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EU Expands COVID-19 Vaccine Options: New Protein-Based Vaccines Join mRNA Offerings for 2024

• The European Commission and 15 EU countries have initiated a joint procurement for protein-based COVID-19 vaccines, providing alternatives to mRNA vaccines for the 2024 vaccination campaigns.

• Four COVID-19 vaccines are currently authorized in the EU: two mRNA-based (Comirnaty and Spikevax) and two protein-based (Nuvaxovid and Bimervax), with adapted versions targeting newer variants.

• The European Medicines Agency has approved multiple adapted vaccines for autumn 2024, including Comirnaty JN.1, Spikevax JN.1, and Nuvaxovid JN.1, with Bimervax JN.1 under current assessment.

The European Commission has taken significant steps to diversify COVID-19 vaccine options for EU citizens, launching a joint procurement initiative for protein-based vaccines alongside 15 member states in July 2024. This move aims to provide alternatives for individuals who cannot or choose not to receive mRNA-based vaccines.

Current Vaccine Landscape

The European Union's COVID-19 vaccine portfolio currently includes four authorized vaccines: the mRNA-based Comirnaty and Spikevax, alongside the protein-based Nuvaxovid and Bimervax. For the autumn 2024 vaccination campaigns, the European Medicines Agency (EMA) has approved several adapted versions specifically targeting emerging variants.
The newly authorized adapted vaccines include Comirnaty JN.1, Comirnaty KP.2, Spikevax JN.1, and Nuvaxovid JN.1. Additionally, an adapted version of Bimervax targeting the JN.1 variant is currently under EMA assessment. These updated formulations are expected to provide protection against the emerging XEC variant as well.

Regulatory Framework and Vaccine Development

The availability of protein-based COVID-19 vaccines is primarily driven by vaccine developers' clinical development priorities, with neither the Commission nor EMA having direct control over development decisions. However, EU regulators, including EMA, maintain their role in rigorously assessing scientific evidence submitted through marketing authorization applications.

Joint Procurement Initiative

The Commission's recent call for tender specifically targets manufacturers of EU-authorized protein-based COVID-19 vaccines. This procurement strategy reflects the EU's commitment to maintaining diverse vaccine options while respecting national vaccination policies. As stated by Commissioner Várhelyi, "The Commission supports the availability of any type of COVID-19 vaccine following EMA's recommendation on approval."

National Implementation

While vaccination policy remains under national jurisdiction, the European Commission continues to facilitate coordination among EU countries regarding their vaccination policies and programs. This collaborative approach ensures member states can maintain effective vaccination campaigns while offering citizens choice in vaccine types.
The outcome of the joint procurement procedure will be announced following the closure of the tender process, potentially expanding the availability of protein-based vaccines across participating EU nations.
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