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Update: EAPM B1MG meeting to bring together national genomics and data infrastructures online for 21 October

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Greetings colleagues, and welcome to the final European Alliance for Personalised Medicine (EAPM) update of the week. We hope you are looking forward to your weekend, and that you enjoy news of the upcoming B1MG Conference on 21 October and the update of recommendations from our recent German EU Presidency Conference, writes European Alliance for Personalised Medicine, Executive Director, Denis Horgan.

B1MG Stakeholder Co-ordination Group Meeting

Registration is still very much open for the B1MG meeting on 21 October. The aim of the the B1MG is to support the connection of national genomics and data infrastructures, co-ordinate the harmonization of the ethical and legal framework for sharing data of high privacy sensitivity, and give practical guidance for the pan-European co-ordination of implementing genomic technologies in national and European health-care systems. 

Thus, the B1MG is a means to bring the different stakeholders together on Oct 21st so as to act as a catalyst to provide a benchmark approach for alignment of complex, fractionated health-care provisions into health-care systems.  The objective of the meeting is to discuss the key drivers which are the stakeholders to make this a reality. Register here and read the full agenda here.

German EU Presidency Conference

 Held during the auspices of the Germany Presidency of the Council of Ministers on 12 October, EAPM's conference was very successful in its own right, with an agenda packed with insights from distinguished speakers on ‘Ensuring access to innovation and data-rich biomarker space to speed better quality of care for citizens’. 

The report, which will be issued on Monday (19 October), delivered a message on the immediate need for a new way of thinking about health care. It presented this urgency through discussions on adequate health care frameworks, better allocation of resources, the potential of advanced testing, co-ordinated approaches to cancers and of the deployment of advanced therapy medicinal products - all against the background of the ongoing battle against COVID.

More than 200 delegates attended, and there were contributions from European politicians, officials from the European Commission and the European Medicine Agency, and a multitude of key stakeholders from countries including Germany, which is presently hosting the EU Presidency.

Principal Recommendations:Although there was no formal process of agreeing recommendations at the meeting, the following are among the recurring elements from the discussions which will be elaborated on the report which will be issued on Monday. 

  • Inequalities in access to testing and treatment across Europe must be addressed.
  • Adequate data infrastructure and processing capacity must be available.
  • Real-world evidence must be developed and acceptance criteria agreed with regulators, HTA agencies and payers.
  • Greater flexibility in regulatory requirements is needed to accommodate evaluation of products destined for small populations.
  •  Multi-stakeholder collaboration must be developed to agree research priorities, standards and quality assurance of testing, and evaluation criteria for testing and treatments.
  • Trust must be developed among citizens about the security and possible use of their data.
  • Communication must be developed by healthcare stakeholders to persuade policymakers to effect constructive change

No Strasbourg plenary...again

European Parliament President David Sassoli has cancelled next week’s trip to Strasbourg. The Parliament plenary “will not take place in Strasbourg, but will be held remotely,” he wrote on Twitter. “The situation in France and Belgium is very serious and travelling is not advised.” Sassoli said his decision to cancel “was a very difficult choice for me because I was convinced this time that I could manage the transfer to Strasbourg.” But it’s about something bigger than managing a move, he suggested: “We must do everything possible … to avoid the closure of the Parliament” and commit to “make sure that democracy is not blocked, above all in a moment like this one.”

Spain imposes state of emergency in Madrid 

The Spanish government has ordered a 15-day state of emergency to bring down Covid-19 infection rates in the capital, after a court overturned a partial lockdown imposed a week ago. Madrid and nearby cities will see restrictions enforced by 7,000 police. The capital has been at the centre of a political row, with the centre-right city authorities challenging the Socialist-led government's demands. Cases are down and a state of emergency is unjustified, say city officials. Madrid health minister Enrique Ruiz Escudero insisted that measures already in place were working and that the national government order was "a measure no Madrileño will understand". 

World Health Organization (WHO) reform

 The German Council presidency has set October 30 as its date for a formal meeting of health ministers. Officials have given member states an overview of the COVID-19  response to date and provided updates on the changes that have taken place within the organization to support coronavirus response efforts. These changes include the creation of WHO’s science division — which initiated the Solidarity Trial to compare COVID-19 treatments and assess their effectiveness — and the new emergency preparedness division under the WHO Health Emergencies Programme.

Great and good in place

The Council is meeting for a two-day summit today (16 October) and COVID-19 is obviously high on the agenda. Conclusions ahead of the EU summit read: “The Council calls on the Commission and the member states to continue the overall coordination effort, notably regarding quarantine regulations, cross border contact tracing and the joint assessment of testing methods.” Vaccines are also on the list of topics up for discussion.  The Council will discuss “overall co-ordination and the work on the development and distribution of a vaccine at the EU level”.

UK government has 'powers to enforce Manchester restrictions' in lockdown row 

 The government has the power to impose tougher COVID restrictions in Manchester and other towns amid a growing row over tough new measures, foreign secretary Dominic Raab has said. Raab told Sky News that Westminster will “keep talking” with local leaders over further coronavirus restrictions but said the "government has the powers to proceed in any event" should these talks fail. He accused Labour of sending mixed messages and accused the opposition of "political confusion". 

Worried Merkel lays down the law in Germany 

Germany’s states agreed on Wednesday (14 October) to extend measures against the spread of the coronavirus to larger parts of the country as new cases soared, but Chancellor Angela Merkel warned even tougher steps may be needed. “What we do in the coming days and weeks will be decisive for how we get through this pandemic,” Merkel said at a news conference after a meeting with the heads of Germany’s 16 states, adding that the goal was to safeguard the economy. 

