A study published today in the science journal Nature shows Johnson & Johnson’s COVID-19 vaccine elicits a strong immune response that protects against subsequent infection in preclinical models. Based on these results, a first-in-human phase I/II clinical trial now underway in US and Belgium, and a phase III clinical trial is expected to commence in September.
Planning is also underway for a phase IIa study in the Netherlands, Spain and Germany, and a phase I study in Japan.
The vaccine elicited a robust immune response as demonstrated by neutralising antibodies, successfully preventing subsequent infection and providing complete or near-complete protection in the lungs from the virus in non-human primates.
“We are excited to see these pre-clinical data because they show our SARS-CoV-2 vaccine candidate generated a strong antibody response and provided protection with a single dose. The findings give us confidence as we progress our vaccine development and upscale manufacturing in parallel,” said Paul Stoffels, chief scientific officer of Johnson & Johnson.
The Decision project to develop an easy-to-use, low-cost, disposable test for COVID-19 that can give results within minutes, is offcially underway, following signing of the formal grant agreement by the EU’s Innovative Medicines Initiative.
The idea is that the test can be used in a variety of settings, including drive-through centres, airports and at home. It will be based on Pulse Controlled Amplification, a technology that works much faster than the current PCR method of amplifying viral genetic material in samples. The German company leading the project, GNA Biosolutions, says the amplification process can take place in situ and is completed in minutes. “It’s still a molecular amplification of the viral genetic material, but we can miniaturise and simplify and accelerate the process so the test can be done on-site, by anyone,” said project lead Anastasia Liapis.
GNA Biosolutions previously received funding as part of an earlier IMI project, Filodiag, to develop an Ebola virus rapid diagnostic test. The Decision project hopes the first demonstrators of the disposable molecular platform and coronavirus test will be available in 2021.
The European Commission has signed a contract with Gilead Sciences for supplies of its antiviral drug remdesivir, now brand named Veklury. The drug is the first to be approved by the European Medicines Agency for the treatment of COVID-19. Batches of Veklury will be available from early August to member states and the UK, with the coordination and support of the commission.
Stella Kyriakides, commissioner for health said, “The commission has been working tirelessly with Gilead to reach an agreement to ensure that stocks of the first treatment authorised against COVID-19 are delivered to the EU.” The commission's Emergency Support Instrument will finance the contract, worth a total of €63 million.
This is enough to treat approximately 30,000 patients with severe COVID-19 symptoms. It will cover current needs over the next few months, while ensuring a fair distribution at EU level, taking into account advice from the European Centre for Disease Prevention and Control.
The commission is now also preparing a joint procurement for further supplies of Veklury, expected to cover additional needs and supplies from October onwards.
UK pharma company GlaxoSmithKline and French counterpart Sanofi have reached an agreement with the UK government to supply up to 60 million doses of the COVID-19 vaccine they are co-developing. The product is based on the recombinant protein technology used by Sanofi to produce its flu vaccine, with GSK's adjuvant to boost the immune response. Roger Connor, president of GSK Vaccines said, “We believe that this adjuvanted vaccine candidate has the potential to play a significant role in overcoming the COVID-19 pandemic, both in the UK and around the world.” The UK government advance purchase agreement supports the significant investment being made to scale up development and production of the vaccine in advance of knowing whether it will be effective or not.
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 the data are positive, approval could be by the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant to produce up to one billion doses per year overall.
The European Commission wants researchers involved in EU-funded COVID-19 projects to make their data and results available “without delay”.
“Make scientific papers and research data available in open access,” says the commission’s “manifesto”, published on Tuesday. Coronavirus research data should be uploaded to the EU’s COVID-19 data site, for other researchers to access.
The commission says scientists should also grant non-exclusive royalty free licences on any intellectual property resulting from EU-funded research, for as long as the pandemic lasts.
Belgium’s life sciences sector has come together to launch ExeVir Bio, a company dedicated to developing scaled down antibodies, or nanobodies, as the basis of therapies for COVID-19. From a standing start in February, the company arrives on the scene today with a €23 million series A financing led by the venture capital firm Fund+, with the Flanders Institute for Biotechnology - VIB, UCB Ventures, the venture investment arm of the pharmaceutical company, the Belgian government and several Belgian family offices, all supporting the round. ExeVir Bio will harness llama-derived nanobodies to develop antiviral therapies that provide broad protection against coronaviruses. Alongside its direct investment, UCB assisted in the generation of the lead candidate and is now producing batches of the product for clinical trials that are due to start in November.
