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Opening statement by Stanley Erck European Parliament – ​​Hearing of the COVI committee Delivered on October 10, 2022

Introduction

Good afternoon. My name is Stan Erck and I am President and CEO of Novavax. First of all, I want to thank the esteemed committee for giving me the opportunity to be here. The partnerships between governments and businesses present today have made possible the unprecedented response to the COVID-19 pandemic. The work this committee will do to advance these lessons is critically important to being prepared for future pandemics, and Novavax looks forward to contributing.

Novavax is a biotechnology company that promotes improved global health through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. Our protein-based COVID-19 vaccine, Nuvaxovid™, is licensed in over 40 countries. Nuvaxovid is the first and only protein-based COVID vaccine currently available in the EU. Our vaccine offers a differentiated option to individuals and serves to diversify the vaccine portfolio in Europe.

Our company

Unlike many other biopharmaceutical companies, Novavax focuses exclusively on the development of life-saving vaccines to fight infectious diseases. Over the past ten years, we have refined our recombinant protein platform technology and adapted it to various emerging diseases.

We know vaccines don’t save lives, vaccinations do. To realize the benefits of vaccines, there must be robust uptake. Access to and availability of COVID-19 vaccines, as well as public confidence in the safety and efficacy of these products, are critical to adoption. And to that end, Novavax is committed to transparency and accountability. Our company has been transparent about our clinical trial protocols and scientific data, which we believe is one of the best ways to ensure public confidence in any vaccine that is ultimately licensed and whose use is recommended.

We also know that pandemics do not respect country borders, and while there will be a global surplus of COVID-19 vaccines, that will not always be the case. Novavax is committed to providing reasonable prices, equitable distribution and allocation, and expanded access to vaccines.

Our COVID-19 vaccine in the EU

In early 2020, our scientists knew that our protein-based platform could be applied to address the emerging threat of SARS-CoV2, and we started working on our candidate. Just two years later, Nuvaxovid has been licensed for use in over 40 countries.

The European Medicines Agency granted conditional marketing authorization for Nuvaxovid in December 2021. This approval was for vaccination to prevent COVID-19 in adults aged 18 years and over.

In July, this authorization was expanded for use as a primary series for adolescents aged 12 to 17, and in September, the authorization was further expanded for use as a booster for adults aged 18 and over. more, regardless of their vaccination history.

We continue our research and development to make Nuvaxovid widely accessible to all populations. This summer, we launched a clinical trial to assess the safety and efficacy of two doses of the Novavax COVID-19 vaccine in young children aged six months to 11 years, followed by a booster six months after the primary vaccination. Additionally, we have begun studies to evaluate a combination vaccine against COVID-19 and influenza, as it appears there may be a need for recurring boosters to combat both COVID-19 and seasonal influenza.

Our footprint

I would like to tell you more about our footprint in Europe. Vaccines like ours can be produced efficiently at scale to help meet global demand. Novavax vaccines are manufactured, transported and stored at standard refrigeration temperatures. This is a very important feature as it helps to simplify production, global distribution and usage.

In mid-2020, we began building a global manufacturing operation to produce our COVID-19 vaccine at commercial scale around the world. In the year since, there have been significant constraints on supplies, raw materials and facilities with vaccine manufacturing capabilities. Novavax is committed to vast partnerships and technology transfers to meet the challenges of these constraints.

Today, a large part of our supply chain is based in Europe. We have acquired a state-of-the-art vaccine manufacturing plant in the Czech Republic to produce our antigen, and our plant in Sweden has a long history of producing our adjuvant. We have also partnered with organizations in Germany, Ireland, Belgium, Spain, Poland and the Netherlands who will produce our final packaged product for European and global use. Beyond Europe, we have partnered with manufacturers around the world, including SK bioscience in the Republic of Korea, Takeda in Japan and the Serum Institute of India.

Lessons learned

Before concluding, I would like to address the key lessons of the COVID-19 pandemic from Novavax’s perspective. These lessons can support innovation and access to vaccines in Europe and improve the speed of our response to future public health challenges.

FirstCOVID-19 vaccines have been made available in record time, not because shortcuts have been taken, but because of

  • speed of review by regulators and active engagement with product developers,
  • at-risk manufacture by the vaccine industry prior to regulatory clearance, and
  • strong public-private partnerships.
  • The range of regulatory flexibilities, such as
    • continuous revisions,
    • easy meeting opportunities,
    • and effective regulatory review processes should continue even after the pandemic.

  • Other positive examples include
    • the use of virtual and digital methods for the execution of routine tasks,
    • flexibilities on language and labeling to deal with shortages and supply constraints,
    • and flexibilities in administrative processes such as registration variations, import testing, and protocol changes.

Second, vaccine supply chains are extremely complex and in many cases involve multiple partners across the EU and around the world. We have learned that actions at Member State level need to be coordinated to avoid unnecessary burdens and difficulties in getting vaccines to where they are most needed.

During major public health emergencies in the EU, monitoring of supply and forecasting of demand for medical countermeasures should take place at EU level. It is also important that the Commission maintains an open dialogue between EU Member States, the United States and key international organizations on potential bottlenecks in supply chains that could hinder the effective manufacture of counter-products. measures.

Third, the R&D ecosystem that has provided key solutions to health threats such as COVID-19, relies on intellectual property rights. Europe needs a dynamic and well-funded research ecosystem. This means securing long-term investments in R&D, skills, networks and health data infrastructure. It also requires regulatory flexibility and a supportive intellectual property framework. Novavax has partnered with dozens of organizations around the world to leverage every opportunity to increase capacity so we can deliver on our commitment to accelerate equitable access to safe and effective COVID-19 vaccines, by particularly in countries where vaccination rates are currently low.

During the pandemic, we have spent months transferring our know-how to our partners to ensure that they can manufacture vaccines that meet the strict safety and efficacy standards of regulatory authorities. The weakening of intellectual property rights weakens these partnerships and undermines the ability to continue to invest in capacity building and R&D. Governments should continue to invest in public health infrastructure, manufacturing capabilities, and early-stage research into medical countermeasures that can be advanced through commercialization by industry.

Fourth, people want choice when it comes to vaccines. They must be informed to have confidence in these choices and to decide which is the best option for themselves. Our differentiated vaccine provides important choice as we see continued surges of COVID-19 and work to increase vaccination rates. The special report recently published by the European Court of Auditors also highlighted that the EU’s current vaccine portfolio relies heavily on a unique technology. Diversifying vaccine availability across the European portfolio will be essential to boost preparedness levels and enable the EU to live with and mitigate the impacts of COVID-19.

As I mentioned at the beginning, the work of this committee to advance the lessons learned from this pandemic is critically important. I hope my contribution to today’s hearing will help advance your efforts, and I look forward to continuing to serve as a resource.

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In conclusion, as COVID-19 evolves, we remain committed to increasing access to diverse vaccine options in the EU and globally.

It is essential that the EU has a strong and diverse vaccine portfolio reflecting multiple vaccine platforms to ensure the widest access to vaccines and their uptake. I believe our vaccine has an important, long-term role to play in protecting people around the world from COVID-19.

Going forward, Novavax will leverage our COVID experience to further develop candidate vaccines against some of the world’s most challenging viral threats and use the power of our innovative vaccine platform to reduce the human toll of preventable disease. by vaccination.

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