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EAPM update: Lung cancer screening event beckons, newsletter now available

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Greetings all, and please find EAPM’s monthly newsletter by clicking here. Prior to tipping into our previous month, November, and the start of December, we still have our virtual lung cancer screening conference on 10 December, with a wide range of great speakers, a variety of hot topics, and lively Q & A sessions to keep everyone involved, writes European Alliance for Personalised Medicine(EAPM) Executive Director Denis Horgan.

Lung cancer screening round table

The round table is entitled ‘Lung Cancer & Early Diagnosis: The Evidence Exists for Lung Screening Guidelines in the EU’, and the idea is to present a case for the co-ordinated implementation of lung-cancer screening across the EU Region.You can check out the agenda of the EAPM 10 December conference on lung-cancer screening here, and register here. In addition, much information can be found in EAPM’s latest newsletter, which is available here.

A perspective on Alzheimer’s Disease (AD)

In addition, EAPM recently launched an academic publication on Alzheimer’s Disease (AD), with a multistakeholder perspective to tackle the issue of biomarkers, entitled Piercing the Fog of Alzheimer’s and Related Dementia. The paper is available here.

End of Horizon 2020, looking to the future 

 Horizon 2020 has ben the largest research and innovation funding programme in the whole world. It has had a duration of seven years and ends this month. The successor programme is called Horizon Europe and will be from January 2021 till December 2027. The Commission's proposal for Horizon Europe is an ambitious €100 billion research and innovation programme to succeed Horizon 2020. The European Parliament and the Council of the EU reached in March and April 2019 a provisional agreement on Horizon Europe.

The European Parliament endorsed the provisional agreement on 17 April 2019. Following the political agreement, the Commission has begun a strategic planning process. The result of the process will be set out in a multiannual Strategic Plan to prepare the content in the work programmes and calls for proposal for the first 4 years of Horizon Europe. The strategic planning process will focus in particular on the global challenges and European industrial competitiveness pillar of Horizon Europe. It will also cover the widening participation and strengthening the European Research Area part of the programme as well as relevant activities in other pillars.

Portugal sets out enhanced health co-operation

The Portuguese government will “promote enhanced cooperation between member states in the area of health,” a draft document outlining the government’s priorities for its upcoming Council presidency has announced. The aim is to help “produce and distribute a safe and accessible vaccine”.

COVID-19 delaying cancer advances nearly 18 months, say researchers 

Cancer researchers are afraid advances for patients of the oft-terminal disease may suffer delays of nearly one and a half years — because of the massive reallocation of global resources to fight the COVID-19 crisis, according to a recent survey shared in a blog post shared on the Institute of Cancer Research's website. The scientists at The Institute of Cancer Research (ICR) in London told the survey their own research advances would sadly see a delay — on average, six months long — because of the initial lockdown, and subsequent restrictions on laboratory capacity, in addition to the unavailability of national scientific facilities, reports MedicalXpress. With wider effects on charity funds, including disruption of collaboration and interpersonal teamwork between scientists, and the reallocation of research efforts to thwart the COVID-19 crisis, the respondents predict major advances in cancer research would suffer a delay of 17 months, on average.

However, the researchers emphasized how scientific procedures have adapted in several ways to the pandemic — noting how long-lasting damage to cancer research might be mitigated with extra funding from charitable donations, and support from national governments. This is why the researchers called for staffing investment, and new technology like robotics and computing power.

The ICR has discovered more drugs to help cancer patients than any other academic centre in the world — but like many other research institutes it was hit hard with cuts to fundraising income, and grants from other various charities. Consequently, the ICR had to put much of its work on hold amid the initial lockdown, and is as of writing running a critical fundraising appeal to kick-start its research and recover its losses in the race to treat and eventually cure cancer.

EU seeks fast-track bypassing of pharma patents in emergencies 

The European Union wants faster procedures to produce generic versions of drugs without the consent of patent holders, an EU document says, in a move meant to bypass usual intellectual rights protections in exceptional circumstances.

So-called compulsory licensing is allowed under World Trade Organization (WTO) rules in emergencies as a waiver of normal regulations and could be applied during the COVID-19 pandemic. “The Commission sees the need to ensure that effective systems for issuing compulsory licences are in place, to be used as a means of last resort and a safety net, when all other efforts to make IP (intellectual property) available have failed,” the document published last week said. The measure, if ever applied, would effectively allow EU states to produce generic drugs without the consent of the pharmaceutical companies that developed them and still own the intellectual property rights.

