Welcome, everyone, to the last European Alliance for Personalised Medicine (EAPM) update of the week – we hope you are enjoying your holidays. August is getting hot, and is likely to get hotter still this weekend, so make sure you’re well armed with sunscreen to prevent melanoma. On the coronavirus front, attitudes range from ‘We’re doing much better’ to ‘Ulp! Winter is en route’, so on with the news, writes EAPM Executive Director Denis Horgan.
Memories of February
Compared to the early days of the coronavirus deluge, says World Health Organization (WHO) European Region chief Hans Kluge, “We know how to target the virus instead of targeting society, we are not back in February.” Kluge was referencing countries’ new-found abilities to avoid fully fledged lockdown with hard-won techniques “to apply smart, time-limited and risk-based measures”. And WHO Europe is set to hold a meeting for officials from all 53 countries in the region on 31 August to discuss strategies for safely restarting schools, including heightened hygienic measures and shutting classrooms down if needed.
Watch for winter
The UK must prepare now for a potential new wave of coronavirus infections this winter that could be more serious than the first, says a new report from the Academy of Medical Sciences. Combined with the disruption already created in the health service by SARS-CoV-2 and COVID-19 disease, a backlog of patients needing NHS assessment and treatment, and the possibility of an influenza epidemic, a new peak of virus infection poses a serious risk to health in the UK. These new pressures are in addition to the challenge winter usually presents to the NHS, when other infectious diseases are more common, and conditions such as asthma, heart attack, chronic obstructive pulmonary disease and stroke tend to worsen.
Masking the problem
Alain Bazot, head of France’s consumer association UFC Que Choisir, has stridently criticized businesses in an interview with Le Parisien, saying that companies should resolutely *not* make money out of face masks during COVID-19. Following the announcement that face masks will be made compulsory in French workplaces from 1 September, Bazot said that free masks should be provided because “the issue is of access to public services for all”. Apparently, and rather disgracefully, numerous French companies are charging more than the cap of €0.95 per mask which has been put in place.
Portugal spends €20 million on first batch of vaccines
Portuguese Prime Minister António Costa announced on Thursday (20 August) that the government has authorized a €20 million investment in contracts to purchase vaccines against COVID-19, and the Council of Ministers, through an electronic meeting, authorised the investment of €20m in the purchase of the first batch of vaccines. The vaccination will be “progressive, universal and free” for the Portuguese population to ensure this immunization, Costa said at an event in Gaia.
The government clarified that this amount “corresponds to the first phase of the acquisition procedures, to be carried out in 2020, ensuring the acquisition of 6.9 million doses”. as Infarmed had anticipated this Wednesday. These 6.9m doses of vaccines – which cover about two-thirds of the Portuguese population – correspond, according to the TSF, to Portugal’s share of the 300m vaccine batch agreed between the Commission and the French laboratory Sanofi-GSK. The EU also has an agreement with AstraZeneca for a further 300m doses and with Johnson & Johnson for a further 400m doses.
Variations in clinical trial reporting brings controversy
According to TranspariMED, which is an advocacy group committed to encouraging scientists to report their findings, the Dutch are coming up short concerning European clinical trial reporting rules. Apparently, Nijmegen’s Radboud University, which failed to upload over 100 clinical trial results to the European trial register, is one of the worst offenders. Erasmus University is apparently another serious offender. However, Irish and UK universities could afford to be the most smug, as both sets of institutions have reported results for almost all their clinical trials. Germany and Austria are getting better, as are top institutions in Italy and Spain. TranspariMED concluded that if the Netherlands’ universities “didn’t get the message this time around, we’ll keep putting out follow-on reports until they do”.
New research casts doubt over accuracy of contact tracing apps
A study, published on the Lancet Digital Health, declares that the usefulness of the technology still has everything to prove. Bluetooth technology is set to be used to allow phones with the app installed to make an anonymous 'handshake' which will be used to measure how close they are, and for how long. One thing that emerged consistently from the review was that if the apps were going to make a meaningful difference, they needed to be embraced by a substantial portion of the population.
