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EAPM: Keeping tabs on lung cancer and Commission pharma strategy

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Good day, and welcome, health colleagues, to the first European Alliance for Personalised Medicine (EAPM) update of the week. We have more news on the upcoming EAPM round table on lung cancer, as well as all the usual health-care updates, writes European Alliance for Personalised Medicine, Executive Director Denis Horgan.

Lung-cancer screening and European Beating Cancer Plan

Yes, we are all aware that by far the best way to reduce numbers of lung cancer patients is to persuade smokers to stop. Although not all sufferers are, or have ever been, smokers. High-risk groups exist, of course, and early diagnosis is vital. Currently, five-year survival rates stand at a mere 13% in Europe and 16% over in America. This will be discussed in our upcoming event on 10 December. 

It is the most commonly found cancer in men and lung cancer in women is being represented by a “worrying rise” according to the World Health Organization.  Some one billion people on the planet are regular smokers. And figures show that lung cancer causes almost 1.6 million deaths each year worldwide, representing almost one-fifth of all cancer deaths. 

The European Respiratory Society and the European Society of Radiology (also a supporter of the event, as is the European Cancer Patient Coalition - ECPC), the societies have recommended screening for lung cancer under the following circumstances: “In comprehensive, quality-assured, longitudinal programmes within a clinical trial or in routine clinical practice at certified multidisciplinary medical centres.”

NELSON and victory?

The NELSON study into computed tomography (CT) screening of lung cancer showed that such screening reduces lung cancer deaths by 26% in high-risk asymptomatic men.  The findings also indicated that, with screening, the results could be even better in women.

For screening to be cost effective, it has to be applied to the population at risk. For lung cancer, this is not simply based on age and sex, as it is in the majority of breast or colon cancer screening. Europe needs to involve all key groups in developing recommendations and guidelines for implementation, adapted according to the healthcare landscape of individual countries. 

Various member states have already shown a willingness to move forward in lung-cancer screening, and several countries representatives will take part in the event.

The Alliance and its stakeholders realize that, among other elements, what is required in Europe is: continuous screening monitoring, with regular reports; assured consistency and enhanced quality of commented data for the screening reports; reference standards for quality and process indicators should be developed and adopted. 

All of the above will be discussed at the lung-cancer screening event, and it is envisaged that a coordinated plan will emerge, which will make its way to Commission and Parliament policymakers and member state health system chiefs.

You can check out the agenda of the 10 December conference here, and register here.

EU Pharma strategy on the horizon 

Affordability, availability and sustainability are the main focus points of the EU’s new pharmaceutical strategy, due to be published tomorrow (25 November). Coming in the wake of the COVID-19 pandemic, the EU’s pharmaceutical strategy aims to “future-proof” the European health-care sector. The new strategy, set to be unveiled on Wednesday, is designed to improve and accelerate patients’ access to safe and affordable medicines while also supporting innovation in the EU pharmaceutical industry. 

Health Commissioner Stella Kyriakides has previously described the strategy as a “cornerstone” of health policy over the next five years. It is considered a key pillar of the Commission’s vision to build a stronger health union, as President von der Leyen set out in her 2020 State of the Union speech. It will also inform the newly proposed EU4Health Programme and align with the Horizon Europe programme for research and innovation, as well as contribute to Europe’s Beating Cancer plan. 

And the European Commission has unveiled the first building blocks of a broader health package aimed at increasing the range of preparedness tools to respond to future cross-border health threats. Patient-oriented approach A first part of the strategy underlines that “research priorities should be aligned to the needs of patients and health systems.” 

Therefore, the whole EU system of pharmaceutical incentives should be reoriented to stimulate innovation in areas of unmet medical needs, such as neurodegenerative and rare diseases as well as pediatric cancer. An example of unmet medical needs mentioned in the document is antimicrobial resistance (AMR), which decreases a doctor's ability to treat infectious diseases and perform routine surgery. By 2022, the Commission will explore new types of incentives for innovative antimicrobials, as well as measures to restrict and optimise the use of antimicrobial medicines.

