Quarterly Newsletter:

July 2023

Issue #8

Editorial

The COVID-19 pandemic has been a stark example of how people’s lives can be significantly affected by an infectious disease. Even though COVID-19 is no longer a Public Health Emergency of International Concern (PHEIC), it continues to circulate in the population, putting people’s health at risk and pressuring healthcare systems. We cannot afford to forget the lessons learnt from the pandemic – one of which has been around the importance of vaccine innovation.  

To continue benefitting from vaccine innovation, the EU needs to prioritise immunisation and foster the right environment for it. Currently, there is limited funding available in Europe for vaccine research, yet this early investment is crucial for nurturing vaccine innovation. Furthermore, we need the right infrastructure in place, including a skilled workforce, to develop, manufacture and supply new innovative vaccines. During the COVID-19 pandemic, regulatory flexibilities such as rolling review were adopted, and extending them beyond emergency situations would also encourage vaccine R&D. Lastly, ensuring greater coordination and accountability of Member States to provide more timely and equitable population access to innovative vaccines, and an EU-wide policy prioritisation of immunisation would make Europe a more attractive place for the vaccine industry to invest.

Vaccination has been widely recognised as one of the most effective healthcare prevention tools we have available today, saving millions of lives every year. Thanks to vaccination, we have eradicated smallpox, eliminated polio from nearly every region in the world and controlled many other infectious diseases such as measles, rubella and pertussis. We’re at a pivotal time when we have the opportunity to formally recognise vaccination’s contribution towards public health too – but this is not an easy task. 

It is no secret that the vaccine ecosystem is incredibly complex and currently, there are numerous disparities across the continent. This is why in our recently published Manifesto we’re calling for an EU Immunisation Strategy to ensure people are protected from vaccine-preventable diseases at every stage of life. Our mission is an innovative, healthy and prosperous Europe. 

Vaccines Europe Manifesto

Vaccines Europe launched its Manifesto, calling on the EU to put in place an #EUImmunisationStrategy for an innovative, healthy and prosperous Europe

Immunisation is paramount for building more resilient and sustainable health systems, serving as a powerful tool that prevents sickness, saves lives, saves money, and contributes to strong economic growth and more resilient communities. It is an investment that delivers innovation, health, and prosperity. 

This is why we're calling for an EU Immunisation Strategy, including:

• Promoting forward-thinking policies that foster innovation and establishing a framework for transparent, inclusive and regular exchange between all relevant stakeholders in decision-making;
• Putting in place life-course immunisation targets;
• Setting appropriate financial targets to increase financing of national immunisation programmes.

Key Figures

Vaccines Europe External Engagement

Events we participated in

• Europe's Tomorrow: Vaccination and Prevention Summit - event by Think Young (Brussels), 28 June
• Pharmacists and immunisation, protecting the future generation - webinar by EPSA, 28 April
• Fulfilling public health mission: Vaccination and the role of pharmacists - workshop by Vaccines Europe at the 44th EPSA Annual Congress  (Slovenia), 22 April
• Presentation of the study "Perception of the Value of Vaccines" - event by APIFARMA (Portugal), 20 April

Communications Highlights

World Immunisation Week

Vaccine innovation is instrumental for protecting people's health and building resilient healthcare systems. For people to benefit from the innovative vaccines that are in development, time to access needs to be reduced across Europe. Finally, a shift in mindset is needed towards adopting a lifelong immunisation approach across the entire vaccine ecosystem, to make sure people are protected against vaccine-preventable diseases at every stage of life, including in adulthood. During this year's World Immunisation Week, we communicated on these topics and how they are interconnected, emphasising on the value of vaccination.

The complexity of vaccine manufacturing

The vaccine manufacturing process is long and complex, involving multiple steps. In May, we published a new paper that looks into how long it takes to produce different types of vaccines, and what might delay, as well as improve the production process. We also communicated on the different stages of the manufacturing process, the importance of investing in diverse technology platforms and the crucial role of resilient global supply chains.

