Written by Luisa Antunes and Clément Evroux.
| This paper is one of 11 policy responses set out in a new EPRS study which looks first at 15 risks facing the European Union, in the changed context of a world coming out of the coronavirus crisis, but one in which a war has been launched just outside the Union’s borders. The study then looks in greater detail at 11 policy responses the EU could take to address the risks outlined and to strengthen the Union’s resilience to them. It continues a series launched in spring 2020, which sought to identify means to strengthen the European Union’s long-term resilience in the context of recovery from the coronavirus crisis. Read the full study here. |
The issue in short: The challenge and the existing gaps
Cases and variants of concern
Cases
As of 7 March 2022, 450 million cases and 6 million deaths had been reported worldwide since the start of the pandemic. Of these, 115 million cases and 1 million deaths had been recorded in the EU. Although alarming, these numbers are still an underestimation, as vaccination and the emergence of new variants have led to an increase in asymptomatic cases and, consequently, to under-reporting and under-ascertainment. On a positive note, vaccination figures continue to grow, with 64 % citizens worldwide already having received at least one vaccine dose, and 75 % in the EU.
Variants
Four ‘variants of concern’ are currently circulating worldwide: Omicron, first identified in South Africa in November 2021; Delta, first identified in India in December 2020, and Beta and Gamma, first identified in September 2020 in South Africa and Brazil, respectively.
In addition, keeping the pandemic in check involves the constant monitoring of new ‘variants of interest‘ that could pose a future threat to global public health. At the moment, these include Mu, first identified in Colombia, and Lambda, from Peru. Both currently only show sporadic transmission in the EU and have an unknown impact on Covid-19 disease severity.
Omicron, currently the dominant variant in the EU, has emerged too recently for its epidemiology and pathogenicity to be fully understood. It seems to carry a five-fold higher risk of reinfection compared with the previous dominant variant, Delta. It is also more transmissible than Delta. This could be due to mutations in the spike protein that allow it to escape the host immunity more easily, as well as its increased ability to colonise the upper respiratory tract. In contrast, Omicron seems to show reduced disease severity compared with Delta, partly on account of slower growth in lung tissue. Four Omicron sub-lineages are currently in circulation. BA.1 is the current prevalent sub-lineage and BA.2 is steadily emerging worldwide, with the possibility of overcoming BA.1 in the coming months and delaying a current downward curve heading out to the summer. Several differences in the spike protein composition separate BA.1 from BA.2, with BA.2 reproducing twice as fast as BA.1 and seemingly more transmissible.
‘Long Covid’
Although the figures for infection cases, hospital occupancy and deaths are continuing to fall modestly in the EU, with Omicron seeming to cause less severe symptoms overall compared with previous variants, one aspect of the disease that is still not totally clear is the persistence of Covid‑19‑associated symptoms over more than three months (commonly defined as ‘Long Covid’). Reports differ depending on the methods used, but more than half of infected people have reported experiencing at least one chronic complication following Covid-19 infection, including type 1 diabetes, myocarditis and reduced respiratory capacity. In addition, many patients report extreme fatigue, memory issues, ‘brain fog’, tinnitus and depression. Research will continue to ascertain the biological causes and the full extent of the Covid-19 health impact, years into the pandemic. What is certain is that Covid-19 has the capacity to affect virtually all the organs of the body, to varying degrees of severity, and that these symptoms are a result of the viral capacity to infect the central nervous system, heart and lungs. Possible risk factors include type 2 diabetes, circulating SARS-CoV-2 mRNA fragments, Epstein-Barr virus viremia and specific autoantibodies. The differences between variants are not clear. However, vaccination has been shown to protect against ‘Long Covid’.
Medium-term scenarios
It is difficult to predict when the Covid-19 pandemic will evolve into an endemic state. The main factors involved are the parallel ‘race’ between increased immunity due to both natural recovery from infection and vaccination campaigns, and the emergence of new variants potentially able to escape acquired immunity. The World Health Organization (WHO) optimistically predicts an end to the acute phase of infection this year, if vaccination campaigns continue and the global vaccination rate reaches at least 70 % in the coming months.
Varied levels of vaccine distribution worldwide could hamper these plans, as higher topical virus circulation will serve as a hotbed for the emergence of new variants with the potential to escape immunity. In this regard, it could be argued that vaccine equity is an urgent goal that transcends local population needs and serves a common global interest of leading the way out of the pandemic.
