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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.

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.

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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Papua New Guinea: EU allocates €1 million to strengthen the resilience of the most vulnerable during COVID-19

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The EU has mobilized €1 million in emergency aid from the Epidemics Tool to assist those affected by COVID-19 in Papua New Guinea. The number of cases has skyrocketed in the last month, pushing the country's already stretched health system to the limit. The funding will support the International Committee of the Red Cross to implement a six-month intervention focused on the most urgent needs such as increasing treatment capacity of public health care system, supporting local health authorities to scale up the response and providing assistance to vaccination campaigns. This emergency Epidemics Tool allows the EU to provide rapid funding in case of an epidemic outbreak in a humanitarian context.

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How a WHO push for global vaccines needled Europe

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A nurse prepares to administer the AstraZeneca/Oxford vaccine under the COVAX scheme against the coronavirus disease (COVID-19) at the Eka Kotebe General Hospital in Addis Ababa, Ethiopia March 13, 2021. REUTERS/Tiksa Negeri
A man displays a vial AstraZeneca's COVISHIELD vaccine as the country receives its first batch of coronavirus disease (COVID-19) vaccines under COVAX scheme, in Accra, Ghana February 24, 2021. REUTERS/Francis Kokoroko
European Commission President Ursula von der Leyen delivers a statement on EU's coronavirus disease (COVID-19) vaccine strategy, following a college meeting at the EU Commission headquarters in Brussels, Belgium April 14, 2021. John Thys/Pool via REUTERS

Last April, at the start of the COVID-19 pandemic, European Commission President Ursula von der Leyen added Europe to a global effort to ensure equitable access to a vaccine, which she said would be deployed "to every single corner of the world", write Francesco Guarascio and John Chalmers.

But despite pledging billions of dollars for the scheme set up by the World Health Organization (WHO) and publicly endorsing it, European Union officials and member states repeatedly made choices that undermined the campaign, internal documents seen by Reuters and interviews with EU officials and diplomats show.

A year after its launch, Europe and the rest of the world have yet to donate a single dose through the vaccine scheme, which is part of an unprecedented effort to distribute vaccines, tests and drugs to fight the pandemic. Diplomats say Europe's ambivalence stemmed partly from short supplies and a slack start to the global campaign, but also from concerns that the EU's efforts would go unnoticed in a vaccine diplomacy war where highly publicised promises from China and Russia were winning ground, even in its own backyard.

The programme, co-led by international agencies and the Global Alliance for Vaccines and Immunization (GAVI), is a bulk-buying platform to share doses worldwide. But with the administration of former U.S. President Donald Trump having turned its back on the WHO, the plan, called COVAX, was slow to win support and focused on using funds from rich countries to buy doses for less-developed ones.

Von der Leyen presented Europe's support for the COVAX campaign as a gesture of international unity. EU officials privately cast the bloc's vaccine aims in a less altruistic light.

"It's also about visibility," that is, public relations, Ilze Juhansone, Secretary-General of the EU Commission and the Commission's top civil servant, told ambassadors at a meeting in Brussels in February, according to a diplomatic note seen by Reuters. Juhansone declined to comment.

A senior diplomat said many of those at that meeting felt Europe, which is by far the largest exporter of vaccines in the West, had goals that would be better served by plastering "more blue flags with yellow stars" on vaccine parcels and sending them out itself, rather than through COVAX.

Brussels, which is coordinating vaccine deals with its members, has reserved a huge surplus - 2.6 billion doses for a population of 450 million so far. It has promised nearly €2.5 billion ($3bn) in support to COVAX. That made the EU the biggest funder until the administration of US President Joe Biden pledged $4n this year to the plan, which aims to distribute 2 billion doses by the end of the year.

But supplies for Europe's own population are behind schedule, and despite giving funds, the EU and its 27 governments have also hampered COVAX in several ways. Like other rich countries, EU nations decided not to buy their own vaccines through COVAX, and competed with it to buy shots when supplies were tight. All except Germany offered the overall programme less cash than requested.

More than this, Europe promoted a parallel vaccine donation system that it would run itself, to raise the EU's profile.

"There is huge frustration because there is a feeling that right now the race is on but we're not really out of the starting blocks," a senior diplomat told Reuters.

"We're spending money on COVAX and the return in terms of political visibility is nil."

Russia says it wants to supply vaccines to countries directly. China has pledged support to COVAX. But both Moscow and Beijing have separate deals to deliver more than 1 billion doses to Africa, Latin America, and to EU partners such as Turkey, Egypt, Morocco and Balkan states that are candidates to join the bloc.

Most doses will take time to be delivered, but Russia and China have already exported about twice COVAX's deliveries of around 40 million doses.

COVAX was also hit in March by export restrictions on vaccines from India, which slowed supplies from its main provider of shots.

WHO chief Tedros Adhanom Ghebreyesus has repeatedly urged rich countries to set aside nationalistic impulses and share vaccines, calling the current situation "a shocking imbalance." Non-EU member Britain, for instance, has already injected about as many shots as COVAX has delivered to more than 100 countries.

COVAX officials told Reuters they received sufficient funds by the end of last year, but these came later than expected.

A spokeswoman for GAVI, the vaccine alliance that runs the scheme and speaks for COVAX on such issues, said EU support had been "unequivocal" and it expects doses to be donated soon. The WHO added that von der Leyen's personal support had been "invaluable."

An EU Commission spokesman told Reuters COVAX had been very successful in structuring global collaboration and securing millions of doses. He called the programme "our best vehicle to deliver on international vaccines solidarity" and the EU's "key channel for sharing vaccines."