Time for Europe to prioritise preventive health

An article in Health Europa Quarterly

"Vaccine confidence has fallen to pre-pandemic levels but there is a need and value in boosting immunisation for people of all ages", says Sibilia Quilici in an article for Health Europa Quarterly. Read more about how we can capture the momentum from the COVID-19 pandemic, the importance of preventive health and the need for timely data. 

#AdvancingImmunology

Vaccine innovation

Vaccination brings health benefits at every stage of life and for every population. Listen to this interview with Sibilia Quilici, part of ITN Business' Advancing Immunology programme, where she discusses how vaccine innovation can help tackle the health challenges of today and tomorrow.

Health Policy Highlights

European Commission unveils landmark pharmaceutical reform

After several delays, the European Commission has finally presented its proposals to revise the European Union's General Pharmaceutical Legislation, also known as the pharma package. The reform would change the EU's 20-year-old rules for producing and authorising pharmaceuticals, including new provisions on IP, environmental protection and packaging.

As Executive Director Sibilia Quilici has pointed out, vaccines are regulated within the same legislative framework as all medicinal products. It is therefore important that the EU's pharma strategy adopts a more holistic approach to health, from prevention to care. Vaccination is one of the greatest healthcare interventions in human history and is crucial to creating healthy and resilient societies.

The value of vaccines has been confirmed during the COVID-19 pandemic, on the frontlines of major health crises caused by war and earthquakes, and as a tool to fight outbreaks of infectious diseases. Looking to the future, vaccination can make a real difference in facing challenges such as ageing populations, antimicrobial resistance (AMR), geopolitical instability and climate change.

In light of this, Vaccines Europe welcomes the inclusion of a new definition of a 'vaccine' that recognises the innovation happening in the field of prevention of infectious diseases. Other positive steps include futureproofing the regulatory framework through leveraging several lessons learned from the COVID-19 pandemic, such as the establishment of the temporary marketing authorisation and the transition to electronic product information.

However, there are also significant points of concern for vaccine innovation, such as reduced baseline regulatory data protection (RDP) from 8 to 6 years and linking additional protection to access, comparative clinical trials and a narrow definition of unmet medical needs. These provisions could hurt the EU's global competitiveness in the years to come. In the upcoming negotiations, it will be key to ensure that vaccine specificities are taken into account, such as the heterogeneous processes for providing access across member states.

The revision of the General Pharmaceutical Legislation is a once-in-a-generation opportunity to equip Europe with the necessary tools to address health challenges of today and tomorrow. Vaccines Europe will engage with all stakeholders in an open dialogue to ensure the EU's new pharma rules recognise the real value of vaccination and incentivise vaccine innovation.

For more insights, read Vaccines Europe's response to the pharma package.

Health ministers recognise the value of vaccines to fight AMR

EU health ministers in Council have adopted a Recommendation endorsing European and national actions to combat antimicrobial resistance (AMR) in a One Health approach. The Recommendation includes targets to reduce antimicrobial use by 2030, including a 20% reduction in total human consumption of antibiotics. EU countries are encouraged to strengthen national action plans to implement these targets and monitor antimicrobial consumption (AMC), including indicators to assess progress.

The Council recognises vaccines as "cost-effective powerful tools to prevent communicable diseases" that reduce AMR infections and AMC. To this end, ensuring access to vaccines and promoting their use is critical. The ministers call for implementation of national immunisation programmes to effectively prevent vaccine-preventable diseases and for the development of vaccines targeting antimicrobial-resistant pathogens.

The EU can only achieve the target of a 20% reduction in antimicrobial use by 2030 if this is tied to actions promoting immunisation and implementing the WHO's Immunisation Agenda. This includes sustainable immunisation financing, linking national immunisation programmes with AMR action plans, as well as monitoring of vaccination uptake for all vaccines at national level. There is also a need to raise awareness among healthcare professionals and the general public on the role of vaccines in fighting AMR and invest in researching new vaccines against antibiotic-resistant bacteria.

What We Are Reading & Watching

Increasing risk of mosquito-borne diseases in EU/EEA following spread of Aedes species - a news item by the European Centre for Disease Prevention and Control (ECDC)

Fluzine: ESWI's 2023 Young Scientist Award Winners - a newsletter by The European Scientific Working group on Influenza and other Respiratory Viruses (ESWI)