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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: Successful IVDR meeting points the way to future collaborations

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Good afternoon, health colleagues, and welcome to the second European Alliance for Personalised Medicine (EAPM) update of the week, in which we discuss the successful In Vitro Diagnostic Regulation (IVDR) meeting conducted by EAPM yesterday (22 July), and other pressing health issues, writes EAPM Executive Director Dr. Denis Horgan. 

IVDR issues raised

Yesterday, EAPM was pleased to have conducted a successful meeting on In Vitro Diagnostic Regulation (IVDR), with more than 73 representatives from 15 countries participating as well as the European Medicines Agency (EMA) and member states’ representatives. 

The IVDR will come into force on 26 May 2022. There are a number of areas in which there is a lack of awareness or clear guidance to support implementation at member state level. The main areas of concern relate to two issues, namely the limited capacity within Notified Bodies to grant CE marking in a timely manner, with a bottleneck occurring in the approval of some IVDs which are likely to be used for patient selection for use with precision medicines. The Commission’s Medical Device Coordination Group (MDCG) Task Force is reviewing this.

In addition, a significant proportion of predictive testing in Europe to support access to oncology precision medicines is delivered through the use of laboratory developed tests (LDTs), and there will be a new legal requirement for labs to use commercially approved tests (CE-IVD) in place of their current LDTs. If there is no CE-IVD commercial test available, public laboratories may be able to use an LDT, subject to certain provisions in the IVDR. The lab will be required to meet all the relevant requirements for safety and performance, whilst carrying out the manufacture under an appropriate quality management system.

Although health institutions are broadly aware of the IVDR, further guidance for laboratories on compliance with its key provisions would be welcomed, particularly on the exemptions to the Regulation granted under Article 5. An MDCG Task Force has very recently been established to develop such guidance, although there is little time left for laboratories to prepare for the regulation. 

Another key issue was whether member states are expecting cost impacts as a result of the IVDR (incurred through either the switch from LDTs to CE-IVDs or the need to improve their laboratory’s quality and performance processes), and whether they have engaged with their national health authority or other relevant stakeholders on this issue. 

Finally, a key outcome of the meeting was the issue of how the regulation can facilitate some of the solutions that were proposed by member states’ representatives, and a meeting will be organized with the Commission and member states at a later date. 

On to other EU health news...

Making Europe fit for the digital age

The EU continues to lag behind China and the US when it comes to investments into key technologies such as artificial intelligence and quantum computing, the European Commission President Ursula von der Leyen has warned. “Europe is still punching well below its weight. I believe this is because of two main reasons. The first one obvious, a lack of investment,” she said. 

While European companies invest massively in research and development in sectors such as automotive or pharma, “our investment in other fields still lags behind the US and China” she added. “Artificial intelligence and quantum computing are two good examples, and due to this, far too many European startups in the tech world have had to leave the continent in order to scale up.”

Bulgaria creates patients rights’ body

Bulgaria’s council of ministers has given the go-ahead to the creation of a new directorate for patients rights under the health ministry. The new body will aid the health ministry in ensuring that patients rights are protected and work on creating programs and guidelines to improve patient protections. Generally, in Bulgaria the rights envisaged in the European legislative framework have been regulated. 

A person’s rights, including in a situation of illness (when a person is in the position of a “ patient” ) are part of the human rights regulated by the UN convention ratified in Bulgaria in 1992. 

The citizens of the Republic of Bulgaria are entitled to accessible health care and health insurance (Art. 52 ofthe Constitution, Art. 33, 35 of the Health Insurance Act (HIA)), healthy environ-ment and conditions of work, guaranteed food quality and protection against abuse of their personality. Each patient is entitled to obtain the best healthcare in conformity with the legislation. 

Cyber concerns on health 

Plans to set up an EU rapid-response cyber unit that could quickly respond to attacks like the recent ransomware hack of Ireland’s Health Service Executive (HSE) have been unveiled. Across Europe, cyberattacks rose 75% last year, with 756 such incidents logged, including an increasing number of attacks on health-care systems, representing a growing risk to society with critical infrastructure at stake, according to the European Commission. “We have a lot of cyber enemies around us,” 

European Commissioner Thierry Breton said. “Ireland’s public healthcare system suffered a pretty strong ransomware attack. I believe it affected a system with more than 80,000 computers, so that was something which was pretty, pretty strong. It could have been a very important plus, if we could have sent dedicated experts very quickly to react even faster, because we know that, of course, the longer you wait the worse it is.” 