It was further noted that people who are likely higher risks – such as the elderly and homeless – are less likely to have smartphones to download the apps. There was also the very real risk that technology-driven approaches distract from more basic measures. “When you look at the approach that was taken in South Korea, it did use technology, but it also did use an incredibly resource-intensive approach, with a large number of people doing contact tracing, looking at CCTV footage, credit card records, as well as phone location data,” the study said.
Spanish concern over second wave of COVID-19
A virologist at the Severo Ochoa Cell Biology Center in Madrid, Margarita del Val, has said she is not convinced that Spain will be able to avoid another serious wave of COVID-19 cases given Spaniards’ “way of life” during the summer. “Nobody wants yet another strict confinement, but in order to avoid that we must apply all the other restrictions with rigor, not how it is being done now,” she told a university seminar on COVID-19 in Santander, Spain. During the first wave of the COVID-19 pandemic in March, Spain was one of the most heavily affected countries in Europe. The country struggled to control the surge of new cases during the first wave, resulting in high fatalities from cases. The country was then placed under one of the harshest lockdowns in Europe in an attempt to flatten the curve.
Similar to other countries in Europe, Spain’s COVID-19 daily confirmed cases started to decline in May and the country seemed to have regained control of the situation. However, the daily confirmed cases have started increasing again, raising concerns that Spain will experience a second wave of COVID-19. As Spain has started to reopen its economy amid the rapidly rising cases, there is a major risk that COVID-19 cases will not decline in the near future.
Private health insurance bringing medical treatment faster in Sweden?
In much the same way that society as a whole is reproving of people who don’t wear masks or follow other social distancing rules, criticisms are being raised in Sweden that private health insurance is letting some citizens skip the queue and get medical treatment faster, even in public hospitals. A chief legal officer has been appointed at the Dental and Pharmaceutical Benefits Agency to determine any imbalances caused by the expansion of private insurance in the health system, as well as proposals to remedy this and ensure that publicly-funded medical treatment is fair.
“A cornerstone of Sweden’s welfare system is that citizens can be confident that care is provided based on need, not based on the size of one’s wallet,” said Lena Hallengren, the country’s minister of social affairs.
And that is all from EAPM for another few days – as best you can, enjoy your weekend, enjoy your ongoing August break, and stay safe and well.
Vaccinating the world: ‘Team Europe' to share more than 200 million doses of COVID-19 vaccines with low and middle-income countries by the end of 2021
Ensuring access to safe and affordable COVID-19 vaccines around the world, and notably for low and middle-income countries, is a priority for the European Union.
At the Global Health Summit in Rome, on 21 May 2021, President von der Leyen announced that ‘Team Europe' would share with low and middle-income countries at least 100 million doses by the end of 2021, mainly via COVAX, our partner in vaccinating the world.
Team Europe (the EU, its institutions and all 27 member states) is on track to exceed this initial goal, with 200 million doses of COVID-19 vaccines foreseen to be shared with the countries that need them most, by the end of 2021.
President von der Leyen said: “Team Europe takes its responsibility in helping the world fight the virus, everywhere. Vaccination is key – that's why it is essential to ensure access to COVID-19 vaccines to countries worldwide. We will be sharing more than 200 million doses of COVID-19 vaccines with low and middle-income countries by the end of this year.”
The more than 200 million doses of COVID-19 vaccines that have been committed by Team Europe will reach their destination countries, mainly through COVAX, by the end of this year.
COVAX has so far delivered 122 million doses to 136 countries.
In parallel, Team Europe has launched an initiative on manufacturing and access to vaccines, medicines and health technologies in Africa.
The initiative will help create the right conditions for local vaccine manufacturing in Africa, backed by €1 billion from the EU budget and the European development finance institutions such as the European Investment Bank (EIB).
