17 Sep 2020

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

covid vaccine

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.

 

BioNTech announced an agreement with Novartis to acquire its GMP certified manufacturing facility in Marburg, Germany, enabling BioNTech to expand production of its COVID-19 by up to 750 million doses per year, once fully operational. The transaction is expected to close in the fourth quarter of 2020. BioNTech said it plans to produce up to 250 million doses of the vaccine in the first half of 2021, thanks to the established team and approved manufacturing capabilities at the site.

The Marburg site, located within one hour from the Frankfurt airport and within 90 minutes from BioNTech’s headquarters in Mainz, currently employs around 300 staff. 

“We are working closely with Novartis to prepare for a smooth transition, and we look forward to welcoming the new members of our team,” said Sierk Poetting, chief financial officer at BioNTech.

 

In her first state of the union address since coming into office, European Commission president Ursula von der Leyen has set out plans for a stronger European Health Union, with improved crisis preparedness and better management of cross-border health threats.

As a first step, she proposes to reinforce and empower the European Medicines Agency and the European Centre for Disease prevention and Control. Secondly, von der Leyen wants to set up a European equivalent of the US Biomedical Advanced Research and Development Authority. “This new agency will support our capacity and readiness to respond to cross-border threats and emergencies – whether of natural or deliberate origin,” von der Leyen told MEPs. “We need strategic stockpiling to address supply chain dependencies, notably for pharmaceutical products.”

Von der Leyen also hit out at the cut - from €9.4 billion to €1.7 billion - that the European Council made to the new EU4Health programme, which the commission wants to set up to help member states strengthen their healthcare systems. EU4Health “must be future proof” von der Leyen said, telling MEPs she supports their attempt to get more money for the programme. “I am grateful that this parliament is ready to fight for more funding and remedy the cuts made by the European Council,” she said.

If that gets a lukewarm reception in EU capitals, a proposal that the European Commission be given more influence over national health systems seems likely to be even more unpopular. But said von der Leyen, “It is clearer than ever that we must discuss the question of health competences.” This is “a noble and urgent task,” she said.

 

BioNTech announced that it will receive a grant of up to €375 million from the German Federal Ministry of Education and Research (BMBF) to support the accelerated development of COVID-19 vaccines it is developing in collaboration with Pfizer and the Chinese pharma company Fosun. The money will fund expansion of vaccine development and manufacturing capabilities in Germany, and an increase in the number of participants in late-stage clinical trials.

“The funding is an important contribution to accelerate the development and scaling-up of our COVID-19 vaccine manufacturing capacities in Germany,” said Ugur Sahin, CEO and co-founder of BioNTech.

The milestones defined by BMBF include preclinical evaluation of the vaccines, initiation and implementation of clinical phase I and phase II/III  trials, scaling up production capacities to supply the clinical trials and for commercial supply, and submission for regulatory approval.

BioNTech said it has already triggered five of the eight defined milestones. Most recently, it received approval from the German regulator to start the German arm of the global phase II/III trial. To date, over 28,000 participants have been inoculated in the US, Brazil, Argentina and Europe.

 

Kiadis Pharma has received $9.5 million in funding from the US Advanced Regenerative Manufacturing Institute (ARMI), in partnership with the US Department of Defense, to fund research on its COVID-19 natural killer cell therapy, K-NK-ID101. The money will be used to investigate K-NK-ID101’s activity and mode of action, and fund a phase I/II clinical trial. Kiadis will also collaborate with ARMI to set up large-scale manufacturing capacity for K-NK-ID101 in the US.

The vast majority of COVID-19 patients have a shortage of lymphocytes, a type of white blood cell that helps protect the body from infection. Natural killer cells are lymphocytes and COVID-19 disease severity is correlated with a reduction in the number, or exhaustion of, these cells. Natural killer cells have been shown to fight various other viral infections, and Kiadis’ research will study the properties of the cells in COVID-19 infections.

Arthur Lahr, CEO of Kiadis, said natural killer cell therapy could potentially offer a universal preparedness platform, for COVID-19 and future pandemics. “Over time, [natural killer] cells could be developed to protect immunocompromised and high-risk patients against multiple seasonal respiratory infections, including influenza and respiratory syncytial virus, either alone or in combination with vaccines and antibodies,” he said. If the phase I/II study is successful, Kiadis will look for further funding to support late stage development and to scale up production to millions of doses in the US.

 

The UK government has signed a €1.4 billion deal with French biotech Valneva for its COVID-19 vaccine VLA2001. The company will manufacture 190 million doses of the vaccine at its facility in Scotland over the next five years.

