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#EAPM - Seychell swaps DGs as Commission stays busy, busy, busy




Welcome all, to the latest European Alliance for Personalised Medicine (EAPM) update, not surprisingly dominated by the coronavirus crisis. Before we give you the round-up, here’s just a quick reminder of our upcoming virtual conference on 30 June, writes EAPM Exececutive Director Denis Horgan.

Entitled 'Maintaining public trust in the use of Big Data for health science in a COVID and post-COVID world', it acts as a bridging event between the EU Presidencies of Croatia and Germany. Alongside our many great speakers, attendees will be drawn from leading experts in the personalised medicine arena – including patients, payers, healthcare professionals, plus industry, science, academia and the research field.

Here is the link to register.

Meanwhile, a great supporter of personalised health and the public health community, and a shining light within DG SANTE, Martin Seychell will be leaving his current DG - where he is deputy director general for health - to take the number two place at International Cooperation and Development. Martin has been involved in several EAPM events, and we’d like to take this opportunity to thank him for his support, while wishing all the best to his successor - who will be Sandra Gallina from DG TRADE.

Touted as a “strong negotiator”, Gallina will “bolster [the Commission’s] work on numerous health priorities in the current context”, including on the advance vaccine purchase strategy announced this week. She will also “contribute to the massive effort the Commission is currently making on global access to vaccines following last week’s mandate from Council”. Moving Martin “allows the Commission to reinforce its capacity in terms of the global health dimension of development actions” according to a statement. 

“His expertise in ensuring synergies between different policies will allow him to add significant value in the current context of a global health crisis and its expected social and economic consequences in the EU’s partner countries.” We wish him the very best of luck.

And so to COVID-19…

The Lancet medical journal has published a study that estimates that 22% of the global population - which equates to 1.7 billion people - has an underlying condition that puts them at a higher risk of COVID-19 infection. Such conditions are most common in countries with older populations; African nations with a high prevalence of HIV/AIDS; and small island countries with high numbers of patients with diabetes. Andrew Clark, of the London School of Hygiene & Tropical Medicine, said of the study: “We hope our estimates will provide useful starting points for designing measures to protect those at increased risk of severe disease.” Further research meanwhile, shows that people suffering from obesity and related conditions such as type 2 diabetes and hypertension are also particularly vulnerable to this virus.

And a third study - this time commissioned by the World Health Organization - has come under attack from scientists. Its topic is optimal distancing measures to reduce coronavirus transmission rates, and states that reducing minimum distance requirements between people to one metre from two raises the risk of infection only slightly. But David Spiegelhalter, a statistician from Cambridge, as well as others, has questioned its reliability. - just as UK Chancellor Rishi Sunak said that the government is reviewing the two-metre rule currently in force in the country.

APPs the way to do it

Amid news that the UK’s bluetooth track and trace app is to be ditched and swapped (it’s not the only nation, by any means, that has found that it doesn’t work particularly well), Germany has gone ahead with its own national app to trace interactions between smartphone users and track potential infections with the coronavirus. Chancellor Angela Merkel’s chief of staff Helge Braun said: “The app we’re presenting today is unique,” although like the Brit version it also uses short-range Bluetooth signals. It is, however, “very secure” from a privacy point of view (which is more than we can say for many of them), and is totally voluntary. 

Lars Lensdorf, who’s a partner at law firm Covington and Burling’s Frankfurt office, said: “Nobody can force you to download the app,” including an employer or a restaurant that you may visit. His colleague at the firm, Moritz Hüsch, noted that consent is continually required, even for example, when inputting a coronavirus test result. Meanwhile, in France, it turns out that its own ‘StopCovid’ tracing app may not be able to connect with others across the EU due to it storing data centrally. 

