Quarterly Newsletter:

September 2022

Issue #5

Editorial

When COVID-19 was declared a pandemic in early 2020, it became clear that this would be a public health threat of unseen before scale, creating significant challenges for patients, health systems, governments and industry. Although we now have a much better understanding of the disease and how to control it, COVID-19 continues to be a threat. And it’s not the only one we face today – monkeypox has been declared a Public Health Emergency of International Concern by the World Health Organization, polio has been detected in sewage and wastewater samples in London and New York, and AMR continues to claim lives every year. These threats, potential environmental (natural disasters, climate change) and geopolitical risks, drive the need to build more resilient supply chains for critical medicines. 

The COVID-19 pandemic has shown the importance of a flexible and agile framework (e.g., regulatory requirements) for the development, production and delivery of medicines and vaccines.  

A resilient global supply chain is therefore essential for public health. This should be supported by policies to strengthen it further, both at national and EU level. 

A resilient supply chain is the adaptive capability of a supply chain to prepare for and/or respond to disruptions, to make a timely and cost-effective recovery, and therefore progress to a post disruption state of operations – ideally, a better state than prior to the disruption [1]. Particularly during a health emergency, the supply of raw materials and reagents must be maintained. Medicines and vaccines may also need to be reallocated from one place to another in response to rapidly evolving situations and to allow for equitable access. At the same time, maintaining the continued supply of other healthcare products remains critical. As emergencies can result in sudden surges in demand for medicines, supply chain should be capable of reacting – for example by increasing capacity and reallocating inventories where required.   

Vaccines are particularly complex biological products with hundreds of ingredients and, in most cases, with long lead times. They are a highly effective prevention tool that has been instrumental in tackling the pandemic – COVID-19 vaccines are estimated to have saved 20 million lives in their first year [2]. There are several lessons we can learn from this experience. For example, continuous dialogue between manufacturers and governments can help to minimise supply chain bottlenecks; giving access to relevant information and data can help forecast demand more accurately; and regulatory flexibilities could allow accelerated development of high-quality new medicines and facilitate a faster increase of manufacturing capacities.  

In contrast, increasing the requirements for national stockpiles would be a much less efficient approach, significantly adding to the potential for waste and undermining efforts to optimise supply allocation through cross-border re-distribution in response to demand.  

The swift evolution and the growing complexity of the environment makes global supply chain management difficult to handle. The resilience of the supply chain demands flexibility and agility which should be supported by the local or regional (European Commission) regulatory authorities. These flexibilities have been implemented with success to the benefit of patient and public health during the COVID-19 pandemic. A comparable approach could bring significant benefit for public health if implemented in a routine context. As part of the proposed permanent solutions supported by Vaccines Europe, adopting common EU packaging for vaccines, replacing the paper Patient Information Leaflet with an electronic leaflet, and Point of Delivery technology deployment could be among the efficiency boosters of the supply chain.  

The upcoming revision to the pharmaceutical legislation presents a unique opportunity to unlock barriers to resilient supply chains of high-quality vaccines and support better and faster access to life-saving products like vaccines.

[1] Tukamuhabwa, Benjamin R., Stevenson, Mark, Busby, Jerry and Bell, Marta (2015) “Supply chain resilience: definition, review and theoretical foundations for further study”. International Journal of Production Research https://doi.org/10.1080/00207543.2015.1037934

[2] Watson OJ et al. (2022) "Global impact of the first year of COVID-19 vaccination: a mathematical modelling study" The Lancet Infectious Diseases https://doi.org/10.1016/S1473-3099(22)00320-6

Key Figures

Vaccines Europe External Engagement

• Public Roundtable: The benefits of Public-Private Partnership generated RWE for vaccine monitoring - Lessons from DRIVE - DRIVE Project Annual Forum - watch here or read a recap here.
• The Iron Curtain of Vaccination in Europe: barriers and opportunities for tackling E-W inequalities - webinar by ReThink Health - watch here.

What's next?

