Quarterly Newsletter:

April - July 2021

Issue #1

Editorial

COVID-19 has put vaccines and the vaccine industry in the spotlight like never before. It has not only revealed the full complexity of the vaccine ecosystem, but also motivated a strong emotional response at all levels.

One thing is clear: the vaccine industry has worked non-stop from day one of the pandemic to deliver safe and effective vaccines in record time around the world. In any crisis – especially one of unprecedented scale – there is a tendency to look for simplistic narratives and play the blame game. But this is at odds with facts and figures. It has been 1.5 years since the WHO was first informed of unexplained cases of pneumonia in Wuhan (31 December 2019). Since then:

Globally:

• 3.3 billion vaccine doses produced globally
• 83 operational production sites (many in Europe!)
• 300+ partnerships/agreements established between large pharmaceutical companies and contract manufacturing organisations, in both developed and developing countries

In Europe:

• 4 approved vaccines
• Over 438 million doses distributed
• More than 371 million doses administered

This unprecedented feat could never have been achieved so quickly without a strong research-based pharmaceutical industry (the role played by IP* here is undeniable); an unprecedented collaboration among all stakeholders (this should be a key lesson learned from the pandemic); and the infinite commitment of those still working relentlessly to find solutions to end the pandemic and allow everyone to go back to a new normal life. Let’s not forget that in the end, this is all about people!

With COVID-19 vaccines now available to many (and access rapidly increasing around the world), the challenge remains to ensure they are used to create a wall of protection for those who cannot be vaccinated.

With over 4 million deaths globally, there is no room for complacency.  Viruses do not respect borders, but rather thrive on fragmented immunisation policies. The best protection vaccines can offer can only be achieved if there is no hole in the wall of protection.

Beyond COVID-19, resilient healthcare systems and economies rely on vaccines across the entire life course. Vaccines are one of the most cost-effective public health tools, saving lives both young and old. They save money for healthcare systems, support freedom of being and movement, thereby boosting the whole economy. They also contribute to the fight against AMR and vaccine-preventable cancers.

This is why Vaccines Europe’s overarching mission is to drive a sustainable and resilient vaccine environment in Europe, protecting people against infectious diseases at all stages of life. Three pillars underpin this:

1. Driving innovation in vaccines through supportive, competitive and sustainable policy and regulatory environments for vaccine development, manufacturing and supply
2. Ensuring recognition of the value of vaccines and vaccine innovation, and translating this into timely and broader market access
3. Building resilient immunisation systems to increase vaccine coverage rates at all stages of life

As Vaccines Europe marks its 30th anniversary, I hope that we can count on the support of EU policymakers and other partners to help achieve these objectives for the benefit of Europe’s citizens. Ultimately, let’s all remember: an ounce of prevention is worth a pound of cure!

*IP – Intellectual Property

Sibilia Quilici, Executive Director Vaccines Europe

Key Figures

Vaccines Europe celebrates its 30th anniversary this year. Take a look at some of our members' most memorable moments over the last 3 decades, as well as what we're looking forward to in the future.

Save The Date

Vaccines Europe will host a virtual event bringing together representatives from EU and national institutions and agencies, civil society and industry, to discuss how to strengthen Europe’s leading role in public health and crisis preparedness, leveraging the implementation of the European Health Union.

Communications Highlights

IP Waiver

Strengthened collaboration is how we beat this pandemic, not by waiving patents

Patents have not been a limiting factor in ramping up vaccine production, and relying on patent waivers – such as the proposal currently being discussed at the WTO level – will not solve the huge challenges that we currently face.

In fact, intellectual property has played a pivotal role in fighting this pandemic. It has spurred on unprecedented innovation, with more than 200 clinical trials and nearly 300 partnerships and collaborations among manufacturers worldwide (Airfinity data here).

This framework has led to astonishing results: 4 vaccines approved by the EMA, and production increased from zero to 4 billions with 3.5 billion doses of COVID-19 vaccine administered globally as of  July 2021 – set to rise to 11 billion by the end of 2021 (Airfinity data here). This will be enough doses to vaccinate the world’s adult population. However, COVID-19 vaccines currently are not equally reaching all priority populations worldwide and the urgency today is to ensure people have timely access to these vaccines.

Our commitment, and what policymakers can do

Manufacturers, governments, and non-governmental organisations must work together to take urgent steps to further address this inequity. Immediate action must focus on stepping up responsible dose sharing and maximising production without compromising quality or safety.

Vaccines Europe has signed a joint commitment which called on manufacturers, governments, and non-governmental organisations to take immediate action to advance COVID-19 vaccine equity, proposing 5 steps to take – 1) step up dose sharing, 2) continue to optimise production, 3) call out trade barriers to be eliminated, 4) support country readiness, and 5) drive further innovation – with urgency.

EFPIA and Vaccines Europe conducted extensive media outreach on the WTO IP waiver issue with 533 media mentions reaching an audience of around 2.56 billion.

European Health Union

Vaccines Europe welcomes the Commission's ambitious European Health Union package. The package was first unveiled with three initiatives– the ECDC’s revised mandate, the EMA’s revised mandate and the Serious Cross-Border Health Threats Regulation (SCBHT). These represent a crucial opportunity to take onboard the lessons learned from COVID-19 and strengthen Europe’s resilience and preparedness. The package also includes the planned proposal for a Health Emergency Response Authority (HERA), and is linked to the Pharmaceutical Strategy and Europe's Beating Cancer plan.

