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

26 Aug 2021 | Live Blog

This blog has been archived. A new one has been set up at this link.

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 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.” 

Partners Sanofi and GlaxoSmithKline say they are on track to get approval of their COVID-19 vaccine before the end of the year, after reporting positive results from a phase II trial.

The vaccine was initially expected to be approved in the first half of 2021, but the companies had to go back to the drawing board after an earlier phase II that reported last December found there was an insufficient immune response in people aged 50 and over.

In the latest trial, involving 722 volunteers, the product achieved strong rates of neutralising antibody responses after two doses, in line with those measured in people who have recovered from COVID-19. A phase III study is expected to start in the coming weeks.

After a single injection, high neutralising antibody levels were generated in those volunteers who had recovered from a natural SARS-CoV-2 infection, suggesting there is potential to develop the vaccine for use as an immune booster.

"Our phase II data confirm the potential of this vaccine to play a role in addressing this ongoing global public health crisis, as we know multiple vaccines will be needed, especially as variants continue to emerge, and the need for effective and booster vaccines, which can be stored at normal temperatures, increases,” said Thomas Triomphe, head of Sanofi Pasteur. “We are set to progress to a global phase III efficacy study.”

The phase III trial is expected to enrol more than 35,000 participants in a number of countries and will assess the efficacy of two formulations, against the original virus that emerged in China and the B.1.351 South African variant that has shown some resistance to first generation COVID-19 vaccines.

In parallel, the companies intend to conduct booster studies with various variant formulations in order to assess the ability of a lower dose of the vaccine to generate a strong booster response regardless of the initial vaccine received.

The clinical studies to date have been financed by the US Biomedical Advanced Research and Development Authority.

The EU Health Security Committee (HSC) has agreed to update the common list of COVID-19 rapid antigen tests, easing the way for the EU’s single digital vaccine certificate to allow foreign travel.

Following the update, 83 tests are now included in the common list, of which the results of 35 tests are mutually recognised by all member states.

Commissioner for health, Stella Kyriakides, said, “Rapid antigen tests play a crucial role to slow down the spread of COVID-19. Having a wider list of recognised rapid antigen tests will make it easier for citizens to benefit from digital green certificates and to facilitate safe free movement inside the EU in the coming months.”

In addition, the Commission and the Joint Research Centre have agreed a new procedure for updating the list of common and mutually recognised tests in the future. In future, there will be a common procedure for carrying out independent validation studies to assess the clinical performance of rapid tests.

The European Commission launched a strategy to support development of, and access to, COVID-19 therapies, including for the treatment of people who have recovered from the acute phase of infection but are now suffering from long COVID.

The strategy, intended to parallel the EU’s efforts in COVID-19 vaccines, is targeting approval of three new treatments for COVID-19 by October 2021, and possibly two more by end of the year. On the back of this, the Commission says it will launch new contracts for the purchase of authorised drugs by the end of the year.

A total of €90 million will be invested in population studies and clinical trials to look for links between risk factors and health outcomes, to further inform public health policy and clinical management, including for long COVID patients.

By July, the Commission will set up a therapies innovation ‘booster’ to support the most promising products through from preclinical research to market authorisation. This will build on current initiatives and investments in drug development, working in a close cooperation with the new European Health Emergency Preparedness and Response Authority, to ensure the coordination of all research projects on COVID-19 therapies.

A further €5 million is to be invested under the EU4Health programme to generate better safety data in clinical trials, to help produce robust results in a timely manner.

EU member states will be eligible for €2 million under EU4Health in 2021, to carry out expedited and coordinated assessments of applications to conduct clinical trials.

In addition, there will be a horizon scanning programme, with €5 million to map therapies and diagnostics and analyse what phase of development they are at, and the production capacities and supply chains. That will inform the establishment of a broader portfolio of ten potential COVID-19 therapies, with the five most promising identified by June 2021.

The Commission is keen not to make the same mistake in therapeutics as it did in vaccines, where despite large advance purchase agreements, there was no support for manufacturing. In this case, it is putting in €40 million to support flexible manufacturing and access to COVID-19 drugs.

The European Medicines Agency said it started a rolling review of a monoclonal antibody developed by GlaxoSmithKline and US biotech Vir Biotechnology for the treatment of COVID-19.

The decision to conduct the accelerated review is based on preliminary results from an ongoing study looking at the ability of the drug, sotrovimab, to prevent hospitalisation or death in patients with COVID-19 being treated in the community.