Once it reaches an endemic state, Covid-19 could see an annual seasonal curve similar to that of influenza, with an autumn-winter peak in the EU. This tendency to seasonality has already started to emerge and is influenced by lower temperatures and intermediate relative humidity, which allow the virus to survive and remain in suspension in smaller water particles for longer periods of time, especially in closed environments with little aeration. Disease severity will depend on individual risk, affecting mostly the elderly, the immunocompromised and the unvaccinated. Of note, circulation in animal reservoirs, including domestic cats and dogs, could lead to the repeated emergence of new, immuno-resistant variants.
Preparedness and management
Crisis preparedness and management will depend on three main factors: the detection and surveillance of new variants; vaccination and therapeutic options; and voluntary protective behaviours (mask wearing, social distancing and isolation when showing symptoms or infection detected).
Surveillance
A possible solution for the under-reporting that arises with the asymptomatic cases that are more prevalent with Omicron is the surveillance of waste water. This strategy of random sampling allows continuous monitoring of viral circulation levels and the detection of new variants, while removing the logistical and socioeconomic burden of long-term active PCR (polymerase chain reaction) monitoring. It could be used in conjunction with more active monitoring in cases of sporadic local outbreaks, which will be a likely future scenario for Covid-19. In addition, it would concomitantly allow other common human pathogens to be monitored.
Vaccines and immunity
Vaccination has been shown to be successful in reducing the risk of severe and lethal Covid-19 (60‑70 % probability of protection from Omicron, with no decline). It also helps alleviate less severe symptoms, but with less probability and stability over time: protection from Omicron drops from 60 % to 10 % after five months, for both second and third doses; it is lower compared with other variants and wanes faster.
A fourth vaccine dose has been found to be useful in managing the disease, as it doubles protection against infection and quadruples protection against severe infection. However, even with variant-targeted vaccines, full protection has never been verified. Therefore, other protection measures, such as mask wearing, ventilation, and distancing, continue to be fundamental to preventing transmission and consequently dampening disease severity.
Therapeutics
A few treatment options for potential over-the-counter use are currently under review by the European Medicines Agency (EMA). Paxlovid, an antiviral pill developed by Pfizer, has received conditional marketing authorisation from EMA and is already being rolled out in the UK. It has shown 90 % efficacy in preventing hospitalisation and death. Lagevrio, a second antiviral option developed by Merck, is currently under marketing evaluation by EMA. Unfortunately, it shows only 30 % efficacy in preventing infection and could have associated mutagenic risks.
For severe and critically-ill patients requiring hospitalisation, several types of medicinal products are already available and at use in hospitals. These are classified as systemic corticosteroids, immunomodulatory agents, monoclonal antibodies against SARS-CoV-2 and antivirals.
Antibiotics will continue being prescribed for patients with suspected bacterial co-infections or secondary infections, which are quite rare.
Convalescent plasma, that is, the administration of plasma with antibodies from patients who have recovered from Covid-19, has not been recommended by the WHO, as its benefits are unproven.
Medium-term scenarios
It is difficult to predict when the Covid-19 pandemic will evolve into an endemic state. The main factors involved are the parallel ‘race’ between increased immunity due to both natural recovery from infection and vaccination campaigns, and the emergence of new variants potentially able to escape acquired immunity. The World Health Organization (WHO) optimistically predicts an end to the acute phase of infection this year, if vaccination campaigns continue and the global vaccination rate reaches at least 70 % in the coming months.
Varied levels of vaccine distribution worldwide could hamper these plans, as higher topical virus circulation will serve as a hotbed for the emergence of new variants with the potential to escape immunity. In this regard, it could be argued that vaccine equity is an urgent goal that transcends local population needs and serves a common global interest of leading the way out of the pandemic.
Once it reaches an endemic state, Covid-19 could see an annual seasonal curve similar to that of influenza, with an autumn-winter peak in the EU. This tendency to seasonality has already started to emerge and is influenced by lower temperatures and intermediate relative humidity, which allow the virus to survive and remain in suspension in smaller water particles for longer periods of time, especially in closed environments with little aeration. Disease severity will depend on individual risk, affecting mostly the elderly, the immunocompromised and the unvaccinated. Of note, circulation in animal reservoirs, including domestic cats and dogs, could lead to the repeated emergence of new, immuno-resistant variants.
Preparedness and management
Crisis preparedness and management will depend on three main factors: the detection and surveillance of new variants; vaccination and therapeutic options; and voluntary protective behaviours (mask wearing, social distancing and isolation when showing symptoms or infection detected).
