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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.


COVID-19 vaccinations: More solidarity and transparency needed 



MEPs supported the EU's common approach to fighting COVID-19 and called for more unity and clarity during a debate on the roll-out of vaccines and the EU's vaccines strategy.

During a plenary debate on 19 January about the EU’s strategy on Covid-19 vaccinations, most MEPs expressed support for the EU's common approach, which ensured the quick development and access to safe vaccines. However, they called for even more solidarity when it comes to vaccinations and transparency regarding contracts with pharmaceutical companies.

Esther de Lange (EPP, Netherlands) said: “Only more transparency can take away the widespread perception – whether this is justified or not – that often, too often, profit is put before people in this (pharmaceutical) industry.” She praised the EU's joint purchase of vaccines, which led to a stronger negotiation position than individual EU countries would have had: “That means more vaccines for a better price and under better conditions. It shows what Europe can do when we stand united. We can help save lives.”

Iratxe García Pérez (S&D, Spain) warned against "health nationalism" that could damage cooperation on vaccines in Europe. According to her, solidarity and unity is the answer: “If we can keep unity and have equitable distribution of vaccines in member states, we have reasons to believe that 380 million European citizens will be vaccinated by the summer. This is a scientific and health feat that cannot be ruined by parallel contracts and direct purchases." She added: "Let us speak with one voice so that the largest vaccination campaign in history will bring hope back to us in 2021.”

“What are we doing exactly to increase the speed of administering vaccines across the EU?” asked Dacian Cioloș (Renew, Romania). “I know this is a race against time, but in this race we cannot forget that we have a responsibility to do things in full transparency, a responsibility to our citizens to gain their trust. That trust is largely what the vaccination campaign depends on."

Joëlle Mélin (ID, France) said the negotiation of the vaccine contracts lacked transparency. “We are now in the distribution phase and we discover that there are shortages and broken promises from the pharmaceutical companies,” she added.

Philippe Lamberts (Greens/EFA) also talked about the need for transparency and the fact that the European Commission kept the contracts with laboratories secret: “This opaqueness is an insult to democracy. In every single contract the buyer has to know what he or she is buying at what conditions and what price.” He also spoke about potential liability issues: “It is crucial to know who will hold the liability if there were to be negative side effects of the vaccination - would it be the public decision makers or would it be the drug makers? We have no idea.”

Joanna Kopcińska (ECR, Poland) said the decision for the common vaccination strategy was right: “We need an overarching strategy and of course scepticism has a lot to do with a fear that the vaccination is moving slowly, the delivery is maybe late and the contracts are not transparent." She called for the systematic update of treatment strategies and appropriate information campaigns that reach out to everyone.

Marc Botenga (The Left, Belgium) called for more transparency of contracts and responsibility from pharmaceutical companies. He criticised uneven access to vaccines globally, noting poorer regions have difficulties obtaining enough vaccines. “No profit needs to be made on this pandemic and we certainly do not want segregation at vaccinations.”

Plenary debate on the EU global strategy on Covid-19 vaccinations Some of the speakers during the debate on COVID-19 vaccinations  

Health Commissioner Stella Kyriakides assured MEPs that their calls for transparency had been heard. She welcomed the fact that the first of the vaccine suppliers had agreed to make the text of their contract available and said the Commission was working to get other producers to do the same.

Kyriakides said she expects to see more applications for the authorisation of vaccines in the coming months. She stressed the importance of a global approach: “No country will be safe and no economy will truly recover until the virus is under control in all continents." She also talked about Covax - the global facility to ensure fair and universal access to Covid-19 vaccines that the EU helped to set up - which aims to purchase two billion doses by the end of 2021, including more than 1.3 billion for lower- and middle-income countries.

Ana Paula Zacarias, the Portuguese Secretary of State for European Affairs who was speaking on behalf of the Council, said the common EU approach, which sped up the process of developing, authorising and securing access to vaccines, must continue to ensure the availability and efficient rollout of vaccines in all member states.

Zacarias said that a number of issues still need to be resolved, including the format and role of the vaccination certificate, a common approach on the use and validation of antigen rapid tests and the mutual recognition of COVID-19 test results.

Backgound: Race for vaccines

From the very beginning of the coronavirus outbreak, the European Parliament has closely followed the vaccine research and development process. The EU coordinated a joint effort to secure the speedy deployment of vaccines against the disease, through the mobilization of hundreds of million euro for research projects and more flexible procedures. Parliament approved a temporary derogation from certain rules for clinical trials to allow vaccines to be developed faster.