That would fill a gap in the care pathway, because currently there are no therapies specifically approved for patients at high risk of developing severe COVID-19 who are being treated at home.

Rolling reviews involve looking at data as they become available from ongoing studies, before a formal application is submitted. EMA said while the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation.

A separate EMA review of sotrovimab is underway to provide EU-wide recommendations to support national authorities in case they want to use the drug prior to marketing authorisation.

Sotrovimab is designed to attach to the spike protein of SARS-CoV-2, the virus that causes COVID-19, reducing the ability of the virus to enter the body’s cells. Preclinical data suggest it has the potential to both block viral entry into healthy cells and to clear infected cells.

The decision to start the rolling review is based on the interim analysis of efficacy and safety data from the phase III study, which is evaluating sotrovimab as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation.

In March, the independent safety board monitoring the trial recommended it should stop enrolling more patients because there was already evidence of efficacy. Enrolled patients continue to be followed up.

European Commission president Ursula von der Leyen said EU is ready to discuss any proposal that addresses the pandemic crisis in an effective and pragmatic manner, including over-riding patents. “That is why we are ready to discuss how the US proposal for a waiver on intellectual property protection for COVID-19 vaccines could help achieve that objective,” she said in a speech this morning to the State of the Union conference at the European University Institute.

That follows a decision by the US to support the waiver, with US trade commissioner Katherine Tai saying on Wednesday, “The US supports the waiver of IP protections on COVID-19 vaccines to help end the pandemic and we’ll actively participate in [World  Trade Organisation] negotiations to make that happen.”

Von der Leyen’s change in tone is at odds with the European Parliament, which voted against the waiver on 29 April 2021.

European pharma companies joined counterparts elsewhere in the world in condemning the move, with Nathalie Moll, director general of the industry body EFPIA saying, “This short-sighted and ineffectual decision by the Biden administration puts the hard-won progress in fighting this terrible disease in jeopardy. While we wholeheartedly agree with the goal of protecting citizens around the world through vaccines, waiving patents will make winning the fight against the coronavirus even harder.”

Moll said increasing capacity to deliver doses to citizens around the world requires the skills and technical know-how of the vaccine developer to bring on-board partner manufacturing organisations. “You simply cannot achieve this kind of capacity expansion by waiving patents and hoping that hitherto unknown factories around the world will turn their hand to the complex process of vaccine manufacture,” she said.

A waiver also risks diverting raw materials and supplies away from well established supply chains to less efficient manufacturing sites and opens the door to counterfeit vaccines entering the supply chain around the world, Moll said.

The decision of the US administration to support a patent waiver for COVID-19 vaccines is “disappointing”, according to a statement from pharma companies.

“We are fully aligned with the goal to ensure COVID-19 vaccines are quickly and equitably shared around the world. But, as we have consistently stated, a waiver is the simple - but the wrong answer - to what is a complex problem,” the statement says.

Waiving patents of COVID-19 vaccines will not increase production nor provide practical solutions needed to battle the global health crisis. On the contrary, it is likely to lead to disruption, while distracting from addressing the real challenges in scaling up production and distribution of COVID-19 vaccines globally, the industry says.

Pharma companies hit back after the general council of the World Trade Organisation (WTO) agreed to allow the Council for Trade-Related Aspects of Intellectual Property Rights to continue consideration of the proposal first put forward by India and South Africa for a temporary waiver of certain intellectual property obligations in response to COVID-19.

The waiver had the support of 60 WTO members, but the one that is likely to swing things is the US. “This is a global health crisis, and the extraordinary circumstances of the COVID-19 pandemic call for extraordinary measures. The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines,” said US trade representative Katherine Tai in a statement announcing the US had changed its position.

The industry squarely aims at trade barriers it says are holding up supply chains. Another problem that would not be solved by waiving intellectual property rights is shortages of raw materials and other essential items, such as glass vials and filters used in bioprocess of bulk materials.

Demand continues to outstrip supply, but the industry says there should be “willingness” by rich countries to start sharing doses with poor countries.

“We will continue to leave no stone unturned to further scale up manufacturing of COVID-19 vaccines, as no one is safe until everyone is safe,” the statement says.

Companies have voluntarily agreed more than 200 technology transfer agreements to expand delivery of COVID-19 vaccines based on “unprecedented” partnerships, companies say.

Subscribe to Live Blog Entries