15 Apr 2021

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

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.

Dynamic modelling of the movements of the proteins in the spike structure via which SARS-CoV-2 enters and infects human cells, has led to the identification of a 'hinge' mechanism, that gives the spike of the virus purchase to hook onto the cell.

The modelling also pinpointed changes in the shape of the virus that then enable it to fuse with the host cell membrane and enter the hooked cell.

The research, led by Warwick University as part of Eutopia, an alliance of six universities funded by the EU Erasmus+ programme, involved simulating movements in the structure of 287 proteins of the Covid-19 virus, in an effort to identify drug targets.

In a paper published in Scientific Reports, the team of physicists and life scientists have made their data, movies and structural information, detailing how the proteins move and how they deform, publicly accessible.

“Knowing how this mechanism works is one way in which you can stop the virus, and in our study we are the first to see the detailed movement of opening,” said lead author, Rudolf Roemer, professor in the department of physics at Warwick University, who did the work while on a sabbatical at CY Cergy-Paris Université. “Now that you know what the range of this movement is, you can figure out what can block it,” he said.

 

 

 

 

 

Pfizer and BioNTech announced results from a laboratory study that provides additional data on the capability of blood samples from individuals immunised with their COVID-19 vaccine to neutralise variants of the SARS-CoV-2 that have the South African mutations in the spike protein.

This study, which builds on previous work, was conducted by Pfizer and the University of Texas Medical Branch and investigated the full set of South African variant (also known as B.1.351) spike mutations.

Three genetically engineered recombinant viruses were produced, one with the full set of spike mutations found in the South African variant and the other two with subsets of these mutations. These viruses were tested against blood from 15 participants who were immunized in the previously reported phase II trial.

Although the results indicated a reduction in neutralisation of virus with all the South African variant spike glycoprotein mutations, all the blood samples neutralised all the viruses tested.

The two companies said there is also no clinical evidence to date that the South African variant virus escapes the protection provided by their vaccine. However, Pfizer and BioNTech are taking steps and making investments to be in a position to develop and seek authorisation for an updated mRNA vaccine or booster once a variant that significantly reduces the protection from the vaccine is identified.

 

 

 

 

 

The Commission has announced a European bio-defence preparedness plan against COVID-19 variants, which will bring together researchers, biotech companies, manufacturers and public authorities in the EU and globally, to detect new variants of SARS-CoV-2 that could reduce the efficacy of vaccines.

There will be incentives to develop new and adapted vaccines, speed up regulatory approval and support scale up of manufacturing capacities.

Key actions will include developing tests for new variants; supporting viral genome sequencing in member states with at least €75 million in EU funding to reach the target of sequencing 5% of viral samples from positive tests to help identify variants, monitor their spread and assess their impact on transmissibility; and speeding up research and data exchange on variants with €150 million funding.

 

 

 

 

 

 

US biotech Moderna said the European Commission is buying an additional 150 million doses of its COVID-19 vaccine, bring confirmed orders to 310 million doses for delivery in 2021. The latest doses are scheduled to be delivered in the third and fourth quarter of the year.

Under the terms of the agreement, the Commission has an option to purchase an additional 150 million doses for delivery in 2022.

Stéphane Bancel, CEO of Moderna, said, “The European Commission is in discussions with us on how to prepare for 2022, including addressing potential variants [of the virus].”

 

 

 

 

 

Pfizer and BioNTech have announced an agreement with the European Commission to supply an additional 200 million doses of their COVID-19 vaccine Comirnaty, to the EU.

This new agreement is in addition to the 300 million doses that have already been committed to the EU in 2021 under the first supply agreement signed last year. The additional 200 million doses are expected to be delivered in 2021, with an estimated 75 million to be supplied in the second quarter.

The total number of doses to be delivered to the EU member states by the end of 2021 is now 500 million, with the potential to increase to 600 million based on an option granted in the new agreement.