Surveillance
A possible solution for the under-reporting that arises with the asymptomatic cases that are more prevalent with Omicron is the surveillance of waste water. This strategy of random sampling allows continuous monitoring of viral circulation levels and the detection of new variants, while removing the logistical and socioeconomic burden of long-term active PCR (polymerase chain reaction) monitoring. It could be used in conjunction with more active monitoring in cases of sporadic local outbreaks, which will be a likely future scenario for Covid-19. In addition, it would concomitantly allow other common human pathogens to be monitored.
Vaccines and immunity
Vaccination has been shown to be successful in reducing the risk of severe and lethal Covid-19 (60‑70 % probability of protection from Omicron, with no decline). It also helps alleviate less severe symptoms, but with less probability and stability over time: protection from Omicron drops from 60 % to 10 % after five months, for both second and third doses; it is lower compared with other variants and wanes faster.
A fourth vaccine dose has been found to be useful in managing the disease, as it doubles protection against infection and quadruples protection against severe infection. However, even with variant-targeted vaccines, full protection has never been verified. Therefore, other protection measures, such as mask wearing, ventilation, and distancing, continue to be fundamental to preventing transmission and consequently dampening disease severity.
Therapeutics
A few treatment options for potential over-the-counter use are currently under review by the European Medicines Agency (EMA). Paxlovid, an antiviral pill developed by Pfizer, has received conditional marketing authorisation from EMA and is already being rolled out in the UK. It has shown 90 % efficacy in preventing hospitalisation and death. Lagevrio, a second antiviral option developed by Merck, is currently under marketing evaluation by EMA. Unfortunately, it shows only 30 % efficacy in preventing infection and could have associated mutagenic risks.
For severe and critically-ill patients requiring hospitalisation, several types of medicinal products are already available and at use in hospitals. These are classified as systemic corticosteroids, immunomodulatory agents, monoclonal antibodies against SARS-CoV-2 and antivirals.
Antibiotics will continue being prescribed for patients with suspected bacterial co-infections or secondary infections, which are quite rare. Convalescent plasma, that is, the administration of plasma with antibodies from patients who have recovered from Covid-19, has not been recommended by the WHO, as its benefits are unproven.
Existing policy responses
European health union package
The European health union initiative draws on the lessons learned from the pandemic. It aims to strengthen the EU’s health security framework, while also reinforcing the crisis preparedness and response role of key EU agencies. It is composed of a set of legislative and non-legislative acts[i] that are all directly relevant to the tasks and governance of the Health Emergency Preparedness and Response Authority (HERA).
HERA has been set up to strengthen the EU’s ability to prevent, detect, and rapidly respond to cross-border health emergencies, by ensuring the development, manufacturing, procurement, and equitable distribution of key medical countermeasures (i.e. vaccines and therapeutics). An early milestone of this cooperation is VACCELERATE, the first EU-wide network for Covid-19 vaccine trials, launched as part of the HERA incubator. Preparedness efforts also include forming resilient industrial capacities to ensure timely and commensurate supply of counter-measures. HERA will establish EU FAB, a network of ‘ever-ready’ multi-technology production capacities for vaccine and therapeutics manufacturing in the EU. The objective is to unlock a production capacity of 700 million doses of vaccine, of which 50 % within six months following the breakout of a crisis situation.
HERA activities will cover preparedness and crisis phases. This will lead to governance based on two main operation modes (preparedness and crisis). This calls for smooth interplay with other EU institutions and agencies (such as the EMA or the ECDC), Member States and stakeholders. Through their recovery and resilience plans, Member States are expected to contribute further to resilience and preparedness.
Future cross border health threats could also be of a non-infectious nature. HERA will conduct a technology review and gap analysis on antimicrobial resistance (AMR) medical countermeasures (expected towards the end of 2022). These new capabilities complement the Commission’s EU ‘one health’ action plan against AMR, which aims to promote best practices for antimicrobials and boost research and innovation. The European Food Safety Authority (EFSA) also plays a key role in fighting AMR by monitoring resistance in food and animals. For this it uses data from Member States, and provides independent scientific advice on risk assessments in collaboration with the ECDC and EMA. HERA also plans to monitor human-made threats such as a bio-terrorism, including chemical, biological, radiological and nuclear (CBRN) threats.
