Mariya Gabriel is in self isolation after a member of her staff tested positive for Covid-19 on Sunday. Gabriel and her entire staff are now working from home pending test results. “I feel well and have no symptoms,” Gabriel said in a tweet on Monday.
The European Medicines Agency has started the first ‘rolling review’ of a COVID-19 vaccine, in which it is evaluating the preclinical data on the vaccine being developed by AstraZeneca in collaboration Oxford University.
Rolling review is one of the ways EMA can speed up the assessment of drugs or vaccines during a public health emergency. Normally, all data on effectiveness, safety and quality must be collected and submitted in a single file once clinical trials are completed, but in a rolling review, EMA reviews data as they become available from ongoing studies.
The decision to start the rolling review of the vaccine is based on preliminary results from preclinical and early clinical studies suggesting it triggers production of antibodies and T cells that target the virus.
EMA will complete the assessment according to its usual standards. While the overall review timeline cannot be forecast, the process should be shorter. The rolling review route was used in assessing the first therapeutic to be approved for treating COVID-19, Gilead Sciences’ Veklury (remdesivir).
The COVID-19 pandemic has created a flood of potentially substandard research amid the rush to publish, with a string of papers retracted or under a cloud, and a surge in submissions to pre-print servers where fewer quality checks are made, according to Katrina Bramstedt, secretary general of the Luxembourg Agency for Research Integrity and adjunct professor at Bond University, Queensland, Australia.
This has implications for patients, clinicians, and potentially government policy, Bramstedt warns in the Journal of Medical Ethics.
The rapid spread of COVID-19 and its transition into a global pandemic prompted a huge surge in research to understand the virus and develop treatments and vaccines. Scientific and medical journals have since been flooded with submissions, while thousands of papers, which have not undergone thorough quality checks, have been posted on preprint servers.
As of 7 May 2020, 1,221 studies on COVID-19 were registered on the US clinical trial registry site, ClinicalTrials.gov. And as of 31 July 2020, 19 published articles and 14 preprints about COVID-19 had been retracted, withdrawn, or had serious doubts raised about the integrity of their data.
"No research team is exempt from the pressures and speed at which COVID-19 research is occurring. And this can increase the risk of honest error as well as deliberate misconduct,” Bramstedt said.
The reasons for the removal of the 30 papers include data falsification, methodological issues, and concerns about interpretation of data and conclusions, as well as authorship and participant privacy issues. Two preprints and two research papers in The Lancet and New England Journal of Medicine were retracted because of unverifiable data common to all four.
There are obvious implications for the journal and the researchers involved, even if they are innocent of any research misconduct, Bramstedt said. The evidence suggests that in such cases, the citations of prior collaborators can fall by 8 – 9 per cent.
There may be optimistic vibes coming out of some COVID-19 vaccines development programmes, but even with safe and effective products, there are issues to be resolved over their use. The Data Evaluation and Learning for Viral Epidemics multidisciplinary group, convened by the UK Royal Society, outlines the key challenges and sets out strategies to mitigate them in a new report published today.
Amongst the issues they highlight are:
- Potential differences in the ability of vaccines to protect against transmission and disease.
- Likely variability of the effectiveness of vaccines in different populations, such as the elderly.
- Possible short half-life of immunity provided by vaccines, meaning that multiple doses or boosters might be needed to achieve immunity.
- Vaccines providing only partial immunity will require higher vaccination rates to achieve the same levels of protection in a population.
- The need to establish systems for careful data collection to monitor population effectiveness and safety.
- The logistical challenges of manufacturing and delivering a global immunisation programme are enormous and some of the most promising vaccine candidates, notably those based on messenger RNA are using technologies that have not been manufactured at scale before.
- Public trust in a vaccine programme will have to be established and maintained.
Vaccines are held up as our best chance of getting our lives back to some sense of normality, but we have to be realistic, said Fiona Culley of the National Heart and Lung Institute at Imperial College London and one of the lead authors of the report. “The path to successful vaccines is filled with potential problems in finding vaccines that will work effectively in the ways we need and in being able to roll them out. Planning now for the different scenarios that might play out will give us the best chance of taking rapid advantage of any vaccines that are proven to be safe and effective.”
Gavi, the public-private partnership that helps provide vaccines to developing countries, has appointed former EU chief José Manuel Barroso as its new chair, beginning in January 2021.
Barroso served as president of the European Commission from 2004 – 2014, and as prime minister of Portugal from 2002 - 2004. He is currently non-executive chair of the US investment bank, Goldman Sachs International.
“As we face the worst pandemic in over a century, the world needs Gavi now more than ever, both to ensure COVID-19 vaccines reach every country, rich and poor, and press ahead with its core mission to protect hundreds of millions of people from preventable diseases,” said Barroso.
Barroso will replace Ngozi Okonjo-Iweala, former finance and foreign affairs minister of Nigeria, and World Bank managing director, whose term ends in December.
Biotechs developing treatments for COVID-19 are calling on the government to make grants available to cover the cost of late stage clinical trials. The industry organisation BIO Deutschland notes that while the German government has set aside more than €1 billion for COVID-19 vaccines research - and has made a large portion of these funds available to three vaccine developers in Germany - it has not yet considered providing support for the later stages of clinical development for drugs to treat Covid-19.
