 participants who had completed the three-dose regimen, for whom there were approximately 6 months of follow-up data, were included in the updated primary efficacy analysis that was conducted at the second data cutoff date of December 15, 2021. In the updated analysis, primary end-point cases were reported in 158 of 12,625 participants in the ZF2001 group and in 580 of 12,568 participants in the placebo group, for a vaccine efficacy of 75.7% (95% confidence interval [CI], 71.0 to 79.8). Severe-to-critical Covid-19 occurred in 6 participants in the ZF2001 group and in 43 in the placebo group, for a vaccine efficacy of 87.6% (95% CI, 70.6 to 95.7); Covid-19-related death occurred in 2 and 12 participants, respectively, for a vaccine efficacy of 86.5% (95% CI, 38.9 to 98.5). The incidence of adverse events and serious adverse events was balanced in the two groups, and there were no vaccine-related deaths. Most adverse reactions (98.5%) were of grade 1 or 2. CONCLUSIONS: In a large cohort of adults, the ZF2001 vaccine was shown to be safe and effective against symptomatic and severe-to-critical Covid-19 for at least 6 months after full vaccination. (Funded by the National Science and Technology Major Project and others; ClinicalTrials.gov number, NCT04646590.).


Assuntos
Vacinas contra COVID-19 , COVID-19 , Vacinas de Subunidades Antigênicas , Adolescente , Adulto , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Vacinas contra COVID-19/uso terapêutico , Método Duplo-Cego , Humanos , SARS-CoV-2 , Vacinação , Vacinas , Vacinas de Subunidades Antigênicas/efeitos adversos , Vacinas de Subunidades Antigênicas/uso terapêutico , Adulto Jovem
2.
Vaccine ; 31(31): 3111-5, 2013 Jun 28.
Artigo em Inglês | MEDLINE | ID: mdl-23684836

RESUMO

At the annual general meeting of the Developing Countries Vaccine Manufacturers Network (DCVMN) members renewed their engagement and cooperative spirit in pursuing the mission of increasing the quality and availability of affordable vaccines for all people. Thirteen years after its establishment, DCVMN moves into the Decade of Vaccines with renewed dynamism and synergy to create greater impact and shape the global and regional vaccination landscape, while supporting national growth. The DCVMN is growing: 12 new members joined in 2012, making a total of 37 members from 14 countries; 9 of these 37 manufacturers make WHO-prequalified vaccines. More than one hundred and forty delegates from 23 countries attended the annual general meeting, representing 24 vaccine manufacturers and leaders of 20 major global health institutions. Over the course of two days, delegates exchanged information and ideas on how to jointly achieve the common goal of protecting people against known and emerging infectious diseases. In an increasingly complex environment of new technologies, demanding regulatory requirements, higher cost of production, and a growing number of legal and intellectual property issues, it is observed that many manufacturers and stakeholders are engaged in technology transfer initiatives. This well-attended meeting highlighted the growing impact and important contributions of developing country vaccine manufacturers in shaping the global vaccine landscape. The successful introduction of the first ever vaccine against hepatitis E and of a new vaccine against meningitis A, tailored for African meningitis belt countries, illustrate the innovative capacity of DCVMN members. An increase in the variety of collaborations, partnerships and alliances between DCVM and various institutions was observed. Interestingly, bilateral technology transfer partnerships between DCVMs themselves are on the rise.


Assuntos
Vacinas , África , Congressos como Assunto , Países em Desenvolvimento , Saúde Global , Humanos , Programas de Imunização/economia , Cooperação Internacional , Invenções , Meningite/prevenção & controle , Controle de Qualidade , Transferência de Tecnologia , Vacinas/economia , Vacinas/normas , Vacinas/provisão & distribuição , Vacinas contra Hepatite Viral , Organização Mundial da Saúde
3.
Vaccine ; 31 Suppl 2: B176-83, 2013 Apr 18.
Artigo em Inglês | MEDLINE | ID: mdl-23598479