Tackling the infodemic
The Covid-19 pandemic broke out at a time when the profile and impact of misinformation and disinformation are facilitated by various trends, including digitalisation. The EU had already adopted initiatives to tackle the phenomenon. For instance, in 2016, the Commission and the High Representative/Vice-President of the Commission (HR/VP) set out a joint framework on countering hybrid threats. The Covid-19 pandemic magnified the global reach and risks of this trend, to the extent that the WHO adopted the concept of ‘infodemic‘ (i.e. too much information including false or misleading information in digital and physical environments during a disease outbreak). In 2021, the Commission included ‘improving the coordination and sophistication against disinformation’ as one of the top 10 lessons drawn from the pandemic.
Obstacles to implementation
Beyond pandemics
It is important to bear in mind the threat of risk aggregation, between risks to health and other risks identified in this report. For example, semiconductor supply chain interruption (and in an extreme situation, collapse of the internet) could have a major impact on health systems, and vice versa, as seen during the Covid-19 pandemic. In this regard, the EU Chips Act will pool resources and provide a new framework to ensure security of supply, and HERA plans ensure the availability of critical technologies and production sites for medical countermeasures. Furthermore, the risk of extreme weather events brought about by climate change, like the floods seen across the Benelux region and Germany in 2021, could cause widespread fatalities.
This further highlights the need for a single EU approach to health, as the health of the human population and of the planet go hand in hand. Similarly, international conflicts may hamper the effectiveness of the international dimension of the EU’s vaccine strategy. Acting together as ‘Team Europe‘, the EU, its Member States, and financial institutions, in particular the European Investment Bank and the European Bank for Reconstruction and Development, is expected to invest over €3 billion to help secure 1.8 billion doses of vaccines for 92 low and middle-income countries in 2021 and 2022.
Policy proposals by experts and stakeholders
HERA has been commented on by several stakeholders’ organisations. The European Public Health Alliance (EPHA) has stressed the global relevance of HERA’s activities. According to EPHA, HERA’s results should, where relevant, reflect the public good dimension, as well as ensuring affordability, accessibility and availability. A network of 19 pan‑European organisations representing patients, consumers, health professionals, and civil society, coordinated by the European Alliance for Responsible R&D and Affordable Medicines, have voiced their preference for an inclusive and transparent governance scheme, to allow all interested actors to take part, including patients.
Under the Conference on the Future of Europe, European Citizens’ Panel 3: ‘Climate change and the environment / Health’ adopted several recommendations relevant to HERA, including for instance recommendation 43, which will be taken forward to the Conference Plenary: ‘We recommend that the European Union increases its budget dedicated for joint research and innovation projects in the area of health (without budget cuts in other EU health-related programmes). This would also strengthen European scientific and research institutions overall’.
Position of the European Parliament
Health Emergency Preparedness and Response Authority (HERA)
While supporting the aims of HERA in general terms, Parliament – in its October 2021 resolution on EU transparency in the development, purchase and distribution of Covid-19 vaccines – criticised the Commission’s decision to refrain from using the ordinary legislative procedure through Article 168 TFEU in setting up HERA, thus failing to establish HERA as a fully-fledged independent agency subject to the same scrutiny requirements as other agencies, such as the EMA and the ECDC. The Parliament regretted ‘the fact that the Commission’s approach, which has led to Parliament being excluded from designing and overseeing the work of HERA, can be regarded as yet another shortcoming that has undermined transparency and accountability for public spending and decision-making in the area of public health’.
Parliament further stressed the importance of accountability, including parliamentary monitoring of HERA, in its November 2021 resolution on a pharmaceutical strategy for Europe. None of the European health union proposals and initiatives has been subject to a formal impact assessment. In this context, the Parliament’s monitoring competence, such as budgetary control, will be key to assessing the effectiveness and efficiency of the European health union’s implementation, including HERA’s activities. However, the evaluation framework developed under the health union differs significantly from that established under the US Pandemic and All Hazards Preparedness Act. While the US legislator ensures congressional oversight of the evaluation by including several provisions that require the assistant secretary for preparedness and response also to report annually to the ‘relevant committees of Congress’, the European Parliament committees are not mentioned in connection with a review of HERA. Article 8 of the Commission decision establishing HERA mentions only an obligation for the Commission to report to the European Parliament, to the Council and to the HERA Board on a review of implementation of HERA’s operations by 2025.
