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US biotech Moderna announced that it has completed enrollment of 30,000 participants for the phase III COVE study of mRNA-1273, its vaccine candidate against COVID-19, being conducted in collaboration with National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
To date, more than 25,650 participants have received their second vaccination. As of today, the COVE study includes more than 7,000 Americans over the age of 65 and more than 5,000 under the age of 65 with chronic diseases that put them at increased risk of severe COVID-19, such as diabetes, severe obesity and cardiac disease.
The primary endpoint of the trial is the prevention of symptomatic COVID-19 disease. The formal study efficacy analysis will be triggered when 151 of the volunteers have tested positive for COVID-19 infection, with two earlier interim analyses after 53 and 106 cases.
The Coalition for Epidemic Preparedness Innovations (CEPI) has announced new agreements with Biofabri in Spain and GC Pharma in South Korea to reserve vaccine manufacturing capacity for more than one billion doses of the COVID-19 vaccines it is helping to develop.
CEPI aims to reserve capacity at multiple vaccine manufacturers around the world to support its goal to produce two billion doses of safe and effective vaccine by the end of 2021 for global distribution.
Under the terms of the agreements, both Biofabri and GC Pharma will reserve manufacturing capacity exclusively for the production of drug product of COVID-19 vaccines designated by CEPI. One or more CEPI-supported vaccine candidates will be manufactured at each facility, and it is anticipated that vaccines manufactured under these agreements would be procured and distributed through the COVAX, a global initiative which will enable equitable access to COVID-19 vaccines for all participating countries.
CEPI has already secured a supply of glass vials to hold up to two billion doses of vaccine.
“There is finite global capacity to manufacture vaccines, so we must act now to secure the necessary capacity to produce doses of vaccine which will be made globally accessible through COVAX,” said Richard Hatchett, CEO of CEPI.
The World Health Organisation (WHO) and the Wikimedia Foundation, the nonprofit that administers Wikipedia, announced a collaboration to expand public access to the latest and most reliable information about COVID-19.
The collaboration will make trusted, public health information available under the creative commons ShareAlike license, at a time when countries face a resurgence of COVID-19 infections and enforcing public health controls increasingly depends on public understanding of the facts.
Through the collaboration, people will be able to access and share WHO infographics, videos, and other public health assets on Wikimedia Commons, a digital library of free images and other multimedia.
Wikipedia’s more than 250,000 volunteer editors can also build on and expand the site’s COVID-19 coverage, which currently offers more than 5,200 coronavirus-related articles in 175 languages. The WHO content will also be translated across national and regional languages through Wikipedia’s network of global volunteers.
“Equitable access to trusted health information is critical to keeping people safe and informed during the COVID-19 pandemic," said Tedros Adhanom Ghebreyesus, director general of WHO.
Since the beginning of the pandemic, WHO has taken steps to prevent an “infodemic”, defined by the organisation as “an overabundance of information and the rapid spread of misleading or fabricated news, images, and videos.”
Wikipedia editors have similarly been on the frontlines of preventing the spread of misinformation surrounding the coronavirus, ensuring information about the pandemic is based on reliable sources and updated regularly.
COVID-19 vaccine developed by Brazilian Institute and Chinese biotech Sinovac reports good safety data
Brazilian State of Sao Paulo and the Butantan Institute announced the COVID-19 vaccine being developed in partnership with Chinese biotech Sinovac and the Butantan Institute, has been found to have clean safety profile, with results involving 9,000 volunteers aged between 18 and 59 years, showing only 35 per cent had light reactions such as pain at the injection site and headaches.
The State of Sao Paulo has signed a contract for 60 million doses of the Coronavac vaccine. Development of the vaccine, which started in July, is expected to involve 13,000 volunteers in total. Later this month, tests will begin on older volunteers, people with comorbidities and pregnant women.
Sanofi Pasteur and its partner Translate Bio announced preclinical results of their mRNA COVID-19 vaccine candidate MRT5500, showing it induced high levels of antibody in non-human primates and mice.
Based on this, a phase I/II clinical trial is due to begin by the end of 2020. “These results provide additional support for using our mRNA platform to potentially expedite the development of alternative approaches to traditional vaccines.”, said Ronald Renaud, CEO of Translate Bio.
Pharmaceutical services specialist Open Orphan of Dublin has signed a €10 million contract with the UK government to develop a COVID-19 human challenge study model, in which it will manufacture the virus and then deliberately infect volunteers in order to track how the infection progresses and understand what an effective immune response looks like.
In addition, the government has secured three slots to test vaccines using this COVID-19 challenge model, with each slot costing £2.5 million.
The contract starts immediately, with the £10 million contract value depending upon the final number of volunteers that are included in the characterisation study, to be conducted at a specialist unit at the Royal Free Hospital in London.
The characterisation study, which is expected to complete in May 2021, will enable identification of the most appropriate dose of the virus for human challenge studies, which play a vital role in helping to develop vaccines and antivirals for COVID-19. The study is sponsored by Imperial College London.
Open Orphan’s hVIVO subsidiary has a long history of successfully delivering human challenge studies. The company was set up in 1989 as a spin out from Queen Mary University London by founding scientists who previously worked at the Salisbury Flu Clinic, which began running human challenge studies in 1945.
