Coronavirus: Commission welcomes Council’s vote on the development of vaccines containing GMOs

Yesterday, the Council adopted the Commission’s proposal to accelerate clinical trials and the supply of medicinal products that contain genetically modified organisms (GMOs) in the fight against COVID-19. The Commission proposal was presented as part of the Vaccines Strategy and has a twofold objective: to support the development of safe and effective products for the treatment or prevention of COVID-19 by ensuring that clinical trials with medicinal products containing or consisting of GMOs can start as soon as possible; and secondly to facilitate their use in case of emergency. Stella Kyriakides, Commissioner for Health and Food Safety said: “I welcome the swift support given by both the European Parliament and Council. This endorsement is another clear signal that, in times of crisis, the EU’s institutions can react quickly and adapt legislation to tackle emergencies. The objective of the proposal is clear: we are ensuring that clinical trials with medicines against COVID-19 can start as soon as possible and that there is prompt availability of vaccines and treatments in cases of emergency.  We are doing this whilst ensuring that all environment concerns are addressed.” Some of the ongoing efforts to develop a vaccine against COVID-19 are based on genetically modified attenuated viruses or viral vectors. These products fall under the definition of “genetically modified organism” and are subject to the GMO legislation. The application of the GMO legislation can delay the conduct of clinical trials with these vaccines. First, the GMO legislation does not contain any flexibility for crisis management (such as a pandemic).  Secondly, experience shows that, in clinical trials with investigational medicinal products containing or consisting of GMOs, the procedure to achieve compliance with the GMO legislation is complex and may take a significant amount of time. The regulation will allow for a temporary derogation for clinical trials with the contained used of GMOs and it also allows for Member States to use medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19 in certain urgent circumstances. The regulation will apply only as long as COVID-19 is regarded as a pandemic by the World Health Organization (WHO) or as long as an implementing act by which the Commission recognises a situation of public health emergency due to COVID-19 applies.