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European Alliance for Personalised Medicine

Recruiting serology to the long fight ahead against pandemics

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Europe's ability to respond effectively to health threats has already been called into question by the coronavirus pandemic. Heroic collaboration between researchers and policymakers has made the first vaccines available at record speed, but Europe still stands before a major challenge that goes way beyond the current COVID crisis. There is a critical failure to develop and implement the testing technologies that not only can help protect citizens against COVID-19, but that will also be crucial in preserving public health over the longer term, in the face of future and even more deadly cross-border infections, writes European Alliance for Personalised Medicine (EAPM) Executive Director Dr. Denis Horgan.

To address these topics, EAPM hosted two webinars on the matter. The first virtual round table, 'Forward together with innovation: Understanding the need and framing the discussion for Serology testing for SARS-CoV', took place on 17 December 2020, and the on 'Recruiting serology to the long fight ahead against pandemics', on 3 February. Together they comprehensively highlighted the questions still needing answers and gathered input from European and international public health officials and organisations, academia, and industry.

As the experts concluded, action is needed to introduce meaningful testing strategies leveraging the comprehending strengths of the available testing technologies such as serology. This can contribute to more efficiency of vaccination programs.

Not the end of a battle - just the beginning

"We are only at the beginning now," Bettina Borisch, Executive Director World Federation of Public Health Associations, told a recent expert roundtable on serology testing, organised by EAPM to highlight the challenges and opportunities of making the best use of testing. "We are confronted with not just a short-term crisis but a long one, to ensure future capacity for protection." Testing and diagnosis have been Cinderella areas of medicine for too long, she said, urging the use of serology as a vital element in any pandemic strategy. The point was reaffirmed by Kevin Latinis, a scientific advisor for one of the US task forces to tackle Covid, at a follow-up EAPM roundtable in January: "The pandemic has demonstrated dramatically what an asset adequate testing would be, but the opportunity is being missed," he said. Or, as Denis Horgan, EAPM's executive director, who chaired both roundtables, expressed it: "More vaccines are now becoming available, but it is vital to ensure they are used effectively in clinical practice, and for that we need better understanding of which patients will respond to different vaccines and how the vaccines will tackle variants."

The confident but chilling scientific consensus is that the next decades will bring further and more virulent pandemics that threaten disruption and death on an even greater scale than the current outbreak. And while the hope is that vaccines now being created in extremis will overcome the immediate danger, Europe – and the world – can no longer afford to rely on hasty improvisation. The harsh reality is that much of the current vaccine development is shooting in the dark at moving targets.

As the first vaccines reach the general public at the start of 2021, it is still unknown for how long vaccination confers immunity (and, topically, how much flexibility in altering dosage schedules is justified), how it affects different population groups, or to what extent vaccination impedes transmission. As the European Medicines Agency observes in reporting on its first positive opinion on a Covid vaccine, Comirnaty, "It is not currently known how long protection given by Comirnaty lasts. The people vaccinated in the clinical trial will continue to be followed for two years to gather more information on the duration of protection." And "there were not enough data from the trial to conclude on how well Comirnaty works for people who have already had COVID-19." Similarly, "The impact of vaccination with Comirnaty on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known how much vaccinated people may still be able to carry and spread the virus."

Sharper identification of the nature of the virus – and any of its mutated variants – as well as greater precision over the effectiveness of vaccines and measurements of immunity are still urgently needed.

Help is at hand – in principle…

The mechanisms are available to bring that precision and clarification. Notably, serology testing can help confirm the efficacy of vaccination, and could be used to establish a threshold for protection or immunity. It can also confirm an initial antibody response from vaccination, and provide subsequent tracking of antibody levels at regular intervals. Because data from initial vaccine trials will be limited to certain populations and exposure patterns, serology can provide additional data on antibody response and duration to help inform vaccine efficacy in larger, more-diverse populations, and to determine appropriate use in the context of variables such as ethnicity, level of viral load exposure, and individual immune system strength. Testing is vital also to distinguish successful from suboptimal vaccine responses and to detect antibody declines after natural infection.

How serology testing works...

Serology is the study of antibodies in blood serum. Serologic antibody tests help determine whether the individual being tested was previously infected, by measuring the person’s immune response to the virus—even if that person never showed symptoms. Antibodies are immune proteins that mark the evolution of the host immune response to infection, and they provide an archive that reflects recent or previous infection. If maintained at sufficiently high levels, antibodies can rapidly block infection on reexposure, conferring long-lived protection.