COVID 'mabs'

The US drug regulatory agency, FDA (Food and Drug Administration), has just issued an Emergency Use Authorization (EUA) for the treatment of mild to moderate intensity COVID-19 in adult and pediatric patients who they have not been hospitalized. The therapy, still under investigation, is based on monoclonal antibodies and goes by the name of bamlanivimab. This therapeutic agent, developed by the pharmaceutical company Eli Lilly, is a monoclonal antibody (mab) similar to those that were part of the cocktail of drugs for COVID-19 that was administered to Donald Trump. 

Beginning EU Health Union

The European Commission is beginning the building of the new European Health Union to help strengthen the EU’s health security framework, and to reinforce the crisis preparedness and response role of key EU agencies. The creation of the European Health Union was announced by the European Commission‘s President, Ursula von der Leyen, in her State of the Union address. The Commission is putting forward a set of proposals to reinforce Europe’s health framework as more co-ordination is needed at an EU level in order to step up the fight against the COVID-19 pandemic and future health emergencies. 

Protecting the health of European citizens

The proposals focus on revamping the existing legal framework for serious cross-border threats to health, as well as reinforcing the crisis preparedness and response role of key EU agencies such as the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). President of the European Commission, Ursula von der Leyen stated: “Our aim is to protect the health of all European citizens.

The coronavirus pandemic has highlighted the need for more coordination in the EU, more resilient health systems, and better preparation for future crises. We are changing the way we address cross-border health threats. Today, we start building a European Health Union, to protect citizens with high quality care in a crisis and equip the Union and its member states to prevent and manage health emergencies that affect the whole of Europe.” 

Von der Leyen urges gradual lifting of coronavirus lockdowns

European governments should lift coronavirus lockdowns and other social restrictions gradually to prevent a third wave of infections, according to European Commission President Ursula von der Leyen. Europe has been grappling with a second surge in Covid-19 infections since September which has led to the re-introduction of lockdowns in certain countries and an overall stepping up of restrictions across the region. 

Despite a slowdown in cases in some countries in recent days, the numbers are still high and are not yet showing clear signs of a cresting. In the meantime, Europeans are pondering whether they’ll be able to gather with their families over the holiday period.

Vaccine hope

News that the AstraZeneca/Oxford vaccine is effective and could have up to 90% efficacy was met with widespread joy on Monday (23 November). “We expect COVID-19 vaccines to develop into a significant market as new products gain approval and begin to meet the high demand for protection from the disease,” according to a brief analysis by Fitch Solutions. It notes that with more products looking likely to pass regulatory hurdles, “these products will help to develop COVID-19 vaccines into a multi-billion-dollar commercial opportunity”. 

Prices are expected to rise in the short-term as countries look to secure access in light of positive Phase 3 trial results, but over the long-term are expected to fall back as new products enter the market,” the briefing added. “Companies will soon be in a position to capitalize on success in Phase III trials through commanding high prices for vaccines,” the analysis states.

Extra plenary session between Christmas and New Year’s Eve

The European Parliament is preparing for an extra plenary session between Christmas and New Year’s Eve to give its consent to a possible post-Brexit trade deal with the UK, according to several EU officials and diplomats. It is likely to be held on 28 December, to give EU governments the opportunity to have the very last say, as foreseen by the bloc’s procedures, before the end of the UK’s Brexit transition period on 31 December.

Private Greek hospitals compelled to take COVID-19 patients

The Greek government took over two private hospitals in Thessaloniki on 19 November in which transmission of the coronavirus has been particularly widespread. The decision was reached after the private clinics failed to voluntarily provide 200 beds for COVID-19 patients despite appeals by the Health Ministry. Public hospitals in Thessaloniki and other parts of northern Greece have been struggling to cope with the influx of coronavirus patients, adding beds from other wards and setting up isolation tents after reaching their official capacities.

And that is everything from EAPM for now, do stay tuned during the week for further updates on all health-related issues, stay safe, and remember to check out the agenda of EAPM’s 10 December lung cancer round table here, and register here.

