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Novavax

Novavax is a global biotechnology company with a proven vaccine technology.

Lobbying Activity

Meeting with Nicolás González Casares (Member of the European Parliament) and PTC Therapeutics

19 Mar 2025 · Health

Meeting with Stine Bosse (Member of the European Parliament)

18 Mar 2025 · European health policy

Meeting with Marta Temido (Member of the European Parliament)

17 Mar 2025 · EU health priorities around prevention and immunization

Meeting with Andrea Wechsler (Member of the European Parliament)

14 Jan 2025 · EU Health policy

Meeting with András Tivadar Kulja (Member of the European Parliament)

30 Oct 2024 · European Healthcare

Meeting with Nicolás González Casares (Member of the European Parliament)

17 Oct 2024 · Covid vaccines

Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

17 Jul 2024 · COVID vaccines

Meeting with Adam Jarubas (Member of the European Parliament, Committee chair)

15 Feb 2024 · 2023/2024 COVID vaccination lessons learned

Meeting with Tomislav Sokol (Member of the European Parliament)

9 Nov 2023 · Vaccines - COVID-19

Response to Evaluation and revision of the general pharmaceutical legislation

8 Nov 2023

Novavax is a global company that promotes improved health by discovering, developing, and commercializing innovative vaccines to help protect against serious infectious diseases. Our COVID-19 vaccine was the first protein-based option available in Europe during the pandemic. Novavax employs over 1,600 people worldwide, which gives us a unique perspective as a smaller-sized vaccine manufacturer. Approximately 600 of these employees are in Europe, including our manufacturing sites in Czechia and Sweden. We recognise the importance of revising the EU general pharmaceutical legislation to future-proof the regulatory framework and ensure its adaptability for the health challenges of both today and tomorrow. These reforms provide an opportunity to address many of the challenges that stakeholders encountered during the COVID-19 pandemic and continue to face as we move to an endemic phase. In addition to the input provided below, we also endorse the position of Vaccines Europe. Regulatory Data Protection (RDP) Dir. Arts. 80-82 aims to link RDP with access and shortage conditions. The Directive reduces the current RDP from 8 to 6 years and offers an additional 2 years for releasing and continuously supplying a product in all 27 Member States (MS). This proposal fails to consider the complexity and specificity of the vaccine market and could undermine innovation as well as equitable and timely access to vaccines. The proposed requirements will be challenging for vaccine manufacturers to meet, particularly smaller companies. The proposal fails to recognize that the decision to include a vaccine in a national immunization programme is ultimately made by the MS national authorities. To have a vaccine recommended for use and supplied in all 27 MS, a manufacturer must go through complex and MS-specific processes. NITAG assessments can be initiated in only 14 MS and procurement of vaccines is, in most MS, a tender-driven process in which MS authorities make the final decision on the tender award recipient. A stable and predictable intellectual property (IP) framework enabled timely access to COVID-19 vaccines and supports future innovation. With this in mind, we urge the Commission to amend Art. 81 to include certain conditions under which the requirement to launch a vaccine in 27 MS shall be automatically waived. These conditions include the following: 1. The non-inclusion of a vaccine in the National Immunisation Programme, or 2. The non-publication of a tender for the purchase of such a vaccine, or 3. The awarding of a tender to a different vendor (in case of interchangeable products). Shortages and Supply Reg. Art. 116 outlines an obligation for vaccine manufacturers to notify MS at least 6 months in advance of temporary supply disruptions, and an obligation in Art. 117 to establish and maintain a shortage prevention plan (SPP). As written, the proposed rules do not consider the unique characteristics of vaccines and fail to address the underlying root causes of supply shortages. Currently, vaccine manufacturers are required to provide a 2-month advanced notice of a disruption, which in many cases cannot be met. The causes of shortages vary and are sometimes the result of sharp demand increases. Thus, an extension of the notice period to 6 months is not only an unreasonable expectation, but one which will do little to mitigate the risks of shortages. The SPP obligation should be reserved for critical medicines only. In the case of vaccines, Novavax supports early dialogue between manufacturers and authorities to better anticipate the evolution of vaccine recommendations and forecast vaccine demand.
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Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

12 Apr 2023 · Current negotiations on vaccine contracts

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

27 Mar 2023 · Vaccines

Meeting with Jutta Paulus (Member of the European Parliament)

1 Feb 2023 · Covid 19 Vaccine

Meeting with Kateřina Konečná (Member of the European Parliament, Shadow rapporteur)

1 Feb 2023 · COVI final report

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

30 Jan 2023 · Vaccines

Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur)

15 Nov 2022 · Lessons learned on impact of COVID-19 pandemic

Meeting with Stelios Kympouropoulos (Member of the European Parliament)

9 Nov 2022 · Lessons-learnt from COVID-19

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

13 Oct 2022 · The EU’s long-term COVID-19 vaccines strategy

Meeting with Susana Solís Pérez (Member of the European Parliament)

13 Oct 2022 · Health Policy

Meeting with Sara Cerdas (Member of the European Parliament)

29 Sept 2022 · Relutância na vacinação

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

28 Sept 2022 · Vaccines