Albert Bourla, CEO of Pfizer said, “With this new agreement with the European Commission, we now expect to deliver enough doses to vaccinate at least 250 million Europeans before the end of the year.”

“We have taken additional steps to expand our manufacturing capacity to two billion doses in 2021,” said Ugur Sahin CEO of BioNTech. “We will initiate production at our Marburg facility this month.”

 

 

 

 

 

The UK government has awarded funding to extend its support for COVID-19 clinical trials to the earliest phase I studies, making it possible to rapidly progress new therapies through all stages of development in the country.

Four therapies have so far been selected for phase I development. Future treatments will be selected by the UK COVID-19 therapeutics advisory panel, which is open to receiving proposals from academic groups and companies.

Currently, the government is funding phase II and III studies, including the large scale Recovery trial, which is testing existing drugs in hospitalised COVID-19 patients. The randomised study, which recruited its 36,000 patient last week, has found two therapies, dexamethasone and tocilizumab, that are effective, and shown that four suggested treatments are not.

Phase I trials are the essential first step that ensures treatments are safe. The government backing is for Agile, a phase I/IIa clinical trial platform run in a collaboration between Liverpool, Lancaster and Southampton universities, and other external partners

The design of the platform means that multiple potential treatments can be evaluated in parallel and testing can be completed in months rather than years.

Patients in the early stages of COVID-19 infection will be recruited to Agile from the community, in addition to patients who have been hospitalised with COVID-19. Drugs that show a signal of benefit in Agile will be considered for advancement into later phase clinical trials.

 

 

 

 

 

Policymakers should learn lessons from the success of research and development (R&D) in responding to COVID-19, to rethink approaches to tackling healthcare and environmental challenges, according to a new study.

Economists from Bath University and the International Monetary Fund examined the drivers of innovation in global pharmaceutical R&D, finding research carried out by the industry typically follows a law of diminishing effort. This means that while the global death burden of a disease doubles, the intensity of research effort rises by only 50%.

However, the scientific response to COVID-19 is a major exception, with seven to twenty times more COVID-19 clinical trials than this historical relationship would imply.

During the pandemic, global pharmaceutical R&D, as measured by the number of clinical trials, has scaled up by 38%, with only a modest reduction of research on other diseases.

But much of this response occurred via public research institutions, which account for 70% of all COVID-19 trials globally.

The researchers say their findings suggest global pharmaceutical innovation has room to grow, but that government incentives and support from public research institutions should play a crucial role in supplementing the private research.

Patrick Gaule, senior lecturer in economics at Bath University and co-author of the study said, “The rate and direction of innovation is shaped by incentives and government policy actions. Traditionally, economists have emphasised the market size as an important driver for innovation - the greater the private demand for an innovation, the more innovation we should expect in that domain.”

"However, this may not be sufficient by itself to encourage innovation to address the deadliest diseases - from coronary heart disease to lung cancer, or indeed other major challenges facing humanity, namely climate change.”

Instead, the response to COVID-19 suggests that scaling up global innovation in the future may require moves to complement the market size effect with early-stage incentives that harness the power of public research institutions and non-monetary incentives, for example altruism, Gaule said.

 

 

 

 

 

The European Medicines Agency said it is developing guidance for manufacturers planning changes to existing COVID-19 vaccines, to tackle emerging new virus variants.

The agency has asked all vaccine developers to investigate if their vaccine offers protection against new variants, such as those first identified in the UK, South Africa and Brazil, and submit relevant data.

EMA will then publish guidance on what data and studies are needed to support modifications of existing vaccines to current or future mutations of SARS-CoV-2 in the EU.

Questions that will be addressed include: what are the options for introducing a new variant into an existing approved vaccine?; what will be required to demonstrate quality, safety and efficacy of modified vaccines?; which bridging studies will be required to provide adequate reassurance of a vaccine’s efficacy against a new variant, either as first vaccination or as booster?

