Priority question for written answer P-000048/2025
to the Commission
Rule 144
Gerald Hauser (PfE)

On 12 December 2024, the Committee for Medicinal Products for Human Use (CHMP) recommended that Kostaive, a vaccine to prevent COVID-19 in adults, be given a marketing authorisation. Kostaive is an RNA-based vaccine with self-strengthening mRNA This mRNA contains instructions for a protein called replicase that produces further mRNA copies in muscle. This increases the production of the spike protein, intended to increase the immune response.

Following the positive opinion of the CHMP, the final decision lies with the Commission.

Japan was the first country in the world to authorise a self-replicating mRNA vaccine. However, this technology is controversial. In an interview with Mike Adams, Dr Yasufumi Murakami, Emeritus Professor at Tokyo University of Science, expressed concerns and warned about possible long-term risks.

• 1.Were critical voices and experiences from Japan taken into consideration when coming to a decision?
• 2.How has the long-term safety of self-replicating mRNA vaccines been reviewed?
• 3.Does the Commission intend to grant authorisation despite international concerns?

Submitted: 8.1.2025