Serology tests are not the primary tool for diagnosing an active infection, but they provide information essential to policymakers. They help determine the proportion of a population previously infected with SARS-CoV-2, providing critical information on infection rates at a population level, and providing information about populations that may be immune and potentially protected. Accurate assessment of antibodies during a pandemic can provide important population-based data on pathogen exposure, facilitate an understanding of the role of antibodies in protective immunity, and guide vaccine development. Population-level surveillance is also critical to the safe reopening of cities and schools.

..but not always in practice

Serology testing is not being used systematically, and in many EU countries there is still hesitation over putting in place the organisation and infrastructure to make it possible.

The European Commission has already pointed out that short-term EU health preparedness depends on robust testing strategies and sufficient testing capacities, to permit early detection of potentially infectious individuals and to provide visibility on infection rates and transmission within communities. Health authorities must also equip themselves to conduct adequate contact tracing and run comprehensive testing to rapidly detect an increase in cases and to identify groups at high risk of disease, it has said in its guidance. But at present, European countries are in many cases falling short and functioning sub-optimally.

Charles Price of the European Commission's health department, DG Santé, admitted that despite the recent intensive collaboration among European Union institutions and the member states, "We are still short of consensus on the best serology tests for particular jobs – to assess the level of infection, to inform vaccination strategies, or to inform clinical decision-making on individuals." These all depend on good serology testing, and the EU is trying to coordinate additional observation at country level of vaccinated populations to feed into evaluation of vaccines by the European Medicines Agency, he told the round table.

Hans-Peter Dauben, secretary general of Euroscan, the international health technology assessment network, also admitted that authorities are often too slow: "We don't have a model to improve our understanding of what is going on," he said. Serological data can be collected within existing systems, he said, but there is no consensus on how it can be used.

He pointed out that while there are multiple settings and scenarios where a diagnostic technology can be used, ranging from clinical usage on treatment decisions in outpatient and inpatient care, and in public health interventions on isolation, tracing and tracking, and epidemiology, "Each scenario requires a unique approach with a set of validation criteria located in the relevant decision-making context."

Exploring the questions

Given the current uneven degree of readiness and capacity among European countries to utilize serology testing technology, and the current absence of plans for systematic serological testing for surveillance, Horgan queried how far public health professionals and institutes understand the barriers and enablers to adoption of serology testing in vaccination surveillance systems. And he questioned whether revised recommendations were needed from the EU on testing strategies and on adaptations to different types of vaccines. "We need to know who to vaccinate and how to vaccinate, and we need to allocate resources accordingly," he said.

Achim Stangl, Medical Director at Siemens Healthineers, was concerned that there is insufficient information about what subpopulations particularly benefit from vaccination, such as immunosuppressed patients, lymphoma patients, or very young children. His colleague Jean-Charles Clouet insisted that there are still open questions on vaccines that only testing will elucidate: "The importance has not been fully grasped of showing the impact of vaccination on the immune system, and of conducting long-term monitoring to define an optimal immunity threshold." Latinis focused on the need to understand not only the immunity conferred by vaccines, but also how far and fast it wanes. Or as Stangl put it, "The big question is how long antibodies are present and able to provide immunity

The questions come in the wake of many similar expressions of concern and counsel. The International Coalition of Medicines Regulatory Authorities warned in 2020 of the need for "stringent regulatory requirements for Covid-19 studies" and agreed to provide guidance on the prioritisation of clinical trials and on serology in order to promote a harmonised approach. The US Centre for Disease Control has issued serology testing guidelines listing important applications in monitoring and responding to the COVID-19 pandemic.

The World Health Organisation states clearly that the use of serology in epidemiology and public health research enables understanding of the occurrence of infection among different populations, and how many people have mild or asymptomatic infection, and who may not have been identified by routine disease surveillance. It also provides information on the proportion of fatal infections among those infected, and the proportion of the population who may be protected against infection in the future. Information that might impact serologic recommendations is rapidly evolving, particularly evidence of whether positive serologic tests indicate protective immunity or decreased transmissibility among those recently ill.

What can be done?

Serology is the scientific study of serum and other body fluids. In practice, the term usually refers to the diagnostic identification of antibodies in the serum.[1] Such antibodies are typically formed in response to an infection (against a given microorganism),[2] against other foreign proteins (in response, for example, to a mismatched blood transfusion), or to one's own proteins (in instances of autoimmune disease). In either case, the procedure is simple.