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EAPM enters 2021 with confidence and healthy hope for the future

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Welcome, health colleagues, to the first European Alliance for Personalised Medicine (EAPM) update of 2021, and a Happy New Year to all. The harrowing scenes at Capitol Hill in the US yesterday (6 January) may have us all wondering whether the new year is going to proceed much like its predecessor, but EAPM is confident of a good working relationship ahead, working with the US on all health issues from the outset of Joe Biden’s presidency, writes EAPM Executive Director Denis Horgan.

Beating Cancer Plan receives fresh publishing date 

Every year, 3.5 million people in the EU are diagnosed with cancer, and 1.3 million die from it. Over 40% of cancer cases are preventable. Without reversing current trends, it could become the leading cause of death in the EU. Europe’s Beating Cancer Plan aims to reduce the cancer burden for patients, their families and health systems. 

It will address cancer related inequalities between and within member states, with actions to support, coordinate and complement member states’ efforts.And the Commission plans to publish Europe’s Beating Cancer Plan on 3 February, to set out the Commission’s strategy to fight the disease throughout Europe. It was originally intended to be published in early December 2020, but has been delayed to 2021, as the pandemic response took priority.

CorWave takes lead as first Commission start-ups shareholder

On Wednesday (6 January), the European Commission began investing in “highly innovative” start-ups as well as small and medium-sized businesses. In the first investment round, the EU pumped €178 million into 42 companies through its new European Innovation Council (EIC) Fund. The French company CorWave, which develops a new type of implantable blood pumps, was the first to see the EU as its shareholder. There are 117 more companies in the pipeline to receive investments. The EIC fund is expected to total around €3 billion.

Portuguese EU Presidency puts emphasis on coronavirus vaccines 

Portuguese Deputy permanent representative, Ambassador Pedro Lourtie, said: “What is important … is to be able to co-ordinate, to share information, and make sure the purchase of vaccine[s] that was made through the joint contracts [is] being fulfilled. And in that sense the European Commission will be giving us regular information.”

Council President Charles Michel has said he wants to co-ordinate the rollout “with the heads of state and government in a regular way,” Lourtie said. “We will maintain this coordination in accordance, of course, with the national competencies.” 

In addition to vaccinations, the Portuguese presidency also has several other health ambitions, such as omproving access to medicines, reinforcing the EU’s ability to respond to crises and championing digital health.

Contact-tracing apps controversy

In the wake of the coronavirus crisis, the European Commission’s Digital Strategy has gained renewed importance as digital tools are used to monitor the spread of the coronavirus, research and develop diagnostics, treatments and vaccines and ensure that Europeans can stay connected and safe online. However, Spain has announced that it’s planning to register people who had refused to take the vaccine so that it can share that data with the EU. A ministry spokesperson has said that all data would be pseudonymized and that it would only note the reasoning for turning down the vaccine. Sergio Miralles, an expert on Spanish data protection law at the law firm Intangibles, said the proposed data processing is “reasonable” since it’s limited to people who visit vaccination centers to voice their disapproval. But “any sharing of data with other countries should … be limited to those vaccinated and therefore exclude those opposing the vaccination,” he added.

EU seeks more doses of BioNTech vaccine as Germany outlines earlier deal

The European Commission is in talks with BioNTech on ordering more doses of their COVID-19 vaccine, a spokesman said on Monday (4 January), as Germany said it had secured additional shots for itself last September. The bloc, with a population of 450 million, has already ordered 200 million doses of the Pfizer-BioNTech vaccine and has taken up an option to buy another 100 million under a contract signed with the two companies in November. The vaccine needs to be administered in two doses per person.“The Commission is checking with the companies whether there is a way to add additional doses to those for which we already have a deal,” the spokesman told a news conference.A spokesman for Pfizer declined to comment on whether new talks were under way with the EU.

EMA recommends COVID-19 Vaccine Moderna for authorization in the EU

The European Medicines Agency (EMA) has recommended granting a conditional marketing authorization for COVID-19 Vaccine Moderna to prevent coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorization. EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorization be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.

“This vaccine provides us with another tool to overcome the current emergency,” said EMA Executive Director Emer Cooke. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.

“As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure ongoing protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.”

A large clinical trial showed that COVID-19 Vaccine Moderna was effective at preventing COVID-19 in people from 18 years of age.The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections. Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection.