The HSE expects it will take as long as six months to recover from the attack, with many hospital and patient data systems still affected. The cyberattack was part of a growing trend of attacks on critical systems, including on the Colonial Pipeline in the US.

Spain offers to test-run the EU's AI regulation

Spain has pitched itself to the European Commission as a laboratory to test the Artificial Intelligence Act - with more 117 AI ethics initiatives springing up around the world, initiatives to regulate artificial intelligence (AI) have sprung up around the world, spearheaded by the likes of Spain, OECD and UNESCO. It‘s time to harmonize and consolidate, a conference on AI ethics held under the auspices of Slovenia’s presidency of the EU Council heard this week. “We are clearly at a developmental point where you’ve got a lot of actors right now contributing to this movement from principles to practice, and we simply need to work together in a multistakeholder way to harmonize these approaches,” said David Leslie, of the Council of Europe’s Ad hoc Committee on Artificial Intelligence (CAHAI). 

WTO and WHO demand more vaccines

The World Trade Organization (WTO) and the World Health Organization (WHO) The World Trade Organization (WTO) have mapped critical inputs for the production of COVID-19 vaccines, in a bid to clarify complex supply chains for sourcing raw materials and components. The organizations this week published an indicative list of 83 inputs, most of which cover the manufacturing of coronavirus jabs, but also those relevant to storage, distribution and administration. It covers the vaccines produced by AstraZeneca, Janssen, Moderna and Pfizer-BioNTech, including product details and their likely HS codes when exported. The list was jointly produced with the Asian Development Bank, the OECD and the World Customs Organization, as well as representatives from the pharmaceutical industry, academia and logistics. It is subject to further modification and improvement depending on expert advice, the WTO says. The exercise was carried out amid concerns over the rate of vaccine production.

MEPs call for mutual recognition of intensivists

While Europe is getting ready to spend a second summer under the shadow of COVID-19, European decision-makers are pushing forward an ambitious agenda and preparing to deliver a more resilient and sustainable European Health Union. To make the best use of the hard-learned lessons from the pandemic, policymakers are now joining the call of the heroes of this unprecedented health crisis: the health-care workers in Intensive Care Units (intensivists) who came under enormous pressure and outdid themselves constantly to save lives. Pandemics don’t stop at our borders and Members of the European Parliament (MEPs) acknowledge the need for European solutions to a European problem. In a letter addressed to European Commission President Ursula von der Leyen, MEPs urge for intensive care medicine to be recognized as a main pillar of the new European Health Union. According to the MEPs, there is a lack of mutual recognition for intensive care medicine training among many EU countries, which prevents a fast and efficient European response in times of pandemics and other cross-border health threats.

Good news to end: EU countries double vaccine-sharing promise to 200M doses

EU countries have committed to sharing 200 million doses of coronavirus vaccines to low- and middle-income countries by the end of 2021, doubling a previous commitment.

The Commission has also pointed today to its other efforts to increase access to vaccines in Africa in particular, however the EU remains firmly opposed to a waiver of intellectual property rights for coronavirus vaccines.

That is all from EAPM for now – make sure you stay safe and well and have an excellent weekend, see you next week.

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European Alliance for Personalised Medicine

EAPM: Truly active summer ahead for EU health policy

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Good afternoon, health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week, in which we discuss the range of items ahead for the summer months as far as EU health policy is concerned, so it’s a busy time ahead for EAPM, writes EAPM Executive Director Dr. Denis Horgan. 

In-vitro diagnostic expert panel

And it is a busy week for EAPM, with an in-vitro diagnostic expert panel on Thursday (22 July). This deals with legislation that is due to come into force next year on 26 May, 2022 - the question will be how will this legislation have an impact on bringing innovation into health-care systems and being able to diagnose patients earlier? 

