LIVE BLOG: R&D response to COVID-19 pandemic (Archived)

The UK government is backing two more coronavirus vaccine projects, with £4 million in grants for clinical trials awarded to the biotech companies Vaccitech and Scancell. Vaccitech has preclinical data showing its vaccine induces antibody and cell-mediated immune responses, and could be used as a standalone product or as a booster for first generation COVID-19 vaccines. Meanwhile Scancell is developing a DNA vaccine using technology that has been applied to cancer vaccines and which it has shown is safe, cost-effective and scalable. The product targets dendritic cells to stimulate T cells that identify and destroy infected cells.

The European Open Science Cloud’s (EOSC) COVID-19 Data Platform, a free to use, open, digital space for researchers to share and upload data sets, has seen more than 73,000 users and 2.6 million requests since its launch on 20 April of this year.

The portal provides a single point of access to difficult to find data, such as raw and assembled viral sequences, and signposting to datasets that cannot openly be shared, in particular patient data subject to GDPR requirements, from clinical trials, hospitals and national healthcare systems.

“We are seeing the platform play a key role in allowing scientists to understand fundamental questions about the virus. Researchers are sharing knowledge on how the virus mutates when spreading, the basic biology of the virus, how it infects, whether there are any drug targets or intervention points where known drugs can be repurposed, and the human response, for example, the genetic risk factors for the severity of the disease,” said project coordinator Niklas Blomberg.

Much of the patient data needed to build a comprehensive picture of the virus, for example, genetics, proteomics and serology collected from a large number of COVID-19 patients, is unlikely to be consented to leave national jurisdictions. “These data need to be stored and shared in a secure and GDPR-compliant manner,” Blomberg said.

Swedes perceive the tone of reporting on COVID-19 as less hyped and alarmist than they did prior to the summer, according to the latest findings of a study looking at reporting on the pandemic in the Swedish media being conducted by the Swedish non-profit organisation Vetenskap & Allmanhet (Public & Science) in collaboration with researchers from the Karolinska Institute and Södertörn University. These are the findings from the seventh wave of the survey, which was undertaken between 17 and 21 July 2020.

Three out of ten Swedes now perceive the tone to be fairly or very hyped/alarmist, a decrease of ten percentage points since the end of May/beginning of June, and 36 percentage points lower than in March. The proportion of Swedes who perceive the tone to be fairly or very cautious/watchful has gradually increased from 5 per cent in March to 15 per cent in this wave.

There was a decrease in the consumption of corona-related news in July for most media channels, with one in ten Swedes saying they had not viewed any news about the coronavirus during the preceding two-day period, the largest proportion since the survey began.

Confidence in reporting on the coronavirus is declining across all media, according to Vetenskap & Allmanhet, whose goal is to ensure the public understands what science is, how research works, and its role in society.  In contrast, following a decline in confidence in government officials at the end of the spring, confidence has strengthened by nine percentage points since the beginning of June.

Deployment of an artificial intelligence tool for stratifying and personalizing treatment of COVID-19 patients, developed with funding from the European Institute of Innovation and Technology’s EIT Health is due to start scale up in September, following initial validation.

The tool, developed by researchers at the Hospital Clinic Barcelona, stratifies hospitalised patients with confirmed a diagnosis of COVID-19m according to if they are likely to suffer inflammatory, co-infection and/or thrombotic complications, allowing for timely and appropriate treatment.

In an initial assessment of the performance of the tool carried out in Barcelona, personalising treatment according to this stratification led to a 50% reduction in mortality. “The AI system that we have built is capable of supporting clinicians in the early diagnosis of patients more prone to develop complications,” said lead researcher Carolina Garcia-Vidal of the department of infectious diseases at Hospital Clinic Barcelona. “Thus we have been able to provide timely and personalised treatments,” she said.

Development of the AI tool was funded by EIT Health as part of its emergency call for research proposals to help deal with the pandemic.

The number of patients in the initial validation study was only 246, but it is a requirement of EIT funding is that the results can be replicated. Two more hospitals in Spain and one each in Belgium and the Netherlands, will take part in the initial scale-up.

“I am very proud of the early results demonstrated by our Digital Control Centre for COVID-19 project, which has been rapidly implemented and is already showing its potential to save lives,” said Jan-Phillip Beck, CEO of EIT Health. “We look forward to further validation and will work to make it available for as many patients as possible.”

Hungary’s National Research, Development and Innovation Fund has launched a €20 million call for projects to develop diagnostics and therapies that would help the country’s health services react quickly and efficiently to future public health emergencies. Higher education and research institutions, non-profits and companies based or operating in Hungary can get funding of up to €427,000. The call closes on 4 December 2020.