On 9 July, Team Europe agreed to support large-scale investment in vaccine production by the Institut Pasteur in Dakar, alongside other support measures. The new manufacturing plant will reduce Africa's 99% dependence on vaccine imports and strengthen future pandemic resilience in the continent.
The EU has been the driving force behind the Coronavirus Global Response and the creation of the ACT-Accelerator, the world's facility for access to COVID-19 vaccines, diagnostics and treatments.
As most low and middle-income countries need time and investments to build their own manufacturing capacities, the immediate and most effective response still is vaccine sharing.
The Global Health Summit was convened by President von der Leyen and the Prime Minister of Italy Mario Draghi on 21 May 2021. This very first G20 summit on health marked the beginning of a new chapter in global health policy.
World leaders committed to multilateralism, global cooperation in health and to ramping up vaccine manufacturing capacities worldwide, to make this pandemic the last pandemic.
Ensuring smooth air travel while checking EU Digital COVID Certificates: New guidelines for member states
Following the launch of the EU Digital COVID Certificate on 1 July, the European Commission has issued guidelines for EU member states on the best ways to check them before travel, ensuring the smoothest possible experience for air passengers and staff alike. The non-mandatory EU Digital COVID Certificate provides either proof of vaccination, shows if a person holds a negative SARS-COV-2 test result, or has recovered from COVID-19. Therefore, the EU Digital COVID Certificate is essential to support the re-opening of safe travel.
As passenger numbers will rise over the summer, an increased number of Certificates will need to be checked. The airline sector is particularly concerned by this since, in July for example, air traffic is expected to reach more than 60% of 2019 levels, and will rise thereafter. Currently, how and how often passenger's Certificates are checked, depends on the holder's departure, transit and arrival points.
A better-coordinated approach would help avoid congestion at airports and unnecessary stress for passengers and staff. Transport CommissionerAdina Vălean said: “Reaping the full benefits of the EU Digital COVID Certificate requires the harmonization of the verification protocol. Cooperating for a ‘one-stop' system to check the certificates makes for a seamless travel experience for the passengers across the Union.”
To avoid duplication, i.e. checks by more than one actor (airline operators, public authorities etc.), the Commission recommends a ‘one-stop' verification process prior to departure, involving co-ordination between authorities, airports and airlines. Moreover, EU member states should ensure that the verification is carried out as early as possible and preferably before the passenger arrives at the departure airport. This should ensure smoother travel and less burden for all involved.
Coronavirus: Commission steps up research funding with €120 million for 11 new projects to tackle the virus and its variants
The Commission has short-listed 11 new projects worth €120 million from Horizon Europe, the biggest European research and innovation programme (2021-2027), for supporting and enabling urgent research into the coronavirus and its variants. This funding is part of a wide range of research and innovation actions taken to fight the coronavirus and contributes to the Commission's overall action to prevent, mitigate and respond to the impact of the virus and its variants, in line with the new European bio-defence preparedness plan HERA Incubator. The 11 short-listed projects involve 312 research teams from 40 countries, including 38 participants from 23 countries outside of the EU.
Innovation, Research, Culture, Education and Youth Commissioner Mariya Gabriel said: “The European Union has been taking strong action to fight the coronavirus crisis. Today we are stepping up our research efforts to meet the challenges and threats that coronavirus variants present. By supporting these new research projects and reinforcing and opening relevant research infrastructures, we continue to fight this pandemic as well as prepare for future threats.”
Most of the projects will support clinical trials for new treatments and vaccines, as well as the development of large scale, coronavirus cohorts and networks beyond Europe's borders, forging links with European initiatives. The Commission has been at the forefront of supporting research and innovation and coordinating European and global research efforts, including preparedness for pandemics. It pledged €1.4 billion to the Coronavirus Global Response, of which €1bn comes from Horizon 2020, the previous EU research and innovation programme (2014-2020). The new projects will complement those previously funded under Horizon 2020 to fight the pandemic. More information is available in a press release.
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