At present a significant proportion of predictive testing in Europe to support access to oncology precision medicines is delivered through the use of laboratory developed tests (LDTs), with the following implications under the IVDR, and there will be a new legal requirement for labs to use commercially approved tests (CE-IVD) in place of their current LDTs. If there is no CE-IVD commercial test available, public laboratories may be able to use an LDT, subject to certain provisions in the IVDR. 

The lab will be required to meet all the relevant requirements for safety and performance, whilst carrying out the manufacture under an appropriate quality management system. As a consequence, many laboratories may face additional procurement costs for commercially approved tests and/or the need to improve their safety and performance requirements for any LDT offerings.

All these issues will be discussed in the expert panel this Thursday through various case studies. A policy paper will be the outcome of this meeting so more on this in the months ahead. 

EU Health Union 

As discussed in the previous updates, the European Health Union package includes proposals to strengthen the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), and a regulation on cross-border health threats. 

Slovenia, who holds the EU Presidency now and its predecessors at the helm of the EU, Portugal and Germany, are working to finalize negotiations on three draft regulations that form the basis of the EU Health Union, Slovenian Health Minister Janez Poklukar has said. 

The desire is to co-ordinate the regulations in trialogue with other EU institutions as soon as possible, the minister added in a statement. The comments came after a high-level conference on implementing innovative solutions for resilient health systems that also featured the health ministers of Portugal and Germany, Marta Temida and Jens Spahn. Spahn said the shared objective of all three countries was to establish a trialogue with the European Parliament and the Commission. 

“We want actual results in practice,” Spahn added. Temida said it was essential that the work done by the German and Portuguese presidencies continues to produce good results and that the transition was smooth. 

She said adoption of the legislative package would mark “a significant milestone in Europe’s preparedness for extraordinary health events”. The Health Union package includes proposals to strengthen the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC), and a regulation on cross-border health threats.

Research and innovation 

The Commission has adopted its proposal for a Council Recommendation on ‘A Pact for Research and Innovation in Europe' to support the implementation of national European Research Area (ERA) policies.

This is an issue that the EAPM has followed closely. 

The Pact proposal defines shared priority areas for joint action in support of the ERA, sets out the ambition for investments and reforms, and constitutes the basis for a simplified policy coordination and monitoring process at EU and member states' level through an ERA platform where member states can share their reform and investment approaches to enhance exchanges of best practices. Importantly, to ensure an impactful ERA, the Pact foresees the engagement with research and innovation stakeholders. 

A Europe fit for the Digital Age Executive Vice President Margrethe Vestager said: “The pandemic has shown us the importance of uniting research and innovation efforts that swiftly bring results to the market. It has shown us the importance of investment in jointly agreed strategic priorities between Member States and the EU. 

"The Pact for Research and Innovation we propose today, will facilitate better collaboration and join our efforts to tackle research and innovation objectives that matter the most for Europe. And it will allow all of us to learn from each other.” 

New rules on open data and reuse of public sector information start to apply 

17 July marked the deadline for member states to transpose the revised Directive on open data and reuse of public sector information into national law. The updated rules will stimulate the development of innovative solutions such as mobility apps, increase transparency by opening the access to publicly funded research data, and support new technologies, including artificial intelligence. 

A Europe Fit for the Digital Age Executive Vice President Margrethe Vestager said: “With our Data Strategy, we are defining a European approach to unlock the benefits of data. The new directive is key to make the vast and valuable pool of resources produced by public bodies available for reuse. Resources that have already been paid by the taxpayer. So the society and the economy can benefit from more transparency in the public sector and innovative products.” 

Internal Market Commissioner Thierry Breton said: “These rules on open data and reuse of public sector information will enable us to overcome the barriers that prevent the full re-use of public sector data, in particular for SMEs. The total direct economic value of these data is expected to quadruple from €52 billion in 2018 for the EU member states and the UK to €194bn in 2030. Increased business opportunities will benefit all EU citizens thanks to new services.” 

Commission to make HERA proposal on 14 September

The European Commission will present its European Health Emergency Preparedness and Response Authority (HERA) package on 14 September. The COVID-19 pandemic demonstrated the need for co-ordinated EU level action to respond to health emergencies. It revealed gaps in foresight, including demand/supply dimensions, preparedness and response tools. 

