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#EAPM – Experts rally in fight against #Coronavirus



Welcome, everyone, to the last European Alliance for Personalised Medicine (EAPM) update of the week – we hope you are enjoying your holidays. August is getting hot, and is likely to get hotter still this weekend, so make sure you’re well armed with sunscreen to prevent melanoma. On the coronavirus front, attitudes range from ‘We’re doing much better’ to ‘Ulp! Winter is en route’, so on with the news, writes EAPM Executive Director Denis Horgan.

Memories of February

Compared to the early days of the coronavirus deluge, says World Health Organization (WHO) European Region chief Hans Kluge, “We know how to target the virus instead of targeting society, we are not back in February.” Kluge was referencing countries’ new-found abilities to avoid fully fledged lockdown with hard-won techniques “to apply smart, time-limited and risk-based measures”. And WHO Europe is set to hold a meeting for officials from all 53 countries in the region on 31 August to discuss strategies for safely restarting schools, including heightened hygienic measures and shutting classrooms down if needed.

Watch for winter

The UK must prepare now for a potential new wave of coronavirus infections this winter that could be more serious than the first, says a new report from the Academy of Medical Sciences. Combined with the disruption already created in the health service by SARS-CoV-2 and COVID-19 disease, a backlog of patients needing NHS assessment and treatment, and the possibility of an influenza epidemic, a new peak of virus infection poses a serious risk to health in the UK. These new pressures are in addition to the challenge winter usually presents to the NHS, when other infectious diseases are more common, and conditions such as asthma, heart attack, chronic obstructive pulmonary disease and stroke tend to worsen.

Masking the problem

Alain Bazot, head of France’s consumer association UFC Que Choisir, has stridently criticized businesses in an interview with Le Parisien, saying that companies should resolutely *not* make money out of face masks during COVID-19. Following the announcement that face masks will be made compulsory in French workplaces from 1 September, Bazot said that free masks should be provided because “the issue is of access to public services for all”. Apparently, and rather disgracefully, numerous French companies are charging more than the cap of €0.95 per mask which has been put in place.

Portugal spends €20 million on first batch of vaccines

Portuguese Prime Minister António Costa announced on Thursday (20 August) that the government has authorized a €20 million investment in contracts to purchase vaccines against COVID-19, and the Council of Ministers, through an electronic meeting, authorised the investment of €20m in the purchase of the first batch of vaccines. The vaccination will be “progressive, universal and free” for the Portuguese population to ensure this immunization, Costa said at an event in Gaia.

The government clarified that this amount “corresponds to the first phase of the acquisition procedures, to be carried out in 2020, ensuring the acquisition of 6.9 million doses”. as Infarmed had anticipated this Wednesday. These 6.9m doses of vaccines – which cover about two-thirds of the Portuguese population – correspond, according to the TSF, to Portugal’s share of the 300m vaccine batch agreed between the Commission and the French laboratory Sanofi-GSK. The EU also has an agreement with AstraZeneca for a further 300m doses and with Johnson & Johnson for a further 400m doses.

Variations in clinical trial reporting brings controversy

According to TranspariMED, which is an advocacy group committed to encouraging scientists to report their findings, the Dutch are coming up short concerning European clinical trial reporting rules. Apparently, Nijmegen’s Radboud University, which failed to upload over 100 clinical trial results to the European trial register, is one of the worst offenders. Erasmus University is apparently another serious offender. However, Irish and UK universities could afford to be the most smug, as both sets of institutions have reported results for almost all their clinical trials. Germany and Austria are getting better, as are top institutions in Italy and Spain. TranspariMED concluded that if the Netherlands’ universities “didn’t get the message this time around, we’ll keep putting out follow-on reports until they do”.

New research casts doubt over accuracy of contact tracing apps

A study, published on the Lancet Digital Health, declares that the usefulness of the technology still has everything to prove. Bluetooth technology is set to be used to allow phones with the app installed to make an anonymous 'handshake' which will be used to measure how close they are, and for how long. One thing that emerged consistently from the review was that if the apps were going to make a meaningful difference, they needed to be embraced by a substantial portion of the population.

It was further noted that people who are likely higher risks – such as the elderly and homeless – are less likely to have smartphones to download the apps. There was also the very real risk that technology-driven approaches distract from more basic measures. “When you look at the approach that was taken in South Korea, it did use technology, but it also did use an incredibly resource-intensive approach, with a large number of people doing contact tracing, looking at CCTV footage, credit card records, as well as phone location data,” the study said.

Spanish concern over second wave of COVID-19

A virologist at the Severo Ochoa Cell Biology Center in Madrid, Margarita del Val, has said she is not convinced that Spain will be able to avoid another serious wave of COVID-19 cases given Spaniards’ “way of life” during the summer. “Nobody wants yet another strict confinement, but in order to avoid that we must apply all the other restrictions with rigor, not how it is being done now,” she told a university seminar on COVID-19 in Santander, Spain. During the first wave of the COVID-19 pandemic in March, Spain was one of the most heavily affected countries in Europe. The country struggled to control the surge of new cases during the first wave, resulting in high fatalities from cases. The country was then placed under one of the harshest lockdowns in Europe in an attempt to flatten the curve.

Similar to other countries in Europe, Spain’s COVID-19 daily confirmed cases started to decline in May and the country seemed to have regained control of the situation. However, the daily confirmed cases have started increasing again, raising concerns that Spain will experience a second wave of COVID-19. As Spain has started to reopen its economy amid the rapidly rising cases, there is a major risk that COVID-19 cases will not decline in the near future.

Private health insurance bringing medical treatment faster in Sweden?