Around the bloc 

Greece aims to vaccinate 220,000 by January end

Coronavirus vaccinations will reach a minimum of 220,000 citizens by the end of January, Greek health authorities announced on Monday.Health Ministry Secretary General for Primary Health Care, Marios Themistokleous, said it is likely that other vaccines, such as the one by pharmaceuticals manufacturer Moderna, will be delivered imminently, thus increasing the number of available vaccines.Greece is faring well within the European average as far as progress with ongoing vaccinations is concerned, he added.Vaccinations of health workers, including doctors and nurses, were carried out at 56 public hospitals on Monday.

Will the Dutch coronavirus lockdown be extended? 

The past few days have seen a number of countries either strengthen or extend their coronavirus lockdowns. On Monday it was revealed that Germany would likely extend their existing lockdown, while British Prime Minister Boris Johnson has placed England under a complete national lockdown that will last until at least mid-February.The current so-called hard-lockdown that is in place in the Netherlands is only forecasted to last until 19 January. However, the date of Prime Minister Mark Rutte’s next press conference – 12 January - is fast approaching. While the daily reports from the RIVM have shown that the number of coronavirus infections in the Netherlands has dropped slightly, with 6.671 reported on Monday, the number remains high. Add to this the fact that the full impact of the Christmas holidays remains unknown, and the spread of the new highly contagious ‘British coronavirus’, and experts fear the number of infections will remain too high to justify lifting the lockdown.

Stricter measures for Italy

Italy is extending its holiday pandemic restrictions through at least 15 January, government officials there have announced.The rules prohibit travel between regions of the country unless it's for health care or work. Bars and restaurants nationwide are restricted to takeout and delivery. In the hardest-hit areas of Italy, people are told to visit no more than one other private home each day in groups no larger than two. Italian officials are making allowances for small town residents to travel on certain days. On 9 and 10 January, for example, residents of towns with fewer than 5,000 people will be permitted to travel about 18 miles past regional borders.

And that is all for the beginning of 2021 – it is good to be back, stay safe and well, and see you early next week for more updates.

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Update: Lung cancer experts capture imagination and drive towards success with outstanding lung-cancer screening event

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Welcome, health colleagues, to the European Alliance for Personalised Medicine update before your well-earned weekend – great progress was made at the EAPM lung-cancer screening event on 10 December, so more of that below, writes EAPM Executive Director Denis Horgan.

Real progress can be made with lung cancer through screening

More than 130 high-level delegates and speakers attended the conference on 10 December, with representatives of leading medical societies, MEPs, Commission officials as well as a host of member states delegates and patients. Lung cancer is the biggest killer of all in terms of cancer-related mortality but, unfortunately, the odds against effective implementation of lung-cancer screening across member states in the near future are still high.

Consensus was reached in the conference that the enormous challenge of reducing morbidity and mortality from lung cancer will continue for many years. Low-dose CT (LDCT) scan screening is effective in reducing lung cancer mortality and given the scale of the lung cancer pandemic, LDCT screening can play an important role in reducing deaths from the disease. But a large-scale impact of screening on lung cancer mortality will not be achieved without widespread implementation – and that appears to depend heavily at present on strong presentation of strong arguments from LCS stakeholders to policymakers to take the necessary action.

A key outcome of the conference was there needs to be concrete actions at both EU and member state levels to tackle lung cancer through screening. The EU-27 should look to improve all aspects of screening going forward. There is still much to be decided then, crucially in the context of the European Beating Cancer Plan when it is implemented, and there is a need for greater efforts, supported by collaboration between member states and professional, organizational and scientific support for those countries seeking to implement or improve population-based screening programmes. This will be a key policy priority for EAOM going forward. A report on the EAPM lung-cancer screening conference will be available in due course, stay tuned.

EU COUNCIL NEWS

EU leaders agree

€5.1 billion for the EU4Health programme is now set to be allocated, after EU leaders agreed to the 2021 budget and recovery fund on Thursday (10 December). And European Commission President Ursula Von der Leyen “offered European leaders a sneak peek into the Commission’s plans for a pro-vaccine communication campaign, to be rolled out in two phases”. “The first will ‘explain the product’ in all languages, while the second will encourage people to get vaccinated and aim to dispel scepticism — with the help of influencers such as ‘UEFA football stars,’ von der Leyen said.