ECDC – read our full position here

We strongly support many of the original proposals, such as the expansion of the ECDC’s role in epidemiological surveillance, the creation of a platform to monitor vaccine safety and effectiveness, increased preparedness planning, reporting and auditing. We call for extended and continuous engagement between the ECDC and industry, while ensuring sound regulation to avoid any unnecessary perception of conflict of interest. We also hope that the ECDC is empowered to take relevant decisions by itself.

EMA – read our full position here

It is essential that the revision of the EMA’s mandate establishes appropriate regulatory pathways to allow for regulatory approval of vaccines as soon as possible after the declaration of an emergency (e.g. a mock-up dossier). Furthermore, we hope that the proposed Steering Group on Shortages of Medicines involves manufacturers and other supply chain stakeholders on a permanent basis. Finally, we call for appropriate regulatory mechanisms to promote collaboration while preserving commercially sensitive information and technical know-how.

SCBHT – read our full position here

The SCBHT Regulation should limit any future measures on joint procurement and/or stockpiling of vaccines to pandemic threats. Joint procurement is not a feasible solution for more sustainable supply of vaccines in Europe in general. There are several root causes of shortages (such as sudden increases in demand, suboptimal forecasting, inflexible purchasing requirements), and joint procurement as used today does not address these. The prospect of stockpiling also raises a number of important challenges regarding vaccines characteristics and global supply dynamics.

HERA – read our full position here

HERA could be a core pillar of a robust European preparedness system to tackle current and future health emergencies. To achieve this, we are calling for an ambitious and sustainable proposal. This entails a scope that is both reactive (current pandemics) and proactive (future threats), a mandate that focuses only on areas in which existing incentives cannot ensure better results and that gives the agency a coordinating role, linking all activity stages in the R&D process (risk assessment, early development, late development, regulatory pathways, manufacturing, purchasing and stockpiling) as well as appropriate funding and an adequate intellectual property framework to bring vaccines or other therapeutic solutions to market.

Other key topics

While we want to keep this update concise and deep dive on two topics in particular, Vaccines Europe has responded to many of the major EU public health initiatives currently under consideration. If you would like to hear more from us, take a look at our website, or look at some of the positions below:

• Our position on the joint procurement of vaccines in Europe
• Our response to the Pharmaceutical Strategy
• Our response to Europe's Beating Cancer Plan 

The support of the Vaccine Manufacturers Associations to COVID-19 national immunisation – example from Austria

While nearly 20 vaccines are available today to prevent infectious diseases across the lifespan (from birth to grave) on routine basis, many EU members states have not considered adult immunisation as a priority and were not ready in many ways to implement rapidly a new mass vaccination programme in time of pandemics in the adult population while COVID-19 vaccines doses started to be delivered.

Whereas vaccines are recognised as one of the most cost-effective public health tool, and the COVID-19 pandemic highlighted the exactitude of this statement, immunisation funding represents a ridiculously small proportion of total healthcare spend in Europe (median 0.3%).

In Austria, only a defined number of paediatric vaccines up to the age of 14 years old is offered for free. Adult immunisation is normally not reimbursed – these are on the-so-called private market without any reimbursement.

Vaccines against tick-borne encephalitis (TBE) are the only “adult” vaccines which are covered by the sick fund (partial reimbursement). Having these key facts in mind, it is not surprising that in Austria, there is not a high awareness for adult vaccination resulting in low vaccination coverage rates (VCR). This situation is well reflected with influenza vaccination coverage rates as low as 8% during the 2019/2020 influenza season, far from the 75 % coverage target laid down in the Council recommendations on seasonal influenza back to 2009!

In this worrying context, the Austrian Vaccine Manufacturers Association (ÖVIH) together with health experts supported the implementation and the roll-out of COVID-19 vaccination by delivering an extensive educational programme on COVID-19 vaccines. Initiated in autumn 2020, this programme included broad COVID-19 media outreach composed of conferences, press releases, fact sheets, 1:1 media briefings and media toolkits (e.g. with focus on technologies, complexity of the vaccine production). Materials have been made available on the association website.

As result, the initiative gained high media coverage with more than 100 media inquiries within 6 months, more than 45 interviews given and invitations to live TV-shows and more than 150 articles providing reliable information on COVID-19 vaccines. This contributed significantly to building vaccine confidence in COVID-19 vaccines in Austria and demonstrated that the Austrian Vaccine Manufacturers Associations is a reliable industrial partner to tackle confidence issue related to vaccines.

What We Are Reading & Watching

A forward looking public private collaboration to fit with a new vaccine era: an article by Sibilia Quilici, Executive Director Vaccines Europe, in the most recent European Files issue

Value-based Vaccination: What Is the Cost of Non-vaccination for Public Health?: a webinar by the World Federation of Public Health Associations

Vaccine hesitancy and uptake. From research and practices to implementation: a report by Joint Action on Vaccination

Immunization funding across 28 European countries: a paper published in Expert Review of Vaccines