Serological tests are diagnostic methods that are used to identify antibodies and antigens in a patient's sample. Serological tests may be performed to diagnose infections and autoimmune illnesses, to check if a person has immunity to certain diseases, and in many other situations, such as determining an individual's blood type. Serological tests may also be used in forensic serology to investigate crime scene evidence. Several methods can be used to detect antibodies and antigens, including ELISA,[4] agglutination, precipitation, complement-fixation, and fluorescent antibodies and more recently chemiluminescence.

All this increases the chances of monitoring the spread of Covid-19 infection. Vicki Indenbaum of the World Health Organization told the round table that serology will become more important not only before vaccination, but after vaccination takes place, to let public health decision-makers know exactly what is going on, and what proportion of population has been infected. It is, she said, an essential element to ensure trust between policymakers, professionals and the public. Sarper Diler, a Faculty Member Istanbul University Istanbul Medical Faculty in Turkey, similarly urged a more rigorous schedule of serology tests, "before vaccination, and some months after to see whether a booster shot is needed or not, and to see the impact on wider populations." He also called for development of wider array testing to detect antibodies as vaccines – and virus variants – evolve.

What's needed now

A co-ordinated response across Europe – and beyond – is needed now to ensure that serology can play its part in defending citizens against pandemic infections.

Diler emphasised the importance of communication with citizens to minimize fear and anxiety and non-compliance with preventive behaviour: "We have to find a common language to communicate, and right now it is lacking in Europe," he said. His point was reinforced by Latinis and Daubens, who both warned that a confusion of voices is distracting for strategy formation and implementation. Boccia too urged building trust among public and professionals so as to minimise the likelihood of vaccine hesitancy – and for this, she indicated, clarity over the mechanisms of vaccination is essential.

Some consensus emerged from the roundtables on the need for testing itself to be refined and stepped up. Serology assays should have the appropriate characteristics for assessment of need to vaccinate and vaccine response: an automated, scalable serology assay used in the context of vaccination should include key technical features for effective use: measurement of spike receptor-binding domain neutralizing IgG antibodies, very high (≥99.5%) specificity, and quantitative results.

The requirements also extend to infrastructure. This applies to capacity as well as to physical facilities. Availability at a large and accessible scale is key to ensuring that the needs of the population can be met. This would allow for measuring antibodies in relation to vaccine use for establishing a threshold for protection or immunity, for confirming an initial neutralizing antibody response shortly (approximately 1 week to 1 month) after vaccination, and for tracking of antibody levels (at approximately 3, 6, and 9 months and annually) following vaccination. In the event of limited vaccine availability, antibody assessment can also support decision making for administration to the most vulnerable populations.

Strangl pointed out that the unprecedented speed at which COVID 19 vaccines have been developed leaves the scientific community with very limited data on duration of effective immunity and safety, and on the variability of responses among minority and underserved populations, children and the elderly, "many of whom may not develop antibodies to one or another of the vaccines," he added.

In these circumstances, serology testing can prioritize the use of vaccine resources and inform long-term vaccination strategy. Prior to vaccination, it can help prioritize individuals for vaccination , establish serological baselines and help ensure scarce supply reaches the most vulnerable. Testing one week to one month after vaccination can confirm an initial neutralizing antibody response, and help ensure that the antibody response clears the threshold for immunity. Further testing 3 six and nine months after vaccination can confirm persistence and duration of immunity , and can provide the means 2 agree on abridged trial requirements for additional populations. And testing annually after vaccination can assess persistence and duration of immunity and inform requirements for future vaccinations.

As Stangl summarized it: "Successful implementation of broad serological testing will require the right tools." This means quantitive considerations to establish a protective threshold, assess response and monitor antibody levels overtime. It means testing of specificity high enough for investigating responses in low-prevalence populations, and capable of minimizing false positive results. And it means capacity, reach and speed for sufficient production to address large populations, a large fleets of immunoassay analyzers installed worldwide, and high analyzer productivity and ease of use.

The European Commission's Communication ‘Preparedness for COVID-19 vaccination strategies and vaccine deployment’ notes that “to monitor the performance of the vaccination strategies, it is essential for member states to have suitable registries in place. This will ensure that vaccination data is appropriately collected and enables the subsequent post-marketing surveillance and ‘real time’ monitoring activities. Member states should ensure that …vaccination registries are up-to-date". Dauben suggested that all vaccinated patients should be included on a mandatory registry to allow proper study of the effects.

Stefania Boccia of Milan's Università Cattolica del Sacro Cuore quoted the recommendations of the EU expert panel on effective ways of investing in health, including integrating information and communication technologies across care levels and public health, and investment in comprehensive resilience testing of health systems and sharing of lessons. She also highlighted findings from EU surveys of member states over recent months that show the still incomplete status of monitoring systems for vaccine coverage, safety, effectiveness and acceptance. Survey conclusions also note that recommendations will be updated "as more evidence becomes available about COVID-19 disease epidemiology and characteristics of vaccines, including information on vaccine safety and efficacy by age and target group."

