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BioNTech is taking its mRNA mpox vaccine into the clinic, thanks in part to $90 million from a leading pandemic prevention organization. | BioNTech has partnered up with pandemic prevention organization CEPI to the tune of $90 million to help advance a couple of phase 1 stage mpox vaccines. The funding is part of CEPI's latest 100 Days Mission to help stymie future outbreaks. BioNTech began work on its vaccine, BNT166, as mpox (formerly known as monkeypox) began to spread globally in the summer of 2022. A phase 1/2 trial just got off the ground in August and will test two similar candidates (BNT166a and BNT166c) in patients with or without prior history of mpox infection. “Our work on mpox could broaden the portfolio of vaccines available against this potentially deadly disease, while building our understanding of how mRNA technology performs against orthopoxviruses, a family of viruses that have long afflicted humankind and remain an ongoing threat today,” CEPI CEO Richard Hatchett, M.D., said in the release....
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All COVID-19 vaccine developers can use the network of five laboratories working together as part of centralised network to reliably assess and compare immunological responses generated by COVID-19 vaccine candidates. Five laboratories initially selected to work together as part of centralised network to reliably assess and compare immunological responses generated by COVID-19 vaccine candidate. Global group will minimise variation between individual lab analyses to enable uniform way of evaluating and identifying the most successful candidates. All COVID-19 vaccine developers (both CEPI-funded and non-CEPI funded) can use the network. In order to monitor interest and adjust the testing capacity, we are requesting that all COVID-19 vaccine developers interested in using CEPI’s centralised laboratory network complete this short survey. For any COVID-19 vaccine developer ready to submit their samples to the network, please complete our Sample Analysis Request Form. 2 October 2020, Oslo, Norway –The Coalition for Epidemic Preparedness Innovations (CEPI) has today announced partnerships with five clinical sample testing laboratories to create a centralised global network to reliably assess and compare the immunological responses generated by COVID-19 vaccine candidates. Located across multiple regions globally, the laboratories initially selected for this vaccine-assessment network are: Nexelis (Canada) and Public Health England (PHE, UK), VisMederi Srl (Italy), Viroclinics-DDL (The Netherlands), icddr,b (formerly International Centre for Diarrhoeal Disease Research, Bangladesh), and Translational Health Sciences and Technological Institute (THSTI, India). The network will use the same testing reagents—originating in the labs of Nexelis and PHE—and follow common protocols to measure the immunogenicity of multiple COVID-19 vaccine candidates (both CEPI-funded and non-CEPI funded developers). This approach will ensure uniformity in assessment and informed identification of the most promising vaccine candidates. CEPI is actively negotiating with additional laboratories to participate in this network. Advantages of centralising immunological response assessment Typically, the immunogenicity of potential candidate vaccines is assessed through individual laboratory analyses, aiming to determine whether biomarkers of immune response—such as antibodies and T-cell responses—are produced after clinical trial volunteers receive a dose(s) of a vaccine candidate. However, withover 320 vaccine candidates against COVID-19 currently in development, there are likely to be numerous differences in data collection and evaluation methods. This includes potential variation in the range of correlates of immunity being measured by laboratories. Technical differences in how and where samples are collected, transported and stored can also occur, impacting the quality and usefulness of the data produced and making comparisons between measurements in individual laboratories difficult. In addition, with the wide range of COVID-19 vaccine approaches and technologies currently being deployed (e.g., recombinant viral vectors, live attenuated vaccines, recombinant proteins and nucleic acids), standard evaluation of the true potential of these vaccine formulations becomes very complex. Through centralising the analysis of samples obtained from trials of COVID-19 vaccine candidates, the new clinical-sample-testing network will minimise variation in results obtained, which could otherwise arise due to such technical differences when carrying out independent analysis. The samples from participating vaccine developers will instead be tested in the same group of laboratories using the same methods, therefore, removing much of the inter-laboratory variability and allowing for head-to-head comparisons of immune responses induced by multiple vaccine candidates. Supporting global COVID-19 vaccine development Through this new network, up to the limit of programme funding, eligible COVID-19 vaccine developers (both CEPI-funded and non-CEPI funded developers) can use the laboratories, without per sample charges, to analyse the immune response elicited by their COVID-19 vaccine candidates in preclinical, Phase I and Phase IIa studies. Data obtained on the immunogenicity of CEPI-funded vaccine candidates will be used to inform and advance CEPI’s COVID-19 vaccine portfolio by providing quick and accurate evaluation of its candidate vaccines. By opening the sample testing network to other COVID-19 vaccine programmes, CEPI also aims to ensure that all eligible developers—regardless of their size—can benefit from this analysis. Certain commitments may be required for eligibility, such as making timely publication of sample testing results and sharing data that will be produced on the immunogenicity of COVID-19 vaccine candidates to facilitate future regulatory decisions. The number of samples available for testing per developer may be limited depending on response...
