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

17 Jun 2021 | Live Blog
Covid 19 blog

The coronavirus pandemic is disrupting universities and research institutes across the world. But the same institutions are also working very hard to find out how the disease can be stopped and its effects mitigated.

Follow this live blog for the latest updates on how the crisis is impacting research and innovation, and what governments, funders, companies, universities, associations and scientists are doing to stop or cope with the pandemic.

You can read the full archive of this blog here.

The World Health Organisation has come up with a new naming system for key variants of SARS-CoV-2 virus that it says are easier to say and remember.

Rather than a single letter followed by a string of numbers, as in B.1.1.7, also known as the Kent variant; the South African variant B.1.351; the Indian variant, B.1.617; and the Brazil variant P1, WHO recommends using letters of the Greek alphabet.

The Kent variant becomes alpha, South African delta, Brazilian gamma and the Indian variant delta.

These labels were chosen after wide consultation and a review of many potential naming systems. WHO convened partners from around the world including experts who are part of existing naming systems, nomenclature and virus taxonomic experts, researchers and national authorities.

WHO will assign labels for viral variants that are designated as variants of interest or variants of concern, because it is thought they could be more transmissible and/or more virulent.

The labels do not replace the existing scientific names, which convey important scientific information and will continue to be used in research. But while they have their advantages, WHO says these scientific names can be difficult to say and recall, and are prone to misreporting.

As a result, people often resort to calling variants by the places where they are first detected. That is “stigmatising and discriminatory” WHO said. To avoid this and to simplify public communications, WHO encourages adoption of the new labels.

The European Centre for Disease Prevention and Control (ECDC) adopted a technical report on COVID-19 vaccination of adolescents, setting out key elements to take into account when considering whether or not to vaccinate this age group.

This follows a European Medicines Agency decision last week that the Pfizer/BioNTech vaccine is safe for use in 12 – 15 year olds.

ECDC is now following up with “practical evidence based considerations” to support member states that are considering expanding national vaccination programmes to adolescents, said health commissioner Stella Kyriakides. 

Such vaccinations should be considered in the broader context of the COVID-19 vaccination strategy for the whole population, ECDC says.

The vaccination of adolescents at high risk of severe COVID-19 should be considered a priority, as with other age groups.

The design and implementation of adolescent vaccination is a national responsibility, and member states are now in a position to start using the vaccine for 12-15 year olds should they decide to do so, the Commission said.

Researchers from Aarhus University have developed electronic support stockings and tested them on COVID-19 patients at Copenhagen University Hospitals, showing the stockings significantly counteracted the loss of muscle mass typically seen in people who are confined to bed.

The Aarhus researchers developed a biocompatible electrode for electrical muscle stimulation that was 3D-printed onto the medical support stockings. These were tested on consenting patients who were in hospital with COVID-19 infection in the winter 2020/2021.

The participants , who were hospitalised for five to seven days wore a support stocking on each leg, only one of which had the printed electrodes, meaning patients acted as their own control.

Participants' thigh muscles were electrically stimulated for 30 minutes, twice a day, at an individually adapted intensity.

"The study demonstrated that these patients lost approximately 10% of their muscle mass after just five to six days of hospitalisation,” said Charlotte Suetta, chief physician and lead investigator in the clinical trial. “However, with this new technology we've been able to counteract the loss,” Suetta said.

Muscle loss is a serious problem for hospitalised patients, especially those that need intensive care and are on ventilators for long periods. Recovering from muscle loss after several weeks of total inactivity may take months or years, and some people never recover fully.

While there is nothing new about electrical stimulation of muscles, there are several disadvantages with existing products including difficulties in getting electrodes on and off, and skin irritation in the stimulated areas.

"Our invention is much easier to use because the electrodes are an integral part of the textile," said Shweta Agarwala, an expert in printed electronics.

The electrodes have three ultra-thin, flexible layers, and these can be printed directly onto different types of material, making it possible to stimulate the muscles through the stocking with minimal irritation. “Since the electrodes are an integral part of the stockings, they can also tolerate hospital cleaning processes,” Agarwala said.

To date, Aarhus University has printed almost 600 support stockings for medical use. It is likely the stockings can be used for a far larger group than just COVID-19 patients, including bedridden patients in general, as well as in rehabilitation and for wheelchair users.

A new pandemic sciences centre is being set up at Oxford University to build on global research collaborations developed over the past 40 years, with the aim of ensuring that the world is better equipped to prepare for, identify, and counter future pandemic threats.

The university is now looking to raise over £500 million to invest in this centre 

The centre, which will include a number of core institutes, will also harness the collaborations that have developed in record time across national borders between academia, industry and public health bodies, during the current coronavirus pandemic.  