RESUMO

The Developing Countries Vaccine Manufacturers Network (DCVMN) is a unique model of a public and private international alliance. It assembles governmental and private organizations to work toward a common goal of manufacturing and supplying high-quality vaccines at affordable prices to protect people around the world from known and emerging infectious diseases. Together, this group of manufacturers has decades of experience in manufacturing vaccines, with technologies, know-how, and capacity to produce more than 40 vaccines types. These manufacturers have already contributed more than 30 vaccines in various presentations that have been prequalified by the World Health Organization for use by global immunization programmes. Furthermore, more than 45 vaccines are in the pipeline. Recent areas of focus include vaccines to protect against rotavirus, human papillomavirus (HPV), Japanese encephalitis, meningitis, hepatitis E, poliovirus, influenza, and pertussis, as well as combined pentavalent vaccines for children. The network has a growing number of manufacturers that produce a growing number of products to supply the growing demand for vaccines in developing countries.


Assuntos
Parcerias Público-Privadas , Vacinas/economia , Vacinas/normas , Países em Desenvolvimento , Indústria Farmacêutica , Humanos , Cooperação Internacional , Transferência de Tecnologia
4.
Vaccine ; 31(12): 1641-5, 2013 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-22884665

RESUMO

With the current enzootic circulation of highly pathogenic avian influenza viruses, the ability to increase global pandemic influenza vaccine production capacity is of paramount importance. This has been highlighted by, and is one of the main pillars of, the WHO Global Action Plan for Influenza Vaccines (GAP). Such capacity expansion is especially relevant in developing countries. The Vaccine Formulation Laboratory at University of Lausanne is engaged in the technology transfer of an antigen-sparing oil-in-water adjuvant in order to empower developing countries vaccine manufacturers to increase pandemic influenza vaccine capacity. In a one-year project funded by United States Department of Health and Human Services, the Vaccine Formulation Laboratory transferred the process know-how and associated equipment for the pilot-scale manufacturing of an oil-in-water adjuvant to Bio Farma, Indonesia's state-owned vaccine manufacturer, for subsequent formulation with H5N1 pandemic influenza vaccines. This paper describes the experience acquired and lessons learnt from this technology transfer project.


Assuntos
Adjuvantes Imunológicos/normas , Vacinas contra Influenza/normas , Transferência de Tecnologia , Tecnologia Farmacêutica/normas , Adjuvantes Imunológicos/farmacologia , Países em Desenvolvimento , Fiscalização e Controle de Instalações , Indonésia , Vacinas contra Influenza/farmacologia , Cooperação Internacional , Controle de Qualidade , Esqualeno/farmacologia , Tecnologia Farmacêutica/métodos
5.
Vaccine ; 29 Suppl 1: A22-5, 2011 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-21684423

RESUMO

In Indonesia, avian influenza A(H5N1) virus started to spread in humans in June 2005, with an alarming case-fatality rate of more than 80%. Considering that global influenza vaccine production capacity would barely have covered 10% of the world's pandemic vaccine needs, and that countries with no production facilities or prearranged contracts would be without access to a vaccine, the Government of Indonesia embarked on a programme to increase its readiness for a future influenza pandemic. This included the domestic production of influenza vaccine, which was entrusted to Bio Farma. This health security strategy consists of developing trivalent influenza vaccine production capacity in order to be able to convert immediately to monovalent production of up to 20 million pandemic doses for the Indonesian market upon receipt of the seed strain from the World Health Organization (WHO). For this purpose, a dedicated production facility is being constructed within the Bio Farma premises in Bandung. As an initial stage of influenza vaccine development, imported seasonal influenza bulk has been formulated and filled in the Bio Farma facility. Following three consecutive batches and successful clinical trials, the product was licensed by the Indonesian National Regulatory Authority and distributed commercially for the Hajj programme in 2009. With continued support from its technology transfer partners, Bio Farma is now advancing with the development of upstream processes to produce its own bulk for seasonal and pandemic use.


Assuntos
Vacinas contra Influenza/provisão & distribuição , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , Tecnologia Farmacêutica/métodos , Tecnologia Farmacêutica/organização & administração , Ensaios Clínicos como Assunto , Humanos , Indonésia/epidemiologia , Vacinas contra Influenza/administração & dosagem , Vacinas contra Influenza/imunologia , Pandemias/prevenção & controle
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