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Juan Lama
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CEPI has raised $1·5 billion for its work on tackling the next pandemic as civil society calls for a sharper focus on equitable access to new vaccines. Ann Danaiya Usher reports. The Coalition for Epidemic Preparedness Innovations (CEPI), which was established in 2016 in the wake of the Ebola virus outbreak in west Africa, has become a key player in the global health architecture in a few short years. Its initial focus on research into vaccines against diseases prevalent in low-income and middle-income countries (LMICs) gave way to an active role in supporting the development of COVID-19 vaccine candidates during 2020–21. Now, CEPI proposes to expand its mission further. The first COVID-19 vaccine produced by Pfizer–BioNTech took a record 326 days to complete, but this time period, CEPI argues, was still too long. CEPI aims to accelerate the process of developing a vaccine against the next great pandemic threat in as little as 100 days, in what it is calling its moonshot. If this capability had been in place when COVID-19 first struck, the first vaccines could have been administered in April, 2020, when there were fewer than 4 million cases recorded, rather than in December, 2020, when the number of confirmed cases had reached 67 million. The result, CEPI says, could have potentially averted millions of deaths and trillions of dollars in economic damage. Today, the number of confirmed cases stands at 450 million worldwide. At a replenishment conference hosted by the UK last week, CEPI sought to raise US$3·5 billion for CEPI 2.0, its work programme for 2022–26. Donors pledged $1·5 billion, led by Japan, the UK, the Bill & Melinda Gates Foundation, Wellcome, the USA, and Norway. Several others indicated that they would also contribute. Chief executive officer of CEPI, Richard Hatchett, said that this support would kick-start CEPI's work on preparing for so-called disease X, an unknown pathogen with pandemic potential. “For the first time in history, we have the tools we need to eliminate the risk of future pandemics,” he said. “It is vital that we capitalise on the scientific developments we’ve seen over the last 2 years and seize the rare alignment of political will, practical experience, and technical and scientific progress emerging from the pandemic to prevent such devastation happening again.” CEPI's investment case for the next 5 years states that the organisation's record on COVID-19 makes it well positioned to assemble the capabilities, actors, and expertise needed to develop vaccines against disease X. CEPI, along with WHO and Gavi, the Vaccine Alliance, established the COVAX mechanism for global distribution of vaccines in early 2020. Over the past 2 years, CEPI has spent almost $2 billion in mostly public funding to support more than a dozen promising COVID-19 vaccine candidates. The idea was that CEPI-funded manufacturers of successful vaccines would supply doses through COVAX, thereby ensuring access for all. COVAX's problems in securing supply are well documented. Of CEPI's four largest investments, two—the Novavax and Oxford–AstraZeneca vaccines—have been given WHO Emergency Use status and only the Oxford–AstraZeneca vaccine so far has been distributed globally in significant volumes. After delays, deliveries of Novavax vaccine to Australia, Austria, France, and Germany began in the first months of 2022. COVAX has been allocated 13 million doses but shipments have not yet begun. “We are of course disappointed that first supply [of Novavax] has not yet come to COVAX”, a CEPI spokesperson said. A burning issue at the centre of CEPI's work through the COVID-19 pandemic has been how to ensure that unprecedented scientific advancements benefit the many rather than the few. CEPI's mission is to accelerate the development of vaccines and other biological countermeasures against pandemic threats, “so they can be accessible to all people in need”. However, grossly unfair distribution of vaccines and other COVID-19 tools have plagued the global COVID-19 response, in which CEPI is a key player. Tedros Adhanom Ghebreyesus, Director-General of WHO, highlighted this dilemma at the CEPI replenishment meeting. He welcomed CEPI's 100-day mission and urged donors to fully fund the $3·5 billion ask. But he added a warning: “the pandemic has…taught us that science can actually serve to widen inequalities rather than narrow them…As we speak, 83 percent of the population of Africa is yet to receive a single dose of vaccine, and there is an even wider discrepancy in access to tests”. Civil society organisations worry that CEPI's work to hasten the development of new vaccines risks deepening this divide even further. In the worst case, a successful vaccine against a new deadly pathogen, produced in just 3 months, would quickly become available in high-income countries but remain out of reach for everyone else. Manuel Martin at the Médecins Sans Frontières Access Campaign says that CEPI has been “spot on” when it comes to the science and “ahead of the curve” in many of its investment decisions. “It's just that we haven’t really