Atriva Therapeutics, a developer of antiviral therapies, has sealed a €24 million financing agreement with the European Investment Bank (EIB) to support development clinical testing of a novel therapy for severe respiratory infections, including COVID-19. Atriva’s ATR-002, an oral small molecule, has been shown to block replication of SARS-CoV-2 in pre-clinical trials. It is thought the molecule will also be effective against flu.
Ambroise Fayolle, EIB vice president in charge of innovation and transactions in Germany, said, “If, as Atriva’s research indicates, one small molecule can work to treat both diseases, this would be excellent news not only for the millions of people who fall ill from the flu every year but also for the many more who are affected by the coronavirus.”
Research commissioner, Mariya Gabriel said, “With this loan to Atriva, the EU continues its support for the development of innovative COVID-19 treatments. “[ATR-002] can add to the range of complementary solutions that we need to tackle this disease.”
The EIB funding enables Atriva to start a phase II study in patients with moderate to severe COVID-19 infections, said Rainer Lichtenberger, co-founder and CEO of Tübingen-based Atriva. “Our ultimate goal, though, is to develop a broad-spectrum antiviral drug that will also be effective against future viral outbreaks.”
ATR-002 works by inhibiting MEK, an enzyme produced in human host cells, that is essential for the replication of viruses, including the influenza virus and SARS-CoV-2. Atriva’s pre-clinical studies, performed at the Universities of Tübingen and Münster, have demonstrated that MEK inhibition by ATR-002 prevents SARS-CoV-2 replication.
In addition, ATR-002 significantly decreases expression of pro-inflammatory cytokines and chemokines, which it thought could help avoid over-activation of the immune systems that is seen in seriously ill COVID-19 patients.
Atriva will receive the EIB loan in three tranches upon the completion of pre-defined milestones.
The loan is backed by the Infectious Diseases Finance Facility, part of the Horizon Europe programme.
A manifesto for COVID-19 grant winners drawn up by the European Commission has been signed by more than 500 organisations, including universities, research institutes and private companies, and 1,500 individuals around Europe, following its launch in July.
The manifesto sets out three guiding principles for EU research grantees: to make research results public and accessible without delay, to provide open access to scientific papers and research data on the European COVID-10 data platform or elsewhere; and where possible, to grant time-limited non-exclusive royalty free licenses for intellectual property, to encourage rapid distribution of products and services.
Interim results from the global Solidarity therapeutics trial, coordinated by the World Health Organisation, indicate that remdesivir did not reduce mortality or length of hospital stay, in 2,750 patients in 30 countries who were treated with the antiviral drug.
The results were published a week after the European Commission agreed to procure 500,000 treatment courses of remdesivir - which has a fixed price of $2,340 per patient - on behalf of 36 European countries.
Remdesivir was granted conditional marketing approval by the commission on 3 July, based on a US clinical trial in 1,000 patients in hospital with COVID-19 who needed assistance with breathing. Overall, the study showed that patients treated with remdesivir, brand name Veklury, recovered after about 11 days, compared with 15 days for patients given placebo.
Gilead, the developer of remdesivir announced the pricing for remdesivir in June, justifying it on the basis that in the US earlier hospital discharge would result in hospital savings of approximately $12,000 per patient. “We have decided to price remdesivir well below this value. To ensure broad and equitable access at a time of urgent global need, we have set a price for governments of developed countries of $390 per vial,” the company said.
Most patients are expected to receive a course of six vials of remdesivir, giving the headline figure of $2,340 per patient. Gilead said that at this price, remdesivir is positioned to provide immediate net savings for healthcare systems.
The first half of 2020 saw an unprecedented decline in CO2 emissions - larger than during the financial crisis of 2008, the oil crisis of the 1979, or world war II. In the first six months of this year, 8.8 per cent less carbon dioxide was emitted than in the same period in 2019, a total decrease of 1,551 million tonnes, according to new research.
The study not only offers a much more precise look at COVID-19's impact on global energy consumption than previous analyses, it also suggests what steps could be taken to stabilise the global climate in the aftermath of the pandemic.
By looking at daily figures compiled by the Carbon Monitor research initiative it was possible to get a much faster and more accurate overview, including timelines that show how emissions decreases corresponded to lockdown measures in each country. In April, at the height of the first wave of COVID-19 infections, when most major countries shut down their public life and parts of their economy, emissions declined by 16.9 per cent.
The greatest reduction of emissions was observed in ground transport, which is attributed to working from home restrictions, with transport CO2 emissions decreasing by 40 per cent worldwide.
The research also found strong rebound effects. With the exception of a continuing decrease of emissions stemming from transport sector, by July 2020, as soon as lockdown measures were lifted, most economies resumed their usual CO2 emission levels. Even if they had remained at their historically low levels, this would have a rather minuscule effect on the long-term CO2 concentration in the atmosphere.
Based on this, the only valid strategy to stabilise the climate is a complete overhaul of the industry and commerce sector, says Hans Joachim Schellnhuber, founding director of the Potsdam Institute for Climate Impact Research and co-author of the research published in Nature Communications today. "While the CO2 drop is unprecedented, decreases of human activities cannot be the answer," he says. "Instead we need structural and transformational changes in our energy production and consumption systems. Individual behaviour is certainly important, but what we really need to focus on is reducing the carbon intensity of our global economy."