The pandemic has demonstrated the contributions research universities can make to pandemic preparedness, said Louise Richardson, Oxford’s vice chancellor. “We are building on decades of medical research on infectious disease and data science, we have longstanding international partnerships and we have the ability to act and to adapt quickly.”

Within the university, the centre will draw together academics and experts including from infectious diseases, vaccinology, immunology, structural biology, diagnostics, drug discovery, clinical trials, data science, public health, and social and political sciences.

The inaugural director of the centre will be Peter Horby, professor of emerging infectious diseases, who is leader of the UK-wide Recovery clinical trial, which has tested a number of  different drugs in the treatment of COVID-19 infections. The Recovery trial demonstrated the steroid dexamethasone is an effective treatment for severe disease, while showing the malaria drug hydroxychloroquine is not.

“The COVID-19 pandemic has shown us that spectacular advances are possible through an alliance of science, the public sector and industry – creating digital disease control tools, diagnostic tests, and life-saving treatments and vaccines at unprecedented speed,” Horby said. “But it should not take a pandemic to make this happen. This level of innovation and multi-sectoral collaboration must be applied, day in and day out, to prevent another catastrophe like COVID-19.”

GlaxoSmithKline and its US partner Vir Biotechnology said the US. Food and Drug Administration (FDA) has granted an emergency use authorisation (EUA) for sotrovimab, an antibody drug for treating mild to moderate COVID-19 in adults and children aged 12 and older, who are at high risk for progression to severe COVID-19, including hospitalisation or death.

The latest analysis of clinical trial data showed sotrovimab resulted in an 85% reduction in all-cause hospitalisations or death, while in vitro studies show it retains activity against all known variants of concern, including the variant of the virus from India

The EUA was granted to sotrovimab based on an interim analysis of efficacy and safety data from the phase III trial in high risk adult outpatients, which was stopped early by an independent data monitoring committee in March 2021 because of the evidence of profound clinical efficacy.

Sotrovimab targets a conserved part of the viral spike protein that is less likely to mutate over time. The EUA submission also included data from in vitro studies, which demonstrated that sotrovimab maintains activity against all known circulating variants of concern, including the variants from Brazil (P.1), California (B.1.427/B.1.429), India (B.1.617), New York (B.1.526), South Africa (B.1.351) and the UK (B.1.1.7).

On 21 May 2021, the European Medicines Agency issued a positive scientific opinion for sotrovimab, and the agency has started a rolling review of data on the drug that will continue until enough evidence is available to support the filing of a formal marketing authorisation application.

Sanofi and GlaxoSmithKline plc said they started enrolment in a phase III clinical study to assess the safety, efficacy and immunogenicity of their COVID-19 vaccine.

The study will include more than 35,000 volunteers aged 18 and older from several countries, including the US, Asia, Africa and Latin America.

If the phase III is positive, the vaccine could be approved in Q4 2021. Manufacturing will begin in the coming weeks to enable rapid access to the vaccine should regulators approve.

The primary endpoint of the study is the prevention of symptomatic COVID-19 in people who have not previously been exposed to the infection, with secondary endpoints being the prevention of severe COVID-19 disease and prevention of asymptomatic infection.

In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus that emerged in Wuhan, China, while a second stage will evaluate a second formulation targeting the South African variant. Recent evidence indicates antibodies created against this variant may provide broad cross-protection against other more transmissible variants. 

The design of the phase III study also allows evaluation of the efficacy of the vaccine against a variety of circulating variants.

Following encouraging interim results from the recent phase II study, the companies will also begin clinical studies in the coming weeks to assess the ability of their vaccine to generate a strong booster response regardless of the initial vaccine received.

“We have adapted our vaccine development strategy based on forward-looking considerations as the virus continues to evolve, as well as anticipating what may be needed in a post-pandemic setting,” said Thomas Triomphe, head of Sanofi Pasteur. “This trial is testament to the urgency and agility in our approach to help overcome the ongoing impact of this pandemic.”

The phase III study follows the interim phase II results which showed that the COVID-19 vaccine candidate achieved high rates of neutralising antibody responses in all adult age groups,

This trial has received funding from the US Biomedical Advanced Research and Development Authority.

The EU is come forward with a proposal in the World Trade Organisation (WTO) clarifying and facilitating the use of compulsory licencing of vaccines patents in crisis times like the COVID-19 pandemic.

The commitment was made at the global health summit of G20 leaders, co-hosted on 21 May by the European Commission and Italy, and convened to share lessons learned from the COVID-19 pandemic.

Speaking after the meeting, Commission president Ursula von der Leyen said the global community acknowledges intellectual property is an instrument to boost vaccines manufacturing capacity and the G20 is committed to working on this within the existing Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and the 2001 Doha declaration, which sets out the terms on which governments can take compulsory licenses.