In an open letter to the federal minister of research, federal minister of health and the federal minister of economic affairs, BIO Deutschland is calling for late-stage funding to be made available quickly, in order to enable development of therapies for severely ill patients.
Helga Rübsamen-Schaeff, co-head of the health policy group at BIO Deutschsland, said even following the approval of any vaccines, it is likely patients will continue to become seriously ill with COVID-19. “We therefore urgently need effective therapy options to alleviate severe COVID-19 [….] One must never forget that one cannot predict the means by which a pandemic can be controlled. To date there is no vaccine for HIV. Here, effective drugs have taken the horror away from the virus,” Rübsamen-Schaeff said.
Niels Riedemann, co-head of the association's health policy working group said the development of effective therapies against COVID-19 is time-consuming and expensive, especially in the late development phases. “It is important to understand that small and medium-sized biotech companies are for the most part the drivers of these developments. Since they often do not yet make a profit from the marketing of drugs, these companies can hardly finance such developments on their own.”
The government has recognised this is the case for vaccine developers in Germany and it should do the same for small companies developing COVID-19 therapies. “Such therapeutics could prove their effectiveness in the next nine to twelve months and then become available. From a health policy and economic point of view, it is therefore imperative to give special support to these projects and to start them now,” said Riedemann.
Ireland has announced an investment of €5.5 million in 41 projects under its COVID-19 Rapid Response research programme. Science minister Simon Harris said they are “practical projects” which “could make a real difference in our lives. They, “will prepare us to live in a changing environment that requires new thinking and innovative approaches,” he said.
The 41 projects cover a wide range of areas including, how to reduce damage to the skin on the face from wearing protective equipment; decontaminating face masks for reuse; detecting airborne SARS-CoV-2 in healthcare and airport environments; the development of plastic packaging resistant to Covid-19; early detection of secondary waves of COVID‐19 infection; and home monitoring of respiration in COVID-19 patients using smartphone technology.
The COVID-19 Rapid Response programme was established by Science Foundation Ireland, Enterprise Ireland, IDA Ireland, the Health Research Board and Irish Research Council. The latest grants build on previous investment of €8 million across 17 COVID-19 projects. All of the projects funded were internationally peer reviewed at the assessment stage.
The COVID-19 response research funding is critical to supporting Ireland’s national action plan in response to the pandemic, said Mark Ferguson, director general of Science Foundation Ireland and chief scientific adviser to the government. The projects “will play a pivotal role in developing societal and economic solutions to challenges we face,” he said.
The UK is to become the first country to run challenge trials of COVID-19 vaccines, in which healthy volunteers who receive either a vaccine or placebo are then administered SARS-CoV-2, the virus that causes COVID-19.
In addition to showing if a vaccine is effective, these trials will be valuable in helping to establish what an effective immune response looks like. That insight can then be read across to the large phase III trials of vaccines. The trials, to be funded by the UK government, will be run by Dublin-based contract research organisation Open Orphan plc from its specialist unit in London.
The World Intellectual Property Organization has added some 1,500 new COVID-19-related terms in 10 languages to its terminology database, providing people working on coronavirus treatments and diagnostics with a baseline set of terms and their multilingual equivalents. WIPO says this will foster international collaboration and promote easier access to information in patent documents, and in other public resources around the world.
WIPO’s Pearl database now contains 147 key concepts related to COVID-19, drawn from the fields of biology, medicine (especially epidemiology and diagnostics), and public health. Each concept is translated into Arabic, Chinese, English, French, German, Japanese, Korean, Portuguese, Russian and Spanish, the official languages of WIPO’s International Patent System. The aim is to help provide consistency and clarity across different languages on key terminology relevant to the COVID-19 pandemic.
“A verified multilingual set of commonly understood COVID-19-related terms creates a knowledge base that helps researchers access and build upon work created in another language,” said WIPO director general Francis Gurry.
The collection of COVID-19 terms is also linked to PATENTSCOPE, a one-click search that allows any patents containing these terms, in any of the 10 languages, to be easily retrieved. A researcher could, for example, start with an English term and, by using the validated equivalents for the term in other languages, be able to retrieve relevant patents in up to nine other languages. The COVID-19 terms are available for free download.
Denmark, Greece, Hungary and Sweden have joined Germany and Romania as host states of the rescEU medical equipment reserve. With financial support from the European Commission, these six EU member states are building up common European stocks of protective equipment that will be available for distribution across Europe at times of medical emergency, for example if national health systems are overwhelmed by coronavirus patients.
“With winter approaching and coronavirus cases increasing across Europe, building up stocks of critical medical equipment is crucial. With the further host states, rescEU is stepping up a gear,” said Janez Lenarčič, commissioner for crisis management.
The medical stocks now include clinical grade face masks, protective gowns, gloves and ventilators
The rescEU capacity is constantly replenished. The reserve is hosted by member states, which are responsible for procuring the equipment, with the European Commission providing 100% of the finance, including paying for storage and transport.
The emergency response coordination centre manages distribution of equipment to ensure it goes where it is needed most, based on the needs expressed by countries requesting EU assistance under the union civil protection mechanism.