Part of COVAX's difficulty is structural. Soon after it was set up, the wealthiest countries were sealing advance orders with drug companies to secure doses as they became available. The vaccination scheme has always relied on rich states for cash, which they have been slow to give.

COVAX aimed to be a platform for countries to buy vaccines, which would give it bargaining power and allow it to dispense doses among those most in need worldwide. Recognising supplies would be tight, its initial aim was to distribute doses for at least 20% of each country's populations to cover the people most at risk.

At an internal meeting last July, an EU Commission official told ambassadors that member states should not buy their shots through COVAX as they would come too slowly, diplomatic notes show. The Commission later set the target to vaccinate 70% of adults in the EU by the end of September.

COVAX changed some of its terms the next month to try to convince wealthy nations to join in, but no EU nations signed up to use the platform for their vaccination drives. The EU gave COVAX financial guarantees to pay for vaccines, but also made it harder for COVAX to do this, by arranging to buy far more doses than the bloc needed.

In November, the EU pledged more money to COVAX, but only after it had signed contracts with vaccine makers for nearly 1.5 billion doses - more than half Brussels' estimate then of global production capacity for this year, internal documents show.

Even though Europe had reserved such a large share, the Commission told diplomats in a meeting that month that COVAX was too slow in procuring doses.

That was when the Commission raised the possibility of setting up a mechanism of its own to send shots to poor countries outside the EU.

Within a month, France started to flesh out that plan. Shots would be sent directly from manufacturers - possibly before deliveries started through COVAX - and labelled as "Team Europe" donations, a draft plan said.

The move, revealed at the time by Reuters, caused an outcry among officials at COVAX. Read more

One told Reuters in April the plan was driven by France's desire to get shots to Africa, where France formerly had colonies, and smacked of colonialism. French diplomats said they never showed a preference for any country, and Africa was most in need.

EU Health Commissioner Stella Kyriakides said in mid-January the EU's own plan would go ahead - because COVAX was not yet fully operational. Countries to focus on would include the Western Balkans, the EU's southern and eastern neighbours and Africa.

The next month, having reserved more than 2 billion doses but with actual deliveries hit by production problems, the EU doubled COVAX funding to €1bn. Russia and China had already delivered millions of doses across the world. COVAX had yet to deliver any. And France's President Emmanuel Macron was publicly losing patience.

Europe and the United States should quickly send enough vaccines to Africa to inoculate the continent's healthcare workers or risk losing influence to Russia and China, Macron said in a speech at a security conference, without specifying how these donations should be made.

Unless rich countries speeded up deliveries, "our friends in Africa will, under justified pressure from their people, buy doses from the Chinese and the Russians," Macron told the conference. "And the strength of the West will be a concept, and not a reality." Read more

Despite Macron's urgency, France's cash support for the overall WHO programme - to cover tests and treatments as well as vaccines - was limited.

The WHO asked countries for contributions in proportion to their economic power. France has committed $190 million - about 13% of the $1.2 billion requested, a WHO document dated March 26 shows.

Other EU countries are also far below expected contributions; some have given zero. But Germany has helped offset this by publicly pledging $2.6bn, well above the $2bn requested.

French diplomats said the country's contributions are expected to increase soon.

On 24 February, COVAX shipped its first vaccines. The EU softened its criticisms.

At a meeting on 9 March, at the height of the European Union's own problems in procuring shots for its own citizens, a Commission official told diplomats COVAX was the main tool for donating vaccines to other countries.

But the official said Europe still needed its own mechanism, because COVAX had money, but only a tiny portion of the shots it needed. And the EU scheme would have "the advantage of giving us visibility," the official said.

At that same meeting, EU ambassadors were shown data compiled by the EU's foreign affairs service which those present said revealed how far the bloc's vaccine diplomacy was lagging behind its competitors.

They learned that Russia had orders for 645 million doses of its Sputnik V COVID-19 vaccine with dozens of countries, and that China was shipping millions of doses to EU neighbours, the data showed.

"We are completely out of this game," one of the diplomats who was there told Reuters.

Reuters could not confirm the data exactly. But figures assembled by the United Nations agency UNICEF, which works with COVAX on vaccine deliveries, show Russia has deals to deliver nearly 600 million doses, including to EU states. China has deals to sell about 800 million doses, including agreements with European countries such as Serbia, Ukraine and Albania.

Later that month the EU's top diplomat, Josep Borrell, made the point candidly: "The EU is the major driver behind COVAX," he wrote in a blog on 26 March. "But we do not get the recognition that the countries using bilateral vaccine diplomacy do."

On Tuesday, the EU Commission said the EU would share over half a million doses with Balkan countries from May through the EU scheme. That was two weeks after COVAX had delivered its first shots to the region. Read more

($1 = €0.8282)

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EMA finds a possible - very rare - link to blood clots for Janssen vaccine

Catherine Feore

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The European Medicines Agency (EMA)  safety committee has concluded (20 April) that a warning about unusual blood clots with low blood platelets should be added to the product information for the COVID-19 Vaccine developed by Dutch company Janssen, also known as the Johnston and Johnson vaccine. 

The new advice comes after eight reports of serious cases of unusual blood clots in the United States, which has already used this product to vaccinate more than seven million people. One of these cases resulted in a fatality. All cases occurred in people under 60 years of age within three weeks of vaccination, the majority in women. The cases reviewed were very similar to the cases that occurred with the COVID-19 vaccine developed by AstraZeneca, Vaxzevria.

It will be up to individual EU countries to decide whether they want to use this vaccine. The Janssen vaccine has the notable advantage of only requiring a single-shot, rather than a two-dose process.

The EMA are clear that the use of the vaccine continues to outweigh the risks for people who receive it. The vaccine is effective at preventing COVID-19 and reducing hospitalisations and deaths.

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