Health Union

 Commission President Ursula von der Leyen, who has spent precisely a year in office as of today (1 December), is commemorating the occasion with a debate with S&D group leader Iratxe García and health ministers from Italy, Spain and Sweden on how to move forward with the European Health Union which she has called for

So, who gets the coronavirus vaccine first in the US?

 After months of deliberation and debate, a panel of independent experts in the US advising the Centers for Disease Control and Prevention is set to decide today (1 December) which Americans it will recommend to get the coronavirus vaccine first, while supply is still short.

The panel, the Advisory Committee on Immunization Practices, will vote in a public meeting on Tuesday afternoon, and it is expected to advise that health care workers be first in line, along with residents of nursing homes and other long-term care facilities.

If the C.D.C. director, Dr. Robert R. Redfield, approves the recommendations, they will be shared with states, which are preparing to receive their first vaccine shipments as soon as mid-December, if the Food and Drug Administration approves an application for emergency use of a vaccine developed by Pfizer. States don’t have to follow the C.D.C.’s recommendations, but most probably will, said Dr. Marcus Plescia, the chief medical officer for the Association of State and Territorial Health Officials, which represents state health agencies.

The committee will meet again soon to vote on which groups should be next to receive priority. Here are answers to some common questions about the vaccine and its distribution. Who will get the vaccine first? Based on its recent discussions, the C.D.C. committee will almost certainly recommend that the nation’s 21 million health care workers be eligible before anyone else, along with three million mostly elderly people living in nursing homes and other long-term care facilities.

And that is everything to start your first week in December – don’t forget, you can still check out the agenda for EAPM’s 10 December event on lung cancer screening here, register here, and the newsletter is available here. Have an excellent and safe start to your week.

 

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Dutch PM condemns lockdown riots as 'criminal violence'

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Dutch Prime Minister Mark Rutte (pictured) on Monday (25 January) condemned riots across the country at the weekend in which demonstrators attacked police and set fires to protest against a night-time curfew to slow the spread of the coronavirus, calling them “criminal violence”, writes .

The police said hundreds of people had been detained after incidents that began on Saturday evening and lasted until the early hours of Monday, including some in which rioters threw rocks and in one case knives at police and burned down a COVID-19 testing station.

“This has nothing to do with protest, this is criminal violence and we will treat it as such,” Rutte told reporters outside his office in The Hague.

Schools and non-essential shops in the Netherlands have been shut since mid-December, following the closure of bars and restaurants two months earlier.

Rutte’s government added the curfew as an additional lockdown measure from Saturday over fears that the British variant of COVID-19 may soon lead to an increase in cases.

There have been 13,540 deaths in the Netherlands from COVID-19 and 944,000 infections.

The police trade union NPB said there could be more protests ahead, as people grow increasingly frustrated with the country’s months-long lockdown.

“We haven’t seen so much violence in 40 years,” union board member Koen Simmers said on television program Nieuwsuur.

Police used water cannon, dogs and officers on horseback to disperse a protest in central Amsterdam on Sunday afternoon. Nearly 200 people, some of them throwing stones and fireworks, were detained in the city.

In the southern city of Eindhoven, looters plundered stores at the train station and set cars and bikes on fire.

When police said the demonstrators were violating the country’s current lockdown rules “they took weapons out of their pockets and immediately attacked the police”, Eindhoven Mayor John Jorritsma said.

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Head of French health regulatory body: COVID situation is 'worrying'

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The COVID-19 situation in France is worrying, the head of the country’s Haute Autorite de Sante (HAS) health regulator told France Inter radio on Monday (25 January), as President Emmanuel Macron’s government considers a new lockdown, write Sudip Kar-Gupta and Dominique Vidalon.

France has the world’s seventh-highest COVID-19 death toll, with more than 73,000 deaths.

“It is a worrying moment. We are looking at the figures, day by day. We need to take measures pretty quickly....but at the same time, not too hastily,” said HAS head Dominique Le Guludec.

Jean-François Delfraissy, head of the scientific council that advises the government on COVID-19, had said on Sunday that France probably needed a third national lockdown, perhaps as early as the February school holidays, because of the circulation of new variants of the virus.