As part of the advance purchase agreement, the UK government will help fund ongoing clinical trials evaluating VLA2001, and has also invested in Valneva’s manufacturing site to increase production.

If vaccine development is successful, Valneva will supply the UK with 60 million doses in the second half of 2021. The UK government then has options over 40 million doses in 2022 and a further 30 million to 90 million doses, in aggregate, across 2023 to 2025. The vaccine is expected to require two doses. The up-front investment in the scale up and development of the vaccine will be recouped against the vaccine supply.

VLA2001 draws on Valneva’s established technology for inactivating viruses so that they cannot cause infections, but will still generate an immune response. A vaccine against Japanese encephalitis based on the technology has approval. VLA2001 is expected to start clinical trials by December 2020. If effective, a first regulatory approval could be granted in H2 2021.

 

German biotech BioNTech and its partner Pfizer announced they have submitted an amended protocol to the US Food and Drug Administration to increase the number of participants in the phase III trial of their COVID-19 vaccine from 30,000 to approximately 44,000 participants. Enrollment in the trial has been proceeding as planned and BioNTech expects to reach the initial target of 30,000 this week.

The proposed expansion is to allow the companies to further increase trial population diversity, to include people as young as 16 years of age,  and volunteers with chronic HIV, hepatitis C and hepatitis B viral infections. The expansion will also provide additional safety and efficacy data.

Demonstrating efficacy in the trial depends on showing people inoculated with the vaccine did not contract COVID-19, while those who received placebo remained exposed to infection. Based on current infection rates, the companies expect a conclusive readout on efficacy is likely by the end of October.

 

The hold has been lifted on the phase III randomised controlled UK clinical trial of AZD1222, the COVID-19 vaccine being developed by AstraZeneca and Oxford University, a week after it was halted because a participant fell ill.

A review by the trial’s independent safety committee and the UK regulator, the Medicines and Healthcare products Regulatory Agency, concluded it is safe for the study to recommence in the UK. The vaccine is also being tested in the U.S., Brazil and South Africa. AstraZeneca said it will “work with health authorities across the world and be guided as to when other clinical trials can resume.”

No details are being released of the medical condition of the participant who fell ill,  but AstraZeneca said all trial investigators and participants will be updated with the relevant information and this will be disclosed on global clinical registries.

To date, some 18,000 individuals have received the vaccine as part of the trial. The sponsors say that in large trials such as this, it is expected some participants will become unwell and every case must be carefully evaluated to ensure the safety of the vaccine.

 

A new Horizon Europe project, Support-E, has received €4 million in funding to gather an evidence base demonstrating safety and efficacy of using convalescent plasma from people who have recovered from COVID-19, in treating patients who are newly infected.

Support-E, led by the European Blood Alliance, brings together 12 research institutes and clinical centres in six EU member states, Switzerland and the UK, to coordinate and enable randomised controlled clinical trials of convalescent plasma transfusions across Europe. In addition to safety and efficacy, the project aims to better understand which patients should be transfused and how, and to establish protocols for how plasma donations should be tested and selected to ensure the best treatment outcome. The output will be harmonised recommendations on COVID-19 convalescent plasma collection, testing and use.

The money comes from the commission’s €1 billion COVID-19 fund for research into vaccines, therapies and diagnostics to treat and prevent the infection.

 

German research minister Anja Karliczek announced a €20 million fund to expand the country’s specialist medical technology programme. The new money is for multidisciplinary projects involving academics, industry and end users developing diagnostics and devices that improve testing for, and treatment of, COVID-19 infections. The first close for the call is on September 28, with a second close on 30 January 2021. The government is interested in backing fast and reliable diagnostics, less invasive ventilation procedures, and intelligent patient management systems.

 

BioNTech and Pfizer announced an outline agreement with the European Commission to supply 200 million doses of their mRNA-based COVID-19 vaccine to member states, with an option to purchase a further 100 million doses. Deliveries will start by the end of 2020, subject to clinical success and regulatory authorisation. The companies will now enter into formal contract negotiations with the commission.

Vaccine supplies for Europe will be produced at BioNTech’s manufacturing sites in Germany and Pfizer’s site in Belgium. If the vaccine is approved, the commission will lead the process of allocating doses among the EU27.

Albert Bourla, chair and CEO, Pfizer, said, “We have activated our supply chain, most importantly our site in Belgium, and are starting to manufacture so that our vaccine would be available as soon as possible, if our clinical trials prove successful and regulatory approval is granted.”

The companies say they are on track to seek regulatory approval as early as October 2020 and if approved, currently plan to supply up to 100 million doses worldwide by the end of 2020 and approximately 1.3 billion doses by the end of 2021.

 

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