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EAPM makes first focus of 2021 on lung cancer

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Welcome, dear health colleagues, to the first update of the week from the European Alliance for Personalised Medicine (EAPM). With the publication of the EU’s Beating Cancer Plan imminent (4 February), EAPM has a full focus on lung cancer taking place this week with its members, writes EAPM Executive Director Dr. Denis Horgan.

Screening – most effective way to combat biggest cancer killer

While there may well be any number of worthy schemes and tactics in Europe to combat the terrible damage wreaked by cancer, one of the most promising modus operandi is being neglected for lung cancer – and many Europeans are dying unnecessarily as a consequence.

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Lung cancer, the biggest cancer killer, is still on the loose, largely unchecked, and the most effective method for combating it – screening – is being sidelined. Bearing in mind that screening is very important in treating lung cancer because most cases are discovered too late for any effective intervention, this will be the key issue at the heart of EAPM’s engagement this week. Screening is the use of tests or exams to find a disease in people who don’t have symptoms.

Regular chest x-rays have been studied for lung cancer screening, but they did not help most people live longer. In recent years, a test known as a low-dose CAT scan or CT scan (LDCT) has been studied in people at a higher risk of getting lung cancer. LDCT scans can help find abnormal areas in the lungs that may be cancer.

Research has shown that using LDCT scans to screen people at higher risk of lung cancer saved more lives compared to chest x-rays. For higher risk people, getting yearly LDCT scans before symptoms start helps lower the risk of dying from lung cancer.

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70% of patients are diagnosed at an advanced incurable stage, resulting in the deaths of a third of patients within three months. In England, 35% of lung cancers are diagnosed following emergency presentation, and 90% of these 90% are stage III or IV. But detecting disease long before symptoms appear permits treatment that forestalls metastasis, drastically improving outcomes, with cure rates above 80%.Given the potential for such a large number of lives to be positively impacted by a timely diagnosis of early-stage treatable disease, the initiation of these programmes should be given the highest priority by healthcare institutions and providers.

The new EU Cancer Screening Scheme envisaged in the BCP should have its vision extended beyond breast, cervical and colorectal cancer screening to lung cancer. The Commission proposal to review the Council recommendation on cancer screening should at last recognise LC screening. The EU Beating Cancer Plan, setting out the European Union’s strategy for cancer care, will be launched on 4 February. EAPM will be publishing a number of publications in the next weeks to coincide with this Commission publication.

European Court of Auditors assesses COVID-19 response

The European Court of Auditors (ECA) has reviewed the EU’s initial response to the COVID-19 crisis and draws attention to certain challenges faced by the EU in its support for member states’ public health actions. 

These include setting an appropriate framework for cross-border health threats, facilitating provision of appropriate supplies in a crisis and supporting the development of vaccines.The EU’s public health competences are limited.   It mainly supports the co-ordination of member state actions (through the Health Security Committee), facilitates procurement of medical equipment (by creating joint procurement framework contracts), and gathers information/assesses risks (through the European Centre for Disease Prevention and Control - ECDC). 

Since the start of the COVID-19 pandemic, the EU took further action to address urgent issues, facilitating the supply of medical equipment and information exchange between member states, as well as promoting testing, treatment and vaccine research. 

It allocated 3 % of its annual budget by 30 June 2020 to support public health related measures.“It was a challenge for the EU to rapidly complement the measures taken within its formal remit and support the public health response to the COVID-19 crisis,” said Joëlle Elvinger, the ECA member responsible for the review. “It is too soon to audit ongoing actions or assess the impact of COVID-19 related public health EU initiatives, but these experiences can provide lessons for any future reform of the EU’s competences in this field.”

Commission calls on member states to ‘scale up’ vaccination ambitions

The European Commission will today (19 January) call on member states to scale up their ambition in the fight against the pandemic by setting a target of vaccinating at least 70% of the EU’s population by summer. According to the draft of its latest recommendations that we’ve seen, the bloc’s executive will also endorse Greece’s proposal for a “vaccination certificate” that’ll allow those who get the jab to travel. For the rest of us, all non-essential journeys should remain off limits for the foreseeable future, the Commission will say. Beyond that, the “communication” is filled with vague pledges to help boost vaccine production capacity and asks member states to do more genome sequencing to track potentially dangerous mutations. Useful as such pledges and targets may be, they can’t overcome government inefficiency in administering vaccines. 

The procedure the world uses to declare health emergencies “need to be brought into the digital age,” the Independent Panel for Pandemic Preparedness and Response said in a report on Monday (18 January): “A system of distributed information, fed by people in local clinics and laboratories, and supported by real-time data gathering and decision-making tools, is necessary to enable reaction at the speed required — which is days, not weeks — to confront epidemic risk.” The use and scale up of digital health solutions can revolutionize how people worldwide achieve higher standards of health, and access services to promote and protect their health and well-being. 