EU Council announces deal on coronavirus recovery plan

As a first order of business, the leaders on Thursday (10 December) adopted conclusions on addressing the ongoing coronavirus pandemic — essentially granting formal approval to a series of steps that they discussed previously during several informal videoconferences, including the development of national plans for deploying vaccines, and support for creating a European Health Union that would give Brussels more legal power over health policy during pandemics. Leaders reached agreement on a long-term coronavirus recovery package, after weeks of resistance from Poland and Hungary, according to EU Council President Charles Michel. The two countries had initially blocked the €1.1 trillion ($1.3 trillion) seven-year budget and €750 billion recovery package over stipulations that tie the funds to upholding the rule of law.

EU4Health steering board

The EU4Health Civil Society Alliance has expressed its wish to highlight the absolute importance of an inclusive governance framework with direct, clear and meaningful participation of public interest civil society. Only an inclusive EU4Health Programme, which includes public interest and civil society’s expertise can unleash its full potential to improve public health, the Alliance states, adding that it believes that the EU4Health Steering Board proposed by the European Parliament, with the direct involvement of public interest civil society, complements the expertise of the member states and EU institutions and will ensure a clear and meaningful role for civil society in the governance of the programme, facilitating co-production and ensuring a concrete platform for civil society involvement.

CORONAVIRUS NEWS

Sweden steps up for Norway and Iceland on coronavirus vaccine

Non-EU Norway and Iceland will get access to some of the vaccines obtained by the European Union thanks to Sweden, an EU member that will buy more than it needs and sell them to Norway, right after New Year, the health ministry announced on Wednesday (9 December). Sweden is acting as the ‘reseller’ and will handle the financial transactions. “Sweden has undertaken a key role in the delivery of vaccines to its Nordic neighbours,” Norway’s Health Minister Bent Høie said. “The close co-operation with Sweden means that Norway has access to vaccines on equal terms with the EU member states and ties Norway closer to the EU’s vaccine work.”

Northern Ireland announces vaccine roll-out plans

Northern Ireland has announced its plans concerning the BioNTech/ Pfizer vaccine. Concerning the key question of its distribution to care homes, the government says it will deploy mobile teams of staff who will deliver it directly to patients, such as the elderly and care home residents, who cannot get to vaccination centres. Staff will also be vaccinated during this phase of the programme, which is set to begin on 14 December.

EU gets behind co-ordinated coronavirus testing and vaccine certificates

The European Council said on December 11 that it welcomes the recent positive announcements on the development of effective vaccines against COVID-19 and the conclusion of advance purchase agreements by the European Commission, but added that “the arrival of vaccines does not mean that the pandemic is over”. “The epidemiological situation in Europe remains worrying, even though the considerable efforts made by all are starting to yield results,” the EU leaders said in a statement of conclusions adopted at the European Council meeting. “We must therefore sustain our efforts to counter the spread of the virus with a view to preventing further waves of infections,” the statement said. The European Council said that it welcomes the co-ordination of efforts at EU level so far and commits to strengthening this co-ordination, in particular in preparing for a gradual lifting of restrictions and a return to normal travel, including for cross-border tourism, when the sanitary situation allows.

Conditional marketing authorization (CMA) ‘most likely’ for COVID-19 vaccine, EMA says

The most likely scenario for COVID-19 vaccine candidates in the EU is a one-year conditional marketing authorization (CMA), European Medicines Agency (EMA) sources have said. A conditional marketing authorization allows the approval of a medicine or a vaccine that addresses an unmet medical need with a positive benefit-risk balance. It is based on less complete data than is normally the case, and with specific conditions to be met within defined timelines after authorization.The source added that CMAs are valid for one year and can be renewed annually.

And that is all for this week from EAPM – do enjoy a safe, relaxing weekend, and see you next week with a full report on our lung-cancer screening event.

