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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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