Digital health provides opportunities to accelerate our progress in attaining health and well-being related Sustainable Development Goal (SDGs), especially SDG 3, and achieving triple billion targets for 2023 as articulated in its Thirteenth General Programme of Work (GPW13). The purpose for a Global Strategy on Digital Health is to promote healthy lives and wellbeing for everyone, everywhere, at all ages. To deliver its potential, national or regional Digital Health initiatives must be guided by a robust Strategy that integrates financial, organizational, human and technological resources.

Vaccination certificate

European Commission president Ursula von der Leyen supports the idea of a common vaccination certificate, which can be established by the EU, and issued by the member states to every person who gets vaccinated against COVID-19. In an interview for Portuguese media, Von der Leyen was asked regarding the proposal of the Greek Prime Minister Kyriakos Mitsotakis to introduce a common document that would be issued to EU citizens who receive the vaccine against COVID-19.

 “It is a medical requirement to have a certificate proving that you have been vaccinated,” von der Leyen said, welcoming the proposal of PM Mitsotakis on a mutually recognised vaccination certificate. A week ago, the Greek Prime Minister sent a letter to the European Commission President Ursula von der Leyen, calling on the European Commission to introduce a Coronavirus vaccination certificate in order to facilitate travel between the bloc.

Belgian minister demands fine for travellers who refuse coronavirus test

Belgian Justice Minister Vincent Van Quickenborne has called for a fine to be imposed on travelers who refuse to take mandatory coronavirus tests. As of earlier this month, Belgium requires people who stay in a so-called “red zone” for more than 48 hours to take a test on arrival in the country and a second test after seven days. If travelers do not comply, they should be fined €250, Van Quickenborne said. “Anybody returning to Belgium today must fill out the passenger location form … each traveler receives a code that entitles them to two tests,” Van Quickenborne said. “Our systems know who is not using these codes.”

Coronavirus variant from UK 'must not get out of hand' warns EU

Concerns were also shared during the virtual meeting of EU health ministers of a “significant under-reporting” of the new variant by member states, with the commission urging health ministries to make detection of the mutation a priority. Germany’s Health Minister Jens Spahn cited the UK-detected variant as he stressed the need for people to further reduce their contact with others, saying the country would not be able to lift all measures aimed at curbing the pandemic by the end of the month.

And that is everything from EAPM for now – enjoy a safe start to your week, see you later this week.

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Pfizer begins study of oral drug for prevention of COVID-19

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Pfizer Inc (PFE.N) said on Monday (27 September) it has started a large study testing its investigational oral antiviral drug for the prevention of COVID-19 infection among those who have been exposed to the virus.

The drugmaker and its rivals, including US-based Merck & Co Inc (MRK.N) and Swiss pharmaceutical Roche Holding AG (ROG.S), have been racing to develop an easy-to-administer antiviral pill for COVID-19. Read more.

The mid-to-late-stage study will test Pfizer's drug, PF-07321332, in up to 2,660 healthy adult participants aged 18 and older who live in the same household as an individual with a confirmed symptomatic COVID-19 infection.

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In the trial, PF-07321332, designed to block the activity of a key enzyme needed for the coronavirus to multiply, will be administered along with a low dose of ritonavir, an older medication widely used in combination treatments for HIV infection.

To date, Gilead Sciences Inc's (GILD.O) intravenous drug remdesivir is the only approved antiviral treatment for COVID-19 in the United States.

Pfizer has also started another study of PF-07321332 in non-hospitalized, symptomatic adult patients.

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Merck and partner Ridgeback Biotherapeutics recently launched a late-stage trial of their experimental drug molnupiravir for prevention of the COVID-19 infection. Read more.

Molnupiravir is also being studied in a late-stage trial in non-hospitalized patients to see if it reduces the risk of hospitalization or death.Reporting by Manojna Maddipatla and Amruta Khandekar

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EU Digital COVID Certificate: Commission awards €95 million to boost access to tests

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The Commission has awarded grants to 20 member states totalling €95 million to purchase COVID-19 diagnostic tests to facilitate the delivery of the EU Digital COVID Certificate. This goes hand-in-hand with the continued roll-out of COVID-19 vaccinations and is part of the Commission's commitment to support affordable access to fast and accurate testing for those citizens who have not yet been fully vaccinated, in particular those who cannot get vaccinated due to medical reasons.