A serology-defined threshold (from either natural infection or vaccination) remains a key need, and this periodic testing would offer additional data on antibody response patterns to determine optimal serology testing utilization. Longer-timeframe quantitative testing for waning levels of protective antibody, such as through annual testing, would inform the need to revaccinate/boost.

To bring these changes into play, policymakers will need evidence, along with data points needed to substantiate that evidence. A framework of panels of experts will have to be created in which guidance can be offered to support decisions on the use of serological testing. And as Latinis remarked, "It is ultimately up to us who uses serology testing to convince politicians to implement it."

And where should this go?

The round table concluded that this was a key moment for the development of a new approach to pandemic preparedness. The current spread of infection – lamentable though it is in its human consequences – provides an unprecedented scientific opportunity for improving understanding of immunity, vaccination and related mechanisms. With adequate, and adequately rigorous, testing in place, it will be possible to evaluate without risk of bias different populations being treated with different vaccines across the world.

To allow the benefits to accrue from this situation, data will have to be collected and compared from a wide range of studies, and at a truly global scale. This in turn will depend on all stakeholders being ready to operate outside and across the customary siloes that characterise the health community, and to adopt a common language based on a new literacy. But by extension of the EU's new ambition to build a European health union, and taking as a model such international concords as the Paris climate agreement or the UN framework convention on tobacco control, what could and should emerge is a co-ordinated international response to future health crises of this scale, in an international pandemic treaty.

European Alliance for Personalised Medicine

EAPM: Leviathan, or the rudder of public health

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Welcome, health colleagues, welcome to the European Alliance for Personalised Medicine (EAPM) update. In this edition, we take a good, close look at public health provision in the EU, assessing the ramifications of the problems that the size of public health policy has manifested, as well as our usual look at the health news, writes EAPM Executive Director Dr. Denis Horgan.

The great Leviathan

Is public health provision in Europe not big enough, or is it just too big? Certainly its huge size has enabled it to do great things for European citizens for many years. Three generations of western Europeans have enjoyed an increasingly comprehensive range of services that have improved the length and quality of life for many, to the extent that such provision has come to be taken very much for granted. And even in the EU's newer member states and its candidate countries, expectations have risen in line with – and often ahead of – growing prosperity and access to more extensive services.

But the size that public health policy has attained, together with the consequent complexity, also makes it very difficult to manage, to modify, and above all to rethink. The health system in Europe is indeed a leviathan – and as with supertankers, there are no possibilities of a light touch on the rudder to make quick changes to its course.

The time is coming when some agile navigation may be necessary. There are risks in policy complacency when public health provision is confronted with the massive changes in its context, ranging from demography and scientific advance to new technological possibilities and economic constraints unparalleled since the rise of post-World War II public health thinking. The depiction of public health provision as the great leveller, the guarantor of a minimum of care for everyone, is a compelling argument for the retention of a standardized, one-size-fits-all approach. Negligent watch-keeping on the supertanker's bridge, clumsy hands on the tiller, or indeed reliance on an inadequate or unresponsive tiller, could endanger rather than enhance the general good that public health policy is deemed to protect.

Striking the right balance for the common good necessitates taking full account of competing and even conflicting dynamics. An unthinking acceptance that everything is right as it is at present can lead to blindness over emerging risks. Depending on nursery-rhyme reflexes that if ‘the bough breaks, The cradle will fall’ may cause undue attention to be given to just one bough, overlooking both the possibility that cracks may appear over time and the chance that other and younger boughs – or different and more modern technology - may offer equivalent or better support. Unquestioning attachment to the concept of a homogeneous health system could hinder exploitation of opportunities that may arise for local or spontaneous improvements.

The European Union, as the overarching framework for policy formation in most of Europe, brings an additional complexity to discussions about public health. It is a powerful potential channel for informed reflection, and at its best, the EU could serve as a compass, a lodestone in plotting the voyage. But the search for consensus as the EU's constant operating principle can also stifle original thinking, so that at its worst the EU can obscure the horizon with a self-generated fog, or have the effect of barnacles encrusting the hull below the waterline. Specifically in the health field, the strict limitations on EU competence act as a further confounding factor, with responsibility for public health uncomfortably half in and half out of the realm of coherent planning.