seen the impact that they were meant to have on equitable access in a real and tangible way,” he says. Martin has written a policy brief on CEPI, seen by The Lancet, for the People's Vaccine Alliance, a coalition of 100 civil society organisations coordinated by Oxfam. In it, he writes that CEPI's governance structures and policies are in need of fundamental reforms to ensure fair global distribution of future medical innovations. CEPI's equitable access policy, which was whittled down from 13 pages to two back in 2018, is described as “brief, vague, and weak”. Only four of 12 voting board members are from LMICs, and there is no civil society representative. The minutes of CEPI's equitable access committee, which was created in 2019, have not been published on CEPI's website since May, 2020. And of the 17 COVID-19 vaccine candidates and platforms that CEPI has invested in, only five are in LMICs, all of which are in Asia; none is in Latin America or Africa. Martin acknowledges CEPI's recent support to MADIBA, the regional manufacturing hub for COVID-19 and other vaccines in Senegal. But he says that this support has come late. “This is great. But we are into the third year of the pandemic.” A mid-term review of CEPI from last year refers to opposing views between private sector and civil society stakeholders on CEPI's performance in implementing its equitable access provisions. While civil society organisations want to limit the power and influence of pharmaceutical companies over CEPI's funding decisions, others worry that the conditions attached to CEPI's funding agreements have made CEPI an unattractive partner for big pharmaceutical companies. CEPI's commitment to equitable access will be further tested in its work on the 100-day mission in the event of another pandemic. Martin says that this lofty goal risks, again, being relevant for high-income countries only. “The only technology that can even get close to this 100-day objective is mRNA. And the only developers of licensed mRNA vaccines are in high-income countries. So, unless CEPI really invests in mRNA in LMICs, and supports manufacture and development of mRNA in LMICs, the results of all this effort will be skewed toward high-income countries rather than LMICs,” he says. CEPI does not dispute that innovations in mRNA technology will be needed to make vaccines more widely accessible. “It is fair to say there is a strong emphasis on mRNA in the rapid response platform,” says Melanie Saville, CEPI's executive director for vaccine research and development. She explains that the mRNA vaccine was chosen as the initial platform for pilot projects to develop vaccine libraries and prototype vaccines to meet the 100-day mission because it is currently the fastest platform to develop and modify. “The platform developed through these efforts can then be transferred to other technologies in the CEPI portfolio,” she says. CEPI is looking into ways to make mRNA vaccines more easily storable and transportable, to ease the logistical issues related to cold chain, and to improve access for populations in LMICs. Saville says that CEPI is committed to providing equitable access of vaccines to LMICs, which includes vaccines for the 100-day mission to respond to the emergence of a disease X. “The goal is to develop a diversity of very safe and highly effective vaccines for LMICs, but also to develop the platforms as a rapid response platform in the event of a disease X emergence,” she says.
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The French vaccine developer Valneva has received a €21M ($23.4M) grant to catch up with the competition in commercializing the first potential vaccine for the chikungunya virus. Coming from the nonprofit Coalition for Epidemic Preparedness Innovations (CEPI), the grant will boost the manufacturing and development of Valneva’s vaccine for the tropical disease chikungunya, which causes fever and can trigger chronic pain in the joints. Chikungunya has long been a problem in developing countries with endemic tropical diseases, but has received less attention from developed countries until recently. However, climate change could increase the range of disease-carrying mosquitoes, and chikungunga outbreaks in Europe could become more common. Companies developing vaccines for the disease could deliver an important weapon in the fight against the disease. In May, the vaccine showed the potential to protect against the virus in a phase I trial. As the company has already calculated an optimal dose, Valneva’s one-shot vaccine could skip phase II and head directly to phase III. The Austrian biotech Themis Bioscience is also developing a vaccine for chikungunya, which is expected to enter phase III later this year. With a phase III trial expected to begin in early 2020, Valneva might narrow Themis’ lead in the race to get the first chikungunya vaccine to the market. The CEPI allocates grants to fund the development of vaccines against infections causing humanitarian crises. CEPI also recently provided a 19M euros grant to Themis, with the aim of accelerating vaccines for chikungunya and other diseases to the market.
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