In terms of HERA’s mandate, Parliament has adopted various resolutions that either make direct reference to, or offer relevant guidance on, HERA. In its July 2021 resolution on trade-related aspects and implications of Covid-19, the Parliament emphasised the key role played by public sector resources, allowing pharmaceutical companies to de-risk the whole vaccine value chain; it also considered that a multilateral intellectual property rights (IPR) framework could offer the protection and incentives that are critical for preparedness against future pandemics. In its May 2021 resolution on accelerating progress and tackling inequalities towards ending AIDS as a public health threat by 2030, Parliament encouraged the Commission and the Member States to explore the decoupling of research and development spending from the price of medicines, for instance through the use of patent pools, open source research, and grants and subsidies. In its above-mentioned November 2021 resolution on a pharmaceutical strategy, Parliament considered that HERA should initiate and support the development of innovation, establish an EU-level list of medicinal products of major therapeutic interest, facilitate their production within the EU, promote their joint purchase, and build up strategic stocks of these medicines.
In November 2021, the Parliament reflected further on HERA when adopting its first reading position on the proposal for a regulation on serious cross-border threats to health. In particular, the Parliament adopted several amendments aimed at ensuring HERA’s visibility in different key processes and schemes established, and at facilitating the coordination with the set of bodies to be established under the proposal for a regulation on the emergency framework of measures for ensuring the supply of crisis-relevant medical countermeasures.
Infodemic
The European Parliament has been tackling the infodemic situation since the early phase of the Covid-19 pandemic. With the resolution of 17 April 2020, it stressed that disinformation surrounding Covid-19 is a major public health problem and that everyone should have access to accurate and verified information.
In its resolution of 24 November 2021 on a pharmaceutical strategy for Europe, the Parliament stressed the importance of strategic public information, to facilitate the dissemination of knowledge and solutions, beyond the health dimension of the ‘infodemic’.
Furthermore, with its resolution of 11 November 2021 on ‘Strengthening democracy, media freedom and pluralism’, it highlighted that independent and high quality journalism and civil society organisations play a crucial role as guardians of democracy and the rule of law by holding power to account and fighting disinformation and misinformation.
Health beyond the Covid-19 pandemic
The rising incidence of non-communicable diseases (NCDs) places a major burden on European healthcare systems, costing €700 billion in treatment each year. The development of the EU’s capabilities for health monitoring, research, and data analysis through the European health union could contribute to better understanding and coordination to combat NCDs. For example, cancer is the second leading cause of mortality in the EU (after cardiovascular diseases), with 2.6 million diagnoses and 1.2 million deaths every year. To address this, one main pillar of the European health union is Europe’s beating cancer plan, which will have a budget of €4 billion to improve early detection, ensure equal access to diagnosis and treatment, and improve quality of life of patients and survivors. MEPs on the Special Committee on Beating Cancer (BECA) considered this plan ‘a first step towards a real European Health Union’. At its final meeting, BECA Members voted overwhelmingly in favour of the rapporteur’s report, which contains over 1 500 amendments to the plan, arranged across 10 proposals.
Other NCDs, such as obesity, cardiovascular diseases, and mental health disorders, do not currently have dedicated EU action plans. Nevertheless, other proposed initiatives under the European health union, such as the pharmaceutical strategy and the European Health Data Space, will help to fight these by ensuring, respectively, access to affordable medicines, and better cross-border access and interoperability of health data that could underpin medical research and innovation.
| In focus Managing the risks of the Covid-19 pandemic remains a challenge, not least because of the emergence of new variants, and unequal worldwide vaccination distribution. While EU vaccination rates have reached three quarters of the population, new SARS-CoV-2 variants keep emerging in the EU. Although these variants appear to be generally less severe, they still pose challenges to health systems: the risk of reinfection is enhanced and transmissibility appears to be higher than with previously dominant variants. At the same time, new variants are likely to continue to emerge until strategies for worldwide vaccination are effective. Furthermore, the frequency and effects of ‘Long Covid’ (defined as the persistence of SARS-CoV-2-associated symptoms for more than three months) are still under evaluation, requiring further investigation. Although several drugs to treat SARS-CoV-2 infection have been approved and show effectiveness, vaccination remains the most effective tool against the emergence of new variants and to limit the effects of long Covid. The implementation of a globally effective vaccine strategy therefore remains key to enhancing Europe’s resilience. If measures are successful, it is expected that Covid-19 – while still present – will enter a stage of seasonality, characterised by higher case numbers in the winter months, similar to the flu. To achieve this and manage the pandemic, rethinking present surveillance and monitoring schemes, ensuring the distribution of vaccines worldwide and implementing an action plan against disinformation and misinformation could be important milestones. |
Possible action