• Heads of Medicines Agencies (HMA) meeting under the Czech Presidency of the Council of the European Union, 21 September
• European Health Forum Gastein, 26-29 September 
• Annual EU Flu Day, 12 October 2022
• World Vaccine Congress Europe, 11-14 October
• European Public Health Conference, 9-12 November
• Expert meeting on vaccination by the Czech Presidency of the Council of the European Union, 21-22 November

Communications Highlights

A vaccine expert on miracles, misinformation and missing data

Interview with Sibilia Quilici for Brunswick Group

In this interview, the Executive Director of Vaccines Europe talks about COVID-19 vaccines development, manufacture and equitable access, the impact of the pandemic on routine immunisation, strengthening national immunisation schedules and vaccine misinformation.

Addressing vaccine supply challenges in Europe

The COVID-19 pandemic has revealed the vulnerabilities of the vaccine ecosystem that lead to a decreased availability of high-quality, safe, and effective products for everyone. Vaccine shortages represent an increasing concern in the EU and worldwide, and the causes are multiple and inter-connected. Finding solutions can be done only through a concerted effort and continuous dialogue of all key stakeholders.

In a recent publication, we identified the 6 main causes of vaccine shortages in Europe. Throughout autumn, we're running a social media campaign diving into each root cause, including expert views, interesting facts and our set of recommendations.

Vaccines common EU packaging and electronic leaflet

Vaccines are critical for people's health and they need to be supplied in an efficient and timely manner. In Europe, all vaccine packaging components, including the immediate packaging, carton and Patient Information Leaflet, have to be translated into all 24 official EU languages. This enormous language diversity creates inefficiencies in the supply chain and may limit our ability to respond to vaccine shortages. 

Find out more about these issues in this infographic and this video explaining the vaccine packaging process. In addition, this video explores the implications of the current vaccine packaging process in a crisis. To help solve these issues and improve access to the population, we recommend adopting a common EU packaging and replacing the paper Patient Information Leaflet with an electronic leaflet.

With children going back to school in September across Europe, it is crucial that they receive their immunisations on time and in full, to ensure they are protected against life-threatening diseases. The value of paediatric and adolescent vaccination will be a key topic in our communications this month.

The new COVID-19 Omicron-adapted vaccines have been approved in the EU, and vaccination campaigns will be rolling out throughout autumn. In light of this, we will explore how lessons learned from the COVID-19 pandemic can help us prepare for the challenges of tomorrow, and we are #AlwaysInnovating to help keep people healthy. Going beyond COVID-19, it is important to recognise the value of vaccination throughout the life course. We will share stories to highlight that vaccines have done amazing things, but even more incredible is what we may never have to see #VaccinesForLife

Health Policy Highlights

Czech Presidency places immunisation high on the health agenda

On 1 July, the French Presidency of the Council of the EU passed the torch to the Czech Presidency, which will chair the Council until the end of 2022. The Presidency programme outlines a number of important health priorities that will be high on the agenda over the next few months, including addressing the humanitarian crisis related to the large numbers of refugees from the Russian aggression against Ukraine and continuing the work on establishing a European Health Data Space. 

Also among the priorities is the plan to present Council Conclusions on vaccination, which we understand will focus in particular on the implementation of the lessons learned from COVID-19. We hope that the Council Conclusions will send a clear political signal on the steps needed to combat the trend of declining vaccination coverage – as indicated during a recent informal health ministers’ meeting on 6-7 September. 

Vaccination and robust immunisation programmes across Europe are essential elements of strong and sustainable healthcare systems, which has never been as clear as during the COVID-19 pandemic. However, vaccine hesitancy is a serious, growing problem which can be a barrier to realising the full potential of vaccination. We hope that the Expert Meeting on Vaccination taking place on 21-22 November under the Czech Presidency will be fruitful in starting to address these issues from a European perspective. You can read more about Vaccines Europe’s position here. 