The EU attachment to equality – as most recently enshrined in its approach to social affairs and its bill of rights – is laudable as a philosophy, but can run into problems in such a diverse organization, where national conditions vary so widely across the bloc. This raises the question as to what is the appropriate role for the EU, and whether its espousal of a generalization so simplistic as the common good of EU citizens constitutes a route-map for the best service in public health. There is a risk in ready-made slogans, particularly in areas of great complexity, significance and sensitivity.

So the undeniably admirable concern for public health needs some nuance to translate the ideal into practice, both to avoid it being used too bluntly and to prevent it being overshadowed by other policies. A balance difficult enough at national level. In the European context, a more selective approach to policy design may be even more necessary to keep public health policy finely attuned to real public good.

It is not certain that the EU has practiced that selectivity optimally. It has exercised some choices, and some of those choices have worked out better than others. The ban on smoking in public places resulted more from the issue of protection of workers than directly from public health policy. The effect has been beneficial, but it is striking that an obviously valuable public health policy came about uniquely through the exercise of a completely different policy competence.

Diversity of approach

The sheer diversity of approach confirms that there is no underlying logic or overarching perspective for making EU policy decisions on public health. Policy is often the result of random factors, a consequence sometimes of caprice more than of coherence. There is, for instance, a manifest reluctance by some in the healthcare community to make use of emerging technologies, to harvest the fruits of scientific research in new health applications that can treat the patients or the broader public. Just take the example of patients contributing to earlier diagnosis of melanoma by using their own smartphones, making the condition easier to treat – and then just look at how widely that is endorsed and supported across the member states.

As the stakes rise in ensuring sustainable health systems, the time is coming when a more sophisticated rationale will be needed to guide public health policy effectively – a more soundly based social contract to move forward, above all at EU level. Retaining public health as a sovereign member-state competence demonstrably has had adverse unintended consequences, and continues to do so. Most obviously, it has handed each member state an effective veto on any EU-wide joint approaches, because any country can simply invoke the sovereignty clause to bring any common action to a juddering halt.

COVID-19

Since the beginning of the pandemic, the EU has been working with member states to reinforce national healthcare systems and limit the spread of the virus. It has been coordinating action at EU level based on the best available science and giving recommendations to EU countries on public health measures. The EU's response in the field of public health includes increasing capacity for production of a safe and effective vaccine and through the EU vaccine strategy ensuring the provision of medical supplies and personal protective equipment.

There are the seeds of injustice in standing in the way of progress in something so fundamental to each person's rights as health care, and there are the seeds of something approaching an undemocratic élitism in brandishing 'public health' as a pretext for opposing change. And when the current uneasy status of health policy in the EU leaves action within it vulnerable to veto, then the rights are compromised of many who might wish to embrace change – such as those sharing a genetic characteristic or a rare disease.

The rudder that once acted to steer public health is no longer adequate to the job, and new thinking is needed to take advantage of opportunities that did not before exist.

Outgoing German Chancellor Angela Merkel said on 21 April that the European Union needs more power to coordinate the bloc’s response to health crises like the coronavirus pandemic, and did not rule out a treaty change to secure them. Her comments to an online meeting on the Future of Europe of fellow European conservatives raised eyebrows in Brussels, where the start of a large-scale public debate on the future of the EU has revived talk of reopening the bloc’s governing structure.

In other news…

Draft report on pharma strategy will be presented in ENVI committee in late May

MEP Dolors Montserrat will present a draft of the own-initiative report on the Commission’s pharmaceutical strategy to the the European Parliament’s health committee at the end of May, she said today (29 April).

“This requires an ambitious, clear and up-to-date regulatory framework as well as dedicated resource for science and health research,” said Montserrat, speaking at an event organized by the Portuguese EU Presidency and the European Commission. 

Health commissioner offers sweeping ambitions for pharma reform

No patient in Europe should have to go without medicines that he or she needs due to money or other obstacles, said Health Commissioner Stella Kyriakides today (29 April). 

Speaking at an event organized by the European Commission and the Portuguese EU presidency, Kyriakides pledged that EU’s pharmaceutical strategy will tackle the core issues that make medicines unavailable to those who need them. 

Kyriakides’ willingness to tear up the current rules may make drugmakers nervous, since they rely on perks like market exclusivity to protect their bottom line. The 2022 reform will take into account “the relationship with intellectual property rights to address aspects that impede the competitive functioning of markets,” she noted. “The failures of markets should not be the failures of our health systems.”