The technology ExeVir Bio is using has been validated by Ablynx NV, the Belgian biotech that was acquired by French pharma company Sanofi for €3.9 billion in 2018. Since nanobodies are smaller than human antibodies, they can attach to parts of coronaviruses that would otherwise be inaccessible. When the lead product binds to SARS-CoV-2, the virus it is blocked from entering human cells. Torsten Mummenbrauer, CEO of ExeVir Bio, said, “With this series A financing we can rapidly advance the development of our lead compound into clinical studies by the end of the year. We are confident our llama-derived antibodies hold a key to saving the lives of patients who can become seriously ill with coronavirus."
Hilde Crevits, deputy prime minister of the Flemish government and Flemish minister for science and innovation, said, “At the early stage of this crisis, we quickly decided to support VIB in its search for a treatment for COVID-19. As a result, an important first step has now been taken to develop this treatment on a worldwide scale."
The UK government is making moves to ensure any successful COVID-19 vaccine can be produced at scale in the country, announcing a £100 million investment to upgrade an existing facility in Braintree, Essex, into a Cell and Gene Therapy Catapult Manufacturing Innovation Centre. When it opens in December 2021, the centre will have the capacity to produce millions of doses each month.
The new centre will complement the Vaccines Manufacturing and Innovation Centre, currently under construction in Oxfordshire, which is funded by a £93 million investment from the government. Once complete next year, the facility will have the capacity to produce enough vaccine doses to serve the entire UK population.
In addition, the government is investing £38 million to establish a rapid deployment facility, opening later this summer, that will support efforts to ensure a successful vaccine is widely available as soon as possible.
BioNTech has sealed a deal with the US Department of Health and Human Services and the Department of Defense to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the US will get 100 million doses of BNT162, the vaccine BioNTech is developing jointly with US pharma company Pfizer, once Pfizer manufactures and obtains approval or emergency use authorisation from the US regulator FDA. The US government will pay $1.95 billion upon the receipt of the first 100 million doses and can also acquire up to an additional 500 million doses. Americans will receive the vaccine free of charge.
“We are pleased to have signed this important agreement with the US government to supply the initial 100 million doses upon approval, as part of our commitment to address the global health threat. This agreement is one of many steps towards providing global access to a safe and efficacious vaccine for COVID-19,” said Ugur Sahin, CEO and co-founder of BioNTech. “We are also in advanced discussions with multiple other government bodies and we hope to announce additional supply agreements soon.”
On Monday BioNTech announced an advance purchase agreement with the UK government for 30 million doses of the vaccine. If ongoing clinical studies are successful, Pfizer and BioNTech expect to be ready to apply for emergency use authorisation or some form of regulatory approval as early as October 2020
As a result of the COVID-19 pandemic, the 2020 Nobel week will adopt a new format to celebrate and pay tribute to this year’s laureates. The Nobel Foundation expects to be able to go ahead with the Nobel prize award ceremonies in Oslo and Stockholm on 10 December, but the events will both comply with social distancing restrictions and take into account that only some, or perhaps no laureates, will be there in person. “On other occasions when laureates have been unable to travel to Sweden or Norway, we have enlisted the help of our embassies and consulates abroad. That might be relevant this year,” the foundation said. However, the traditional Nobel reception at the Nordic Museum and the banquet at Stockholm City Hall will not take place this year, because both bring together over a thousand people in limited indoor spaces. “This year, it feels especially important to highlight the achievements of the laureates, which inspire us and give us hope for the future,” said Lars Heikensten, executive director of the Nobel Foundation. “This is a very special year when everyone must make sacrifices and adapt to completely new circumstances, but we will be paying tribute in various ways to the laureates, their discoveries and contributions.”
The European Commission on Wednesday said it would co-fund, with €100 million, a new funding call launched by the Coalition for Epidemic Preparedness Innovations (CEPI) to support coronavirus vaccines. The new call is an extension of CEPI’s second COVID-19 vaccine call for proposals launched in May.
It is open until the end of September but proposals will be evaluated “every three weeks in order to secure research funding in a timely manner”, the commission said. The EU money is part of the commission’s pledge to invest €1 billion into diagnostic tests, treatments, vaccines and other prevention tools to counter the spread of the virus. CEPI, a global partnership created in 2017 to develop vaccines to prevent future epidemics, has developed a broad portfolio of candidates.