The European Commission has reached agreement with German biotech CureVac to purchase its potential vaccine against COVID-19. This is the fourth such deal, following pacts with Sanofi/GlaxoSmithKline on 31 July and Johnson & Johnson on 13 August, and the signature of an advance purchase agreement with AstraZeneca on 14 August.

Once signed, the contract with CureVac will allow all member states to purchase the vaccine for their own use, and to donate doses to lower and middle income countries. “Each round of talks that we conclude with the pharmaceutical industry brings us closer to beating this virus,” said Ursula von der Leyen, president of the European Commission. “Our negotiations continue with other companies to find the technology that would protect us all.”

The advance purchase agreements will be financed through the Emergency Support Instrument, which is funding a portfolio of potential vaccines with different profiles, produced by different companies.

In July, the European Investment Bank approved a €75 million loan agreement with CureVac for the development and production of its vaccine.

The European Commission has registered a European Citizens' Initiative (ECI) entitled ‘Right to Cure', which is calling on the EU to “put public health before private profit” and make COVID-19 vaccines and treatments a global public good, freely accessible to everyone.

The initiative aims to ensure intellectual property rights do not block access to any future COVID-19 vaccine or treatment; to create a legal obligation for EU-funded research relating to COVID-19 to be shared; and to introduce legal obligations for beneficiaries of EU funds to be fully transparent on public contributions and production costs, and to provide non-exclusive licenses for vaccines and therapies.

The commission said the ECI is legally admissible and has registered it. That means the organisers now have a year to collect one million statements of support from at least seven member states. The commission will then have to react within six months, deciding either to follow the request, or not, and in both instances explain its reasoning.

The European Citizens' Initiative was introduced with the Lisbon Treaty and launched in April 2012. Once formally registered, an ECI allows citizens to ask the European Commission to propose a legal act. To date, the commission has registered 75 ECIs and refused 26.

The National Research Council of Canada (NRC) is setting up a €8.8 million rapid front-line fund to address challenges posed by the coronavirus. The “Pandemic Response Challenge Programe” will focus research on rapid detection and diagnosis; therapeutics and vaccine development; and digital health. The NRC is inviting researchers at Canadian and international universities, government departments, colleges, and companies, to give apply their expertise to plug the gaps in COVID-19 research.

The commission has concluded talks on an advance purchase agreement that will see it use money from the emergency support instrument to secure 300 million doses of a COVID-19 vaccine being developed by Sanofi and GlaxoSmithKline. The contract will ensure supplies for all EU member states that choose to purchase the vaccine, once it is shown to be safe and effective. Commission president Ursula von der Leyen said, “[This] is a first important cornerstone of a much broader European vaccines strategy. More will follow soon. We are in advanced discussions with several other companies. While we do not know today which vaccine will work best in the end, Europe is investing in a diversified portfolio of promising vaccines, based on various types of technologies.”

Sanofi is leading the clinical development and approval of the COVID-19 vaccine and expects a phase I/II study to start in September, followed by a phase III study by the end of 2020. If data are positive, approval could be achieved by the first half of 2021.

In parallel, Sanofi and GSK are scaling up manufacturing to produce up to one billion doses per year overall. The vaccine will be manufactured in European countries including France, Belgium, Germany and Italy.

BioNTech and its pharmaceutical partner Pfizer have struck a deal with the Japanese government to supply 120 million doses of their BNT162 COVID-19 vaccine, with deliveries of planned for the first half of 2021, assuming the product is safe and effective in clinical trials.

The advance purchase agreement is part of Japan’s preparations to ensure the Tokyo Olympics, which should now be in full swing, can go ahead this time next year.

“In bringing the world together at one place, for centuries, the Olympic Games have been a symbol of a global community. As a renewed version of that very spirit, the 2020 Tokyo Olympics may become a symbol for all of us for how all nations around the world can overcome a global pandemic threat together. We are proud and honoured that our vaccine candidate may contribute to the efforts undertaken by the government of Japan to turn this vision into reality,” said Ugur Sahin, CEO and co-founder of BioNTech. 

On July 27, Pfizer and BioNTech announced they are now starting a phase II/III clinical study in up to 30,000 participants aged 18 – 85 years, at 120 sites around the world. If positive, the two companies say they are on track to file for approval as early as October 2020 and if successful to supply up to 100 million doses worldwide by the end of 2020, and approximately 1.3 billion doses by the end of 2021.