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EAPM update: Lung-cancer screening round table, last chance to register, and news on launch of world’s first coronavirus vaccine

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Welcome health colleagues, and please find the European Alliance for Personalised Medicine (EAPM) monthly newsletter for December by clicking here. Time is ticking for EAPM’s lung-cancer screening event, and these past few days have seen the truly excellent news of the advent of a COVID-19 vaccine in the UK, so more of that below, writes EAPM Executive Director Denis Horgan.

Lung cancer screening round table

In the wake of several conferences on the subject in recent years and the launch of the European Beating Cancer Plan, EAPM is hosting  a round table on lung-cancer screening in association with the European Respiratory Society, European Radiology Society as well the European Cancer Patient Coalition The idea is to present a case for the coordinated implementation of lung-cancer screening across the EU Region. 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, a great deal of information can be found in EAPM’s latest newsletter, which is available here. 

Will health technology assessment (HTA) talks show Europe's countries can work together?

European health ministers met on 2 December to review what has been, and what can be, done to strengthen future defences to counter the COVID pandemic. It's a huge agenda—and in amongst the many components of the European Union bid to find common ground among its 27 member states on the way ahead, one less conspicuous and apparently incidental item may give a clue to how good the chances are of finding agreement on the big picture improvements that are necessary.

That secondary item is health technology assessment, and the discussion among ministers will turn on the proposal now three years old for co-ordinating evaluations at EU level, instead of conducting as many as 50 distinct regional and national evaluations among the member states on every new medicine. The logic behind the plan is obvious: avoiding duplication, saving time and resources, and arriving at the best decisions by pooling expertise from across the continent. But ever since the proposal emerged, other factors have intervened—and notably the reluctance of some countries to abandon their own approach and submit to a judgment reached by a committee. EAPM is working hard towards forward progress with HTA, and will keep you posted.

UK approves Pfizer-BioNTech COVID-19 vaccine, first in world

And, concerning dealing with the COVID-19 pandemic, Britain approved Pfizer’s COVID-19 vaccine on Wednesday (2 December), jumping ahead of the United States and Europe to become the West’s first country to formally endorse a jab that it said should reach the most vulnerable people early next week. Prime Minister Boris Johnson touted the medicine authority’s approval as a global win and a ray of hope amid the gloom of the novel coronavirus which has killed nearly 1.5 million people globally, hammered the world economy and upended normal life.

Elderly care home residents and their carers will be the first people in the UK to receive the vaccine, the government said on 2 December.

Wei Shen Lim, chair of the UK’s joint committee on vaccination and immunization, said that the vaccine rollout would prioritize those most likely to die from COVID-19 as well as protecting health and social care services.

The first phase of the UK’s vaccination programme will work through nine groups, beginning with residents in care homes for older adults and their carers. Next, all those over 80 years of age and other frontline health and care workers will be offered the jab.

Over 75s are in the third tier of prioritization, followed by the over 70s and extremely clinical vulnerable younger adults.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they say is 95% effective in preventing illness, in record time - just 23 days since Pfizer published the first data from its final stage clinical trial. The US Food and Drug Administration (FDA) is set to meet on 10 December to discuss whether to recommend emergency use authorization of the Pfizer/BioNTech vaccine and the European Medicines Agency said it could give emergency approval for the shot by 29 December. UK Health Secretary Matt Hancock said hospitals were ready to receive the shots and vaccination centres would be set up across the country but he admitted distribution would be a challenge given that the vaccine must be shipped and stored at -70C (-94F), the sort of temperature typical of an Antarctic winter.

EU eyes 29 December approval for virus vaccine, later than US

The European Union drug agency has said it may need four more weeks to approve its first coronavirus vaccine. The European Medicines Agency plans to convene a meeting by 29 December to decide if there is enough safety and efficacy data about the vaccine developed by Pfizer and BioNTech for it to be approved, as it was on 2 December in the UK. The regulator also said it could decide as early as 12 January whether to approve a rival shot by American pharmaceutical company Moderna Inc, which submitted its request to U.S. and European regulators this week. If its vaccine is approved, Germany-based BioNTech said the shot's use in Europe could begin before the end of 2020 — but that seems quite ambitious, given that the EU Commission usually needs to rubber-stamp the regulator's decision. Still, the agency has also left open the possibility that the date of that meeting will be brought forward if data comes in faster.