The grants, financed through its Emergency Support Instrument (ESI), will allow member states to provide tests. This support, channelled through the national authorities, will cater for the various needs in the different member states. Health and Food Safety Commissioner Stella Kyriakides said: “The EU Digital COVID Certificate allowed Europeans to resume safe travelling over the summer and has become a symbol of an open and safe Europe. Whilst vaccination is key and our strongest asset to put an end to the pandemic, fast and accurate testing remains important to tackle the spread of COVID-19. The 20 million rapid tests we purchased for member states earlier this year and today's announcements of additional funds prove that we stand firm on our commitment to ensure that citizens have access to tests and that our digital certificates are available for everyone, in particular those who cannot get vaccinated.”

Justice Commissioner Didier Reynders said: “Over 400 million Europeans have so far benefited from the Certificate, and 42 countries are already linked to the EU certificate system. This is a major European achievement which has been highly valued by our citizens. Today's grants will further contribute to the use of the certificates and ensure that people can continue to move freely and safely. I welcome this decision and I call on the 20 member states to make the best use of those additional tests.”

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The ESI provides a needs‐based, co-ordinated emergency response to help member states address needs related to the immediate acute phase of the COVID-19 pandemic, as well as the exit, recovery and prevention of any resurgence.

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US-EU agenda for beating the global pandemic: Vaccinating the world, saving lives now, and building back better health security

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Vaccination is the most effective response to the COVID pandemic. The United States and the EU are technological leaders in advanced vaccine platforms, given decades of investments in research and development.

It is vital that we aggressively pursue an agenda to vaccinate the world. Co-ordinated US and EU leadership will help expand supply, deliver in a more coordinated and efficient manner, and manage constraints to supply chains. This will showcase the force of a Transatlantic partnership in facilitating global vaccination while enabling more progress by multilateral and regional initiatives.

Building on the outcome of the May 2021 G20 Global Health Summit, the G7 and US-EU Summits in June, and on the upcoming G20 Summit, the US and the EU will expand cooperation for global action toward vaccinating the world, saving lives now, and building better health security.  

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Pillar I: A Joint EU/US Vaccine Sharing Commitment: the United States and the EU will share doses globally to enhance vaccination rates, with a priority on sharing through COVAX and improving vaccination rates urgently in low and lower-middle income countries. The United States is donating over 1.1 billion doses, and the EU will donate over 500 million doses. This is in addition to the doses we have financed through COVAX.

We call for nations that are able to vaccinate their populations to double their dose-sharing commitments or to make meaningful contributions to vaccine readiness. They will place a premium on predictable and effective dose-sharing to maximize sustainability and minimize waste.

Pillar II: A Joint EU/US Commitment to Vaccine Readiness: the United States and the EU will both support and coordinate with relevant organisations for vaccine delivery, cold chain, logistics, and immunization programs to translate doses in vials into shots in arms. They will share lessons learned from dose sharing, including delivery via COVAX, and promote equitable distribution of vaccines.

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Pillar III: A Joint EU/US partnership on bolstering global vaccine supply and therapeutics: the EU and the United States will leverage their newly launched Joint COVID-19 Manufacturing and Supply Chain Taskforce to support vaccine and therapeutic manufacturing and distribution and overcome supply chain challenges. Collaborative efforts, outlined below, will include monitoring global supply chains, assessing global demand against the supply of ingredients and production materials, and identifying and addressing in real time bottlenecks and other disruptive factors for global vaccine and therapeutics production, as well as coordinating potential solutions and initiatives to boost global production of vaccines, critical inputs, and ancillary supplies.

Pillar IV: A Joint EU/US Proposal to achieve Global Health Security. The United States and the EU will support the establishment of a Financial Intermediary Fund (FIF) by the end of 2021 and will support its sustainable capitalization.  The EU and United States will also support global pandemic surveillance, including the concept of a global pandemic radar. The EU and the United States, through HERA and the Department of Health and Human Services Biomedical Advanced Research and Development Authority, respectively, will cooperate in line with our G7 commitment to expedite the development of new vaccines and make recommendations on enhancing the world's capacity to deliver these vaccines in real time. 

We call on partners to join in establishing and financing the FIF to support to prepare countries for COVID-19 and future biological threats.

Pillar V: A Joint EU/US/Partners Roadmap for regional vaccine production. The EU and the United States will coordinate investments in regional manufacturing capacity with low and lower-middle income countries, as well as targeted efforts to enhance capacity for medical countermeasures under the Build Back and Better World infrastructure and the newly established Global Gateway partnership. The EU and the United States will align efforts to bolster local vaccine manufacturing capacity in Africa and forge ahead on discussions on expanding the production of COVID-19 vaccines and treatments and ensure their equitable access.

We call on partners to join in supporting coordinated investments to expand global and regional manufacturing, including for mRNA, viral vector, and/or protein subunit COVID-19 vaccines.

More information

Joint statement on the launch of the joint COVID-19 Manufacturing and Supply Chain Taskforce

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