EMA has authorised three vaccines for use in the EU and there are concerns that some mutations could impact to different degrees the ability of the vaccines to protect against infection and disease.

A reduction in protection from mild disease does not necessarily translate into a reduction in protection from serious disease, but more evidence is needed.

Variants of SAR-CoV-2 have been present since March 2020, spreading even before the start of vaccination campaigns.

EMA is working with other regulators in the International Coalition of Medicines Regulatory Authorities to determine possible changes to the composition of COVID-19 vaccines and to align global strategy.

 

 

 

 

 

BioNTech has started manufacturing at its new Marburg facility, making the first batch of mRNA for its COVID-19 vaccine. The batch will produce enough active ingredient for eight million doses of the vaccine, the company said.

After initial production, the raw material will be purified and concentrated, before being encapsulated in lipid nanoparticles that both protect the mRNA and deliver it to the target lymphoid cells, generating an immune response.

Before the vaccine can be shipped the European Medicines Agency will review quality and validation data from the first production batches. This will take place in February and March. Based on approval by the EMA, the initial batches of the vaccine will be delivered to other sites to be put into vials.

BioNTech said it is working with co-developer Pfizer to respond to global demand, increasing manufacturing capacity to up to two billion doses of vaccine in 2021. However, that assumes continuous process improvements, expansion at current facilities and adding new suppliers and contract manufacturers.

It also depends on updating the label on the vials, to allow six doses per vial, rather than five, as envisaged in EMA’s original approval.

Last week, Pfizer announced the modification of production processes at its facility in Puurs, Belgium, which has held up supplies, has been successfully completed. That has put the company back on track to meet the original schedule of vaccine deliveries to the EU in the first quarter, and supply up to an additional 75 million doses to the EU in the second quarter of 2021.

The initial EU order for 300 million doses in 2021 was subsequently increased to 500 million when the contract was amended in January.

The new BioNTech site in Marburg will become one of the largest mRNA manufacturing sites in Europe with an annual production capacity of up to 750 million doses, once fully operational.

BioNTech plans to produce up to 250 million doses at the facility in the first half of 2021, with the first vaccines manufactured at the Marburg site scheduled for distribution in early April.

 

 

 

 

 

COVID-19 has reduced the share of electricity generated by burning coal - a trend that could outlast the pandemic, according to a new German study. Researchers in Potsdam and Berlin found a window of opportunity has opened to make the current fall in coal use irreversible and say that supported by the right climate policy measures, power sector emissions could decline more rapidly than previously thought.

"Coal has been hit harder by the corona crisis than other power sources,” said Christoph Bertram from the Potsdam Institute for Climate Impact Research, lead author of a paper in Nature Climate Science. "If demand for electricity drops, coal plants are usually switched off first. This is because the process of burning fuels constantly runs up costs. The plant operators have to pay for each single ton of coal. In contrast, renewable power sources such as wind and solar plants, once built, have significantly lower running costs and keep on operating even if the demand is reduced."

In 2020 overall global CO2 emissions from the power sector decreased around 7%. In India, the US, and European countries, where monthly electricity demand declined by up to 20% compared to 2019, the fall was more marked, with monthly CO2 emissions down by up to 50%.

As long as clean electricity generation growth exceeds increases in electricity demand, CO2 emissions from the power sector will decline, because the pandemic has weakened the market position of coal-fired power generation and illustrated its vulnerability, the researchers say.

Co-author Ottmar Edenhofer, director of the Potsdam Institute and the Mercator Research Institute on Global Commons and Climate Change said, "In the end, it will certainly take carbon pricing to cut emissions at the required pace and stabilise our climate. Yet the impacts of the corona crisis on the power generation sector have put political leaders in a unique position. Along with additional policies such as eliminating subsidies for fossil fuels and increasing investments in wind and solar power, it is now easier than ever before to put an end to high-carbon electricity."

 

 

 

 

 

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