Parliament approves COVID-19 certificate position

The European Parliament adopted its position on the digital green certificates Brussels wants to use to reboot travel by proving holders got a jab, a test, or have antibodies following a coronavirus infection with a broad majority. In Wednesday’s (28 April) plenary vote, 540 lawmakers voted in favor of the position; 119 opposed and 31 abstained. Parliament’s position on certificates for third-country nationals got the backing of 540 MEPs, while 80 opposed and 70 abstained.

And that is everything from EAPM for now – have a safe, enjoyable weekend, stay well, see you next week.

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European Alliance for Personalised Medicine

EAPM: Lockdown loosening, third wave warnings

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Welcome, dear health colleagues, to the first post-Easter update from the European Alliance for Personalised Medicine (EAPM). We hope you all had an excellent break and, if you are based in one of the more fortunate countries such as the UK, that you are beginning to enjoy the release from coronavirus lockdown restrictions. EAPM certainly has some busy months ahead, looking forward to work on Next Generation Sequencing (NGS) and Real World Evidence (RWE). That is for the future – for now, here are the updates on the leading health stories of recent days, writes EAPM Executive Director Dr. Denis Horgan.

Not-quite Single Market for medicines

It’s not just inequalities in the distribution of vaccines that is causing worries. A group of MEPs have written to the Commission to push for more equitable access to medicines in the EU, maintaining that currently there’s no “no genuine Single Market for pharmaceuticals”. The current EU rules create unfair discrimination against member states with smaller health systems and pharmaceutical markets. The decision to effectively place a product on the member states’ markets is solely based on the pharmaceutical companies’ commercial and economic interests. While the current legislation provides the industry with the right to place their products on the markets of all member states, there is no mirroring right entitling the member states to get access to those products that have been authorised and placed on the EU Single Market.

It is a known fact that unfortunately private companies often have no interest or incentive to place a medicinal product in the small member states. This situation creates difficulty in accessing affordable medicines for certain patients, higher prices, and often even the withdrawal of particular products. This scenario which is faced by multiple states has resulted in a long-standing structural problem and most member states have joined regional groupings like the Valletta Declaration to try and combat this issue.

Long-term effects of COVID-19

What are the long-term side effects of COVID-19?

Most people who have had COVID-19 expect their symptoms to disappear after a few weeks, but some continue to experience effects months after recovery. People who suffer from persistent symptoms after recovering from the acute illness, also known as “long-haulers,” are often healthy prior to getting infected with COVID-19. This can occur in up to 10% of those infected with the virus.

Common long-term COVID-19 symptoms include:

  • Shortness of breath
  • A lingering cough
  • Chest pain and heart palpitations
  • Dizziness and lightheadedness
  • Fatigue with limited ability to exercise or even perform activities of daily living
  • Joint and muscle pain
  • Loss of taste and smell
  • Sleep disturbances with insomnia and sleepiness during the daytime
  • Gastrointestinal symptoms, such as difficulty swallowing, irritable bowel syndrome (IBS) and indigestion.
  • Depressed mood and anxiety

Because long-term effects of COVID-19 vary from person to person, it is difficult to determine when they will end. The best approach is to be evaluated by your physician or a specialized post-COVID clinic – especially if you have persistent symptoms that are affecting your quality of life. It is also important to seek help if symptoms of anxiety, fear and depressed mood develop.

Digital Green Certificates

The Digital Green Certificate will be a proof that a person has been vaccinated against COVID-19, received a negative test result or recovered from COVID-19. It will be available, free of charge, in digital or paper format. It will include a QR code to ensure security and authenticity of the certificate. The Commission will build a gateway to ensure all certificates can be verified across the EU, and support Member States in the technical implementation of certificates. Member States remain responsible to decide which public health restrictions can be waived for travellers but will have to apply such waivers in the same way to travellers holding a Digital Green Certificate.

Values and Transparency Vice President Věra Jourová said: “The Digital Green Certificate offers an EU-wide solution to ensure that EU citizens benefit from a harmonized digital tool to support free movement in the EU. This is a good message in support of recovery. Our key objectives are to offer an easy to use, non-discriminatory and secure tool that fully respects data protection. And we continue working towards international convergence with other partners.”

Germany’s ICU beds filling up

It has been noted that Germany's seven-day incidence rate had dropped, possibly because of the Easter holidays, but that the number of occupied ICU beds across Germany was increasing "much too quickly".

During the first wave of the pandemic, the German Interdisciplinary Association for Intensive Care and Emergency Medicine (DIVI) set up a central registry that records and publicizes the situation in hospitals, or rather in intensive care units, on a daily basis.

A glance at the current map shows that the situation is critical again in some towns and municipalities, meaning that less than 10% of intensive care beds are free — and in some cases none at all. DIVI President Gernot Marx gave a clear statement during a press conference: "Every single day counts; we quickly need a hard lockdown of two or three weeks to lower the number of cases and give us more time for vaccinations."

