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

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.

The international phase III trial of the COVID-19 vaccine being jointly developed by AstraZeneca and Oxford University has been suspended after a volunteer in the UK was taken to hospital. AstraZeneca said the hold is part of a standard process.

The independent safety board monitoring the trial will assess if the illness is an adverse reaction is linked to the vaccine. In the UK arm of the phase III trial the vaccine is being tested in health workers who are more likely to be exposed to COVID-19, and in volunteers over the age of 70 who are at higher risk of developing serious disease if they contract the infection.

Stephen Evans, professor of pharmaco-epidemiology at the London School of Hygiene & Tropical Medicine said, “When large numbers of people are included in trials, coincidental events can occur and when they are unexpected, then an investigation is required to see if they are just coincidence or a result of the vaccine [….].

“We do not know what event has occurred, but given that in the UK those aged over 70 have been included in the trials, coincidental events are to be expected,” said Evans. To date, more than 17,000 of 30,000 volunteers have been recruited to the phase III trial, which is taking place in the UK, US, Brazil, India and South Africa.

The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi have signed a pledge to uphold the integrity of the scientific process, as they work towards potential global regulatory filing for approvals of their COVID-19 vaccines.

This broadside against any regulatory shortcuts follows recent reports that the U.S Food and Drug Administration (FDA) is being leant on to approve a vaccine before the US presidential election.

The text says, “We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as FDA. FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorisation or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomised and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

Always make the safety and well-being of vaccinated individuals our top priority;

Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigour; of manufacturing processes;

Only submit for approval or emergency use authorisation after demonstrating safety and efficacy through a phase III clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA;

Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.”

After postponing from July to September, organisers of the Euroscience Open Forum say they “won their bet” on holding their nerve and staging a part real-life, part online conference in Trieste last week. “ESOF 2020 has provided an innovative hybrid organisational model, something that should not be taken for granted,” said Stefano Fantoni, ESOF2020 champion. Some 2,500 people registered for the event. Of these, more than 1,000 participated in person and 1,400 people connected remotely every day. On average each event was attended online by around 300 people, and the event saw 4,300 virtual visits in total. Online visitors came from 52 countries across 5 continents. The ESOF2020 Facebook page reached more than half a million people, with 26,000 interactions. There were 200,000 interactions on Twitter and 237,000 visits to the ESOF2020 website.

BioNTech and its partner Pfizer announced the German drug regulator, the Paul-Ehrlich-Institut, has given approval for the phase II/III clinical trial of their BNT162b2 COVID-19 vaccine candidate to start recruiting volunteers in Germany. The study in Germany is part of the global pivotal phase II/III programme the two companies started in July this year. The placebo-controlled trial is evaluating the safety and efficacy of BNT162b2 in up to 30,000 participants between 18 and 85 years of age. Each will be randomised to receive either the vaccine or placebo. The study is being conducted in approximately 120 sites globally, including regions where there is significant transmission of the infection. As of today, more than 25,000 participants have been recruited to the study.

“A large, controlled phase III study is a crucial prerequisite to prove the safety and efficacy of a vaccine,” said CEO and co-founder of BioNTech, Ugur Sahin. “The integration of sites in Europe, and now especially in Germany, is aimed at supporting an approval in Europe.”

European pharmas Sanofi and GlaxoSmithKline announced the start of the phase I/II clinical trial for their COVID-19 vaccine. The candidate uses the same recombinant protein technology as one of Sanofi's seasonal influenza vaccines with GSK's established adjuvant, which is added to promote a stronger immune response. The phase I/II clinical trial is a randomised, double blind and placebo-controlled study designed to evaluate the safety, tolerability and immunogenicity immune response.

A total of 440 healthy adults are being enrolled in the trial across 11 sites in the US. The companies anticipate first results in early December 2020, to support the initiation of a phase III trial in December 2020.  If the phase III data are good enough, it is planned to request regulatory approval in the first half of 2021. Pre-clinical data showed an acceptable tolerability profile and levels of neutralising antibodies comparable to levels in humans who recovered from COVID-19 infection.

Pre-clinical results will be published later this year. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021.

A key question facing countries worldwide is how the economic fallout from the COVID-19 crisis will impact start-ups, venture capital, and other traditional sources of innovation financing.

At present many governments are setting up emergency relief packages to cushion the impact of the lockdown and the looming recession. Now, the Global Innovation Index 2020 is advising that further rounds of support must prioritise and then broaden support for innovation, particularly for smaller companies and start-ups that are facing hurdles in accessing rescue packages.

“Even as we all grapple with the immediate human and economic effects of the COVID-19 pandemic, governments need to ensure that rescue packages are future oriented and support the individuals, research institutes, companies and others with innovative and collaborative new ideas for the post-COVID era,” said World Intellectual Property Organisation (WIPO) director general Francis Gurry. “Innovations equal solutions.”

One of the findings of the latest index, published by WIPO, is that money to fund innovative ventures is drying up. VC deals are in sharp decline across North America, Asia, and Europe. The impact of this shortage in innovation finance will be uneven, with the negative effects felt more heavily by early-stage VCs, by R&D-intensive start-ups, and in countries that are not typically VC hotspots.

While the impacts of the pandemic on the science and innovation systems will take time to unfold, there are positive signs of increased international collaboration in science. At the same time, there are concerns of major research projects being disrupted and international closure in the pursuit of innovation, WIPO says.

Mila, the Quebec-based artificial intelligence institute, on Tuesday announced a project with Relation Therapeutics, a London-based drug company, to re-purpose drug combinations as potential therapeutic candidates for COVID-19. Funding for the machine-learning-based project, $1.3 million, comes from the Bill & Melinda Gates Foundation, while the scientific direction will be provided by deeptech pioneer and Mila founder Yoshua Bengio.

Drug discovery is traditionally a slow enterprise but AI-powered systems have helped speed it up. Mila’s new effort joins similar projects led by Oxford-based Exscientia and Cambridge-based Healx to find COVID-19 treatments.

Mila and Relation Therapeutics said they “aim to leverage the most powerful machine learning techniques currently being deployed in the world’s largest tech companies and academia, to revolutionise computational drug development.”

GlaxoSmithKline plc said the first patient was dosed last week in a phase II/III study of GSK4182136, a fully human anti-SARS-CoV-2 monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalisation. The aim of the study, which will enrol approximately 1,300 patients worldwide who have early symptomatic infection, is to assess whether the antibody can prevent symptoms becoming so severe that people are admitted to hospital. That would fill a big gap in the treatment for COVID-19 infection, with no therapies currently available for use in the community. Initial results may be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021, GSK said.

Hal Barron, chief scientific officer and president of R&D at GSK, said, “Monoclonal antibodies directed against the SARS-CoV-2 virus could provide an effective and immediate immune response to COVID-19, bypassing the need for our body to produce its own antibodies, which is particularly important in the absence of an effective vaccine. This study will assess the ability of VIR-7831 to prevent high-risk individuals from progressing to severe disease.”

European Commission is to participate in the international COVAX initiative set up to ensure equitable access to affordable COVID-19 vaccines and will offer €400 million in guarantees to purchase supplies for poorer countries. COVAX, co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations and the World Health Organisation, aims to accelerate the development and manufacture of COVID-19 vaccines and to guarantee access for every country in the world.

The detailed terms and conditions of the EU's participation and contribution will be worked out in the coming days and weeks. The commission is ready to put its expertise and resources to work within COVAX to accelerate and scale-up development and manufacturing of a global supply of vaccines. The EU's participation in COVAX will be complementary to the ongoing EU negotiations on advance purchase agreements with vaccine companies on behalf of member states.