Under Wednesday’s agreement, the threshold at which tougher measures such as late-night curfews on bars and tighter restrictions of private gatherings kick in will be lowered to 35 new infections per 100,000 people over seven days, compared with 50 before. If these measures fail to halt the rise in infections, further measures will be introduced to avoid a second full lockdown that could have a devastating impact on the economy.

Catalonia closes restaurants and bars for two weeks

The Catalan government on Wednesday approved the closure of all bars and restaurants in the region in a bid to slow the spread of the coronavirus. According to data from the regional health department released earlier today, the 14-day cumulative number of coronavirus cases in Catalonia has risen to 290 per 100,000 inhabitants – a figure not seen since the beginning of April. 

Netherlands in ‘partial lockdown’

 Dutch Prime Minister Mark Rutte announced a ‘partial lockdown on Tuesday (13 October), adding that masks will become mandatory in places such as stores and museums — a departure from the country’s longstanding resistance to requiring them in public. Furthermore, restaurants and bars will temporarily shut their doors. The new measures are expected to last for four weeks, but will be re-evaluated in two weeks.

Not so dolce-vita

Italy’s nightlife is under new restrictions with the latest act signed by Prime Minister Giuseppe Conte and Health Chief Roberto Speranza. New rules include closure of all bars and restaurants by midnight, while patrons are required to be served sitting down at a table from 9 p.m. Masks are required inside private businesses and on the street.

Belgium set to tighten restrictions as well

The Belgian government may well announce tighter restrictions today (16 October) as the number of cases reported in the country continues to rise. Options may include a stricter mandate for home working to tighten rules on bars and restaurants. Restrictions on sports are also coming into effect.

And that is everything for this week – have an excellent weekend, stay safe and well, and remember: Register here and read the full agenda here for the B1MG meeting on 21 October. 

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India records world’s biggest single-day rise in coronavirus cases

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Patients are seen inside an ambulance while waiting to enter a COVID-19 hospital for treatment, amidst the spread of the coronavirus disease (COVID-19) in Ahmedabad, India, April 22, 2021. REUTERS/Amit Dave

Patients are seen inside ambulances while waiting to enter a COVID-19 hospital for treatment, amidst the spread of the coronavirus disease (COVID-19) in Ahmedabad, India, April 22, 2021. REUTERS/Amit Dave

India marked a grim milestone in the COVID-19 pandemic on Thursday (22 April), reporting 314,835 new daily cases, the highest one-day tally anywhere, as its second wave and similar surges elsewhere raised new fears about the ability of health services to cope, write Sanjeev Miglani, Neha Arora and Alasdair Pal.

Hospitals across northern and western India including the capital, New Delhi, have issued notices to say they have only a few hours of medical oxygen required to keep COVID-19 patients alive.

More than two-thirds of hospitals had no vacant beds, according to the Delhi government's online data base and doctors advised patients to stay at home.

"The situation is very critical," Dr Kirit Gadhvi, president of the Medical Association in the western city of Ahmedabad, told Reuters.

"Patients are struggling to get beds in COVID-19 hospitals. There is especially acute shortage of oxygen."

Krutika Kuppalli, assistant professor at the Division of Infectious Diseases, Medical University of South Carolina in the United States, said on Twitter the crisis was leading to a collapse of the healthcare system.

The previous record one-day rise in cases was held by the United States, which had 297,430 new cases on one day in January, though its tally has since fallen sharply.

India's total cases are now at 15.93 million, while deaths rose by 2,104 to reach a total of 184,657, according to the latest health ministry data.

Television showed images of people with empty oxygen cylinders crowding refilling facilities in the most populous state of Uttar Pradesh as they scrambled to save relatives in hospital.

"We never thought a second wave would hit us so hard," Kiran Mazumdar Shaw, the executive chairman of Biocon & Biocon Biologics, an Indian healthcare firm, wrote in the Economic Times.

"Complacency led to unanticipated shortages of medicines, medical supplies and hospital beds."

Delhi Health Minister Satyendar Jain said there was a crisis over the shortage of intensive care unit beds, with the city needing about 5,000 more than it could find. Some hospitals had enough oxygen to last 10 hours, others just six.

"We can't call this a comfortable situation," he told reporters.

Similar surges of infections elsewhere around the world, in South America in particular, are threatening to overwhelm other health services. Read more

India has launched a vaccination drive but only a tiny fraction of the population has had the shots.

Authorities have announced that vaccines will be available to anyone over the age of 18 from May 1 but India won't have enough shots for the 600 million people who will become eligible, experts say.

Health experts said India had let its guard down when the virus seemed to be under control during the winter, when new daily cases were about 10,000, and it lifted restrictions to allow big gatherings.

Prime Minister Narendra Modi's government ordered an extensive lockdown last year, in the early stages of the pandemic, but has been wary of the economic costs of tough restrictions.

In recent weeks, the government has come in for criticism for holding packed political rallies for local elections and allowing a religious festival at which millions gathered.

This week, Modi urged state governments to use lockdowns as a last resort. He asked people to stay indoors and said the government was working to increase the supply of oxygen and vaccines.

Experts say new virus variants, in particular a "double mutant" variant that originated in India are largely responsible for the new spikes in cases.

"The double mutant ... is considerably more infectious than the older strain of virus," said Gautam I. Menon, a professor at Ashoka University.

Angela Rasmussen, a virologist at the Center for Global Health and Science Security at Georgetown University said the situation in India was "heartbreaking and awful".

"It's the result of a complex mix of bad policy decisions, bad advice to justify those decisions, global and domestic politics, and a host of other complex variables," she said on Twitter.

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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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