French European Affairs Minister Clement Beaune, when asked about this on French radio on Monday, replied that no firm decision had been taken on the matter.

France is currently in a nationwide 18h to 6h curfew, in a bid to slow down the spread of the virus, but the average number of new infections has increased from 18,000 per day to more than 20,000.

Geoffroy Roux de Bézieux, head of the MEDEF French business lobby group, said he would call on the government to keep as many businesses and schools open as possible in any new lockdown, to protect the economy and help children’s education.

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EU urges AstraZeneca to speed up vaccine deliveries amid 'supply shock'

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The European Union has urged AstraZeneca to find ways to swiftly deliver vaccines after the company announced a large cut in supplies of its COVID-19 shot to the bloc, as news emerged the drugmaker also faced supply problems elsewhere, write and

In a sign of the EU’s frustration - after Pfizer also announced supply delays earlier in January - a senior EU official told Reuters the bloc would in the coming days require pharmaceutical companies to register COVID-19 vaccine exports.

AstraZeneca, which developed its shot with Oxford University, told the EU on Friday it could not meet agreed supply targets up to the end of March, with an EU official involved in the talks telling Reuters that meant a 60% cut to 31 million doses.

“We expect the company to find solutions and to exploit all possible flexibilities to deliver swiftly,” an EU Commission spokesman said, adding the head of the EU executive Ursula von der Leyen had a call earlier on Monday with AstraZeneca’s chief Pascal Soriot to remind him of the firm’s commitments.

A spokesman for AstraZeneca said Soriot told von der Leyen the company was doing everything it could to bring its vaccine to millions of Europeans as soon as possible.

News emerged on Monday that the company faces wider supply problems.

Australia’s Health Minister Greg Hunt told reporters AstraZeneca had advised the country it had experienced “a significant supply shock”, which would cut supplies in March below what was agreed. He did not provide figures.

Thailand’s Health Minister Anutin Charnvirakul said AstraZeneca would be supplying 150,000 doses instead of the 200,000 planned, and far less than the 1 million shots the country had initially requested.

AstraZeneca declined to comment on global supply issues.

The senior EU official said the bloc had a contractual right to check the company’s books to assess production and deliveries, a move that could imply the EU fears doses being diverted from Europe to other buyers outside the bloc.

AstraZeneca has received an upfront payment of 336 million euros ($409 million) from the EU, another official told Reuters when the 27-nation bloc sealed a supply deal with the company in August for at least 300 million doses - the first signed by the EU to secure COVID-19 shots..

Under advance purchase deals sealed during the pandemic, the EU makes down-payments to companies to secure doses, with the money expected to be mostly used to expand production capacity.

“Initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain,” AstraZeneca said on Friday.

The site is a viral vectors factory in Belgium run by the drugmaker’s partner Novasep.

Viral vectors are produced in genetically modified living cells that have to be nurtured in bioreactors. The complex procedure requires fine-tuning of various inputs and variables to arrive at consistently high yields.

“The flimsy justification that there are difficulties in the EU supply chain but not elsewhere does not hold water, as it is of course no problem to get the vaccine from the UK to the continent,” said EU lawmaker Peter Liese, who is from the same party as German Chancellor Angela Merkel.

The EU called a meeting with AstraZeneca after Friday’s (22 January) announcement to seek further clarification. The meeting started at 1230 CET on Monday.

The EU official involved in the talks with AstraZeneca said expectations were not high for the meeting, in which the company will be asked to better explain the delays.

Earlier in January, Pfizer, which is currently the largest supplier of COVID-19 vaccines to the EU, announced delays of nearly a month to its shipments, but hours later revised this to say the delays would last only a week.

EU contracts with vaccine makers are confidential, but the EU official involved in the talks did not rule out penalties for AstraZeneca, given the large revision to its commitments. However, the source did not elaborate on what could trigger the penalties. “We are not there yet,” the official added.

“AstraZeneca has been contractually obligated to produce since as early as October and they are apparently delivering to other parts of the world, including the UK without delay,” Liese said.

AstraZeneca’s vaccine is expected to be approved for use in the EU on Jan. 29, with first deliveries expected from 15 February.

($1 = €0.8214)

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