European Commission Vice President Margrethe Vestager told the French parliament earlier this week: “It’s somewhat more tricky to develop the technical standards for interoperability between decentralised systems, as I think will be the general rule, and the centralised system that France has been aiming for.” German medtech to flex muscles? Germany’s medical device industry is already powerful, and looks likely to ramp up its influence during Berlin’s six-month European Council presidency which begins on 1 July.

The country’s BVMed lobby group has made its priorities known to German Health Minister Jens Spahn as well as Health Commissioner Stella Kyriakides. Topics at the top of the list are bringing medicine production back to Europe (with a note on concerns about environmental and bureaucratic regulations), tracking stockpiles, and “alternative evaluation procedures” to the Medical Device Regulation. Pharma strategy The Commission this week began its public consultation on its Pharmaceutical Strategy for Europe. The strategy will aim to build up Europe’s pharma industry, while improving access to medicines, and the above-mentioned Stella Kyriakides has called on patients’ associations, industry, public authorities, academia and the general public to contribute input. Also in the realm of pharmaceuticals and beyond, bringing their production back to Europe has been an oft-heard theme. And now French President Emmanuel Macron is grasping the nettle. He recently visited a vaccine production plant owned by big-hitters Sanofi, and took the opportunity to announce a €200 million investment aimed at building up France's capacity in the sector.

The cash is also ear-marked to avoid any future shortages of medical goods.

Vaccine latest

The Commission has been pretty busy by all accounts, not least its unveiling of a vaccine plan to shovel billions of euro towards pharmaceutical companies manufacturing coronavirus vaccines. Most won’t work, of course, but for any that do, global health groups are looking to see concrete proposals to ensure effective vaccines are given to low income and fragile countries. 

For its own part, the Commission’s plan will use EU funds to purchase vaccines in exchange for guaranteed supplies if it actually works. The Berlaymont will negotiate with vaccine developers to give them the funding to begin manufacturing the most promising candidates immediately. “There is a very real risk that none of the supported candidates will be successful,” the Commission has said.

“However, the value of earlier access to a vaccine is enormous, in terms of lives saved and economic damage avoided. This makes the risk worth taking.” Anyone remember the HTA talks? Amidst new health proposals from the EU Executive, and the aforementioned vaccines and pharmaceutical strategy, it’s good to know that the Health Technology Assessment file’s lead rapporteur, MEP Tiemo Wölken, has kept his eye on the ball.

The German deputy and the file’s shadow rapporteurs have sent a letter to Commission Vice President Margaritis Schinas and health supremo Stella Kyriakides calling for movement. The letter from MEPs states that the coronavirus pandemic has proved the importance of HTA, thus: “If the HTA proposal would have been already in place it could have enabled a much quicker and more efficient exchange of information between HTA bodies on what works and what does not work in terms of treatment options, diagnostic kits and protective equipment, based on available evidence.” Of course, key to the proposal is improving the availability and accessibility of medicines, so Wölken et al have urged the Commission on. “We want to improve the quality and efficiency of health-care interventions and the sustainability of health systems - a European HTA procedure will help us,” they wrote.

That’s all for now. More next week - and don’t forget to register here in advance for the conference on 30 June.


German vaccine seekers getting aggressive, doctors say





Germans desperate to be vaccinated against the coronavirus are becoming increasingly aggressive, doctors said on Wednesday (12 May), as frustration mounts after six months of lockdowns even though infection rates are now falling.

"The pressure on vaccination centres and doctors' practices is growing. People pushing for vaccination are becoming more demanding," Anke Richter-Scheer, the deputy head of the German association of family doctors, told the Funke media group.

As Germany extends priority for vaccines to more groups, it is becoming less comprehensible to many people why they should have to wait behind others, Richter-Scheer said.

People are showing up at doctors' practices and trying to get vaccines even though it is not their turn, with the mood getting more aggressive, she said.

Some people are also demanding their second shot early so they can go on holiday or profit from advantages such as shopping without needing a COVID-19 test.

​ Older patients who have been assigned AstraZeneca are also demanding a different vaccine.