“Of course, voluntary licensing is the best way to ensure the necessary transfer of technology and know-how together with the IP rights. The existing TRIPS Agreement and the 2001 Doha declaration already today foresee compulsory licensing, as a perfectly legitimate tool for governments to use in a crisis. This has been reconfirmed today by the G20,” von der Leyen said.

However, developing countries are complaining about “how difficult” it is to use these flexibilities, and in response the EU will come forward with a proposal in the WTO “to offer a third way,” said von der Leyen. This will focus on three components, she said. “Trade facilitation and disciplines on export restrictions; support for the expansion of production; on IP, clarifying and simplifying the use of compulsory licenses in crisis times like this pandemic, where necessary.”

The World Health Organisation (WHO) and the UK medical research charity Wellcome Trust are to lead on setting up a Global Pandemic Radar to identify emerging COVID-19 variants and track new diseases around the world.

The aim of the pathogen surveillance network is to spot emerging COVID-19 variants and other infectious diseases before they cause pandemics and enable the rapid development of vaccines, treatments and diagnostics.

WHO will lead an implementation group, supported by the Wellcome Trust, to launch this new international partnership to identify, track and share data on new coronavirus variants and monitor vaccine resistance in populations.

Tedros Adhanom Ghebreyesus, director general of WHO said, “The COVID-19 pandemic underscores the vital need for a robust, modern system to keep the world ahead of emerging diseases through active monitoring at the community level, swift and accurate sequencing of new pathogens, and data-sharing across the globe.”

The pandemic radar will build on existing surveillance mechanisms and data sharing agreements for HIV, TB and malaria. “This pandemic has provided a stark wake-up call to the threat posed by a fast-moving infectious disease,” said Jeremy Farrar, director of the Wellcome Trust. “We are long overdue the essential reinforcement of our local, national and international disease surveillance networks.”

The European Medicines Agency has approved a change to the storage conditions for the Pfizer/BioNTech COVID-19 vaccine that is at the centre of the EU’s vaccination rollout, making the product easier to distribute and administer.

Currently, the vaccine must be kept at ultra-low temperatures, which requires specialised fridges. Once thawed it can be kept for five days in a conventional fridge. The change means it will now be possible to store the thawed, undiluted COVID-19 vaccine at fridge temperatures of 2°C to 8°C, for 31 days.

Within the 31 days, transport of the thawed, undiluted vials is permitted for a maximum of 12 hours in total. The shelf life of the vaccine once it is diluted for administration has not changed. It is stable for six hours at 2-30°C from the point of dilution and must be administered within this time.

The extended storage period is effective immediately and accounts for all currently available and future batches.   

The change in the storage conditions is based on new data from stability studies that confirmed product quality for 31 days. The formulation of the vaccine remains unchanged.

Pfizer and BioNTech have submitted a request for the same change to the US Food and Drug Administration and plan to submit to other regulators.

Norwegian biotech BerGenBio said the phase II trial of its cancer drug bemcentinib in the treatment of COVID-19 infections showed it increased the rate of ventilator-free survival in the 50%-plus of hospitalised patients who had the most severe infections.

In total, 90% of this sub group of bemcentinib treated patients survived without the need for mechanical ventilation, versus 72% of patients who received standard of care.

The trial was conducted from October 2020 across multiple sites in South Africa and India, with 115 patients enrolled at the end of March 2021. The data from this phase II builds on two other studies conducted in the UK.

Patients treated with bemcentinib appeared to be protected from an early deterioration at day 2 or 3, compared to patients treated with standard of care, which included steroids and in some cases the antiviral drug remdesivir. This effect was maintained through to 29 days.

The primary endpoint of time to improvement by two grades from baseline, or time to discharge or fitness for discharge, marginally favoured bemcentinib treatment over standard of care, but the difference was not statistically significant.

In the two UK studies, combining the data showed overall survival to day 29 was 96.5% (83 of 86 evaluable patients) in the bemcentinib arm versus 91% (81 of 89) treated with standard of care alone.

BerGenBio said taken overall, the data clearly points to a benefit in treating a substantial subset of hospitalised COVID-19 patients. Bemcentinib has the advantage over other cancer drugs that are being repurposed for treating COVID-19 that it is administered as a one per day tablet.

The data will support ongoing engagement with regulatory agencies, governments and industry on how to take bemcentinib development forward, the company said.

Stener Kvinnsland, director of BerGenBio said, “The greatest challenge faced by hospitals worldwide is an unmanageable demand for [intensive care unit] capacity and ventilator support for COVID-19 patients. For the foreseeable future, in spite of recent progress with vaccinations, there remains a substantial global need for effective treatments for COVID-19 patients that offers survival benefit and relief for intensive care demand on hospitals.” 

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