Path cleared for the adoption of the serious cross-border threats to health regulation 

The draft regulation on serious cross-border threats to health (SCBTH) is a key part of the European Health Union (EHU) package aiming to ensure better protection from the infectious diseases of today and tomorrow. Along with other EHU initiatives such as the creation of the new Health Emergency Preparedness and Response Authority (HERA), the stronger mandate provided to the EMA and the ECDC, we believe that the SCBTH regulation will be instrumental in improving Europe’s crisis preparedness. 

The SCBTH regulation will bring the establishment of coherent EU-level and national response plans, strengthened ECDC surveillance and monitoring functions as well as a new early warning and response mechanism. During emergencies and on a case-by-case basis, it will also allow the Commission to conduct EU-level joint procurement of medical countermeasures. 

The COVID-19 experience has led to many lessons learned which should be the foundation of upcoming work to improve the EU’s response to crises. For example, continued and proactive dialogue between various stakeholders – including industry – proved very successful during the pandemic, for example in detecting challenges related to the supply of vaccines, as well as identifying policy options to address such challenges. To enhance informed decision-making and improve EU-wide coordination for the future, it will be crucial to continue in this spirit of collaboration. 

As Vaccines Europe, we also want to reiterate that any future measures foreseen on joint procurement of vaccines as well as stockpiling should be strictly limited to pandemics or other serious cross-border health threats. These measures should have a clearly defined scope, and also be feasible and sustainable. While joint procurement is an important mechanism for Europe to secure more equitable access and improved security of supply, due to the complexity of the vaccine ecosystem it is not a feasible solution for more sustainable supply of routine vaccines in Europe in general. Fundamentally, it would create further delays in access to such vaccines if introduced.  

You can read more about our position on joint procurement here, and also watch our video on market access pathways here. 

Vaccine companies join COVI Committee MEPs to discuss lessons learned from the pandemic 

On 5 September, the European Parliament’s COVI Committee held a Public Hearing with the senior representatives of four pharmaceutical companies, including Vaccines Europe member companies AstraZeneca, Sanofi and Moderna. 

The hearings were an opportunity for an exchange with MEPs on lessons learned from the COVID-19 pandemic, as well as recommendations to prepare for future health crises. The rapid development of safe and effective vaccines saved millions of lives during the COVID-19 crisis, and we greatly welcome the role many MEPs played supporting the legislative steps that made this possible. 

As emphasised by the panellists, it will only be possible to prevent the next pandemic through strong collaboration between the public and private sector. This will make it possible to act on the key learnings from COVID-19 – such as the need to support R&D and manufacturing at scale, carrying out comprehensive planning, adoption of regulatory flexibilities, protecting intellectual property rights, ensuring appropriate liability frameworks, providing the Health Emergency Preparedness and Response Authority (HERA) with appropriate funding, and supporting open supply chains. 

Beyond the hearing itself, you can read more about the lessons learned from COVID-19 in Vaccines Europe’s joint paper with EFPIA here. It gives more detail explaining why it is so important to maintain the focus on vaccines that emerged during the pandemic; this needs to translate into increased uptake of routine vaccines. Coverage rates fell dramatically during the pandemic, and must not only recover to pre-COVID levels, but should exceed these. Furthermore, while joint procurement proved effective in the exceptional circumstances of the pandemic, overall joint procurement would not be an appropriate solution beyond a crisis situation, such as for routine vaccines. 

To this end, we are looking forward to a planned follow up meeting on 10 October, to which the COVI Committee has invited representatives from Vaccines Europe’s members CureVac, GSK, Novavax and Pfizer. 

President von der Leyen takes stock of recent achievements and looks ahead 

On 14 September, European Commission President Ursula von der Leyen gave her annual State of the Union address at the European Parliament – a much awaited event where the President takes stock of recent achievements and outlines the Commission’s priorities for the year ahead.  

