Source: European Parliament
Directive 2009/120/EC[1], amending Directive 2001/83/EC[2], excludes vaccines against infectious diseases from the definition of gene therapy medicinal products.
mRNA vaccines authorised in the EU against COVID-19 are not genetically modified organisms and do not contain genes as their active substance. They are not used with the aim to restore, correct, or modify human genes.
mRNA vaccines are biological medicines regulated under the EU pharmaceutical legislation to ensure their quality, safety, and efficacy.
Under the legislation, the Committee for Medicinal Products for Human Use (CHMP) may also recommend additional measures, such as long-term monitoring, based on specific risks following a case-by-case assessment[3].
The safety and efficacy of mRNA vaccines authorised in the EU against COVID-19 have been rigorously assessed through clinical trials and post-authorisation monitoring.
The European Medicines Agency (EMA) and Member States continuously monitor the safety of COVID-19 vaccines to ensure any possible risks are detected and managed as early as possible[4]. All data confirm that COVID-19 vaccines have a favourable safety profile.
Regarding safety concerns in respiratory syncytial virus (RSV) vaccine trials in infants, these are not linked to the mRNA technology[5] but rather to challenges previously observed with other RSV vaccines in this age group.
Currently, RSV vaccines are only authorised for use in adults[6], with trials ongoing to assess their safety and efficacy in infants and toddlers.
The Commission remains committed to ensuring that all medicines, including vaccines, authorised in the EU meet the highest standards of safety, efficacy, and quality, in full compliance with the EU pharmaceutical legislation.
- [1] https://eur-lex.europa.eu/eli/dir/2009/120/oj/eng
- [2] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67, ELI: http://data.europa.eu/eli/dir/2001/83/oj
- [3] https://www.ema.europa.eu/en/committees/committee-medicinal-products-human-use-chmp
- [4] https://www.ema.europa.eu/en/human-regulatory-overview/public-health-threats/coronavirus-disease-covid-19/covid-19-medicines/safety-covid-19-vaccines
- [5] https://www.fda.gov/media/184301/download
- [6] https://www.ema.europa.eu/en/medicines/human/EPAR/abrysvo; https://www.ema.europa.eu/en/medicines/human/EPAR/arexvy; https://www.ema.europa.eu/en/medicines/human/EPAR/mresvia