After a sluggish start, Germany has been ramping up its vaccination campaign and has now given a first dose to a third of the population, with about 10% fully vaccinated.

It started by vaccinating its oldest citizens and has been gradually expanding shots to younger groups and other priority professions such as teachers, journalists and those working in critical infrastructure.

Several German states, including the capital city Berlin, announced plans on Tuesday planning to loosen coronavirus restrictions in coming days as the number of new infections keeps dropping nationwide. read more

On Wednesday, another 14,909 new cases were reported, bringing the total to 3,548,285, while the death toll rose by 268 to 85,380. However the seven-day incidence per 100,000 people dropped to 108 from 115 on Tuesday.

The government should give citizens clear guidelines on whether and where they can go on holiday by the end of May, Finance Minister Olaf Scholz told the Rheinische Post newspaper.

Holidays should be possible within Germany and in some other countries due to rising vaccinations and falling infections, he said. The northern state of Mecklenburg-Vorpommern, popular with holidaymakers, will open up its tourism sector from June 14.

However, Germany's vaccine committee, known as STIKO, dampened expectations for a speedy approval for vaccination of children and adolescents.

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Delaying second COVID-19 vaccine doses can help reduce deaths - study





Vials with Pfizer-BioNTech and Moderna coronavirus disease (COVID-19) vaccine labels are seen in this illustration picture taken March 19, 2021. REUTERS/Dado Ruvic/File Photo
A medical worker prepares a dose of the "Comirnaty" Pfizer-BioNTech COVID-19 vaccine inside the exhibition palace transformed into a vaccination center in Nice as part of the coronavirus disease (COVID-19) vaccination campaign in France, April 29, 2021.  REUTERS/Eric Gaillard/File Photo
A phial of the Pfizer/BioNTech COVID-19 vaccine concentrate is diluted with 1.8ml sodium chloride ready for use at Guy's Hospital. Victoria Jones/Pool via REUTERS

Giving a first dose of COVID-19 vaccine but delaying a second dose among people younger than 65 could lead to fewer people dying of the disease, but only if certain conditions are met, a predictive modelling study showed.

As the coronavirus pandemic continues, there is debate over whether to extend the gap between doses to give as many people as possible some protection, or stick to the intervals designated in clinical trials.

For example, Pfizer (PFE.N) has said there is no clinical evidence to support Britain’s decision to extend the gap between doses of its vaccine to 12 weeks, but data from the rollout in England shows protection against death of around 80% from one dose, with a 70% decline in infections.

The US study, published in the BMJ British medical journal, used a simulation model based on a "real-world" sample of 100,000 US adults and ran a series of scenarios to forecast potentially infectious interactions under different conditions.

These included varying levels of vaccine efficacy and immunisation rates, and varying assumptions as to whether the vaccine prevents transmission and serious symptoms or only prevents serious symptoms, including death.

"The results suggest that under specific conditions a decrease in cumulative mortality, infections, and hospital admissions can be achieved when the second vaccine dose is delayed," wrote the researchers, led by the Thomas C Kingsley of the Mayo Clinic in Rochester, Minnesota.

The specific conditions include having a vaccine with a one dose efficacy of at least 80% and having daily immunisation rates of between 0.1% and 0.3% of a population - but if they are met, a delayed second-dose strategy could prevent between 26 and 47 deaths per 100,000 people compared to the usual schedule.

The study did not recommend an optimum schedule.

"Decision makers will need to consider their local vaccination rates and weigh the benefits of increasing these rates by delaying a second dose versus the risks associated with the remaining uncertainty in this strategy," the team said.

Separately, an Oxford University-led study on giving shots from different manufacturers for the two doses reported its first findings - on the frequency of common post-vaccination symptoms such as sore arm, chills or fatigue.

It found that people vaccinated with a shot of Pfizer's vaccine followed by a dose of AstraZeneca's, or vice versa, were more likely to report mild or moderate symptoms such as headaches or chills than if they received two of the same type.