UK risks third wave

Experts are warning that the UK is risking a third wave as it reopens pubs, hairdressers, outdoor attractions and shops as of 12 April. While prevalence of COVID-19 has fallen to an average of 30.7 per 100,000 across the country, there are hotspots where that rate is double. “However, many people [in those areas] cannot afford to self-isolate,” said Stephen Griffin, of Leeds University medical school. “We need to tackle that issue urgently or the virus will come back again.”

Euthanasia bill fails in France

A bill that would have allowed euthanasia for people with incurable diseases failed last week in France’s National Assembly, despite clear majority support. Because the bill was put on the agenda on a day reserved for a minority group, the chamber had until midnight to pass it. To nip the bill in the bud, a handful of MPs wrote up thousands of amendments to it, making it impossible to debate in a single day.

Romanian hospitals under pressure

According to Romania Insider, Romanian hospitals are overwhelmed. Speaking on Sunday (11 April), Health Minister Vlad Voiculescu said that there were 167 children in hospital — 16 in intensive care — with the minister explaining that they were implementing several measures to manage the cases. According to local media, these include using beds in hospitals that the government had tried to keep for other conditions, such as a cancer institute and another facility for chronic conditions. Voiculescu urged people to wear masks, avoid crowds and stay at home to try and reduce pressure on the health care system. 

Best-case expectations for Q2

In a perfect world, the EU should receive around 470 million doses of approved vaccines by the end of the second quarter. Still, few EU officials believe everything will go according to plan. “We have seen from past experience all sorts of things can go wrong,” said one diplomat this week. One ongoing source of tension is that these second-quarter doses won’t be distributed equally across the EU, because some countries purchased fewer doses than they could have based on their pro-rata allocation. Many smaller and poorer countries, for example, banked heavily on the cheaper Oxford/AstraZeneca jab and purchased fewer mRNA vaccines. Richer countries, like Germany, Denmark and Malta, bought the surplus instead.

And that is everything for now from EAPM – stay safe, stay well, enjo lockdown easing if you can, see you later in the week.

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EU pharma rules, EAPM newsletter and treaties

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Another Easter is around the corner, a further EAPM dispatch for your delight and delectation…and more developments in the current COVID-19 crisis as a new holiday looms. With the aforementioned Easter weekend coming up, it will be interesting to see how many Europeans defy strong recommendations to stay at home. And taking into account the day that it is, EAPM’s newsletter is available here, writes European Alliance for Personalised Medicine Executive Director Dr. Denis Horgan.

In other news....

Changes to EU pharma rules en route

The European Commission has inched a little closer to the wide-ranging changes to EU pharma rules envisioned in its Pharmaceutical Strategy, publishing today (30 March) a document that sets out the objectives of upcoming policy reports and proposals on the topic. 

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. The Commission hopes to deliver the strategy over a number of years.

Its new Pharmaceutical Strategy seeks "to ensure affordable, safe, quality, innovative and solutions-oriented pharmaceuticals for all citizens in the EU", Vice President Margaritis Schinas announced at the strategy's unveiling.  The 25-page document is packed with technical suggestions to fine-tune Europe's pharma system, but the challenge will be to translate these into tangible changes for European consumers. Experts think the strategy — if properly implemented — has the potential to make drugs more affordable, boost the variety of treatments available, drive forward innovation and firm up supply chain resilience. 

COREPER vaccine controversies

An internal squabble with COREPER over extra vaccines was just the latest controversy as the EU tries to speed its inoculation campaign. The decision to seek arbitration among the ambassadors came after Austrian Chancellor Sebastian Kurz virtually sabotaged the meeting by insisting that his country receive extra doses, even though European Commission data shows Austria faring relatively well among EU nations in terms of vaccine supplies. 

Kurz in a corner

A discussion tomorrow (31 March) will focus on Austrian Chancellor Sebastian Kurz’s attempt to get more vaccines. On 12 March, the 34-year-old vehemently accused the EU of unfairly distributing vaccine doses among its 27 member states. 

Lashing out at the ‘EU bazaar’, he demanded adjustments in favor of member states that received less doses than others. Kurz took the dispute all the way to the European Council meeting in Brussels last week, taking precious time away from pressing issues on the agenda—transatlantic relations, a common vaccination “passport,” and possible vaccine export bans. German Chancellor Angela Merkel reportedly got so annoyed with Kurz that she reminded the group that vaccine contracts were signed by member states themselves “and not by some stupid bureaucrats” in Brussels.