The European Medicines Agency has yet to receive any data from the Phase 3 AstraZeneca/Oxford vaccine trial and hasn’t received data on the quality of the vaccine, the EMA said in an email. It’s still waiting for data on the vaccine’s ingredients and the way it’s produced, as well as responses to questions that arose from the submission of initial laboratory studies. Meanwhile, in Belgium, Christie Morreale, health minister for the Walloon region in Belgium, said that the country would receive its first vaccines by mid-January at the earliest, according to the Brussels Times.

Commission’s new pharma strategy ‘has patients and collaboration at its heart’

Plans to cut the time it takes to gain regulatory approval for medicines and medical devices, and drive the development of new antibiotics and other products for treating rare diseases, have been outlined in a wide-ranging new pharmaceutical strategy for Europe. The strategy, developed by the European Commission, is patient-focused and seeks to build on the collaborative efforts of industry seen during the coronavirus crisis, said experts in life sciences at Pinsent Masons, the law firm behind Out-Law. The Commission hopes to deliver the strategy over a number of years.

Catherine Drew of Pinsent Masons said: "The strategy has patients at the heart and it recognises the need to ensure prompt access to high quality safe and effective medicines. In so doing the strategy recognises the value that both innovative and generic and biosimilar products bring to helping achieve that patient centric goal."

Nicole Jadeja, also of Pinsent Masons, said: "Importantly, the strategy recognizes the power and future role for health data and data infrastructures, the need for diverse sources of funding to support innovation, the role of new medicines and alternative uses for existing ones, the need for new business models as advanced therapy medicinal products and cell and gene therapies offer the potential of one-time treatments, and the need for the innovation for environmentally sustainable pharmaceuticals and manufacturing."

Team Europe: EU announces €20 million to support health systems in ASEAN

On 2 December, the European Commission announced a new €20 million programme to support the Association of South-East Asian Nations (ASEAN), as part of Team Europe's global response to COVID-19. The South-East Asia Pandemic Response and Preparedness programme will enhance regional co-ordination in responding to the coronavirus pandemic and strengthen the capacity of health systems in the region. The programme, with a duration of 42 months and implemented by the World Health Organisation, will also pay special attention to vulnerable populations and support timely communication about the COVID-19, its symptoms and risks, especially in rural and remote areas.

Fighting AMR paradoxes in age of COVID-19

Antimicrobial resistance (AMR) is one of the ten most urgent threats facing global health, and yet it remains totally underestimated by much of the population. AMR is more dangerous than car accidents and even cancer, but is still not being prioritised at either the EU or member state levels within public health policies. Furthermore, AMR is interlinked with the COVID-19 pandemic, a fact which has been all-but ignored by the media. The world is losing its most powerful health-care tool, antibiotics; by 2050, super bacteria could cause 350 million deaths. Meanwhile, the research sector is still waiting for EU incentive mechanisms as well as an overall strategy to integrate the development of – and access to – affordable and quality antimicrobials.

In the United States, some 70-80% of hospitalised COVID-19 patients received antibiotic treatment, according to one report, even though less than 10% actually had secondary bacterial infections In Italy, the Italian National Institute of Health affirms that of 3,335 patients who died from COVID-19, 86% of them had undergone antibiotic treatment, despite only 12% of them having had a superimposed bacterial infection.

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.

We will waive COVID travel restrictions for Father Christmas, EU confirms

Asked to reassure children that Santa Claus will be able to cross borders freely to bring them their gifts, Margaritis Schinas, the EU's Vice-President for Promoting our European Way of Life, said the European Commission "can offer this assurance". "We agreed with the religious leaders that this being an issue of trans-border movement — Saint Nicholas, Pere Noel, Babbo Natale, Reyes Magos, Agios Vassilis — they will all be able to deliver the gifts. Young Europeans of all faith should have the conviction that love and hope will never be absent from Europe in these days," he said.

And that is everything to end 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 weekend.

 

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