In a written answer on 22 June 2026, Commissioner Olivér Várhelyi, on behalf of the European Commission, confirmed that mRNA COVID-19 vaccines Spikevax, Comirnaty and Kostaive are considered nanotechnology-based medicinal products because they contain lipid nanoparticles (LNPs). The answer, responding to a question from MEP Gerald Hauser (PfE) submitted on 7 April 2026, stated that these vaccines were developed and tested in accordance with all EU regulatory standards for quality, safety and efficacy, and that there is no dedicated EU legal framework for nanomedicines—they are regulated under existing medicines legislation, complemented by relevant EMA guidance documents.
The Commission's response clarifies that the vaccines underwent all required tests for nanomedicines under the existing regulatory framework. It cited the EMA's 2025 EU-IN Horizon Scanning Report, which notes that LNPs have been thoroughly researched and effectively used in clinical settings for delivering numerous active substances. The answer did not address whether any nanomedicine vaccines that had not undergone all required tests had been withdrawn from the market, as the Commission maintained that all EU standards were met.
This answer provides regulatory clarity for vaccine manufacturers and public health authorities, confirming that mRNA COVID-19 vaccines fall under the existing nanomedicine regulatory umbrella. For EU consumers and patient groups, the Commission's stance reinforces the safety and efficacy of these vaccines. However, critics may argue that the lack of a dedicated nanomedicine framework could lead to gaps in oversight for future products. The Commission's reliance on existing legislation and EMA guidance suggests a preference for regulatory continuity over new, specific rules for nanomedicines.