The speech focused on the war in Ukraine and its consequences, with First Lady of Ukraine, Olena Zelenska, in attendance. As President von der Leyen stated, it was the first time the State of the Union took place in the context of a war raging on European soil. Europe’s determined and immediate response to the war in Ukraine was praised, and the President promised continued support, underscoring that the sanctions are here to stay and announcing new financial aid.  

She continued to put the spotlight on issues currently high on the political agenda, such as the energy crisis, climate, and economy. The importance of working together with countries on challenges such as climate change and digitalisation was emphasised, for which the President referred to the Global Gateway project as a success story, already delivering on the ground with the creation of two mRNA vaccine factories in Rwanda and Senegal.  

Throughout the speech, the President reinforced the message of a Europe in unity, in solidarity and in action, which was particularly demonstrated in the post-pandemic recovery, in which the vaccine industry played a crucial role.  

We look forward to the publication of the Commission’s 2023 Work Programme expected in October, and remain committed to working together with the Commission next year and beyond, towards a healthier and more resilient Europe for future crises. 

Vaccination has been a major issue over the past two years, especially in the context of the COVID-19 pandemic, which has shown us in full detail that our society and healthcare systems are not prepared for a crisis of this magnitude. However, every crisis is also an opportunity, and we can say that many things have been improved or accelerated. 

At the level of the Czech Republic, it is worth mentioning the major progress in the digitalization of healthcare. Thanks to the work of the Institute of Health Information and Statistics, for example, an online system providing data on the ongoing pandemic, the number of hospital admissions and, subsequently, the vaccination coverage of the Czech population was prepared in a relatively short period of time. E-prescriptions, e-sick leave, and online medical consultations became more common. In the area of clinical trials, centralized or teleconference monitoring became available. The pandemic precipitated the adoption of amendments to the Act on Electronic Healthcare, which constitutes the legal basis for effective and secure information sharing in healthcare and electronic communication between healthcare professionals and between healthcare professionals and patients.  

The pandemic has also made it very clear how important prevention and public awareness are. The  AIFP, in collaboration with the State Institute for Drug Control and other experts, created a series of educational materials focused on COVID-19 for the professional and lay public, and engaged in active promotion of vaccination against not only COVID-19 but also other diseases through proactive media statements, exclusive interviews, and TV appearances. The Association also organized several press and professional meetings to discuss, among other things, the challenges and visions of vaccination, a topic that had been overlooked by the state in the Czech Republic in previous years. 

Together with experts, we agreed that there is a crucial need for targeted, repeated, educational communication about the importance and benefits of vaccination as an effective prevention tool, which will be understandable to the general public, as is the case in some other EU countries. We also need to work on evidence-based medicine communication with the professional public, modernizing the vaccination calendar or increasing vaccination coverage (especially in areas where the Czech Republic does not achieve the necessary vaccination rates, e.g., HPV, influenza). 

We should prepare ourselves to deal with COVID-19 in the years to come. I believe, however, that thanks to effective treatment and systemic support for prevention in the form of vaccination, we will be able to mitigate the impact of the crisis both in terms of the consequences on the quality of life of society and in terms of the economic impact. 

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Director Scientific and Medical Affairs

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What We Are Reading & Watching

Dropping the dogma: Europe can support patients and innovation - a blog by Nathalie Moll, EFPIA Director General

European Parliament’s special committee on COVID-19 (COVI) meetings:

• Debates with ECDC, HERA and chief epidemiologists - here
• An exchange of views with Sandra Gallina, Director-General for Health and Food Safety, and EU Health Ministers from Finland, Belgium and Romania - here
• A debate with representatives of civil society organisations - European Public Health Alliance (EPHA) and European Consumer Organisation (BEUC), followed by an exchange with the European Ombudsman - here

Overview of the implementation of COVID-19 vaccination strategies and deployment plans in the EU/EEA - a report by the European Centre for Disease Prevention and Control (ECDC)

Long-term qualitative scenarios and considerations of their implications for preparedness and response to the COVID-19 pandemic in the EU/EEA - a report by the European Centre for Disease Prevention and Control (ECDC)