Source: European Parliament
Question for written answer E-002214/2025
to the Commission
Rule 144
Christine Anderson (ESN)
A recent study published in the New England Journal of Medicine[1] reviews long-term data on COVID-19 vaccinations. It concludes that repeated booster doses provide only limited added benefit for healthy adults under 65 years of age, especially those with a history of prior infection or complete primary vaccination. The study raises concerns over the reliance on non-inferiority trials and short-term immunogenicity data as the basis for vaccine approvals.
The authors focus in particular on updated mRNA vaccines, including bivalent formulations (targeting ancestral and BA.4/BA.5 variants) and monovalent XBB.1.5-based boosters. They argue that these vaccines provide only modest and short-lived protection for low-risk groups and call for more targeted vaccination strategies supported by robust clinical evidence.
- 1.Can the Commission clarify how the European Medicines Agency ensures that its evaluation and authorisation of updated COVID-19 vaccines – specifically bivalent and monovalent XBB.1.5-based mRNA boosters – are based on clinically meaningful outcomes, particularly in light of the study’s critique of non-inferiority trials and short-term immunogenicity data?
- 2.Does the Commission intend to revise its guidance on booster vaccinations to reflect growing evidence supporting more targeted, risk-based approaches?
- 3.In the light of the recent decision by US health authorities to remove COVID-19 vaccinations from the recommended immunisation schedule for healthy children and healthy pregnant women, does the Commission intend to consider a similar adjustment to EU-level guidance?
Submitted: 3.6.2025
- [1] 20 May 2025, DOI: 10.1056/NEJMsb2506929, https://www.nejm.org/doi/10.1056/NEJMsb2506929.