A European HERA is a central element for strengthening the European Health Union with better EU preparedness and response to serious cross-border health threats, by enabling rapid availability, access and distribution of needed countermeasures. Last year, the Commission proposed changing the mandates for both the EU’s infectious disease agency and medicines agency, and made a proposal for a regulation on serious cross-border health threats.

Some good news to end: COVID-19 antibodies persist 'at least nine months after infection', study finds 

Antibodies in COVID-19 patients remain high even nine months after infection, according to a landmark study which tested almost the entirety of a small Italian town. The study, published in the journal Nature Communications, focused on the town of Vo which became the centre of the country's coronavirus pandemic in February 2020 when it recorded Italy's first death. 

Now, researchers from the University of Padua and Imperial College London have tested more than 85% of the town's 3,000 residents for antibodies against COVID-19. 

The researchers found that 98.8% of people who had been infected in the first wave of the pandemic were still showing detectable levels of antibodies nine months later, regardless of whether their infection had been symptomatic or not. Residents' antibody levels were tracked using three different "assays", or tests that detected separate kinds of antibodies which respond to different parts of the virus.

That is all from EAPM for now  - make sure you stay safe and well and have an excellent week, see you on Friday.

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European Alliance for Personalised Medicine

EAPM: Conference Presidency report now available, digital updates, Delta bringing new spikes

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Good afternoon, health colleagues, and welcome to the first European Alliance for Personalised Medicine (EAPM) update of the week, writes EAPM Executive Director Dr. Denis Horgan. 

Innovation, Public Trust and Evidence: EU Presidency Conference report 

On 1 July, EAPM held a virtual online bridging conference to inaugurate the shift leadership of the EU Council of Minister to the new Slovenian EU Presidency  – in line with what is now an established EAPM tradition, the conference provided a necessary bridge to ensure smooth continuation of reflections on its priority health issues across the shifts in leadership of the EU Council of Ministers. Coming immediately after the eventful Portuguese Presidency, and right at the start of the Slovenian Presidency, the meeting reviewed recent advances in personalised health-care innovation, in prostate and lung cancer and in securing patient access to advanced molecular diagnostics. 

Its title of ‘Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems’ also indicated EAPM’s other role as a bridge – in bringing together stakeholders from across the widest spectrum of health care, to seek common ground and consensus, and to candidly identify persisting divergences and challenges still to be overcome in implementing personalised care in Europe and beyond. 

Consequently, its panel of distinguished speakers from the research community, regulatory agencies, public health decision makers, clinicians, patients and industry attracted 164 delegates from an even wider range of disciplines. 

The link to the report is available here, and provides a detailed overview of the insights of each speaker as well as the recommendations. 

ENVI to vote on final HTA agreement 

Today (13 July), the Environment, Public Health and Food Safety (ENVI) Committee will cast final votes on the Health Technology Assessment (HTA) provisional agreement, following Slovenian Health Minister Janez Poklukar addressing ENVI on Monday to present the Presidency’s work programme in the health field. Poklukar reiterated the country’s health priorities. 

Chief among them is resilience against outside threats, which includes both “pandemic and large scale cyber attacks”. As MEP Veronique Trillet-Lenoir noted, the European Medicines Agency has been the target of hackers in the context of its vaccine approval process. The presidency will also focus on “the added value of EU level collaboration in developing and implementing innovative solutions for resilient health systems,” said Poklukar. HERA — the planned European Health Emergency Preparedness and Response Authority (HERA) — will also be a priority. 

Digital Markets Act

“The Slovenian presidency will aim for a targeted Digital Market Act, that is also quickly implementable,” said Slovenia’s Economic Development and Technology Minister Zdravko Počivalšek. He added that Slovenia aimed to achieve a general approach by November for a Competitiveness Council. On the regulatory side, the minister also pointed to the Digital Services Package as the main focus of the next Presidency. 

For both the Digital Services Act (DSA) and the Digital Markets Act (DMA), the Slovenian government has the ambition to broker a general approach at the Competitiveness Council that will take place in November. 

Data Governance Act 

In EU rules to bolster the data economy, the big data era has created valuable resources for public interest outcomes, like health care. In the past 18 months, the speed with which scientists were able to respond to the covid-19 pandemic—faster than any other disease in history—demonstrated the benefits of gathering, sharing, and extracting value from data for a wider good. 