Pfizer and AstraZeneca were the first vaccines available in Britain to be trialled in the “mix-and-match” study. Shots by Novavax and Moderna have since been added to the research.

Key data on immune responses generated by the different combinations of mixed or regular dose schedules is expected to be reported in the coming months, according to Matthew Snape, the Oxford University professor leading the trial.

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Airline launches airbridge to bring relief to virus-stricken India




The airline Emirates has set up a humanitarian airbridge between Dubai and India to transport urgent medical and relief items, to support India in its fight to control the serious COVID-19 situation in the country, writes Martin Banks.

Emirates will offer cargo capacity free of charge on an “as available” basis on all of its flights to nine cities in India, to help international NGOs deliver relief supplies rapidly to where it is needed.

In the past weeks, Emirates SkyCargo has already been transporting medicines and medical equipment on scheduled and charter cargo flights to India. This latest airbridge initiative takes Emirates’ support for India and for the NGO community to the next level.

HH Sheikh Ahmed bin Saeed Al Maktoum, Emirates’ Chairman and Chief Executive, said: “India and Emirates are deeply connected, since our first flights to India in 1985. We stand with the Indian people and will do all we can to help India get back on its feet. Emirates has a lot of experience in humanitarian relief efforts, and with 95 weekly flights to 9 destinations in India, we will be offering regular and reliable widebody capacity for relief materials. The International Humanitarian City in Dubai is the largest crisis relief hub in the world and we will work closely with them to facilitate the movement of urgent medical supplies.”

The first shipment sent as part of the Emirates India humanitarian airbridge is a consignment of over 12 tons of multi-purpose tents from the World Health Organization (WHO), destined for Delhi, and coordinated by the IHC in Dubai.

Giuseppe Saba, CEO of International Humanitarian City, said: “His Highness Sheikh Mohammed bin Rashid built the International Humanitarian City (IHC), so Dubai, in coordination with humanitarian agencies, would be able to assist communities and families, most in need – around the world. The creation of the humanitarian airbridge between Dubai and India, facilitated by Emirates SkyCargo, Dubai’s International Humanitarian City and UN agencies, to transport urgent medical and relief items, is another example of His Highness Sheikh Mohammed bin Rashid’s vision for the IHC, being brought to life. Last year over 1,292 shipments were dispatched from the IHC in Dubai, setting the standard for humanitarian response globally. We appreciate the great efforts by IHC’s partner Emirates SkyCargo establishing this humanitarian airbridge between Dubai and India in this time of need”.

The freight division of Emirates has a close partnership with IHC, developed over several years of delivering relief materials to communities across the world impacted by natural disasters and other crises. IHC will support Emirates SkyCargo in channelling relief efforts to India through the airbridge.

Following the Port of Beirut blasts in August 2020, Emirates also leveraged its expertise in humanitarian logistics to set up an airbridge to Lebanon to assist with relief efforts.

Emirates has led the aviation and air cargo industry in its efforts to help markets around the world combat the COVID-19 pandemic. The air cargo carrier has helped transport thousands of tonnes of urgently required PPE and other medical supplies across six continents over the last year by rapidly adapting its business model and introducing additional cargo capacity through its modified mini freighters with seats removed from Economy Class on Boeing 777-300ER passenger aircraft along with loading cargo on seats and in overhead bins inside passenger aircraft to transport urgently required materials.

In addition, Emirates SkyCargo has partnered with UNICEF and other entities in Dubai through the Dubai Vaccine Logistics Alliance, to transport COVID-19 vaccines rapidly to developing nations through Dubai. So far, close to 60 million doses of COVID-19 vaccines have been transported on Emirates’ flights, equating to nearly 1 in 20 of all COVID-19 vaccine doses administered around the world.

Through its scheduled cargo flights to close to 140 destinations across six continents, Emirates helps maintain unbroken supply chains for vital commodities such as medical supplies and food.

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