In much the same way that society as a whole is reproving of people who don’t wear masks or follow other social distancing rules, criticisms are being raised in Sweden that private health insurance is letting some citizens skip the queue and get medical treatment faster, even in public hospitals. A chief legal officer has been appointed at the Dental and Pharmaceutical Benefits Agency to determine any imbalances caused by the expansion of private insurance in the health system, as well as proposals to remedy this and ensure that publicly-funded medical treatment is fair.

“A cornerstone of Sweden’s welfare system is that citizens can be confident that care is provided based on need, not based on the size of one’s wallet,” said Lena Hallengren, the country’s minister of social affairs.

And that is all from EAPM for another few days – as best you can, enjoy your weekend, enjoy your ongoing August break, and stay safe and well.


Brexit Britain just approved a European vaccine, German health minister says



Celebrating Britain’s swift approval of BioNtech and Pfizer’s coronavirus vaccine as a benefit of Brexit is misplaced since the vaccine was itself a product of the European Union that Britain has left, German Health Minister Jens Spahn (pictured) said, writes Thomas Escritt.

Spahn told journalists that while Britain had been the first to approve the vaccine, he was optimistic that the European Medicines Agency would soon follow. The time difference was due to Britain and the US having conducted an emergency approval process, while the EU was using a regular process.

“But a few remarks on Brexit to my British friends: Biontech is a European development, from the EU. The fact that this EU product is so good that Britain approved it so quickly shows that in this crisis European and international cooperation are best,” he said.

Some have suggested that Britain having its own medicines approval meant it could move more nimbly than the EU’s bloc-wide agency.

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EU criticizes 'hasty' UK approval of COVID-19 vaccine




The European Union criticized Britain’s rapid approval of Pfizer and BioNTech’s COVID-19 vaccine on Wednesday (2 December), saying its own procedure was more thorough, after Britain became the first western country to endorse a COVID-19 shot, writes .

The move to grant emergency authorization to the Pfizer/BioNTech vaccine has been seen by many as a political coup for UK Prime Minister Boris Johnson, who has led his country out of the EU and faced criticism for his handling of the pandemic.

The decision was made under an ultra-fast, emergency approval process, which allowed the British drugs regulator to temporarily authorise the vaccine only ten days after it began examining data from large-scale trials.

In an unusually blunt statement, the European Medicines Agency (EMA), which is in charge of approving COVID-19 vaccines for the EU, said its longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by Britain.

The agency said on Tuesday it would decide by Dec. 29 whether to provisionally authorise the vaccine from U.S. drugmaker Pfizer and its German partner BioNTech.

A spokesman for the European Commission, the EU executive, said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine,” as it was based on more evidence.

June Raine, the head of Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), defended its decision.

“The way in which the MHRA has worked is equivalent to all international standards,” she said.

“Our progress has been totally dependent on the availability of data in our rolling review and our rigorous assessment and independent advice we have received,” she added.

The EMA started a rolling review of preliminary data from Pfizer trials on 6 October, an emergency procedure aimed at speeding up possible approval, which usually takes at least seven months from reception of full data.

The UK regulator launched its own rolling review on Oct. 30, and analysed less data than made available to the EMA.

“The idea is not to be first but to have a safe and effective vaccine,” Germany’s Health Minister Jens Spahn told a news conference.

Asked about the emergency procedure used by Britain, he said EU countries had opted for a more thorough procedure to boost confidence in vaccines.

“If you evaluate only the partial data as they are doing they also take a minimum of risk,” the EMA’s former head Guido Rasi told an Italian radio.

“Personally I would have expected a robust review of all available data, which the British government has not done to be able to say that without Europe you come first,” he added.

EU lawmakers were even more explicit in their criticism of Britain’s move.

“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way,” said Peter Liese, an EU lawmaker who is a member of German Chancellor Angela Merkel’s party.

“A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorization of a vaccine,” said Liese, who represents the centre right grouping, the largest in the EU Parliament.

Under EU rules, the Pfizer vaccine must be authorized by the EMA, but EU countries can use an emergency procedure that allows them to distribute a vaccine at home for temporary use.

Britain is still subject to EU rules until it fully leaves the bloc at the end of the year.

“There is an obvious global race to get the vaccine on the market as fast as possible,” said Tiemo Wolken, an EU lawmaker from the socialist grouping, the second largest in the Parliament.

“However, I do believe that it is better to take the time and make sure that the quality, effectiveness and safety is guaranteed and matches our EU standards.”

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President von der Leyen at the EU Health Summit



On 1 December, European Commission President Ursula von der Leyen gave a speech at the virtually held EU Health Summit. In her address, the president emphasized the need for a common and global response to defeat the virus: “The challenge of this pandemic is unprecedented in modern times. We now know that defeating this virus is possible. But no country and no government can defeat the virus alone. This is true, first of all, at the global level. Secondly, inside Europe. And thirdly, between the public and the private sectors. The EU has taken the lead to convene a global response to COVID-19.” 

President von der Leyen also recalled the “unprecedented co-operation on health issues” in the European Union during the past months, putting us on the path to establishing a European Health Union. This will improve EU-wide preparedness and responsiveness, give more responsibilities and resources to the European Centre for Disease Prevention and Control and to the European Medicines Agency, and allow for close co-operation with the private sector in medicines development and supply.

“Governments alone cannot end this pandemic. That's why the Commission presented last week its Pharmaceutical Strategy. It is about creating win-win situations with the private sector. But we also want to put patients at the centre of medicines development and supply. Europe can take the lead in supplying ground-breaking medicines that are also affordable and widely available”, she said.

Finally, President von der Leyen repeated the mantra that “vaccines don't save lives, vaccinations do”, and that that “development of vaccines has been a remarkable team effort”, but that to deliver them to everyone in the world, we will need an even greater effort: “Vaccination is about self-protection and solidarity.”

Read the full speech here.

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