Access to data from 56 million National Health Service (NHS) patients’ medical records enabled public health researchers in the UK to provide some of the strongest data on risk factors for covid mortality and features of long covid, while access to health records sped up the development of lifesaving medical treatments like the messenger-RNA vaccines produced by Moderna and Pfizer. But balancing the benefits of data sharing with the protection of individual and organizational privacy is a delicate process—and rightly so. 

Governments and businesses are increasingly collecting vast amounts of data, prompting investigations, concerns around privacy, and calls for stricter regulation. In a letter to TranspariMED dated 8 July, the Heads of Medicines Agencies (HMA), a network of the head of regulators in the European Economic Area, said it would be initiating joint action with the European Medicines Agency and the Commission to improve compliance. 

The letter comes just days after a report indicated that medicines regulators in 14 European countries are failing to ensure that data on new medicines is rapidly publicly available as required under EU rules. Explaining the reason for the non-compliance, the HMA said that it’s “a lack of knowledge of the European rules itself on the part of the sponsors that constitute the root cause.” The HMA’s management board is preparing an overview of actions that member countries are taking to improve compliance, to be circulated as a best practice document. 

WHO urges regulation on ethical genome editing 

On Monday (12 July), a World Health Organization (WHO) advisory committee called on the world’s largest public health authority to stand by the 2019 statement of its director-general urging a halt to any experiments that might lead to the births of more gene-edited humans. The committee — established in December 2018, weeks after news broke of the birth of twin girls whose genomes were edited by Chinese scientist He Jiankui — said in a pair of long-awaited reports that the germline editing technology that led to the ‘CRISPR babies’ scandal is still too scientifically and ethically fraught for use. But for other, less controversial forms of gene-editing, the reports offer a path to how governments might establish the technology as a tool for improving public health.

 “The framework recognizes that policies governing the technology will likely vary from country to country,” committee co-chair and former U.S. Food and Drug Administration commissioner Margaret Hamburg said at a virtual press conference. “Nonetheless the framework calls on all countries to incorporate key values and principles into their policies, such as inclusiveness, equal moral worth, social justice, responsible stewardship of science, solidarity, and global health justice.” 

Dealing with Delta - new EU spikes

The delta variant is the fourth variant of concern identified by the World Health Organization (WHO), first identified in India (April 2021) and it's quickly becoming the dominant variant across the world. It has now overwhelmed the medical ecosystem globally. Since then it has made its way to many countries in Europe. As per research, the Delta variant is the most transmissible form of the virus and mostly deadlier too. 

What makes Delta variant different and more dangerous from the other mutations is that it has many spike proteins that enable it to bind to our body cells more rapidly and efficiently. People infected with this mutation tend to transmit more of this virus around, and as a result of which it affects about 60% plus efficiently more than previous variants. 

Factually, all the coronavirus variants share many similarities, however, recent findings show that the delta variant causes more headache to start with, along with sore throat, runny nose, and fever. It was striking to notice that the traditional early symptoms of COVID-19 were observed lesser in this new variant, such as cough and loss of smell. People infected with this new variant have higher chances of being hospitalized as compared to the alpha variant. This can be easily understood considering the alarming death tolls all over the world. 

COVID still ‘troubling and dangerous’ WHO warns 

Dr David Nabarro of the World Health Organization (WHO) has told the UK’s Radio 4's Today programme the virus is "troubling and dangerous", that the "pandemic is advancing ferociously around the world" and that "I don't think we've anywhere near got through the worst of it". Asked about the government's switch to personal responsibility, as of 19 July, he said: "All this doesn't quite fit with the position that was taken by Britain, along with other nations, some months ago when there was a real effort to try to prevent large numbers of people getting the disease, partly because of the risk of death and partly because of the recognition of the risk of long COVID. 

"Yes, relax, but don't have these mixed messages about what's going on. This dangerous virus hasn't gone away, it's variants are coming back and are threatening those who have already been vaccinated - we have to take it seriously."

That is all from EAPM for now – don’t forget to check out our report on our latest virtual conference available here, and make sure you stay safe and well and have an excellent week, see you soon.

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