MEPs on the health committee repeatedly highlighted the need for public trust in vaccines and the importance of fighting disinformation and asked for more transparency regarding vaccine contracts, authorization and deployment in the EU.

Under the EU Vaccines Strategy launched in June 2020, the Commission negotiated and concluded advance purchase agreements with vaccines developers on behalf of EU countries; the EU covers part of the costs faced by the producers in return for the right to buy a specified amount of vaccine doses in a given timeframe and at a given price, once they are granted market authorisation. So far, six contracts with pharmaceutical companies have been concluded.

After scientific evaluation and positive recommendation by the European Medicines Agency, the European Commission  granted conditional market authorisation to the first vaccine against Covid-19, developed by BioNTech and Pfizer, on 21 December 2020. Vaccinations across the EU started shortly afterwards on 27 December. On 6 January 2021, Moderna’s vaccine was given conditional market authorisation. The vaccine developed by AstraZeneca could be authorised by the end of January.

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EU leaders weigh travel curbs over virus variant fears




European Union leaders were seeking on Thursday (21 January) to address the coronavirus pandemic’s mounting challenges, including increased calls to limit travel and tighten border controls to contain more infectious variants of the disease, writes .

German Chancellor Angela Merkel said before an evening leaders’ video conference that European countries needed to take the new mutation found in Britain seriously to avoid a third wave.

“We can’t rule out border closures, but want to prevent them though cooperation within the European Union,” she told a news conference in Berlin.

Leaders, who have full control over their own borders, were discussing testing protocols for cross-border commuters, she added.

Alexander De Croo, prime minister of Belgium, where cases per capita are lower than in its neighbours, said he would ask fellow EU leaders to halt non-essential travel, such as tourism.

“The slightest spark could push the figures back up again. We need to protect our good position,” he told broadcaster VRT.

The heads of EU institutions have urged the leaders to maintain unity and step up testing and vaccinations, though Merkel said she expected no formal decisions to be taken at the meeting from 6 p.m. (1700 GMT), the ninth of its kind since the pandemic began.

European Commission President Ursula von der Leyen said on Wednesday that blanket border closures made no sense and were not as effective as targeted measures.

Luxembourg Foreign Minister Jean Asselborn, whose country relies on commuters from its neighbours, told Deutschlandfunk radio that border closures were wrong in 2020 and still wrong in 2021.

The EU executive also wants member states to agree a common approach to vaccination certificates by the end of January. So a certificate from Estonia would be accepted in Portugal, for example.

Greek Prime Minister Kyriakos Mitsotakis floated the idea last week that they could help restore cross-border travel. Spain is pushing the idea within the EU and the Organisation for Economic Co-operation and Development (OECD), its foreign minister said on Thursday.

EU diplomats said this was premature as it was not yet clear if vaccinated people could still transmit the virus to others.

“As for (non-EU) third countries, then you’d have to look into whether to accept Russian or Chinese vaccines,” one added.

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Extended lockdown needed to slow spread of COVID mutation - Merkel




Chancellor Angela Merkel (pictured) on Thursday (21 January) defended a decision to extend a hard lockdown in Germany by two weeks until mid-February, saying it was necessary to slow a new and more aggressive variant of the coronavirus, write Thomas Escritt and Riham Alkousaa.

Speaking at a news conference, Merkel said that while restrictions were showing results in the form of fewer new infections, it would be a mistake to ease curbs given the mutation had been identified in Germany.

“Our efforts face a threat and this threat is clearer now than at the start of the year and this is the mutation of the virus,” said Merkel.

“The findings show that the mutated virus is much more infectious than the one we have had for a year and this is a main reason for the aggressive rise in infections in England and Ireland.”

Merkel said the mutation was still not dominant in Germany and that only a cautious approach could prevent an aggressive rise in daily new infections caused by the new variant first identified in England.

Germany, which has been in lockdown since early November, reported more than 1,000 deaths and more than 20,000 new infections on Thursday. Merkel and state leaders agreed on Tuesday to extend a hard lockdown that keeps schools, restaurants and all non-essential businesses shut until Feb. 14.

“This mutation has been identified in Germany but it is not dominant, at least not yet,” said Merkel. “Still, we need to take the threat posed by this mutation very seriously. We need to slow the spread of this mutation as much as possible.”

She added: “We cannot wait for this threat to hit us, meaning an aggressive increase in infections, that would be too late to prevent a third wave of the pandemic. We can still prevent this. We still have some time.”

Merkel said vaccines can be adapted for new variants of the virus and Germany should be able to vaccinate everyone by the end of the summer.

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