Raboral
In the 1980s, the French company Rhône-Mérieux developed an anti-rabies recombinant vaccine: Raboral. It was an attenuated strain of the Vaccinia virus which, by adding a single gene, expressed the glycoprotein G of the rabies virus. The application dossier for marketing authorisation of this recombinant vaccine was filed in both Belgium (1992) and France (1993) under Directive 90/220/EEC. It was the second application dossier for the placing on the market of a GMO in Europe, after the vaccine against the porcine Aujeszky disease. Authorisation was granted by the European Commission on 19 October 1993. The decision states that the vaccine, in the form of fox-baits containing the viral suspension, is intended to be distributed manually or by aerial drops, but only on the instructions of the national health authorities.
Major vaccination campaigns were undertaken in Belgium and this new vaccine, more stable than the vaccine containing the attenuated rabies virus, proved to be the vaccine of first choice. Since the end of the 1990s, Belgium has been officially recognised as being free of rabies in urban and forest areas.
Raboral V-RG® is currently distributed by Merial in Europe and around the world. In Canada and the USA, it is used to vaccinate not just foxes but also coyotes and raccoons.
GMO medicinal products for human use
The products that have received a marketing authorisation so far, are listed below with the corresponding date of authorisation (for more details on the product and the authorisation procedure click on the corresponding link):
- Fluenz (vaccine, 27/01/2011) - withdrawn on 03/12/2014 and replaced by Fluenz Tetra (04/12/2013)
- Glybera (autologous cell and gene therapy, 25/10/2012)
- Imlygic (autologous cell and gene therapy (cancer treatment), 16/12/2015)
- Pandemic influenza vaccine H5N1 (20/05/2016)
- Strimvelis (autologous cell and gene therapy, 26/05/2016)
- Zalmoxis (autologous cell and gene therapy (cancer treatment), 18/08/2016)
- Kymriah (autologous cell and gene therapy (cancer treatment), 22/08/2018)
- Yescarta (autologous cell and gene therapy (cancer treatment), 23/08/2018)
- Luxturna (autologous cell and gene therapy, 22/11/2018)
- Dengvaxia (vaccine, 12/12/2018)
- Zynteglo (autologous cell and gene therapy, 04/06/2019)
- Ervebo (vaccine, 11/11/2019)
- Vaxchora (vaccine, 01/04/2020)
- Zolgensma (autologous cell and gene therapy, 18/05/2020)
- ZABDENO (vaccine, 01/07/2020)
- MVABEA (vaccine, 01/07/2020)
- Libmeldy (autologous cell and gene therapy, 16/10/2020)
- Tecartus (CAR-T cell therapy, 14/12/2020)
- Vaxzevria (Astrazeneca) (vaccine, 29/01/2021)
- Ad26_COV2_S COVID-19 Vaccine Janssen (11/03/2021)
- Abecma (autologous cell and gene therapy (cancer treatment), 18/08/2021)
- Skysona (autologous cell and gene therapy, Withdrawn)
- Breyanzi (autologous cell and gene therapy (cancer treatment), 04/04/2022)
- Carvykti (autologous cell and gene therapy (cancer treatment), 30/05/2022)
- Upstaza (treatment of neurometabolic disease, 18/07/2022)
- Roctavian (previously Roxavvy) (treatment against bleeding disorder, 24/08/2022)
- Qdenga (vaccine, 05/12/2022)
- Hemgenix (treatment against bleeding disorder, 20/02/2023)
- Casgevy (Treatment against transfusion-dependent β-thalassemia (TDT) or sickle cell disease (SCD)), 09/02/2024)
- Ixchiq (vaccine, 28/06/2024)
GMO medicinal products for veterinary use
Several GMO medicinal products for veterinary use have been granted a marketing authorisation in the EU. Most of these products are vaccines, one is a treatment against cancer (Oncept IL-2).
Two of them were authorised under Directive 90/220/EEC:
- A vaccine against the porcine Aujeszky disease (genetically modified virus), authorised in December 1992 (authorisation amended in July 1994 – Decision 94/505/EC – to cover a new form of administration);
- The Raboral recombinant vaccine for preventing rabies in foxes (see text box on the right), authorised in October 1993 (Decision 93/572/EEC).
The other products have been processed under Regulation (EEC) No. 2309/93 (between 1993 and 2004) or Regulation (EC) 726/2004.
All these GMO medicinal products for veterinary use are listed below with the corresponding date of authorisation. For more details on the product and the authorisation procedure click on the corresponding link.