Pandemic treaty push

Leaders from 23 countries, the EU and WHO today (30 March) backed a push for a new global treaty to better prepare the world to tackle future pandemics. The call came in an op-ed published internationally that was signed off by leaders from five continents, including Germany’s Angela Merkel, Britain’s Boris Johnson, France’s Emmanuel Macron, South Korea’s Moon Jae-in and South Africa’s Cyril Ramaphosa. “We believe that nations should work together towards a new international treaty for pandemic preparedness and response,” the op-ed said. 

“Such a renewed collective commitment would be a milestone in stepping up pandemic preparedness at the highest political level.”The push to bolster common efforts comes as the planet struggles to combine forces to overcome the COVID-19 pandemic that has killed almost 2.8 million people worldwide. 

The spread of the virus has seen blame traded between capitals and accusations that rich nations have hoarded vaccines as economies around the globe have been battered.

“Together, we must be better prepared to predict, prevent, detect, assess and effectively respond to pandemics in a highly coordinated fashion,” the leaders said. “At a time when COVID-19 has exploited our weaknesses and divisions, we must seize this opportunity and come together as a global community for peaceful cooperation that extends beyond this crisis.”

ECDC – immune transmission

More than one year into the SARS-CoV-2 pandemic, over 120 million people have been infected with the virus across more than 200 countries. Reinfections following natural infections with the same or a new SARSCoV-2 variant have been reported sporadically and questions remain concerning the duration of immunity following natural infection, and whether asymptomatic reinfected individuals may be able to transmit the virus.

COVID-19 vaccines have been evaluated for their efficacy and effectiveness against symptomatic COVID-19 infection and for reducing and/or preventing mild, moderate, or severe COVID-19 disease, including mortality. However, the vaccine trials have not been designed to measure reduction in transmission risk from infected vaccinated individuals to susceptible contacts.

In this context, it is important to understand the available scientific evidence on the extent to which previous SARS-CoV-2 infection or COVID-19 vaccination prevents onward transmission from infected individuals to susceptible contacts. Therefore, ECDC has conducted a review of published and pre-print literature on duration and characteristics of immunity following a natural SARS-CoV-2 infection due to any variant or after COVID-19 vaccination with any of the EU-authorized vaccines now available.

Evidence from studies specifically designed to assess the impact of previous infection on the risk of transmission is currently lacking. Infection with SARS-CoV-2 does not provide sterilising immunity for all individuals and some who are reinfected might still be able to transmit SARS-CoV-2 infection to susceptible contacts. 

There is evidence that reinfection remains a rare event. Results from cohort studies confirm that the protective effect of previous SARS-CoV-2 infection ranges from 81% to 100% from Day 14 following initial infection, for a follow-up period of five to seven months. Protection against reinfection is lower in individuals aged 65 years and older. 

As the number of individuals acquiring natural immunity increases, the total number of infections is expected to decrease significantly, leading to decreased transmission overall, unless the genetic changes in the circulating variants induce significant immune escape. 

Brain on centre stage

The launch of the OneNeurology Partnership, a new initiative from the European Federation of Neurological Associations (EFNA), has taken place — together with the European Academy of Neurology, European Brain Council, World Stroke Organisation and Alzheimer’s Disease International, the partnership is aiming to raise the profile of brain diseases. The goal is “to build political interest” so that the Commission and member countries pay attention to the disease group and start formulating national-level neurology plans. The Commission can act as an organizer and facilitator to co-ordinate different national plans. 

EU vaccine chief says vaccine passports to be launched in June

Internal Market Commissioner Thierry Breton, who back in February this year was put in charge of the new vaccine production task force by the Commission, has unveiled the prototype of the announced EU vaccine passports.

During an interview for RTL radio and TV channel LCI, Commissioner Breton also said that the new documents which will prove that the traveller has been vaccinated, recovered from COVID-19, or his/her test results in case none of the two first has taken place, will be issued to EU citizens somewhere in mid-June ideally.

“From the moment we can be sure that every European who wants to be vaccinated will have fair access to the vaccine, as will be the case in the next two to three months – it will be good to have a health certificate that demonstrates your condition,” the commissioner said.

The Commission brought forward its proposal for the creation of a Digital Green Certificate in a bid to restore travel amid COVID-19 for those who have been vaccinated against the virus, SchengenVisaInfo.com reports.

And that is all from EAPM for now – don’t forget to have a read of our newsletter here, and our very best wishes to you all for a safe and happy Eastertide. Here is the link to our newsletter again. 

Stay safe until next time.

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